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A Proposed Cleaning Classification System For Reusable Medical Devices To Complement The Spaulding Classification

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Journal of Hospital Infection 145 (2024) 88e98

Available online at www.sciencedirect.com

Journal of Hospital Infection


journal homepage: www.elsevier.com/locate/jhin

Review

A proposed cleaning classification system for reusable


medical devices to complement the Spaulding
classification
T. Kremer a, d, *, N.J. Rowan a, b, c, G. McDonnell d
a
Centre for Sustainable Disinfection and Sterilization, Bioscience Research Institute, Technological University of the Shannon
Midlands Midwest, Athlone, Ireland
b
Department of Nursing and Healthcare, Technological University of the Shannon Midwest Mideast, Athlone, Ireland
c
SFI-funded CURAM Centre for Medical Device Research, University of Galway, Galway, Ireland
d
Microbiological Quality and Sterility Assurance, Johnson & Johnson, Raritan, NJ, USA

A R T I C L E I N F O S U M M A R Y

Article history: A central tenet in infection prevention is application of the Spaulding classification system
Received 21 June 2023 for the safe use of medical devices. Initially defined in the 1950s, this system defines
Accepted 22 November 2023 devices and surfaces as being critical, semi-critical or non-critical depending on how they
Available online 14 December will be used on a patient. Different levels of antimicrobial treatment, defined as various
2023 levels of disinfection or sterilization, are deemed appropriate to reduce patient risk of
infection. However, a focus on microbial inactivation is insufficient to address this con-
Keywords: cern, which has been particularly highlighted in routine healthcare facility practices,
Spaulding emphasizing the underappreciated importance of cleaning and achieving acceptable levels
Cleaning of cleanliness. A deeper understanding of microbiology has evolved since the 1950s, which
Reusable medical device has led to re-evaluation of the Spaulding classification along with a commensurate
Hospital-acquired infections emphasis on achieving appropriate cleaning. Albeit underappreciated, cleaning has always
Disinfection been important as the presence of residual materials on surfaces can interfere with the
Sterilization efficacy of the antimicrobial process to inactivate micro-organisms, as well as other risks
Patient risk to patients including device damage, malfunction and biocompatibility concerns.
Unfortunately, this continues to be relevant, as attested by reports in the literature on the
occurrence of device-related infections and outbreaks due to failures in processing
expectations. This reflects, in part, increasing sophistication in device features and reuse,
along with commensurate manufacturer’s instructions for use. Consequently, this con-
stitutes the first description and recommendation of a new cleaning classification system
to complement use of the traditional Spaulding definitions to help address these modern-
day technical and patient risk challenges. This quantitative risk-based classification sys-
tem highlights the challenge of efficient cleaning based on the complexity of device
features present, as an isolated variable impacting cleaning. This cleaning classification
can be used in combination with the Spaulding classification to improve communication of
cleaning risk of a reusable medical device between manufacturers and healthcare facili-
ties, and improve established cleaning practices. This new cleaning classification system

* Corresponding author. Address: Microbiological Quality and Sterility Assurance, Johnson & Johnson, 1000 Route 202 S Building 930, East Raritan,
NJ 08869, USA.
E-mail address: tkremer@its.jnj.com (T. Kremer).

https://doi.org/10.1016/j.jhin.2023.11.018
0195-6701/ª 2024 Published by Elsevier Ltd on behalf of The Healthcare Infection Society. This is an open access article
under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98 89
will also inform future creation, design thinking and commensurate innovations for the
sustainable safe reuse of important medical devices.
ª 2024 Published by Elsevier Ltd on behalf of The Healthcare Infection Society.
This is an open access article under the CC BY-NC-ND license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).

Introduction may only contact mucous membranes or non-intact skin.


