Workshop on Medical Device Cleanliness: How Clean is

Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

November 16, 2010

Grand Hyatt San Antonio
San Antonio, TX

Workshop Co-Chairs:

Reto Luginbuehl
Robert Mathys Foundation
Bettlach, Switzerland

Stephen Spiegelberg
Cambridge Polymer Group
Boston, MA

Terry Woods
FDA
Silver Spring, MD

TUESDAY, NOVEMBER 16, 2010

Program: page 2

Abstracts: page 4

Presentations: page 25

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Program
TUESDAY, NOVEMBER 16, 2010

Opening Remarks
Reto Luginbuehl, Robert Mathys Foundation, Bettlach, Switzerland
Stephen Spiegelberg, Cambridge Polymer Group, Boston, MA
Terry Woods, FDA, Silver Spring, MD

SESSION 1: FDA AND LEGAL IMPLICATIONS

Reprocessing of Reusable Medical Devices: an FDA Perspective

Pamela Scott, Daniel McGunagle, FDA, Silver Spring, MD

The Legal Implications of Medical Device Cleanliness Standards

Steve Bennett, John Schlafer, Baker & Daniels, LLP, Fort Wayne, IN

SESSION 2: CLEANING AND TESTING, PART 1

Exploring Methods of Optimizing Surgical Instrument Reprocessing Operations

Jahan Azizi, Linda Lavey, CBET, University of Michigan, Dearborn, MI, USA

Validation Strategy for an Automated Endoscope Reprocessor

Bradley Catalone, Thomas Gilmore, David Barlow, Olympus America, Center Valley, PA, USA

Effects of Non-Aqueous Vapor Degreasing Solvent Cleaning on Ultra-High Molecular Weight

Polyethylene (UHMWPE)
Ray Gsell, Zimmer, Warsaw, IN, USA

Breaking the Myth that Caustic Surgical Instrument Cleaners are Necessary for Safe and
Effective Decontamination of Medical Devices
Marcia Frieze, Case Medical, South Hackensack, NJ, USA

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

SESSION 3: CLEANING AND TESTING, PART 2

Cleaning and Testing for Debris in Reusable Medical Devices

Shani Haugen, Vicki Hitchins, FDA, Silver Springs, MD, USA

Evaluation of the Cleaning Efficiency of a Aqueous Based Detergent System for Cleaning
Metallic Medical Devices
B. Dhanapal1, N. Weiler1 and J. Rufner2, 1Zimmer GmbH, Switzerland, 2Zimmer Inc, Warsaw, IN, USA

Two-phase Flow Cleaning of Endoscope Channels

Mohamed E. Labib1, Stanislav Dukhin1, Joseph Murawski1, Yacoob Tabani1, Richard Lai1 and Michelle Alfa2,
1
Novaflux Technologies, Princeton, NJ, USA, 2St. Boniface General Hospital, Winnipeg, Canada

Assessment of Organic Residues on Medical Devices

B. Dhanapal1, D. Zurbrügg,2, J. Rufner3, R. Gsell4, 1 Zimmer GmbH, Switzerland, 2 Niutec AG, Switzerland, 3
Zimmer Inc, Warsaw, IN, USA,

SESSION 4: ESTABLISHING CLEANING LIMITS

Establishing and Justifying Limit Values for Residual Analysis

Kierstan Andrascik, QVET Consulting, Layton, UT, USA

Residual Soil on Reusable Medical Devices: How to Determine Limits?

Steve Goldstein, Steve Goldstein Consultants, Albuquerque, NM, USA

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

SESSION 1: FDA AND LEGAL IMPLICATIONS

Reprocessing of Reusable Medical Devices: an FDA Perspective

Pamela Scott, Daniel McGunagle, FDA, Silver Spring, MD

Ineffective reprocessing of reusable medical devices continues to present a public health risk and reports to FDA
from numerous facilities highlight problems with contamination and debris retention. The FDA believes that the
incidents can be prevented through approaches including (but not limited to): (1) improved labeling and cleaning
practices, (2) rigorous validation of the reprocessing instructions, (3) design features that facilitate cleaning and
(4) user facilities implementing strong quality assurance programs. The recently published “Safety
Communication from FDA, CDC and the VA: Preventing Cross-Contamination in Endoscope Processing” is one
example of specific actions to reduce risk. At this workshop, FDA staff will discuss best practices for the
reprocessing of all reusable medical devices.

The FDA actively works with manufacturers, facilities and health care professionals to improve the reusable
medical device landscape and to strengthen standardized practices for reprocessing. Drawing on clinical
standards and FDA guidance, FDA staff will touch on key program areas where there are opportunities to
improve the effectiveness of reprocessing of reusable medical devices.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

The Legal Implications of Medical Device Cleanliness Standards

Steve Bennett, John Schlafer, Baker & Daniels, LLP, Fort Wayne, IN

The question "How clean is clean enough?" has been approached and answered in different ways in the legal
world. Some focus on a manufacturer's validated cleaning process; others on one specific result, the absence of
residue. The discussion and debate over cleanliness standards and contamination have been and will continue to
be played out against the backdrop of product liability litigation, product recalls, and patient safety concerns.
Therefore, the development of cleanliness standards by the ASTM will have legal implications for stakeholders
in the medical device field.
An industry standard for cleanliness that defines acceptable residue limits, as well as appropriate testing methods
for certain residues, will impact the defect analysis in product liability litigation. An ASTM cleanliness standard
could become the guidepost for determining whether a specific explanted medical device contains a
manufacturing defect, i.e., a deviation from the intended design specification. Accordingly, consideration
should be given to the utility of such a standard in the context of explant analysis for contaminants.
A cleanliness standard also could be used as a legal framework for determining the adequacy of a manufacturer's
cleaning and quality assurance processes. Inconsistencies between a manufacturer's cleaning process and an
ASTM cleanliness standard might expose a manufacturer to the claim that a medical device is defective. On the
other hand, an ASTM standard could be used by a manufacturer to defend its validated cleaning process as "state
of the art" or in conformance with industry standards.
Consideration also should be given to the interplay between an ASTM cleanliness standard and the requirements
of regulatory bodies. For example, the FDA's Good Manufacturing Practices regulations require manufacturers
to have procedures "for the use and removal of such manufacturing material to ensure that it is removed or
limited to an amount that does not adversely affect the device's quality." 21 C.F.R. § 820.70(h). The regulations
do not define specific residues, residue limit values, or methods for testing. A medical device industry standard
that provides those definitions may have an impact on cleanliness regulations or the legal interpretation of the
regulations.
This presentation will touch on all of the above legal ramifications of defining or not defining acceptable residue
limits. Case examples will be presented, and litigation, regulatory, and risk management considerations will be
addressed.

no presentation available

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

SESSION 2: CLEANING AND TESTING, PART 1

Exploring Methods of Optimizing Surgical Instrument Reprocessing Operations

Jahan Azizi, Linda Lavey, CBET, University of Michigan, Dearborn, MI

The elimination of bioburden from reusable surgical instruments represents an ongoing challenge for the
manufacturers of such instruments, the hospitals using them, and the patients relying on them for their health and
safety. Recognizing this challenge, a team of risk management personnel and instrument room technicians at the
University of Michigan Hospitals and Health Centers have undertaken a project focusing on directed testing of
the manufacturer’s recommended cleaning methods for surgical instruments.
The objective of this testing is to determine the efficacy of automated instrument reprocessing methods with the
goal of finding the optimum means of sterilizing valuable surgical tools. Faced with an array of instruments
available for testing, investigators settled on suction tips, useful due to their application in virtually every kind of
surgery, their exposure to high levels of bioburden, and their known difficulty to clean. This study focuses on a
variety of suction tips used in orthopedic, neurosurgery, and otolaryngology surgical procedures.
Methods involve a dedicated workstation designed for this project and set up with a Midbrooks reprocessing
machine; a digital video outfit for taking intra-lumen snapshots using flexible scope cameras ranging in size
from 1.9 mm to 2.7 mm; and supplies for determining the presence of protein, ATP (adenosine triphosphate),
carbohydrate, and hemoglobin as markers for bioburden still present. In addition, enzyme solution and hand
tools for manual cleaning were available for continued testing as needed. Testing so far has included three
phases:
Phase 1: Visual check: Suction tips are tested for protein before and after cleaning. Still photographs are
taken throughout, showing bioburden present.
Phase 2: ATP Check: A sample of suction tips is tested for ATP and hemoglobin.
Phase 3: Comparison Testing Using ATP and Channel Check (testing for protein, hemoglobin, and
carbohydrate): Instruments undergo cleaning using the manufacturer’s recommended processes,
requiring as many as three wash cycles. All are tested using ATP and hemoglobin test kits after each
cycle.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Initial testing found bioburden remaining on 100% of the instruments. Additional cleanings were required to
reach a predetermined cleanliness goal. While still focusing on suction tips, investigators also tested additional
instruments as available, including samples of endoscopes and robotic control devices.
Testing is ongoing, with the ultimate goal of finding a process that will reliably produce a verifiably clean
instrument after a set process is performed, time and time again, to meet the needs of a busy teaching hospital
while providing patients with the best possible care. Results so far have been eye-opening, both with regard to
the bioburden left behind and in the obvious limitations of the manufacturer’s recommended cleaning processes.
Ample photographs and numerical data rendered in charts and other graphical means offer an opportunity to
share the scope of this project.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Validation Strategy for an Automated Endoscope Reprocessor

Bradley Catalone, Thomas Gilmore, David Barlow, Olympus America, Center Valley, PA

Flexible endoscopes are complex devices with design features that present a challenge to effective reprocessing:
including multiple, long, thin internal lumens that may bifurcate and/or extend the length of the endoscope; and
a variety of models, each with a unique design and particular steps for reprocessing. One mechanism by which
to address the challenges presented for effective endoscope reprocessing is to automate the parts of the process
that are performed manually and which account for much of the observed variability in clinical practice. Several
studies have identified manual cleaning as the most labor-intensive and variable part of endoscope reprocessing.
This presentation describes a system level approach to validating an automated endoscope reprocessor that takes
over many of the manual steps in the process.

There are clear benefits to automation of a variable process, including consistency and repeatability. However,
there is also a risk in which the user is no longer intimately connected to the device and is unable to detect
abnormal conditions that may present a challenge to the effectiveness of the reprocessing procedure. As a result,
the validation strategy for an automated endoscope reprocessor must be both rigorous and robust to account for
any potential variability in clinical practice.

Our validation strategy was developed at the system level to account for variables in AER performance,
degradation and organic loading of the chemistry, selection of the most challenging device(s) to reprocess, and
failure to follow manufacturer’s instructions prior to automated reprocessing. The AER was modified to
simulate conditions just prior to preventative maintenance and the high-level disinfectant was stressed with an
organic load, diluted to its minimum recommended concentrations and used at or beyond its specified use life.
In addition, a comprehensive evaluation of all devices specified for reprocessing in the AER was performed to
identify those devices that either individually or in combination with another device represented the worst-case
challenge to the reprocessing procedure. To complete the strategy, the validation accounted for user failure to
perform the indicated manual process prior to automated reprocessing, thereby building into the process an
inherent safety margin for effective reprocessing.