Examples include flexible colonoscopes, gastroscopes and
The safe use of any medical device always requires collab- respiratory equipment. It is also recommended that these
oration between the manufacturer and the healthcare user. devices should be adequately cleaned and sterilized prior to
For sterile, single-use medical devices, the product is provided use. However, in many cases, they may be subjected to ter-
ready for use; however, safety can only be assured when the minal high-level disinfection (HLD) instead of sterilization
device is handled correctly during storage and use at the [1,5,7,8]. The purpose of HLD is to remove pathogens safely,
healthcare facility. The requirement for this collaboration but this may or may not include all dormant micro-organisms
becomes even greater with medical devices intended to be such as bacterial spores. Non-critical devices or instruments
processed prior to use or reuse by the healthcare facility. For may contact intact skin but do not penetrate it. Examples
reusable medical devices, greater responsibility for the miti- include blood pressure cuffs, stethoscopes and skin electrodes
gation of infection risk lies with the healthcare facility. This (non-critical patient care devices). They also include a variety
transfer of responsibility is communicated through manu- of equipment and environmental surfaces that may not contact
facturer’s instructions for use (IFU). As described in interna- the patient directly, but can become contaminated during use
tional standards, the medical device manufacturer must or over time in clinical practice (non-critical environmental
provide detailed processing instructions to ensure that, when surfaces). Recommended processing steps can include cleaning
followed correctly, the risk of patient infection or other com- alone or cleaning with disinfection, where the level of dis-
plications is minimized [1e3]. The processing IFU are intended infection can vary depending on the risk to patient or staff
to standardize the quality of the medical device as appropriate safety, as well as country-specific requirements [1,5,7,8].
to patient use. Product, including microbiological, quality is a The Spaulding classification focuses on the resistance of,
qualitative concept that encompasses all activities which and risks with, known micro-organisms (specifically pathogens)
provide confidence that a medical device is safe for its inten- in parallel with the criticality of the device in clinical use.
ded use, and is more than just a consideration of the presence Although more information about microbial resistance profiles
or absence of micro-organisms potentially remaining on a to inactivation is known today, this classification system, which
product. It includes residual chemicals or particulates which focuses on use of disinfection and sterilization practices, is just
may remain on a device following use and processing that may as applicable today as it was when it was developed over 50
also elicit an immune response in a patient [4]. years ago [5]. However, criticism on the foundational resist-
Earle H. Spaulding defined a classification system to address ance profiles of micro-organisms to inactivation has shown
the microbiological quality of medical devices processed within variability depending on the type of antimicrobial process
a healthcare facility in the 1950s [5]. This system needs to being employed (especially with chemical disinfectants) [5]. It
evolve in order to respond appropriately to the increasing has been reported previously that exposure to implicit stresses
complexity of reusable medical devices (e.g. endoscopes) since can enable treated micro-organisms to adapt otherwise-lethal
the late 1960s [5]. The Spaulding classification system for biocidal processes, particularly when embedded in complex
medical devices is based on the risk of transmission of infec- biofilms [9]. Another topic of debate is the persistence of
tions [1]. This risk is based on the level of contact the device micro-organisms on environmental surfaces [10]. Despite being
has with the patient. Devices are classified as critical, semi- ‘non-critical’ surfaces, the transmission of micro-organisms
critical or non-critical [6]. from these surfaces to patients and staff has highlighted the
Critical devices include those that contact ‘sterile’ tissues importance of surface disinfection, particularly with bacterial
(including blood and internal body spaces) during their use. spores (e.g. Clostridioides difficile), meticillin-resistant
Examples include surgical devices. It is recommended that Staphylococcus aureus and, increasing problematic, Gram-
these devices should be adequately cleaned, inspected and negative bacteria (e.g. Pseudomonas aeruginosa). In these
sterilized prior to patient use [1,5,7,8]. Semi-critical devices situations, it is not necessary or practical to ensure that these
surfaces are treated with sporicidal disinfectants/sterilants,
but does emphasize the importance of physical removal
Minimal Moderate Maximal (cleaning). Overall, these examples remind us to remain vigi-
lant in our understanding of microbiology and the potential for
unwanted microbial adaptation to frontline therapeutics and
disinfection practices. It is rare that reports of failure of the
Spaulding classification system have led to patient infections,
MIN MOD MAX when applied correctly. Unfortunately, it is more common that
reports of device-associated infections and other patient
complications with reusable devices/surfaces have arisen due
to incorrect processing practices [7]. A review of the literature
Figure 1. Examples of potential cleaning classification symbols. highlights common examples, such as inadequate device design
90 T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98
or maintenance, poor water quality used at important stages of doses (e.g. chemicals, ultraviolet light) [29]. It is now known
processing, use of inappropriate processing methods or anti- that dry biofilms are also a concern with reusable device pro-
microbial technologies, and poor environmental controls dur- cessing [34]. If biofilms are allowed to develop within a device,
ing storage and handling of devices. Moreover, the most the cleaning challenge is increased, as well as limitations to the
frequent reports appear to be related to failure of adequate access of antimicrobial processes for disinfection and even
cleaning, where a keyword search was completed using ‘pro- sterilization [33,35,36]. For example, Otter et al. [37]
cessing’ and ‘reusable medical device’. Of the 56 results, 18 reviewed the contribution made by interfering substances in
were relevant (Table I). It should be noted that an important, supporting microbial survival (e.g. surface-attached cells and
yet underappreciated, consideration underpinning the earliest biofilms) on hospital contact surfaces and reducing biocidal
use of Spaulding’s classification was that medical devices are efficacy. The authors advocated that new approaches to hos-
clean prior to disinfection or sterilization. This assumption pital cleaning and disinfection are required, including the
does not take into consideration the increasing number of potential use of appropriate novel materials to reduce micro-
different medical devices with highly complex device features bial attachment to surfaces. There is also a commensurate
that are not easy to clean, which reflects the dynamic and need to elucidate the complex nature and physiology of
evolving needs of modern-day medicine. microbes on dry hospital surfaces, which takes into consid-
Cleaning, defined as the removal of soil to the extent nec- eration the prevalence and composition of biofilms and
essary for further processing or for intended use [11], is cleaning/disinfection.
essential, and it has been demonstrated repeatedly in the lit- There has also been interest in defining the scientific end-
erature that cleaning failures are a root cause of failing points for cleaning in the last 30 years. Part of this was due to
decontamination of reusable medical devices [5,12]. Many the characterization of proteinaceous infectious particles
articles over the last 50 years have highlighted the need for (prions), and particular emphasis on risks of protein con-
more attention on the cleaning process related to medical tamination on reusable medical devices in the wake of the
devices with complex features, with increasing focus on the bovine spongiform encephalopathy crisis in the UK and other
relationship between cleaning difficulty and hospital-acquired countries [19]. However, in parallel, there continued to be
infections (HAIs) [13]. reports of outbreaks and potential patient risks with surgical
devices that may not have been cleaned effectively, and the
How clean is safe? risks of transmission of blood-borne pathogens. It is known
from experience that many such episodes occurred but were
At the time the Spaulding classification was widely adopted, not published, so the published literature may have under-
the detailed measurement techniques or endpoints for deter- estimated the true extent of the risk to patients. To address the
mining cleanliness had yet to be established. Visual cleanliness risk of devices not being cleaned effectively, efforts have since
was the expectation, and the Spaulding classification system been completed at international level to establish cleaning
was established with the foundational assumption that all performance requirements during the processing of reusable
devices would be visibly clean prior to the microbial reduction medical devices and medical device manufacturers/healthcare
step of disinfection or sterilization. It was assumed that vigo- facilities to establish and monitor the effectiveness of the
rous cleaning would always be performed, and, in many cases, cleaning instructions. For washer-disinfectors (WDs), the
devices (and their associated features) could be inspected International Standards Organization (ISO) 15883 series was
quickly during or following the cleaning process. If the device first published in 2006 by an international group of experts [38].
was visibly clean, it was assumed that the residual soil level The intention of this standard series was to require WD man-
was sufficiently low to ensure that the antimicrobial process ufacturers and users to have shared responsibility for the
would be effective, even in the presence of some residual soil. effectiveness of cleaning (and disinfection) of the equipment.
In regulatory approval requirements worldwide [39,40], the However, even at the time of publication, there was no con-
effectiveness of disinfection or sterilization products/methods sensus agreement on the definition of ‘clean’, the acceptable
was required to demonstrate activity in the presence of endpoints for a cleaning process, and validation methods to
residual soil. Microbial reduction studies (i.e. disinfection and demonstrate cleanliness under laboratory or clinical con-
sterilization) are typically investigated under laboratory con- ditions. The standards at this stage deferred to country-specific
ditions with little (e.g. micro-organism titre with 5% bovine guidance that varied widely.
serum) or no soil remaining on the device. The resistance Following initial publication, a concerted effort was made
profile of the most resistant micro-organism to the process may by these committees to gain an internationally harmonized
change in the presence of soil, depending on soil components, consensus on cleaning requirements. This culminated suc-
as demonstrated by spore survival studies [32]. cessfully in the recently published updated versions of ISO
Another example centres on the development of complex 15883-1 and ISO 15883-5. While ISO 15883-1 provides general
biofilms in or on device surfaces harbouring problematic micro- requirements for all WDs, ISO 15883-5 focuses solely on the
organisms, a concept that was not considered initially by cleaning requirements. This includes a two-phase evaluation
Spaulding. Roberts et al. described traditional conditions for cleaning efficacy with performance criteria commensurate
required for biofilms to develop, including the presence of to patient safety. The two phases include simulative (type
colonizing micro-organisms, surface to be colonized, sufficient testing) and clinical or typical use conditions (performance
nutrients and water, temperature conditions for growth, and qualification). A major consideration in simulative testing is the
time required for development [33]. Micro-organisms har- choice and method of application of test soils to WD loads,
boured in biofilms exhibit reduced metabolism or switch to a chamber walls and load carriers [39]. The test soil is expected
dormant state (if endospore formers), and can be protected to be proteinaceous (unless otherwise justified for the inten-
from the otherwise-lethal action of biocides at typical labelled ded use of the equipment), justified based on its relevance to
Table I
Examples of reports of healthcare-associated infections due to lapses in medical device decontamination
Source Micro-organism(s)/ Outbreak or infection summary Patient impact Device issue
contaminate
involved
Srinivasan P. aeruginosa Outbreak of P. aeruginosa associated with A total of 414 patients underwent 665 The contamination appeared to be related
et al., lapses in processing best practices including bronchoscopic procedures during the to a loose biopsy port cap on the
2003 [14] a contaminated, loose biopsy port cap in outbreak. The rate of recovery of bronchoscopes, which may have sheltered
bronchoscopes. Bronchoscopes were P. aeruginosa from bronchoalveolar lavage organisms and thus rendered disinfection
cleaned by trained personnel in accordance specimens obtained using endoscopy suite procedures ineffective.
with national guidelines and the bronchoscopes increased from a mean of