An appropriate validation must include a relevant and validated test soil. The previously validated soil used in
this study contained organic components at levels similar to worst-case patient soil levels for GI and pulmonary
endoscopic procedures and two primary indicators (protein and hemoglobin) of cleaning efficacy were selected.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

We targeted previously published endpoints for both residual protein (< 6.4 µg/cm2) and hemoglobin (1.8
µg/cm2 ). These endpoints were based upon residual levels consistently achieved through optimal manual
cleaning, which is the currently accepted standard for endoscope cleaning.

A total of thirty-six samples from nine endoscopes tested following AER reprocessing under worst-case
simulated use conditions met the pre-established acceptance criteria for protein (<6.4 g/cm2) and hemoglobin
(<1.8 g/cm2) residuals. Although the validation testing indicated that AER reprocessing alone provides
effective cleaning of flexible endoscopes such that the manual cleaning process can be eliminated, users were
instructed to perform external surface cleaning and channel brushing prior to AER reprocessing. The additional
requirement for the manual cleaning steps provides enhanced cleaning, verifying that the instrument/suction
channel of the endoscope is not obstructed, and maintains the connection between the reprocessing technician
and the device.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Effects of Non-Aqueous Vapor Degreasing Solvent Cleaning on Ultra-High Molecular Weight

Polyethylene (UHMWPE)
Ray Gsell, M. Guo, H. Brinkerhuff Zimmer, Warsaw, IN

Introduction: Non-aqueous vapor degreaser cleaning (NAVDC) methods have been used for many years. Their
main applications have been for cleaning metal products. These processes had become less popular because of
environmental concerns and regulations on ozone depleting materials; a classification which included many of
the solvents commonly used. With recent advances in equipment technology that essentially eliminated solvent
loss to the environment and the development of suitable non-ozone depleting solvents, there has been a renewed
interest in this technology. The use of NAVDC for cleaning metallic devices is relatively straight forward and
well understood. Although its application to polymeric devices requires greater knowledge and control of the
solvent-polymer interactions, many polymeric systems (e.g. circuit boards) are successfully cleaned with this
technology. UHMWPE is the major polymeric material used by the orthopaedic industry in manufacturing
artificial joints. If NAVDC processes are to be used on these materials it is important to understand the effects
residual solvent has on the mechanical properties (short and long term) of the UHMWPE and product packages
and the biocompatibility of NAVDC materials. The subject of this paper is to discuss some of the effects of
NAVDC on UHMWPE.

Materials and Methods: Two commercially available hydrofluorocarbon solvents were evaluated: HFE-72DA
(3M Company) and Heavy Duty Degreasing Solvent (Micro Care Corp.). Both are mixtures containing trans-
dichloroethene and fluorinated hydrocarbons. The UHMWPE used was non-irradiated compression molded
GUR-1050 slab (Ticona) machined into test bars approximately 6 x 12 x 40 mm.
The UHMWPE test bars were processed in the boiling solvents and their vapors with and without sonication for
2 – 5 minutes (see Table 1). The absorption/desorption depths and rates of a solvent on a processed bar was
monitored using FTIR line scan mapping techniques (Nicolet Magna 500 FTIR coupled to a NicPlan FTIR
Microscope). Desorption of absorbed solvent was evaluated at ambient conditions, elevated temperature and
ambient pressure (oven) and elevated temperature and sub-ambient pressure (vacuum oven). The presence or
absence of absorbed solvent in the UHMWPE was easily detected by FTIR because each solvent has several
unique absorption bands that are non-interfering with the UHMWPE absorption bands (e.g. Figure 1).

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Results:
Figure 1
FTIR Spectra of HDS vs UHMWPE

Table 1 describes some of the solvent processing conditions tested, the observed depths of solvent penetration
into the UHMWPE, the desorption conditions used and the desorption test results.
Table 1
Samples of Tests and Results Using GUR 1050
Liquid Vapor
Contact Contact Drying Drying Drying Solvent Maximum
Time Time Time Temperature Pressure Absorbed Depth (µm)
(Min.) (Min.) (Min.) (oC) (Atm.) (Y/N)
20 0 ambient ambient Y 200
20 40 ambient ambient Y 500
20 68 ambient ambient Y 600
20 0 ambient ambient Y 300
20 30 80/oven ambient Y 1000
20 60 80/oven ambient Y 1100
20 90 80/oven ambient N N/A
20 120 80/oven ambient N N/A

Conclusions: The results of this study indicated both solvents were quickly (within 2-5 minutes) absorbed into
the UHMWPE to depths of about 1 mm, but desorbed from it much more slowly. Desorption may take several
hours even at elevated temperatures and reduced pressures. The use of elevated drying temperatures caused the
absorbed solvents to penetrate deeper into the UHMWPE before being desorbed.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Breaking the Myth that Caustic Surgical Instrument Cleaners are Necessary for Safe and Effective
Decontamination of Medical Devices
Marcia Frieze, Case Medical, South Hackensack, NJ

Green Chemistry is the design of chemical products and processes that reduce or eliminate the use or generation
of hazardous substances. This approach to pollution prevention is the focus of the US Environmental Protection
Agency’s Green Chemistry Program.

It is our position that caustic detergents such as alkaline cleaners followed by acid neutralizers are unnecessary
for instrument processing and present significant hazard to the waste water stream, to the devices to be cleaned,
and result in safety issues for staff and patients. There are validated processes and products available that are pH
neutral, environmentally friendly, and safer for human health and the environment with proven log reduction.
We propose to present a study utilizing a three step process including enzymatic cleaners that demonstrates 6Log
reduction under abbreviated cleaning conditions.

Cleaning is the critical first step performed in the sterile processing process of reusable medical and surgical
devices. Ineffective cleaning of these devices can interfere with the effectiveness of subsequent sterilization or
disinfection and increase the risk of nosocomial infection in patients and healthcare staff. Additionally,
ineffective cleaning can affect the ability of medical devices to function properly and decrease the useful life of
the devices, resulting in increased repair and replacement costs to the healthcare facility. Cleaning is defined as
the removal, usually with detergent and water, of adherent visible soil such as blood, protein substances and
other debris, from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment
by a manual or mechanical process that prepares the items for safe handling and/or further decontamination.

Worldwide industry is faced with the challenge to provide effective devices and products for surgical instrument
cleaning and decontamination while recognizing the importance of sustainability and ecological compatibility.
Sustainability has been defined as meeting the needs of the current generation without impacting the needs of
future generations to meet their own needs. There is a social responsibility to protect the public from exposure to
harm. As a result, all manufacturers need to anticipate and are obligated to design instrument chemistries to
control measures which might lead to possible harm or uncertainty. The burden of proof that the suspected risk
is not harmful falls on those taking action.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

The concept of the precautionary principle includes an ethical responsibility toward maintaining the integrity of
natural systems, a willingness to take action in advance of definitive scientific proof when a delay will prove
ultimately most costly to society and nature as well as unfair and ultimately selfish to future generations.

Cleaning, decontamination and subsequent sterilization are essential steps in breaking the chain of infection.
Cleaning is the most critical step in the decontamination process and requires the commitment from the
manufacturer to design and produce instrument chemistries with demonstrated efficacy and sustainability.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

SESSION 3: CLEANING AND TESTING, PART 2

Cleaning and Testing for Debris in Reusable Medical Devices

Shani Haugen, Vicki Hitchins, FDA, Silver Springs, MD

Residual organic material in reusable medical devices impedes proper sterilization, which can lead to outbreaks
of infections. Thus, proper cleaning is an important first step in preparing a used reusable medical device for
clinical use on the next patient. In the past, “visibly clean” was an acceptable endpoint for determining if a
device was clean and ready for disinfection/sterilization. However, complex devices that have features such as
narrow lumens, stopcocks, sheaths, acute angles, joints, or hinges are becoming increasingly common. Such
design features are not readily visualized by the naked eye; therefore, “visibly clean” is no longer an acceptable
endpoint for “clean”. Currently, there are several methods to detect residual debris on and within devices,
however these methods are not optimized to detect insoluble clinical debris, such as tissue, cartilage, or bone.
Unless the debris is completely digested or solubilized, such material may not be adequately sampled, and/or
may not be accurately measured in a “cleaned” device.
To quantify insoluble debris, we have developed a filter-weighing approach to assess total residual debris in
models of complex devices and actual medical devices. Briefly, after the device or model is inoculated with test
soil and cleaned, the device is immersed in filtered water and agitated for two hours to extract debris. The
extraction liquid is then filtered, and total debris on the filter is assessed. This method is simple, sensitive, and
requires few pieces of specialized equipment. In some instances, the amount of protein in the extraction liquid
was below the level of detection by the Bradford assay, however the filter-weighing approach was able to detect
total debris (>100 micrograms). Additionally, the filtrate can be saved to assay for the presence of soluble
protein, total organic carbon, etc. This method is flexible, and can be used with different devices, with different
types of test soil, by manufacturers performing cleaning validation, or users who seek occasional verification of
device cleanliness. Future experiments will use this assay to assess the impact of device design on retention of
organic material in reusable medical devices.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Evaluation of th e C leaning Efficiency o f a A queous Based D etergent Sys tem fo r Cl eaning Metallic
Medical Devices
B. Dhanapal1, N. Weiler1 and J. Rufner2, 1Zimmer GmbH, Switzerland, 2Zimmer Inc, Warsaw, USA

Introduction: Cleaning orthopaedic implant devices commonly involves aqueous detergent based processes.
The detergent solutions may be acidic, alkaline or neutral and ultrasonics may also be utilized. In this example
system a series of baths using different detergents combination with sonication was used to evaluate the cleaning
effectiveness for 100% metallic medical devices. Detergents of both alkaline and acidic nature were used for the
removal of auxiliary processing materials used in the different manufacturing steps from the raw material to the
final product (such as grinding, blasting, machining and others). This system utilized five consecutive baths.
The first two baths contained alkaline detergents at different concentrations; the fourth bath was an acidic
detergent. The third and fifth baths were rinse baths containing highly purified water to minimize the carry-over
of the detergents to subsequent baths. The concentration of the detergents were monitored and closely controlled
in order to insure the removal of auxiliary materials and the chemical cleanliness of the device. Periodic
adjustment of the detergent concentrations was necessary to ensure optimum concentration and cleaning
potential at all times within the life cycle of the detergent baths.

Monitoring Approach: According to literature published by the supplier of the detergents, the respective
detergent concentrations could be determined by performing an acidimetric titration of the solution. An
empirical factor is provided by the manufacturer to calculate the detergent concentration (v/v %) from the
volume of Hydrochloric Acid or Sodium Hydroxide used in the titration. The weekly monitoring activities of
the cleaning system were as follows:
 Sampling of baths No. 1, 2 and 4
 Acidimetric titration (colorimetric)
 Calculation of the difference be tween the current (m easured)
detergent concentration and the target concentration
 Based on the measured detergent concentration, addition of
detergent as necessary to achieve the target concentration

The detergent baths are analy zed twic e a week wit h rega rd to detergent concentration by acidimetric titratio n
(direct monitoring). A calibrated automatic titrator was used (potentiom etric titration) because this of fered a
higher accuracy and precision than visual titration te chniques. After three full weeks of use, the detergent bath s
were completely renewed. This period defines the life cycle of the detergent baths.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

The test parts were assayed for Carbon Tetrachloride (CCl 4) extractable re sidues by FTIR, water extrac table
residues by Total Organic Carbon (TOC), and for water extractable insoluble particulate matter gravimetrically.