T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98


manufacturer’s recommendations (Olympus 10.4% at baseline to 31.0% during the
America). Bronchoscopic and reprocessing outbreak. There were 48 infections among
procedures were observed during random, 39 of the 414 patients (9.4%) in the 2 weeks
unannounced visits. No significant breaches after bronchoscopy. Based on the authors’
in technique were observed. definition, exposure to a potentially
contaminated bronchoscope may have had a
role in the death of three patients, all of
whom were critically ill at the time of
bronchoscopy.
Muscarella, P. aeruginosa Literature review following laryngoscopy Authors focused on a single case study where Rigid laryngoscopes within the USA are
2008 [15] and suggestion for increased standardization 15 infants were infected, with two fatalities classified as Class 1 devices and are exempt
for manufacturer’s processing instructions. [16]. Literature review recommended the from the Food and Drug Administration
use of sterile disposable sheaths to mitigate oversight. Decontamination instructions,
contamination risk. therefore, vary widely from manufacturer to
manufacturer. The handle and blade of
laryngoscopes have been reported with
residual soil.
Cabronne K. pneumoniae KPC-producing K. pneumoniae type 2 multi- Within 6 weeks, 12 patients were identified The duodenoscope was the only device used
et al., hospital outbreak due to what was as having an HAI with the same molecular commonly among the infected patients.
2010 [17] suspected to be an ineffectively processed typing. Although culturing of the duodenoscope did
duodenoscope. not recover the micro-organism, it was
suspected that this was due to reprocessing
after the contamination, and ineffective
cleaning of the channels was the primary
cause of the outbreak. The duodenoscope
was sent back to the manufacturer for
repair, so no additional analysis was
completed.
Williams Enterococcus spp. Evidence demonstrating HAI risk from lack of Patient-ready laryngoscopes were cultured The design feature of the handle was
et al., S. aureus decontamination of laryngoscope handles. using a swabbing technique to demonstrate evaluated, resulting in a higher occurrence
2010 [18] Klebsiella spp. that 86% of the handles were contaminated of bacteria residing on the knurled surface
Acinetobacter spp. with one or more species of bacteria. compared with the smooth surface. When in
the closed position, the patient-contacting
blade folds against the handle. This study
(continued on next page)

91
92
Table I (continued )
Source Micro-organism(s)/ Outbreak or infection summary Patient impact Device issue
contaminate
involved
confirms that laryngoscope handles can be a
vector for transmission of infection.
Kovaleva Most commonly: Literature review of the challenges with It is estimated that 6% of patients will Endoscopes have a complex design with
et al., Salmonella spp. flexible endoscopy. This meta-analysis is a experience an HAI due to improper infection internal lumens and multiple channels that
2013 [19] P. aeruginosa comprehensive review of 379 sources control procedures. are easy to damage and difficult to clean.
Mycobacteria evaluating the infection risk from flexible
endoscopes.

T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98


Lowman and Enterobacter spp. Ineffective decontamination of A contamination rate of 57.3% in a South Guidelines within the region specify that
Venter, A. baumannii laryngoscope blades is a source of microbial African healthcare facility was reported laryngoscope blades should be cleaned and
2013 [20] contamination and patient risk. from a total of 110 laryngoscope blades disinfected as a semi-critical device. Blades
swabbed for micro-organism recovery. were soaked and scrubbed prior to rinsing
and high-level disinfection. The rate of
contaminated samples indicates that either
the decontamination procedure for the
blades is ineffective, or there is
contamination from the unprocessed handle
or from handling during assembly.
Negri de Non-specific Literature review of cross-infection risk Non-specific literature review. As summarized in this literature review, the
Sousa literature review from laryngoscope blades and handles. 20 laryngoscope is comprised of many pieces
et al., studies were evaluated. that have features of varying complexity,
2013 [21] including rows and furrows, that may hinder
the decontamination process.
Magill et al., C. difficile Additional study by authors to look at Surveys conducted in 183 hospitals found Device-specific information was not
2014 [22] multiple facilities (183 hospitals) for the that, out of 11,282 patients, 452 provided in this analysis, but the authors
detection of HAIs. Of the 11,282 patients, 4% experienced an HAI (4.0%). Device- recommend that devices should be reviewed
were identified with an HAI. associated infections accounted for 25.6%. as a vector for infection transmission.
Kola et al., K. pneumoniae Investigation of a German outbreak with the 7 of 13 cases of K. pneumoniae in two French Duodenoscopes must be thoroughly dried
2015 [23] root cause being a contaminated hospitals were associated with a and reprocessed after a long period of
duodenoscope. contaminated duodenoscope. Extraction of storage. Special handling is required to
the scope channels was conducted by reduce the contamination risk for
flushing 100 mL of sterile water through the duodenoscopes.
channel and collecting it for microbial
cultures.
Marsh et al., K. pneumoniae HAI outbreak investigation with root cause Pulsed-field gel electrophoresis and multi- Authors state that this evidence supports
2015 [24] being endoscopes. locus sequencing were used to evaluate 43 the growing body of literature that
K. pneumoniae patient isolates. Two endoscopes are a risk for bacterial
clusters were recovered from endoscopes. transmission.
Ofstead Protein Monitoring of 60 colonoscopes and Individual channels were swabbed and Contamination was reduced with each stage
et al., Total organic gastroscopes in a clinical setting with extracted using the flushebrusheflush of the reprocessing step. However, patient-
2015 [25] carbon demonstration of microbial contamination method with 20 mL of water and a 6-mm ready devices, disinfected and stored,
Adenosine despite compendial processing protocols. brush. Samples were collected after each contained microbial contamination.
triphosphate cleaning step (i.e. bedside, manual, Cleaning of endoscope channels is time-
disinfected and stored). Of the 60 samples consuming and can be overlooked in
collected, 92% of the scopes cleaned at the practice. The distal end of duodenoscopes
bedside, 46% of scopes manually cleaned, provides a particular challenge for cleaning
64% of scopes that underwent high-level due to the elevator guidewire. Colonoscopes
disinfection and 9% of stored scopes and gastroscopes have multiple channels,
contained micro-organisms. ports and valves that increase the risk of
ineffective cleaning.
Davis, 2017 Non-specific Compilation of data reporting the rate of Meta-analysis of reported events related to Authors hypothesize that the medical device
[26] literature review bioburden per patient claim records. There surgical instruments. An increase in incident design, which includes compound hinges,
is an increasing trend of bioburden reporting is evident. gaps, channels and lumens, can result in
prevalence. bioburden accumulation and subsequent