Evaluation of the Cleaning Efficiency: In order for this defined detergent bath life cycle to be validated, the
product cleanliness was used to define the acceptance criteria. It was analyzed for pre-defined worst-case
conditions in the cleaning system. Worst-case scenarios were defined by taking into account such things as:
devices which possessed the most challenging size, surface texture, geometry etc, longest time period from bath
renewal as well as from the detergent replenishment, and washing programs with the shortest dwell times, lowest
ultrasonic power and lowest temperatures. After washing, the parts were removed from the system and analyzed
using analytical methods.

Results: Three different worst-case devices were subjected to chemical cleanliness analyses (see Table 1).The
following results were obtained:
Chemical Cleanliness Prior to the Chemical Cleanliness After the
Part Description
Cleaning Step Cleaning Step
&
Characteristics Average in Max Value in Average in Max Value in
mg/ Part mg/ Part mg/ Part mg/ Part
Organic Residue: Organic Residue: Organic Organic
5.9 6.0 Residue:<0.5 Residue:<0.5
TOC: 0.21 TOC: 0.22 TOC: 0.07 TOC: 0.08
Hip Cup / Challenging
Ionic Residue: Ionic Residue: 1.30 Ionic Residue: 0.07 Ionic Residue:
Surface
1.24 Particulate Residue: Particulate 0.08
Particulate 23.6 Residue: 0.6 Particulate
Residue: 15.7 Residue: 0.8
Organic Organic Organic Organic
Residue:<0.5 Residue:<0.5 Residue:<0.5 Residue:<0.5
Hip Stem /
TOC: 0.09 TOC: 0.11 TOC: 0.05 TOC: 0.06
High Production Rate,
Ionic Residue: Ionic Residue: 0.19 Ionic Residue: Ionic Residue:
Challenging
0.14 Particulate Residue: <0.05 <0.05
Geometry
Particulate 3.7 Particulate Particulate
Residue: 2.9 Residue:<0.2 Residue:<0.2
Organic Residue: Organic Residue: Organic Organic
2.6 2.9 Residue:<0.5 Residue:<0.5
TOC: <0.05 TOC: <0.05 TOC: <0.05 TOC: <0.05
Femur Component /
Ionic Residue: Ionic Residue: 0.09 Ionic Ionic
Highly porous surface
0.09 Particulate Residue: Residue:<0.05 Residue:<0.05
Particulate 0.4 Particulate Particulate
Residue: 0.4 Residue:<0.2 Residue:<0.2
Table 1: Average Results: Total Organic Carbon (TOC),
Organic Residual, Ionic Residual, Particulate Residual

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Total of 135 specimens were analyzed in the scope of this cleaning validation.

Discussion: During the direct monitoring of the detergent concentrations using potentiometric titrations, a
significant drop in detergent concentration of up to 20 %(v/v) within a week was observed. Thus, the detergents
were replenished twice a week to keep the concentrations within the specified limits. Using these standardized
cleaning processes enabled us to obtain clean products in a reproducible and repeatable manner.

Conclusions: From the results shown in Table 1 for the predefined worst-case parts and worst-case conditions in
terms of cleaning parameters, it is clear the system and operational parameters described were able to produce
parts with very small amounts of chemical residuals.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Two-phase Flow Cleaning of Endoscope Channels

Mohamed E. Labib1, Stanislav Dukhin1, Joseph Murawski1, Yacoob Tabani1, Richard Lai1 and Michelle Alfa2
1
Novaflux Technologies, Princeton, NJ 08540, USA, 2St. Boniface General Hospital, Winnipeg, MB R2H 2A6,
Canada

Cleaning of flexible endoscopes has been traditionally done b y fl owing a cleaning liq uid t hrough endos cope
channels. Because of the s mall dia meter of the narrow lumens o f flexible endoscopes, the magnitude of bulk
shear c reated during liquid flow is low and the cl eaning effici ency is usually lim ited. This is why manual
cleaning is recommended before processing the endoscope in conventional AERs.
During our i nvestigation of two-phase flow in hydrophobic narrow channels, we discovered a new
hydrodynamic mode that can cre ate sh ear stre ss ord ers of magnitude higher th an the bulk s hear generated b y
conventional liquid flow. This hydrodynamic mode was investigated in long Teflon tubes (about 200 cm) and in
endoscopes, in the range of Rey nolds number 6,000 to 30,000 at different water/air volumetric ratios (WAVR).
High-speed video-microscopy techniques have allowed us to visualize a new mechanism of flow instabi lities in
endoscope channels. We were able to com pare the cle aning of such channels with the two-phase flow and with
conventional liquid flow.
We will review and analy ze the fundamentals of cleaning long and narrow lumens with em phasis on
flexible endoscopes. We will also discuss critical issues involved in rem oving macromolecules such as proteins
and adhering organisms from the surface of endoscope channels. We will place emphasis on the novel two-phase
flow process.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Assessment of Organic Residues on Medical Devices

B. Dhanapal1, D. Zurbrügg,2, J. Rufner3, R. Gsell4, 1 Zimmer GmbH, Switzerland, 2 Niutec AG, Switzerland, 3
Zimmer Inc, Warsaw, IN, USA,

Introduction: Although governmental agencies currently have not set limit values for residues on orthopaedic
implant devices, it is the manufacturer’s responsibility to provide clean, safe and effective products. They must
develop appropriate test methods and specify acceptance criteria. Currently ASTM F 2459–051 is the only
standard published which was developed specifically for medical implant devices. It is limited to metallic
devices using gravimetric quantification. A second medical implant cleanliness guide is being developed under
ASTM WK155322. This guide describes a wide range of more specific and sensitive test methods for assessing
implant cleanliness.

Methods: Fourier Transform Infrared spectroscopy (FTIR) method has been to quantify the amount of carbon
tetrachloride (CCl4) extractable residues on 100% metallic devices. The sum of organic residues is quantified
against a calibration curve prepared using a hydrocarbon reference standard such as hexadecane. Other
reference materials, such as known manufacturing lubricants, may also be used. The FTIR technique is widely
used for the quantification of organic residues in different fields like e.g. ASTM 1374-92(2005)3.

The test device is extracted with CCl 4 to dissolve th e residues. The am ount of organic material present in the
resulting extract solution is then quantified (e.g., as mg equivale nt of hexadecane per part ) by m easuring its
-1
maximum ab sorbance in the 2800-30 00 cm region. Using the appropriate calibration curve the absorbance
readings are converted to extract solution concentrations and finally to mg/part readings.

Discussion: Based on our experience using ASTM F 2459–051 to quantify residuals gravimetrically the typical
detection limit for soluble residues of 0.3 mg/part is more than a factor ten (0.02 mg/part) higher than the FTIR
method describe here. Lower limit of detection (LOD) may be necessary to statistically assure a reliable
assessment of the cleanliness of certain products.

Using one or more of the specific methods proposed by WK155322 may be of benefit too. For example, it may
be possible to use techniques such as gas chromatography (GC) coupled with mass spectroscopy detection (MS),
high-performance liquid c hromatography (HPLC) c oupled with such detector sy stems as MS, single or m ulti-
channel or photo diode array ultraviolet (UV) detector systems or evaporative light scattering detection (ELSD).

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

In some cases it is possibl e to not only quantify the total amount of extractable organic residue but to identify
and quantify the specific components from specific lubricant and detergent systems used.

Based on our experience these t echniques (e.g. ASTM F 2459–05 1 and FTIR) can also be applied to poly meric
medical devi ces. Howeve r, one has to consider tha t the poly mer itself m ight release materials which are by
definition not residues. Such material s that are alre ady present in the raw material must b e considered when
setting the extraction and analytical parameters and their acceptance criteria.

Conclusion: Although ASTM F 2459–051 has made a significant contribution to the orthopaedic industry in
regards to evaluating the cleanliness of 100% metallic medical devices, more standardization is needed in
application of the many different techniques available to the analyst. Additionally, application of these
techniques to the many different types of polymeric materials used by the industry presents another major
challenge. To assure the safety of the medical devices, their cleanliness using sensitive methods as proposed
here and by ASTM F 2459-051 WK155322 are necessary.

Reference
[1] ASTM F 2459–05 Standard Test Method for Residue from Metallic Medical Components and Quantifying
via Gravimetric Analysis
[2] ASTM Work Item: WK15532 - New Practice for Reporting and Assessment of Residues on Single-Use
Implants
[3] ASTM 1374-92(2005) Standard Test Method for Ionic/Organic Extractables of Internal Surfaces-
IC/GC/FTIR for Gas Distribution System Components (Ultra-High-Purity Gas Distribution Systems)

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

SESSION 4: ESTABLISHING CLEANING LIMITS

Establishing and Justifying Limit Values for Residual Analysis

Kierstan Andrascik, QVET Consulting, Layton, UT

There are no established regulatory limits for residual analysis. The primary reason for this is due to the number
of variables involved. Every contaminant has differing degrees of toxicity, and that toxicity can change
depending on where and how long it is exposed to the patient. Therefore, regulatory agencies have left it up to
individual companies to establish and justify residue limits.
Probably the most common technique used to justify residue limits is performing biocompatibility
testing. Demonstrating the biocompatibility of the clean devices shows that residues on that clean device are
also biocompatible. Cytotoxicity and other biocompatibility tests are performed based on where and how long
the device is exposed to the patient.
Other tests that may be beneficial to perform are endotoxin and bioburden. These tests would only be
necessary if you wish to claim that the cleaning process reduces endotoxin or bioburden levels.
Another common technique for establishing and justifying residue limits is through comparison. Once
all of the data has been collected concerning the residue amounts on the devices, various statistical calculations
can be performed to establish residue limits. Clean samples from within a cleaning run can be compared to each
other to confirm uniformity in a single cleaning run. Clean samples from multiple cleaning runs can be
compared to demonstrate consistency from run to run.
When the cleaning process being validated has been established for a while, there is usually inventory
available that was cleaned months or years before. These "off the shelf" devices can be analyzed to establish
baseline data and compared to freshly cleaned devices. Since these devices have a history of non-problematic
patient use, an appropriate acceptance criteria is that the amount of residue on the freshly clean devices needs to
be the same or less than the corresponding "off the shelf" devices.
Another technique is a risk-based assessment which would include data concerning where patient
exposure occurs and for how long. The risk of the detected residue amounts may be evaluated using available
LD50 data for the target contaminants. Other available toxicity data can also be used (i.e. TDLO). Of course
this data may not be readily available due to the proprietary nature of many manufacturing and cleaning
materials.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Limits need to justifiable, but it is nice to have some wiggle room. Once a limit is established, it is
much easier to justify lowering the limit than it is raising the limit. Regardless of what technique is used,
regulatory agencies expect that limit values will be set for residual analysis.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Residual Soil on Reusable Medical Devices: How to Determine Limits?

Steve Goldstein, Steve Goldstein Consultants, Albuquerque, NM

Cleaning reusable medical devices has become one of the most controversial reprocessing issues. While the need
to remove foreign material before further processing is widely acknowledged, there has been a great deal of
controversy regarding the amount of residual soil that would be permissible. Various standards organizations
have been reviewing studies, examining data and in some cases facilitating new research in an effort to gain
insight into how to best test for and define acceptable limits for residual soil.

The contemporary concern about cleaning reusable devices can be traced back to a Technical Information
Report published by the Association for the Advancement of Medical Instrumentation (AAMI) in 1993 entitled,
"Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for
device manufacturers" (1994). This document then became the basis for the subsequent FDA publication,
"Labeling reusable medical devices for reprocessing in health care facilities" (1996). Both documents
emphasized the importance of cleaning, the FDA requiring that "All reprocessing instructions include a
statement that the device must be thoroughly cleaned." and that the manufacturer "...evaluate the rigor of the
cleaning process in terms of how adequate the process will be in eliminating visible soil from the device to make
the device patient ready".

After publication of the FDA Labeling Guidance, European regulators mandated that standards be developed for
medical devices sold in Europe. CEN (European Committee for Standardization) and ISO (International
Organization for Standardization) committees began to develop standards for washer-disinfectors in 1996-1997,
which included a substantial effort to move beyond "visibly clean" as a measure of cleanliness. They attempted
to identify appropriate soils, test methods, and endpoints for cleanliness of reusable medical devices processed in
washer-disinfectors. A cleaning document produced through this collaboration required a number of years to
develop and yet agreement on a single or limited number of tests and endpoints was not possible. Rather, the
collaborating committees published a list of national cleaning tests used by various member countries (Washer-
disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy of washer-disinfectors. ISO/TS
15883-5:2005). Although this collection of 19 test methods is very valuable (it does include an ASTM Standard
Test Method), an ongoing effort by ISO and CEN is now re-focused on defining and validating a more limited
number of test method(s) for washer-disinfectors.

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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This international effort has spawned a number of published works on both automated and manual cleaning and
AAMI has published a compendium of these works entitled, "A compendium of processes, materials, test
methods, and acceptance criteria for cleaning reusable medical devices" (2003). This document is currently
being updated and revised. However, research into cleaning reusable medical devices still represents a relatively
small body of work and the standards community looks to the ISO-CEN group to continue their efforts to
develop validation schemes for automated cleaning devices and hopes that their work will be easily transferrable
to manual cleaning. The next challenge will be to identify a reliable means of verifying cleanliness that can be
used at reprocessing sites.

Presentation Slides

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Workshop on Medical Device

Cleanliness: How Clean is Clean
Enough?

Stephen Spiegelberg

Cambridge
Polymer Group, INC.
Consultation, Testing, and Instrumentation for Polymeric Materials

Why do we clean?
• Healthcare-associated infections*
– 2 million infections
– 90,000 deaths
– $4.5 Billion in excess health care costs
• Single use and reusable devices
– Manufacturing residues
– Cleaning agents
– Bacteria
– Endotoxins
• FDA Recalls
– FDA has launched 64 recall for medical devices within the last 7
years among them are 26 due to process contamination

*Weinstein, Emerg Infect Dis, 1998

San Antonio, TX, November 16 2010 page 25

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

A corollary to the 2nd law of

thermodynamics
IMBESI'S LAW OF THE CONSERVATION OF FILTH*

“Whenever something becomes clean, something else becomes dirty.”

Cleaning is the process of moving residues from one location to another

* Ken Kesey, “One flew over the cuckoo’s nest”

Four Laws of Cleaning

1. Whenever something becomes clean, something else becomes dirty

2. Soil is like entropy–never destroyed, always created

3. One can never get something completely clean

4. To get a particle off a surface, first you have to find both

cleaning is soil management

John Durkee “Management of Industrial Cleaning Technology and Processes”

San Antonio, TX, November 16 2010 page 26

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Design to Minimize Cleaning

• Design components for simple, effective cleaning
– Blind spots
– Mixed materials
– Sharp corners, fine features
• Design components for simple manufacturing
– Fewest manufacturing steps
– Fewest number of processing compounds (grit blast, polish, masking)
• Design simplest cleaning operation
– Omnidirectional cleaning vs. directional
– Avoiding redepositing removed soil on clean parts
– Cleaning your clean-line
– Cross-contamination of different components cleaned in the same
clean-line
• Design with cleaning validation in mind
– How to assess how clean your parts are?

Challenges of Cleaning
• Adequate removal of soils without introducing
new residues
– Cleaning agents
– Migration of residues from one location to another
– Elution/extraction
• Damage to component
– Mechanical, thermal, chemical
• Validation of cleaning process
• Cost and process time

San Antonio, TX, November 16 2010 page 27

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

ASTM Activities in Device

Cleanliness (F04.15.17)
– Workshop on Device Cleanliness (May, 2003)
– Symposium on Device Cleanliness (May, 2005)
– Passed first standard on assessing cleanliness
(ASTM F2459-05)
– WK15532: Guide for Assessment of Contamination
and Residues on Medical devices
• Compilation of known assays for residues, including
endotoxins
– WK13292: Standard Practice/Guide for Shipping
Possibly Infectious Materials, Tissues, and Fluids

Upcoming Topics
• Cleaning and analysis methods
• Cleaning reusable devices
– Endoscopes
– Cannula
– Arthroscopic shavers
• Establishing cleanliness limits

San Antonio, TX, November 16 2010 page 28

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Reusable Devices
• Exposure of components to tissue and
fluids
• Cleaning and disinfection require access
to surfaces
– Design for disassembly and cleaning
• Adequate instructions for reprocessing
– Potential damage to component during
cleaning
– How many times can it be reprocessed?

How Clean is Clean Enough?

San Antonio, TX, November 16 2010 page 29

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Fact Finding:
Ongoing Safety Review of Arthroscopic Shavers and
Suction Tips

University of Michigan

Jahan Azizi, Clinical Engineer Risk Management Consultant

Arthroscopic Shaver

San Antonio, TX, November 16 2010 page 30

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Ongoing Safety Review of Arthroscopic Shavers

The FDA has become aware of events in which

tissue has remained within certain arthroscopic
shavers, even after the cleaning process was
believed to have been completed according to
the manufacturer's instructions.
Reports submitted to the FDA suggested that the
tissue retained was not evident to the naked eye.
Multiple manufacturers of these devices recently
informed their customers of this situation and
reiterated the importance of proper cleaning
procedures.

Examples (include but not limited

to)
• Bioburden:
– Blood, Bone, Tissue
ANSI/AAMI/ISO TIR11139:2006 as "population of
viable microorganisms on or in product and/or
sterile barrier system".

• Foreign Bodies (debris ):

– Bone cement, artificial nails, Gelfoam™ and like
products, ink pens/pencils, insects, Ioban ™,
jewelry, knife blades, coins, rust, suture,
unidentified material, bone wax

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 32

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 33

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 34

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 35

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 36

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 37

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Wonder why it is difficult to clean??

San Antonio, TX, November 16 2010 page 38

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Problematic Instrumentation
• Septorrhinoplasty set due • Drills & saws
to all the cannulas • Gamma nail sets
• Coronary suctions due to • Extract All set
the strange shape of the
cannula • Kerrison Rongeurs
• All Ear trays, suctions and • Spring loaded drill guides
the very fine delicate
• flexible scopes
instrments.
• Bipolar forceps with delicate
• Gastroscopes,
tips
Bronchoscopes, etc...
• Tympanomastoid set
• Defribrillator. Paddles
• Kerrisons
• Lenses
• Orthopedic reamers
• Trivex System

San Antonio, TX, November 16 2010 page 39

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 40

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 41

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Next Step
• The Tempest™ Surgical Instrument Washer
is a fully automated, single operator
cleaning system designed for the Central
Processing Department of Hospitals.
• Industrial strength design
• A proven cleaning process developed from
more than 30 years experience as a leader in
the automotive and aerospace industries, the
Tempest™ brings more horsepower to
cleaning all surgical devices than any other
system previously available to the market.

San Antonio, TX, November 16 2010 page 42

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Tempest Surgical Device Washer

Developed for Automotive and Aerospace Industries.

• High fluidheat
agitated
submersion
• Low flow, high
pressure fluid
stream
• Varying
frequencies from
digital ultrasonics

San Antonio, TX, November 16 2010 page 43

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 44

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Questions?

Jahan Azizi: [email protected]

San Antonio, TX, November 16 2010 page 45

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Validation Strategy for an

Automated Endoscope
Reprocessor

November 16, 2010

Bradley Catalone

AER Validation Strategy

System Approach

San Antonio, TX, November 16 2010 page 46

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

AER Validation Strategy

• AER
Scope-specific connectors
Requires prior manual cleaning
• User
High turnover
Resource and time constraints
• Endoscope
Complex, multiple designs, new models consistently
introduced
• Process
Multiple steps
Manual cleaning
Device-specific adapters

Validation Objectives

• Reduce manual steps

• Eliminate scope-specific adapters
during manual cleaning
• Eliminate manual channel flushing
• Improve other cumbersome or
unnecessary steps (eliminate bedside
flush with detergent, reduce manual
flush volumes, etc.)
Reduces variability
Less user dependent
Improves compliance with instructions

San Antonio, TX, November 16 2010 page 47

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Modified Cleaning

 AER automates channel

flushing
 External surface cleaning
and channel brushing
required

 Reduces manual steps

 Reduces labor
 Improves efficiency
 Improves compliance
 Improves consistency

AER Validation Design

San Antonio, TX, November 16 2010 page 48

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

AER Validation Strategy

Simulated Use Testing

• Worst case for identified variables related to process
efficacy
• Specific user-dependent steps not performed for
testing

In Use (Clinical) Testing

• Validate efficacy in clinical environment according to
AER IFUs
• Repeat validation eliminating specific user-dependent
steps

San Antonio, TX, November 16 2010 page 49

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Elevator-Wire
Channel
Partially Occluded
Channel

Small Channels Long Channels

↑ Flow Resistance ↑ Flow Resistance

Large Channels Multiple Channels

↓ Flow Velocity ↓ Efficacy

Elevator-Wire
Channel
Partially Occluded
Channel

Small Channels Long Channels

↑ Flow Resistance ↑ Flow Resistance

Large Channels Multiple Channels

↓ Flow Velocity ↓ Efficacy

San Antonio, TX, November 16 2010 page 50

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Overall Detergent Action

Performance
↓ AC Line Manually Inject
Minimum Amount
Voltage(108 V)

Channel Purging
Restrictor in Air
Compressor Line

Ultrasonic Channel Flushing

Cleaning ↓ Pump Voltage to
↓ Power to US Simulate 2,500
Transducers Cycles of Use