T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98


development of biofilm.
Rauwers E. cloacae Dutch study where duodenoscopes within 73 Dutch ERCP centres submitted Results indicated that a specific design
et al., E. coli the clinical setting were cultured and duodenoscopes for microbial screening. feature on the TJF-Q180V did not allow for
2018 [27] K. pneumoniae demonstrated high levels of bioburden post Samples were collected by flushing the adequate cleaning and disinfection. In
processing. channels with sterile physiological saline. addition to the design features being a risk
15% of the duodenoscopes from 39% of the factor, the age of the device is also a
facilities had microbial contamination in a contributing factor. The brush, forceps
patient-ready state. elevator and protection cap had the highest
occurrence of microbial contamination.
Rahman P. aeruginosa Literature review of duodenoscope- 16 publications were included in this The elevator channel is a key feature that
et al., associated HAIs due to difficult-to-remove literature review from 2000 to 2018 focusing predisposes the duodenoscope to
2019 [28] biofilm. on ERCP-associated outbreaks. contamination.
Shenoy K. pneumoniae HAI investigation with transmission Case study where the transmission of mcr-1- The distal cap defect likely allowed material
et al., associated with a duodenoscope. positive K. pneumoniae for two patients was to penetrate a sealed area that was not
2019 [29] caused by a contaminated duodenoscope as accessible for cleaning. Authors advocate
the epidemiological link. K. pneumoniae was increased awareness of duodenoscope
recovered from the biopsy channel and design with an emphasis of single-use
distal tip. components.
Ofstead Non-specific Literature review of duodenoscope-related Literature review consisting of evidence Reprocessing failures may occur as a result
et al., literature review HAIs and discussion around risk mitigation. suggesting the rate of infection is 1 in 1765 of the complex design that includes elevator
2020 [30] or as many as 10% of ERCP procedures. mechanisms in the distal end and open
wires/channels that are exposed to patient
soil. Suction-biopsy channels are also a
source of residual contamination.
Okamoto S. aureus US study investigating the contamination 859 new-model duodenoscopes (TJF-Q180V) The authors witnessed reprocessing errors in
et al., S. lugdunensis rate of duodenoscopes after processing. and 850 older model duodenoscopes (TJF- 27.7% of the procedural reviews, and
2022 [31] B-haemolytic 160F/VF) were extracted for microbial recommend increased awareness of the
streptococcus, contamination using the flushebrusheflush processing instructions with ongoing staff
Enterococcus spp. method with sterile water. The detected training programmes.
contamination rate for these patient-ready
duodenoscopes was 5.3%.
P. aeruginosa, Pseudomonas aeruginosa; K. pneumoniae, Klebsiella pneumoniae; S. aureus, Staphylococcus aureus; A. baumannii, Acinetobacter baumannii; C. difficile, Clostridioides
difficile; E. cloacae, Enterobacter cloacae; E. coli, Escherichia coli; S. lugdunensis, Staphylococcus lugdunensis; HAI, hospital-acquired infection; ERCP, endoscopic retrograde
cholangiopancreatography.