San Antonio, TX, November 16 2010 page 51

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Overall
Performance Detergent Action
↓ AC Line Voltage Manually Inject
Minimum Amount
(108 V)

Channel Purging
Restrictor in Air
Compressor Line

Ultrasonic Channel Flushing

Cleaning ↓ Pump Voltage to
↓ Power to US Simulate 2,500
Transducers Cycles of Use

San Antonio, TX, November 16 2010 page 52

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Artificial Soil
Inoculation Challenge
High Levels of Protein,
Hemoglobin, Every Channel
Carbohydrate & Completely Filled
Bioburden

Pre-Cleaning
Delayed Reprocessing
No Detergent
Wait 1 Hour
Reduced Flush Volume

Companion Scope
Manual Cleaning
Fully Contaminated
Totally Eliminated
No Channel Brushing Used Model with Largest
Effect on Test Scope

Artificial Soil
Inoculation Challenge
High Levels of Protein,
Hemoglobin, Every Channel
Carbohydrate & Completely Filled
Bioburden

Pre-Cleaning
Delayed Reprocessing
No Detergent
Wait 1 Hour
Reduced Flush Volume

Companion Scope
Manual Cleaning
Fully Contaminated
Totally Eliminated
No Channel Brushing Used Model with Largest
Effect on Test Scope

San Antonio, TX, November 16 2010 page 53

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Test
Endoscopes

Condition Process
of the AER Conditions

Test
Endoscopes

Condition Process
of the AER Conditions

San Antonio, TX, November 16 2010 page 54

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Simulated Simulated Clinical Clinical

Use Use Use Use
Soil ATS ATS Patient Patient

Pre-Clean

Manual Clean

Clean

Rinse
AER

HLD

Rinse

Alcohol

Simulated Use Cleaning

IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water

Channels
AUX - Auxiliary Water Channel EW - Elevator Wire Channel

San Antonio, TX, November 16 2010 page 55

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Simulated Use Cleaning

6.4 μg/cm2

<LOD

IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water

Channels
AUX - Auxiliary Water Channel EW - Elevator Wire Channel

Simulated Use Cleaning

Test Devices
•<LOD

IT - Insertion Tube IS - Instrument/Suction Channel AW - Air/Water

Channels
AUX - Auxiliary Water Channel EW - Elevator Wire Channel

San Antonio, TX, November 16 2010 page 56

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

In Use - Cleaning

• Endpoints
o Protein: < 6.4 μg/cm2
o Bioburden: < 4 Log10 CFU/cm2
• 15 Endoscopes, 65 Samples
• Bronchoscope, Colonoscopes, Duodenoscopes
• Results
Protein Bioburden
(µg/cm2) (Log10 CFU/cm2)
Bronchoscopes <LOD – 0.55 0 - 0.016
Colonoscopes <LOD – 0.60 0 - 0.005
Duodenoscopes
LOD = Limit of Detection<LOD – 0.62 0 - 0.050

In Use - Cleaning

• Endpoints
o Protein: < 6.4 μg/cm2
o Hemoglobin: < 1.8 μg/cm2
• 14 endoscopes, 62 samples
• Bronchoscope, Colonoscopes, Duodenoscopes
• Results
Protein (µg/cm2) Hemoglobin
(µg/cm2)

Bronchoscopes <LOD – 1.39 <LOD

Colonoscopes <LOD – 4.33 <LOD
LOD = Limit of Detection
Duodenoscopes <LOD – 0.88 <LOD

San Antonio, TX, November 16 2010 page 57

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Simulated Use Full Cycle Testing

• Endpoints
o Protein: < 6.4 μg/cm2
o Bioburden: ≥ 6 Log10 reduction in M. terrae
• 13 endoscopes, 65 samples
Gastroscope, Colonoscope, Duodenoscope and
Ultrasound Endoscope
• Results
o All samples < 6.4 μg/cm2 residual protein
o 62 of 65 samples ≥ 6 Log10 reduction in M. terrae
o 3 samples > 5.9 Log10 reduction – sample volume
limitation

Summary

• Covers all Olympus

endoscopes
• Reduced dependence
on scope-specific
adapters
• Reduced burden on
user
• Simplified instructions

 Effective endoscope
reprocessing

San Antonio, TX, November 16 2010 page 58

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

San Antonio, TX, November 16 2010 page 59

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Effects of Non-Aqueous Vapor

Degreasing Solvent Cleaning on Ultra-
High Molecular Weight Polyethylene
(UHMWPE)

Ray Gsell, Ming Guo, Hallie Brinkerhuff

Zimmer, Inc., Warsaw IN, USA

Overview

• Provide a brief summary of the chemistry of HFEs

and HFCs

• Summarize the results of laboratory tests evaluating

the interactions of HFEs and HFCs with UHMWPE

San Antonio, TX, November 16 2010 page 60

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Introduction

Solvent degreasing operations have been

historically used with great success
 Mostly on metal and less so for polymeric components
It had the advantages of:
 Excellent cleaning power
 Low surface tension solvents – small clearance cleaning
 Low Boiling Point solvents – rapid drying
 Simple equipment
Historical degreaser solvents were ozone
depleters
 Fell out of popularity because of laws and costs of
environmental controls
New environmentally friendly solvents developed
New solvent containment equipment designed

Introduction

Composition of 3M HFE-72DA

 Ethyl Nonafluorobutyl Ether

 Ethyl Nanofluoroisobutyl Ether
 Methyl Nonafluorobutyl Ether
 Methyl Nanofluoroisobutyl Ether
 IPA
 trans-1,2-Dichloroethene

San Antonio, TX, November 16 2010 page 61

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Introduction

Composition of Micro Care Heavy Duty

Degreasing Solvent

1,1,1,2,3,4,4,5,5,5-Decafluoropentane
1,1,1,3,3-Pentafluorobutane
 trans-1,2-Dichloroethene

Introduction

Effects of Such Solvents on Metals vs. UHMWPE

 Adsorption (unto) versus Absorption (into)

 Absorption (into) versus Desorption (out of)

San Antonio, TX, November 16 2010 page 62

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Test Methods
Material Processing Methods:

• Mimic Typical manufacturing processes Suggested by Solvent

Suppliers

• UHMWPE Test Specimens:

 6 mm x 12 mm x 40 mm bars
 GUR-1050 Compression Molded Slab Stock (Ticona)

• Typical Solvent Processing Cycle:

 1 minute soak in boiling solvent (HFE ~45 C, HFC ~41 C)
 2-5 minute agitated clean (with or without sonication)
 1 minute vapor phase rinse
 1 minute dry

Test Methods

• A – Sonication probe

• B – Sample submerged in
solvent

• C – Beaker with water for

sonication energy transfer

• D – Processing vessel

San Antonio, TX, November 16 2010 page 63

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Test Methods
Material Post Cleaning Processing Methods:

• Out-gassing, solvent desorption (drying):

 Ambient air drying
 80 C oven drying
 80 C vacuum oven drying

Test Methods
Material Evaluation for Absorption/Desorption Characteristics:

• Weight differences are not very accurate

• FTIR is very efficient at identifying the presence of these
materials within the UHMWPE
• HFE/HFCs have unique FTIR absorption peaks from UHMWPE
• HFE-72DA vs. UHMWPE

San Antonio, TX, November 16 2010 page 64

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Test Methods
HFE/HFC Monitoring Methods:

• HDDS vs. UHMWPE

Test Methods
Material Evaluation for Absorption/Desorption Characteristics:

• FTIR Line-Mapping is very efficient at identifying the presence

of these materials and their location within the UHMWPE

 Processed UHMWPE bars are sectioned to obtain a fresh inner

surface
 ~150 Micron thick microtomed films are collected from this inner
surface
 FTIR transmission line-map spectra are collected every 200 microns
starting from a solvent processed surface
 Examination of individual line-map spectra allows one to determine
the presence or absence of solvent and estimate its depth of
absorption

San Antonio, TX, November 16 2010 page 65

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Test Methods

• Typical FTIR Line-Map spectra

Results
• Typical depth profile of HDDS after 2-minute soak at 41 C

San Antonio, TX, November 16 2010 page 66

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Results
• Typical depth profile of HDDS after a 2-minute soak at 41 C and
2-hour oven drying

Results Summary and comparison

of HFE/HFCs

Samples of Tests and Results Using HFE-72DA and GUR 1050

Liquid Vapor
Contact Contact Drying Drying Drying Solvent Maximum
Time Time Time Temperature Pressure Absorbed Depth
o
(Min.) (Min.) (Min.) ( C) (Atm.) (Y/N) ( µm)
2 0 0 80/Oven Ambient Yes 250
2 0 15 80/Oven Ambient Yes 550
2 0 34 80/Oven Ambient Yes 750
2 0 50 80/Oven Ambient Yes 1100
2 0 90 80/Oven Ambient Yes 1300

San Antonio, TX, November 16 2010 page 67

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Results Summary and comparison

of HFE/HFCs

Samples of Tests and Results Using HDDS and GUR 1050

Liquid Vapor
Contact C ontact Drying Drying Drying Solvent Maxim um
Time Tim e Time Temperature Pressure Absorbed Depth
(M in.) (Min .) (M in.) (o C) (Atm.) (Y/N) ( µm )
2 0 0 Am bient Ambient Yes 200
2 0 40 Am bient Ambient Yes 500
2 0 68 Am bient Ambient Yes 600
2 0 0 Am bient Ambient Yes 300
2 0 30 80/Oven Ambient Yes 1000
2 0 60 80/Oven Ambient Yes 1100
2 0 90 80/Oven Ambient No N /A
2 0 120 80/Oven Ambient No N /A

Conclusions
• These HFE and HFC solvents tend to be rapidly absorbed
into UHMWPE during degreasing cleaning operations but
only slowly desorbed
• The trans-I,2-Dichlorethene component is the ‘culprit’
• HFC is desorbed more rapidly from UHMWPE than HFE
 HFC was completely desorbed after 1.5 hours in an 80 C
convection oven while HFE-72DA was still present
• Solvent components are absorbed to depths of ~1 mm with
solvent contact times of about 2 minutes
 Longer solvent contact times increases penetration depths
 Sonication had little affect on penetration depths
• Elevated temperatures reduce desorption times
• Absorbed solvent moves deeper into material upon drying
• Vacuum oven had little affect on desorption times

San Antonio, TX, November 16 2010 page 68

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Conclusions
• The use of HFEs and HFCs to clean UHMWPE is
complicated by their rapid absorption but slow desorption
from this material
 Although the cleaning cycles may be significantly shorter than
other methods the much longer desorption (drying) times may
make the overall manufacturing process longer
 Additional testing and documentation may be necessary to insure
such a cleaning process produces a product that is free or
‘essentially free’ of residual processing materials

San Antonio, TX, November 16 2010 page 69

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Breaking the Myth

Case Medical

Our Position
• Caustic cleaners are unnecessary for instrument
processing and present significant hazards to
health and safety
• Properly formulated pH neutral instrument
chemistries with excellent surfactants and
synergistic enzymes can offer a safe and proven
alternative
• The need to provide validated cleaning protocols
for reusable medical devices has become a focal
point in medical device reprocessing.