93
94 T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98
the intended use [40] as protein is the major contaminant Processing residuals are also assessed to evaluate patient
detected on reusable devices following clinical use [41]. In impact [48] or an impact on further processing.
addition, the test soil must meet new performance criteria The ISO 15883-5 acceptance criteria have also been
[40,42]. The test method was developed by an interlaboratory harmonized in the requirements established recently in the
collaboration, and based on investigations using coagulating USA for the validation of cleanliness requirement for reusable
blood as a widely used test soil and protein concentration as medical devices [49]. ANSI/AAMI ST98:2022 and the US Food
the analyte criteria. and Drug Administration guidelines detail the conditions in
The testing conditions in which the WD is challenged are which the processing steps for cleaning must be challenged to
intended to simulate worst-case conditions for the devices mitigate the risk of residuals past the point of visual cleanliness
expected to be cleaned in the WD. As performance testing is for reusable medical devices [8,49].
carried out in both a laboratory setting and a clinical setting, The established industry acceptance criteria are supported
the choice of challenge test soil is a critical element of the by the literature, where the primary analyte (i.e. protein) has
evaluation. Using the soil validation test method in Annex B of been evaluated for patient safety [50], and the other analytes
ISO 15883e5:2021 and the soil analyte concentration from the have been established as clinically relevant and measurable
literature [41,43], a comparison of soil performance allows for [51]. The two levels of acceptance criteria provide a level of
standardization when assessing both phases of the cleaning safety within the test system that accounts for variability in the
efficacy test. In addition to the choice of test soil, the device is analyte detection method as well as test system variables that
expected to be soiled as it would be in normal use. For exam- can impact detectability (e.g. sample extraction [44]). A risk
ple, the medical device should be soiled in a manner that is assessment allows the appropriate level to be identified to
representative of clinical use with actuation, exposure to ensure patient safety. For example, if during the cleaning
extreme temperatures (e.g. to simulate cauterization), simu- validation medical device manufactures must be below the
lated use of accessory chemicals (e.g. lubricants or other action level with the most challenging cleaning conditions
chemicals used during surgery), and drying prior to cleaning. included in the experimental design, it may be appropriate
The effectiveness of the method to remove the analyte from during verification testing at a healthcare facility to obtain
the device (i.e. extraction) [44] and the analyte detection results below the alert level for an extra margin of safety.
method must also be evaluated [45]. WDs can be designed for
the cleaning of single or multiple devices with various device Evaluation of risk
features (e.g. lumens or internal moving parts) that can be a
challenge to cleaning effectiveness; therefore, representative ISO 14971 describes the evaluation of risk as being a process
worst-case loads should be defined for testing purposes. This of comparing an estimated risk against a risk criteria to
programme for standardization demonstrates confidence determine the acceptability of that risk [52]. The hazardous
across the supply chain that the WD equipment will perform as situations at the healthcare facility leading to the inadequate
expected under worst-case conditions. processing of a reusable medical device can include human
In addition to the traditional requirement for visual clean- factors (e.g. inadequate training) leading to the inability to
liness, the ISO 15883 series now defines acceptance criteria for execute the required cleaning process [13], the time before or
specific analytes when measuring cleaning efficacy. Quantita- during the decontamination process that can lead to increased
tive, analytical test methods are justified for use based on a cleaning challenge [53], available processing equipment, and
risk assessment, with protein detection being highlighted as a effective process monitoring practices. The estimated risk for
recommended analyte. The acceptance criteria for analytes inadequate decontamination is expressed in terms of patient
have been defined as both alert and action levels (Table II). risk for potential infection/biofilm formation, other adverse
Detection levels of analytes below alert levels over multiple immune responses (e.g. tissue damage or toxicity reactions
test cycles are considered ‘clean’, but those falling between from process residuals), or surgical complications/cancella-
alert and action levels are to be further investigated as they tions/delays or device damage. Medical device manufacturers,
are considered to be at high risk of failure over time. This was when developing the IFU, should assess the acceptability of the
designed to minimize the risk of soil accumulation or periodic, risk of inadequate cleaning, and mitigate any significant risk by
insufficient cleaning during normal use of the WD. These levels either including device designs with features that are com-
have been defined, but the standard does note that country- patible for cleaning, or providing robust instructions that are
specific requirements may also need to be considered, such validated to be reproducible.
as levels of total protein per device [46] or device side [47]. It is reasonable to expect that processing instructions will be
followed faithfully at the healthcare facility, defined by AAMI
ST79 as any ‘specialized facility where professionals deliver
Table II services utilizing medical devices’ [54], using validated
Analyte acceptance criteria for cleaning efficacy equipment that accommodates many decontamination pro-
Analyte Alert level Action level cesses. However, this has many challenges, including a wide
Protein 3 mg/cm 2
6.4 mg/cm2
range of staff training, in-depth knowledge of each device/set
Total organic carbon 6 mg/cm2 12 mg/cm2
of instructions, and the fact that processing instructions can
Carbohydrate 0.9 mg/cm2 1.8 mg/cm2
vary significantly between manufacturers. The reality is that
Haemoglobin 1 mg/cm2 2.2 mg/cm2
sterile or device processing personnel are juggling many
ATP 10 femtomoles 22 femtomoles
products, and handle products the best they can, in established
ATP/cm2 ATP/cm2
processes that have been put in place for the efficient
Endotoxin 2.2 EU/device 20 EU/device
throughput of their facility [55]. This challenge is compounded
when an increasing number of devices with unique processing
T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98 95
instructions are purchased, even though they have many sim- described in the literature [58], and evaluated by standards
ilarities in device complexity. The pressures on equipment and organizations with the intent to inform medical device manu-
sterile processing departments to meet healthcare needs facturers on the cleaning steps that may need to be included in
cannot be underestimated. In these cases, it seems logical to the cleaning IFU based on the device features. Michels et al.
increase throughput and consistency such that groups of devi- described an example based on current validations for reusable
ces can be processed together using the same steps and obtain medical devices, regarding how they can be grouped based on