San Antonio, TX, November 16 2010 page 70

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Sustainability
• Meeting the needs of our current generation
without impacting the needs of future
generations to meet their own needs
• Social responsibility to protect the public
from exposure to harm
• All manufacturers are obligated to design
instrument chemistries to control measures
which may lead to possible harm.

Precautionary Principle
• Ethical responsibility to maintaining the
integrity of natural systems
• Willingness to take action in advance of
definitive scientific proof when a delay
could prove costly to society and nature as
well as selfish to future generations

San Antonio, TX, November 16 2010 page 71

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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Breaking the Chain

• Cleaning, decontamination and

subsequent sterilization are essential
steps in breaking the chain of infection.

Cleaning
• The removal, usually with detergent and
water, of adherent visible soil such as
blood, protein substances and other debris
from the surfaces, crevices, serrations,
joints and lumens of instruments, devices
and equipment by a manual or mechanical
process that prepares the items for safe
handling and further decontamination.

San Antonio, TX, November 16 2010 page 72

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Ineffective Cleaning
• Can affect the ability of medical devices
– To function properly
– Decreases the useful life of the device
– Increases costs for repair and replacement
– Can interfere with the effectiveness of
subsequent sterilization or disinfection
– Increases the risk of nosocomial infection

Green Chemistry
• Chemical products and processes
designed to reduce or eliminate hazardous
substances
• Pollution prevention focus of EPA’s Green
Chemistry program

San Antonio, TX, November 16 2010 page 73

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Caustic Cleaners
• Alkaline detergents followed by acid
neutralizers
• Present hazards to waste water stream
• Cause pitting and corrosion of surgical
devices
• May result in safety issues for patients and
staff

Warning
The use of elevated temperatures in a
cleaning process will cause denaturation
and precipitation of soil components
(blood) and make them more difficult to
remove.

San Antonio, TX, November 16 2010 page 74

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Ideal Cleaning Agents

• Non-corrosive
• Free-rinsing
• Non-abrasive
• Low-foaming
• Biodegradable
• Environmentally Friendly
• Nontoxic in specified use dilution
• Provide for rapid soil dispersion or suspension
• May be used in all water types

Cleaning Reusable Devices

• The critical first step in the
decontamination process
• Multi-step process including manual and
automated cleaning
• Followed by a thorough rinse with high
purity water
– Manual cleaning dependent on individual’s
performance. Mechanical reproducible.

San Antonio, TX, November 16 2010 page 75

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Validation
• The FDA places primary responsibility
for developing and validating methods
for effective processing of the medical
device on the manufacturer of the
device.
• Device manufacturers must provide
procedures that must be easily
replicated and verified by users

The Validation
• Enzymatic detergents are often recommended for
cleaning reusable devices.
– Yet, there was little data to confirm the efficacy of
enzymatic detergents for effective soil removal
from patient-used medical devices
• Validation: Simulated-use evaluation of enzymatic cleaning
– Evaluated static soak, manual cleaning, automated
cleaning, and the recommended process
– Inoculated devices
• Organic soil reduction
• Bioburden reduction

San Antonio, TX, November 16 2010 page 76

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Validation of Process
• Pre-cleaning using a pH neutral multi-
enzymatic foam
• Brief rinse with tap water
• Ultra sonic cleaning with pH neutral
detergent
• Manual cleaning with pH neutral multi-
enzymatic cleaner
• Final rinse with tap water

Results
• Hemostats soiled with ATS and
microorganisms processed by the
manufacturer’s products and method resulted
in a ≥ 6 Log10 reduction bioburden and
> 99.9% reduction in organic material post
processing.
• Conclusion
– The protocol of cleaning that is recommended by
the manufacturer provides efficient cleaning of
medical devices by providing soil and bioburden
reduction.

San Antonio, TX, November 16 2010 page 77

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Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

The pH Effect
• To determine if an increase in pH
(alkalinity level) will improve or change the
outcome of the cleaning protocol
• Two parallel studies were conducted of the
entire cleaning protocol
– One using neutral pH detergent
– One using the same ingredients but with a pH
of 9 (alkaline)

pH Effect Results
• There was no significant difference in
outcome between the pH neutral and the
alkaline detergents
• In fact, there was a slight improvement in
efficacy with the pH neutral detergent in
replicate studies.

San Antonio, TX, November 16 2010 page 78

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Why Use Enzymatic Cleaners?

• Each enzyme is a catalyst working on a
particular substrate much as a lock and key. If
one enzyme is used only one type of organic soil
will be broken down.
– Protease breaks down protein
– Lipase breaks down lipids (fats).
– Amylase breaks down starch and carbohydrates.
• Multiple enzymes are needed to attack organic
soils, so that they may be washed away.
• Hot water is not recommended nor needed.

Why are Detergents

Needed?
• Detergents are required for a thorough cleaning
and removal of organic and inorganic soils,
detergent residue, including enzymes.
• They may be used in hot water wash cycles for
thermal disinfection.
• Detergents with chelating and sequestering
agents are required for removal of salts,
minerals and other hard water ions.
• In automated systems, when filtered, deionized
or RO water systems are used lower
concentrations of detergents may be used.

San Antonio, TX, November 16 2010 page 79

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

What Instrument
Manufacturers Say
• Chemicals used in cleaning and decontamination processes
should be able to remove the type of soil found on the item
while, at the same time, preserving the integrity of the item.
Such cleaning agents should have the following properties:
– Ability to remove organic and inorganic soil.
– Ability to prevent deposits from hard water ions.
– Low foaming.
– Free rinsing.
– Neutral pH (range 7-8)
– Very acid or alkaline solutions can damage the inert layer that keeps
stainless steel instruments from corroding.
– Anodized aluminum containers require pH neutral products for
decontamination and to maintain their corrosion resistance and
useful life.

Why Green Products?

• Environmentally friendly products are safe for the
patient, staff, and the community.
• Color, dye, fragrance mask the degradation of the
product (fading, sediment, mold!) and the odor of
denatured enzymes.
• Most water systems in each of our cities limit the level of
alkalinity in the water supply to a pH of 8.5, yet the
alkaline detergents used may reach a pH of 14, the
highest level possible and are dumped in our water
supply, destroy medical devices, and if used on patients
without rinsing, will cause injury or death.

San Antonio, TX, November 16 2010 page 80

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Summary
• Medical devices are critical for patient care.
• No instrument company recommends caustic
detergents, because of the potential damage to
the device.
• Breaking the myth means that there are
instrument chemistries that are pH neutral,
validated in independent studies, that are
environmentally friendly, safe and effective, and
demonstrate efficacy and sustainability.

San Antonio, TX, November 16 2010 page 81

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Developing a method to
quantitatively assess residual
patient material in reusable medical
devices

Shani Haugen, Ph.D.

Food and Drug Administration

Center for Devices and Radiological Health
Office of Science and Engineering Laboratories
Division of Biology

The comments and opinions

expressed in this presentation are
those of the speaker, and do not
necessarily reflect the formal position
of the FDA.

San Antonio, TX, November 16 2010 page 82

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Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Outline

• Overview
– Goals of project

• Background
– Reprocessing reusable medical devices
– Established methods of test soil detection

• Experimental approach
– Preliminary data

• Future directions

Overview of Project
FDA has received reports of reusable medical
devices that contain residual patient material even
after being cleaned, which poses a risk for infection.

Goals:
1. To develop an assay for assessing residual
debris in reusable medical devices

2. To quantitatively determine the impact of different

device designs on the ability to remove organic
material from reusable medical devices

San Antonio, TX, November 16 2010 page 83

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Background
• Cleaning is an important first step in reprocessing for
effective disinfection and/or sterilization of reusable
devices.
• Organic material has been found to compromise the
effectiveness of certain sterilization processes
• Improper cleaning of reusable devices (e.g.
endoscopes) increases the possibility of infection for
patients
- Patient to patient transmission (Hepatitis)
- Environmental transmission (Pseudomonas)

Endoscopes

San Antonio, TX, November 16 2010 page 84

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Arthroscopic Shaver Handles

Background
April 2009
- During an investigation of an outbreak of Pseudomonas
infections, a hospital found that some of their orthopedic
surgical devices contained residual bits of patient material even
after being cleaned
- residual organic material has been found to compromise the
effectiveness of certain sterilization processes

San Antonio, TX, November 16 2010 page 85

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Regulatory Relevance
• FDA has become aware of other types of reusable devices that
retained patient debris after cleaning, indicating that this issue is not
limited to a particular device or facility

• Manufacturers of reusable medical devices must provide users with

reprocessing instructions, including cleaning instructions
– cleaning instructions must be validated by the manufacturer as
being effective to remove soil
– manufacturers validate cleaning by performing simulated soiling
and cleaning of the device, followed by some measurement of
residual debris

• Any device that is found to have residual debris after performing the
manufacturer-recommended cleaning steps should be reassessed to
determine which aspect of the cleaning validation failed

Factors that must be considered for

validation of cleaning

• type of test soil used (clinically relevant)

• location of the soil in device (inside device;
under sheaths, etc.)
• method of inoculation of test soil
• length of time for the soil to dry on the device (to
simulate worse case conditions)
• assessment of soil removal
• quantitative endpoints of “cleaned” device

San Antonio, TX, November 16 2010 page 86

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Factors that must be considered for

validation of cleaning

• type of test soil used (clinically relevant)

• location of the soil in device (inside device;
under sheaths, etc.)
• method of inoculation of test soil
• length of time for the soil to dry on the device (to
simulate worse case conditions)
• assessment of soil removal
• quantitative endpoints of “cleaned” device

The ideal assessments for residue will be:

Accurate
Sensitive
Quantitative
Fast
Easy
Inexpensive
Can be used by manufacturers and users (using a test
soil or clinical soil)

San Antonio, TX, November 16 2010 page 87

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Methods that have been used to assay for residues

Direct

Scanning electron microscopy, Radionuclide tracers

surface chemistry analysis,
photoelectron analysis
staining

Methods that have been used to assay for residues

Indirect

Liquid Extraction Swab

• Protein (Bradford, ninhydrin, autoanalyzer, etc.) • Protein

• Lipids and oils (Nile Red Dye) • ATP fluorescence assay
• Carbohydrates (phenol-sulfuric acid protocol) • Viable microorganisms
• Endotoxin (limulus amoebocyte lysate assay)
• Hemoglobin
• Total organic carbon
• Viable microorganisms

San Antonio, TX, November 16 2010 page 88

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

The problems with solid debris in liquid eluate:

Sampling error

Inaccuracy

General Protocol
1. Apply test soil to device

2. Allow test soil to dry for defined time periods

3. Clean devices
4. Assess residual debris

San Antonio, TX, November 16 2010 page 89

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Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Test soil and inoculation

Test soil adapted from

Coagulated blood test soil

- Purified blood proteins (hemoglobin, albumin, fibrinogen, thrombin)
- Forms a jello-like substance