the same endpoints despite the IFU provided [56]. There is feature, but did not assess the probability of the risk of soil
currently no global industry guidance for how to adopt devices accumulation based on the feature [59]. AAMI TIR12:2020
into such processes using a family grouping strategy. ISO 17664- Annex D logically describes three device categories based on
1 outlines what instructions must be included in the device IFU cleaning processes designated by device complexity. Category
based upon risk to provide sufficient instructions for device 1 devices are simple devices that can be processed using
processing [1]. As such, it is left to the discretion of the device manual or automated cleaning methods. Category 2 devices
manufacturer to identify the level of detail provided. For have features that require human intervention, such as
example, complex devices may have pages of cleaning brushing, to remove soil which is difficult to clean. Category 3
instructions, whereas simple devices have a single paragraph. devices require sonication to aid in the removal of soil that is
It remains the expectation that each IFU will be followed not accessible or is difficult to remove using brushing and
exactly [54], but this is not practical considering the number of flushing [57]. The categorization of these groups was com-
devices processed each day. pleted by evaluating the cleaning IFU for marketed devices,
Standardization efforts to develop decontamination process and applying them to the complexity of device features of the
flows based on device risk have been an initiative of various medical device. The assumption of this evaluation is that the
standard committees over the last 10 years, and some have IFU contains all necessary steps for cleaning the applicable
been deployed based on the geographical region. For example, device, but no guidance is given regarding how to assess the
the US guidance for device manufacturers, AAMI TIR 12 Annex D device for each category.
and E, recommends processing instructions depending on the A cleaning risk-based approach is proposed that considers
device category and based on difficulty of cleaning [57]. In the probability of risk for residual soil to remain on or in the
Germany, the responsibility shifts to the healthcare facility, various design features of a device following cleaning. For
with the requirement of a process qualification to validate the effective cleaning to occur, the cleaning chemistry (cleaning
cleaning process. The qualification is an assessment of cleaning agent and water) must have access to the soil with enough
performance for the processing steps, and will typically use a exposure (e.g. spray, soak) or force (e.g. brush, flush, soni-
worst-case device or surrogate device as the process challenge cation) to solubilize and remove the residual soil for surface
device. There is often a stronger emphasis placed on complete removal. The device feature is, therefore, the key variable of a
automated processes for cleaning, and the associated reusable medical device that can influence this relationship.
requirements for qualification of cleaning processes are Three categories have been established to describe this risk,
described in ISO 15883-1 [39]. However, it is still at the dis- and are described in Table III.
cretion of the healthcare facility to group devices and adopt The cleaning classification uses device features as the key
them into the appropriate processing procedures. elements for risk analysis for the device cleaning process. As
Device manufacturers have a similar barrier in validating described previously, the device feature approach provides a
each device within a product portfolio that may be comprised more conservative estimate of residual analytes on a reusable
of thousands of devices. An efficient approach to this is the medical device, and allows for identification of the most
identification and use of representative product families, and probable location for soil accumulation, and thereby risk to the
validation of the worst-case designs with demonstrated com- cleaning process. This approach allows the medical device
monality in device materials, design features, intended use manufacturer to assess the risk during the development and
and clinical soil exposure. Processing instructions must be the
same for each device in such product families [1,8,57].
Table III
Cleaning classification Cleaning classification
Risk category Description
When the Spaulding classification was introduced, it pro- Maximal Complex device features with a
vided a necessary framework for manufacturers, regulators high probability of soil
and healthcare personnel to consistently deliver an appro- accumulation with a medical
priate microbiological reduction for devices. However, when device
using the Spaulding classification alone, the entirety of the Moderate Accessible device features that
microbiological quality of the reusable medical device is not require specific intervention (e.g.
considered, as the risk to ensure cleaning is not considered in brushing or flow through lumens,
detail. The introduction of a complementary cleaning classi- mated surfaces requiring
fication system would allow for effective communication disassembly or opening/closing to
between medical device manufacturers and healthcare facili- ensure access)
ties on the proper risk mitigation for associated cleaning Minimal Low-risk reusable medical devices
processes. where all features are exposed
For each device design and associated cleaning process, without specific intervention for
there is a probability of soil retention. This relationship can be cleaning
quantified to assess risk. This relationship has been well
96 T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98
validation of the device processing IFU, and to bring the device design, and ensure that risks are clearly communicated
attention of the healthcare personnel to these high-risk areas and mitigated at healthcare facilities. The Spaulding classi-
(e.g. focus on inspection protocol) [60]. Consider a device fication provides an easy mechanism to connect manufacturers
where the geometry seems simple but, when evaluating the and healthcare facilities regarding how devices must be vali-
features for the cleaning challenge, the device contains a dated and processed. By complementing this with a classi-
lumen [the most difficult-to-clean feature [61] with a junction fication to assess the cleaning risk in more detail, the
point (i.e. bend)]. If evaluating the entire device during the appropriate processing methods can be defined and optimized,
cleaning validation, the surface area of the whole device may thereby further decreasing the risk to patient safety. This
dilute the residual protein concentration from the lumen, and combined approach can help safeguard against and tackle the
under-report patient risk [59]. emergence of increasingly recalcitrant microbial pathogens,
For example, if a medical device is used to flush a solution including drug-resistant fungi [62,63].
into a patient, the lumened portion of the device is the highest
risk feature, as the fluid pathway of the lumen will deposit fluid Conflict of interest statement
into the patient whereas the rest of the device is only com- None declared.
municating externally. Although other features within the
device may be difficult to clean, if the surface of the lumen has Funding sources
direct contact with the fluid being flushed through it, remain- None.
ing soil in the lumen is of the highest risk to the patient. Once
fluid flows through the lumen, any residual soil solubilized in
the fluid pathway and inserted into the patient becomes a References
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