- Dispense test soil directly into lumen of device

- Invert to mix, ensuring that all interior surfaces are coated with test soil
- Set down horizontally
- Allow to dry

l Devices Tested
e be
ic ity La
ev lex e
D p ic Exterior Cross-section
om ev
C D

E
16 Not to scale

San Antonio, TX, November 16 2010 page 90

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

General Protocol
1. Apply test soil to device

2. Allow test soil to dry for defined time periods

3. Clean devices
4. Assess residual debris

Assessments for debris

Swab – followed by Bradford assay for protein

Liquid extraction – followed by Bradford assay

HPLC analysis

Mass spectrometry

Quantitative imaging analysis (FTIR/Raman

spectroscopy)

San Antonio, TX, November 16 2010 page 91

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Pre-weigh filter
Filter-weighing approach to
assess residual debris in
medical devices
Extract debris

Equipment:

Nylon filters (0.2 micron pore size)

Microbalance (or analytical balance) Filter extraction liquid

(can save filtered
Filtered water
liquid for further
Container for device analysis)

Filtering equipment

Dry filter and weigh

Filter-weighing method to assess

residual debris

Sensitive

Quantitative

Requires few pieces of specialized equipment

Relatively straightforward to perform

Saved filtrate can be used in downstream applications

Entire sample is filtered – no sampling error

Accurately quantifies insoluble material

San Antonio, TX, November 16 2010 page 92

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Summary of filter-weighing approach to assess residual debris

700

600

500
Micrograms of Debris

400

300

200

100

0
Water Shaver
Device: A B C D E
control Handle

Summary of filter-weighing approach to assess residual debris

700

= Median
600

500
Micrograms of Debris

400

300

200

100

0
Water Shaver
Device: A B C D E
control Handle

San Antonio, TX, November 16 2010 page 93

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Summary of filter-weighing approach to assess residual debris

700

= Median
600

500
Micrograms of Debris

400

300

200

100

0
Water Shaver
Device: A B C D E
control Handle

Conclusions
The filter-weighing approach to assess residual debris in
devices reveals a trend of increasing debris with increasing
device complexity

These preliminary data support the continued development of

the filter-weighing method to assess residual debris in
reusable medical devices

San Antonio, TX, November 16 2010 page 94

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Future Experimental Directions

Repeat experiments with microbalance
Greater sensitivity – may more precisely define
contributions from designs
Use imaging technology (with Division of Physics)
Characterize debris on filters using Fourier Transfer
Infrared technology
Characterize debris inside devices using Raman
spectroscopy with a microprobe

Purchasing additional medical devices

More data possibly relating debris retention to device
design
Ability to see the range of debris found in these
devices

Acknowledgements

Division of Biology University of MI Hospitals

Vicki Hitchins Jahan Azizi
Rebecca Bour

Division of Solid Fluid Mechanics Special Thanks to

Nandini Duraiswamy CDRH Machine Shop

Division of Physics FDA Commissioner’s

Sophia Tan Fellowship
Ilko Ilev

San Antonio, TX, November 16 2010 page 95

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Evaluation of the Cleaning

Efficiency of an Aqueous Based
Detergent System for Cleaning
Metallic Medical Devices
16 November 2010
Boopathy Dhanapal, Nils Weiler and Jeff Rufner

Implant Cleanliness Confidence in your hands®

Evaluation of the Cleaning Efficiency

• Introduction

• Scope

• Approach

• Results

• Conclusions

San Antonio, TX, November 16 2010 page 96

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Introduction

• To ensure consistent removal of manufacturing materials

21 CFR 820-70 and other contamination to predefined
limits.

• ISO 13485, Section 6.4 / ISO TIR 14969, Section 6.4.2.2

requires that controls be established where the
manufacturing environment could adversely impact
product.

Implant Cleanliness Confidence in your hands®

Evaluation of the dipping bath cascade

San Antonio, TX, November 16 2010 page 97

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Robotic cleaning system

Implant Cleanliness Confidence in your hands®

Test methods used

• Approach and Methods

• Potentiometric Titration three

times a week

• pH and Temperature
measurement
Fig. Titrino & Autorepipet : tools used for the
potentiometric titration

• Chemical Cleanliness Analysis of

three different implants, three
specimens per method: a total of
135 specimens analyzed

San Antonio, TX, November 16 2010 page 98

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Stability of the detergent?

Implant Cleanliness Confidence in your hands®

How do we ensure the detergent content?

San Antonio, TX, November 16 2010 page 99

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Cleanliness validation
Direct Analysis
Continuous Decrease of Detergent
Concentration within a week.
Different Concentrations at the
Beginning of the three weeks Verlauf des Verbrauchs innerhalb der Monitoringperiode

After comparing the data: systematic 9

8.5
deviation from the results of the visual

Verb rau ch an 0.1m N aO H in m l

8

Titrations 7.5

7 Bad 4

6.5

Product-related Analysis 6

With the actual life cycle, the required 5.5

5
chemical cleanliness is generally 0 5 10 15
Tag X in der Monitoringsperiode
20 25

assured.
No decrease of the chemical
cleanliness was observed either within
the week or three weeks.

Implant Cleanliness Confidence in your hands®

Cleanliness validation
Chemical Cleanliness Prior to the Cleaning Step Chemical Cleanliness After the Cleaning Step
Part Description &
Characteristics
Average in mg/ Part Max Value in mg/ Part Average in mg/ Part Max Value in mg/ Part

Organic Residue: 5.9 Organic Residue: 6.0 Organic Residue:<0.5 Organic Residue:<0.5
TOC: 0.21 TOC: 0.22 TOC: 0.07 TOC: 0.08
Hip Cup / Challenging Ionic Residue: 1.24 Ionic Residue: 1.30 Ionic Residue: 0.07 Ionic Residue: 0.08
Surface Particulate Residue: 15.7 Particulate Residue: 23.6 Particulate Residue: 0.6 Particulate Residue: 0.8

Organic Residue:<0.5 Organic Residue:<0.5 Organic Residue:<0.5 Organic Residue:<0.5

TOC: 0.09 TOC: 0.11 TOC: 0.05 TOC: 0.06
Hip Stem / Ionic Residue: 0.14 Ionic Residue: 0.19 Ionic Residue: <0.05 Ionic Residue: <0.05
High Production Rate, Particulate Residue: 2.9 Particulate Residue: 3.7 Particulate Residue:<0.2 Particulate Residue:<0.2
Challenging Geometry

Organic Residue: 2.6 Organic Residue: 2.9 Organic Residue:<0.5 Organic Residue:<0.5
TOC: <0.05 TOC: <0.05 TOC: <0.05 TOC: <0.05
Femur Component / Ionic Residue: 0.09 Ionic Residue: 0.09 Ionic Residue:<0.05 Ionic Residue:<0.05
Highly porous surface Particulate Residue: 0.4 Particulate Residue: 0.4 Particulate Residue:<0.2 Particulate Residue:<0.2

Table 1: Average Results: Total Organic Carbon (TOC), Organic Residual, Ionic Residual, Particulate Residual

San Antonio, TX, November 16 2010 page 100

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Conclusions

1. Effect of the detergent concentration was studied by

monitoring of the detergent baths. It was done via proven
titration methods. Concentration of the detergent is important
to ensure the cleanliness of the implants.
2. It is important to know the minimum and maximum
concentration to meet the cleanliness requirements. This
should be the starting point for the optimisation of a cleaning
process.
3. Chemical residues on the implants are low after the cleaning
process as expected.
4. An optimized cleaning process enhances consistancy and
predicatbility of the cleanliness of implants in accordance
with CFR 211.611.

Implant Cleanliness Confidence in your hands®

Thank you for your attention

San Antonio, TX, November 16 2010 page 101

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Assessment of Organic
Residues on Medical Devices

16 November 2010
Boopathy Dhanapal, Daniel Zurbürgg, Jeff Rufner
Ray Gsell.

Implant Cleanliness Confidence in your hands®

Introduction

1. Important steps for cleanliness assessment

2. Overview of test methods and evaluation

3. FTIR method for organic residues at low levels

4. Identification of residues by GC-MS

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Cleanliness Assessment

Risk Process
assessment evaluation

Monitoring

Validation
Change
control

Implant Cleanliness Confidence in your hands®

Which Test Method ?

Only 1 test method (ASTM 2459) for non bio residues has been published
According to WK15532 more specific methods are required
No standard for non water-soluble organics (e.g. oil residues)

Different strategies, methods and
specifications to assess cleanliness
additional ASTM standards required


Which test method is best?

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Evaluation of Test Method

 Detectability of all potential residues

 Detection limit below specified cleanliness

 Compatibility of device with the method

 Quantitative (comparison with alarm / limit values)

 Accepted by authorities / standardized

 Costs and throughput time

Implant Cleanliness Confidence in your hands®

Test Methods for cleanliness control I

Technique + -
Direct Analysis  Only large visible
 Rapid
Visual spots detectable
(Surface)  Inexpensive
examination  limited for
 No extraction
complex surfaces

 no quant. of total
SEM/EDX
 Rapid identification MD surface
XPS
TOF-SIMS  No extraction  limited for
complex surfaces

Indirect Specific GC-MS  Identification of  Not universal

Analysis (Extraction) ICP-MS mixtures  Expensive
 Low LOD: ng/device  Complex

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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Implant Cleanliness Confidence in your hands®

Test Methods for cleanliness control II

Technique + -
 low LOD: 0.03 mg  no nonpolar
TOC
Indirect Universal  all water-soluble organics
USP 643
Analysis (Extraction) organics  recovery valid.
FTIR  polymer
 low LOD: 0.03 mg
ASTM lachables
 nonpolar organics
JAI13391  recovery valid.
 inorganic and
Conductivity  limited to ions
organic ions
USP 645  recovery valid.
 inexpensive
Gravimetry  most universal:  high LOD:
e.g. ASTM all nonvolatiles 0.3 mg/device
F2459  Inexpensive  recovery valid.

Particle
 low LOD: a few  no solubles
count
particles  recovery valid.
USP 788

Implant Cleanliness Confidence in your hands®

Principle of Cleanliness Testing with Extraction

1.4

1.2 y = 246.82x
R20.9986=
1
Peak Area Abs

0.8

0.6

0.4

0.2

0
0 0.002 0.004 0.006
mg Hydrocarbon

Complete Ultrasonic Analysis with Quantification

immersion in
a (non) polar extraction sensitive with a
solvent of polar, techniques reference
non polar or compound
particulate calibration
residues

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Limitation of ASTM F2459 / Gravimetry

 LOD of 0.3 mg not low enough for cleanliness assessment
 Differentiation between (inorganic / organic) not possible
 long-term experience for reproducible analysis required
 More sensitive methods (e.g. FTIR) 10 x lower LOD required
0.4
Limit of detection (LOD)

0.3
mg/implant

0.2

0.1

0
nonspecific specific to polar organic specific to nonpolar specific to ionic
method residues organic residues residues

ASTM F2459 ASTM F2459 ASTM F2459 ASTM F2459

Gravimetry FTIR TOC Conductivity

Implant Cleanliness Confidence in your hands®

FTIR Method for Organic Residues

Extraction acc. ASTM F2459 with carbon tetrachloride (CCl4)

polymers: 1-10 min Ultrasonic (US) at room temperature
(RT)
metals: US / RT structure dependent
ceramics: US / RT
Hydroxyapatite US / RT

Measurement of IR spectra by FTIR based on ASTM F1374-921

direct measurement of extract in transmission (1 cm cuvette)
recording spectra in the range from 2500 – 4000 cm-1
covers all extractable hydrocarbons (oil, cooling agents etc.)

Quantification
1
integration of hydrocarbon peak (C-H) in the range from 2800 – 3000 cm-1
0.8

quantification against a reference hydrocarbon (hexadecane or reference oil)

0.6
A b s o rb a n c e

0.4
results in mg/implant or mg/area
0.2

1) ASTM F1374-92 Standard Test Method for Ionic/Organic Extractables of Internal

0

3200 3100 3000 2900 2800 2700 2600 2500 Surfaces-IC/GC/FTIR for Gas Distribution System Components (Ultra-High-Purity Gas Distribution Systems)
Wavenumbers cm-1

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Quantification by FTIR

1.2 hexadecane
hexadecane
1
calibration
0.8
Peak absorbance
2800 - 3000 cm -1

0.6

0.4

oil
0.2
R2 = 0.9996

0
0 0.1 0.2 0.3 0.4 0.5 0.6

m g/device
(100 m l extract)

Implant Cleanliness Confidence in your hands®

Organic Residues / Polymer Leachables

Extraction of polymers can release polymer leachables

Differentiation residues / leachables if possible

1.40

1.20
Extractables (mg/device)

1.00

0.80

0.60

0.40

0.20

0.00
Organic Residues Organic Residues + UHMWPE Leachables
UHMWPE Leachables

1. Extraction: 10 min ultrasonication

2. Extraction: 30 min ultrasonication and 120 min shaking
3. Extraction: 60 min ultrasonication and 3 days shaking
Sum of 1. - 3. extraction

San Antonio, TX, November 16 2010 page 107

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Identification of Residues by GC-MS

total ion current total ion current

ion mass m/z ion mass m/z

Retention Time (scans) Retention Time (scans)

Extract of machined Reference processing aid

UHMWPE test device (mineral oil-based cooling agent)

Implant Cleanliness Confidence in your hands®

Conclusions

 ASTM F2459 can be used for polymeric implants

 Gravimetry alone may not be sensitive enough for cleanliness
assessment, therefore it should be used in combination with other
analytical techniques.
 Extraction ASTM F2459 with FTIR
• Sensitive enough with LOD of 0.03 mg/implant
• Good recovery also at low levels > 80 %
• Specific to extractable hydrocarbons, such as oils
 Publication of ASTM standards with FTIR specific for MD

 Highly specific methods (GC-MS) only for identification required

San Antonio, TX, November 16 2010 page 108

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Implant Cleanliness Confidence in your hands®

Thank you for your attention

San Antonio, TX, November 16 2010 page 109

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

QVET
Consulting, LLC
Quality Validations, Experience, & Training

Kierstan Andrascik

ASTM Workshop on Medical Device Cleanliness:

How Clean is Clean Enough?

QVET
Consulting, LLC

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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 Contaminant Toxicity
 Quantity Used
 Patient Exposure

 It’s up to YOU!

QVET
Consulting, LLC

 Zero?
 I don’t think so…

 Validate your cleaning process

◦ Choose test method
◦ High and low parameters
◦ Nominal parameters

QVET
Consulting, LLC

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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 mg/cm2 or µg/cm2
 mg/device or µg/device

 Limit values in same units

QVET
Consulting, LLC

 Average and Standard Deviation

 T-test
 ANOVA
 Confidence Intervals
 Uncertainty of Test Method

QVET
Consulting, LLC

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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 Test “Off the Shelf” Devices

 Compare to Freshly Cleaned Devices

QVET
Consulting, LLC

 Biocompatible Clean Device

=
 Biocompatible Residues

 Cytotoxicity
◦ Sensitive In-Vitro Method
◦ Pass/Fail Criteria

QVET
Consulting, LLC

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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 Endotoxin
◦ Not removed by sterilization
◦ Better to prevent or limit contamination
◦ Pass/Fail Criteria

 Bioburden
◦ Primarily removed by sterilization
◦ Can be removed during cleaning process
◦ 3 log reduction

QVET
Consulting, LLC

 Patient Exposure
◦ How long
◦ Where

 Percent or Log Reduction

◦ LD50
◦ TDLO

QVET
Consulting, LLC

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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 Clear and concise

 Re-evaluate as needed
 Justifiable with wiggle room

QVET
Consulting, LLC

QVET
Consulting, LLC
Quality Validations, Experience, & Training

Email: [email protected]

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

ASTM Workshop on Medical 
Device Cleanliness

Steve Goldstine Consultants
[email protected]

11/16/2010 ASTM: Cleanliness of Medical Devices

ASTM Workshop on Medical 
Device Cleanliness

Standard Practices & Guides for 
Processing Reusable Medical 
Devices

11/16/2010 ASTM: Cleanliness of Medical Devices

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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Can we develop a standard guide or practice for cleaning and processing 
reusable devices for subsequent uses, particularly cannulated medical 
devices?

Standard Practice for Cleaning and Disinfection 
of Flexible Fiberoptic and Video Endoscopes 
Used in the Examination of the Hollow Viscera 
(ASTM F 1518‐00)

Standard Practice for Reprocessing of Reusable, 
Heat‐Stable Endoscopic Accessory Instruments 
(EAI) Used with Flexible Endoscopes 
(Reapproved 2007) (ASTM F 1992‐99)

11/16/2010 ASTM: Cleanliness of Medical Devices

Can we develop a standard guide or practice for cleaning and processing 
reusable devices for subsequent uses, particularly cannulated medical 
devices?

Standard Practice for Care and Handling of 
Orthopedic Implants and Instruments (ASTM 
F565 – 04‐ 2009)

Standard Guide for Care and Handling of 
Stainless Steel Surgical Instruments (ASTM 
F1744 – 96‐ 2008) 

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 117

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Can we develop a standard guide or practice for cleaning and processing 
reusable devices for subsequent uses, particularly cannulated medical 
devices?

Existing Guides & Practices:

• Update & Revise
• Add Discussion or Recommendations for 
Verification of Cleaning (non‐visual)

11/16/2010 ASTM: Cleanliness of Medical Devices

ASTM Workshop on Medical 
Device Cleanliness

Residual soil on reusable 
medical devices: A challenge to 
the standards community

11/16/2010 ASTM: Cleanliness of Medical Devices

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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Cleaning of Reusable Medical Devices
• Disease Transmission

• Occupational Exposure to Potentially
Infectious Materials

• Interference with Subsequent Disinfection or
Sterilization

• Device Performance

11/16/2010 ASTM: Cleanliness of Medical Devices

Visibly Clean & Device Design

• Serrated edges
• Hinges
• Acute angles
• Coils
• Junctions between insulating sheaths
• Long or narrow opaque lumens

11/16/2010 ASTM: Cleanliness of Medical Devices

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 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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Recent History

Designing, Testing, and Labeling Reusable 
Medical Devices for Reprocessing in Health 
Care Facilities: A guide for device 
manufacturers (AAMI TIR12—1994)

Labeling Reusable Medical Devices for 
Reprocessing in Health Care Facilities: FDA 
Reviewer Guidance (FDA‐1996)

11/16/2010 ASTM: Cleanliness of Medical Devices

Standard Test Methods
Standard Test Method for Determination 
of Effectiveness of Cleaning Processes for 
Reusable Medical Instruments Using a 
Microbiologic Method (Simulated Use 
Test) (ASTM E2314 – 03 ‐ 2008) 

Tests the efficacy of a cleaning process for 
reusable medical instruments artificially 
contaminated with mixtures of 
microorganisms and simulated soil.

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 120

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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Standard Test Methods
Standard Guide for Blood Cleaning Efficiency 
of Detergents and Washer‐Disinfectors (ASTM 
D7225 ‐ 06 )

Standard test soil correlating to coagulated 
blood suitable for screening tests and the 
evaluation of the cleaning efficiency of 
washer‐disinfectors used for reprocessing of 
surgical instruments. 

11/16/2010 ASTM: Cleanliness of Medical Devices

Cleaning Review
A compendium of processes, materials, test 
methods, and acceptance criteria for cleaning 
reusable medical devices (AAMI TIR30:2003) 

Compilation of available information that 
can be used by medical device 
manufacturers to validate cleaning 
processes for reusable medical devices.

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 121

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
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A Cleaning Review
A compendium of processes, materials, test 
methods, and acceptance criteria for cleaning 
reusable medical devices (AAMI TIR30:2003) 
• Device design & materials 
• Available cleaning processes
• Test soils
• Test methods, equipment, and acceptance 
criteria
• Regulatory considerations
11/16/2010 ASTM: Cleanliness of Medical Devices

Standard Test Methods

Washer‐disinfectors ‐‐ Part 1: General 
requirements, terms and definitions and tests 
(ISO 15883‐1:2006)

Defines general performance requirements 
for washer‐disinfectors and that are 
intended to be used for cleaning and 
disinfection of re‐usable medical devices. 

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 122

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Standard Test Methods
Part 1: General requirements, terms and definitions and tests (ISO 15883‐
1:2006 )

Part 2: Requirements and tests for washer‐disinfectors employing thermal 
disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, 
receivers, utensils, glassware, etc. (ISO 15883‐2:2006 )

Part 3: Requirements and tests for washer‐disinfectors employing thermal 
disinfection for human waste containers (ISO 15883‐3:2006)

Part 4: Requirements and tests for washer‐disinfectors employing chemical 
disinfection for thermolabile endoscopes (ISO 15883‐4:2008)

Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 
15883‐5:2005)
11/16/2010 ASTM: Cleanliness of Medical Devices

Standard Test Methods
Part 5: Test soils and methods for 
demonstrating cleaning efficacy (ISO/TS 
15883‐5:2005)

“The current state of knowledge has not permitted 
development of a single internationally 
acceptable test method”

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 123

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Standard Test Methods
Part 5: Test soils and methods for 
demonstrating cleaning efficacy (ISO/TS 
15883‐5:2005)
– The 19 test soils and methods from national 
standards and published documents
Blood Wallpaper Paste
Instant Potato Flakes Eggs / Egg Yolks

– Acceptance criteria are based on visual inspection 
(n=18)  and/or a microbiological end‐point (n=6).

11/16/2010 ASTM: Cleanliness of Medical Devices

Moving Forward
Part 5: Test soils and methods for 
demonstrating cleaning efficacy (ISO/TS 
15883‐5:2005)
Revision of Part 5:
1. Artificial Soil (organic)
2. Quantitative Endpoint
3. Standard Instrument Test Loads
4. [Need for relevant verification tests]

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 124

 Workshop on Medical Device Cleanliness: How Clean is Clean Enough?
Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

11/16/2010 ASTM: Cleanliness of Medical Devices

San Antonio, TX, November 16 2010 page 125