A Proposed Cleaning Classification System For Reusable Medical Devices To Complement The Spaulding Classification
A Proposed Cleaning Classification System For Reusable Medical Devices To Complement The Spaulding Classification
A Proposed Cleaning Classification System For Reusable Medical Devices To Complement The Spaulding Classification
Review
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/).
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.
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
major concern. When using the typical recommended method
to determine cleaning efficacy, it is typical for the entire sur- [1] International Organization for Standardization. ISO 17664-1.
face area of the device (or, in some cases, each side of a Processing of health care products e information to be provided
device) to be used to calculate the residual concentration by the medical device manufacturer for the processing of medical
compared with the surface area [49]. This method may under- devices. Geneva: ISO; 2021.
report the concentration of residual soil in the most difficult- [2] International Organization for Standardization. ISO 17664-2.
Processing of health care products e information to be provided
to-clean portion of the device, diluting the analyte to below
by the medical device manufacturer for the processing of medical
the limit of detection for the test method. However, when
devices. Part 2: Non-critical medical devices. Geneva: ISO; 2021.
using the device feature approach, the most difficult-to-clean [3] World Health Organization. Decontamination and reprocessing of
area of the medical device is scrutinized for cleanability, and medical devices for health-care facilities. Geneva: WHO; 2016.
reported against the established acceptance criteria. The [4] McDonnell G, Hansen J. Principles of antimicrobial activity. In:
device feature approach is therefore the most appropriate and McDonnell G, Hansen J, editors. Block’s disinfection, sterilization
conservative method for a risk assessment. and preservation. 6th ed. Philadelphia: Wolters Kluwer; 2020.
This cleaning classification is a quantitative risk-based cat- p. 68e119.
egorization approach utilizing the probability of soil accumu- [5] Spaulding E. Chemical disinfection and antisepsis in the hospital.
lation for the challenging device feature. It can provide J Hosp Res 1957;9:5e31.
[6] Rowan N, Kremer T, McDonnell G. A review of Spaulding’s clas-
guidance to manufacturers to improve the design for clean-
sification system for effective cleaning, disinfection, sterilization
ability, and how to label the medical device within the IFU to
or reusable medical devices: viewed through a modern-day lens
communicate the cleaning risk effectively to healthcare per- that will inform and enable future sustainability. Sci Total Environ
sonnel. Examples of associated symbols with a description of 2023;878:162976.
the device feature that resulted in the categorization are [7] Spaulding E. Chemical disinfection of medical and surgical
suggested for inclusion within the IFU (Figure 1). Communica- materials. In: Lawrence C, editor. Block disinfection, steri-
tion of this information to the healthcare facility can inform lization, and preservation. Philadelphia: Lea & Febiger; 1968.
the device risk for cleaning, and alert when special consid- p. 517e31.
erations for equipment or training are required to ensure [8] Food and Drug Administration. Reprocessing medical devices in
effective and consistent processing. Using the medical device health care settings: validation methods and labeling guidance
for industry and Food and Drug Administration staff. White Oak,
example from above, the cleaning classification might be set as
MD: FDA; 2015.
‘maximal’, leading the manufacturer to require enhanced
[9] McEvoy B, Rowan N. Terminal sterilization of medical devices
visual inspection steps (e.g. use of borescope) to assess it for using vaporized hydrogen peroxide: a review of current methods
cleanliness and mitigate risk. and emerging opportunities. J Appl Microbiol 2019;127:1403e20.
[10] Donskey C. Does improving surface cleaning and disinfection
Decontamination risk mitigation reduce health care-associated infections? Am J Infect Control
2013;41:S12e9.
Ineffective device processing is a major risk for HAIs and [11] McDonnell G, Baseman H, Cordie-Bancroft L. Words matter: a
other patient complications. Complex features of devices can commentary on a glossary of definitions for microbiological
make visual inspection and monitoring for cleanliness difficult, quality. Biomed Instrum Technol 2021;55:143e64.
[12] McDonnell G, Burke P. Disinfection: is it time to reconsider
thereby increasing the risk of soil accumulation and biofilm
Spaulding? J Hosp Infect 2011;78:163e70.
development. Medical device manufacturers can use this [13] Kremer T, Murray N, Buckley J, Rowan N. Blending immersive and
cleaning classification in conjunction with the Spaulding defi- educational technologies to unlock appropriate training for effec-
nitions to assess the risk for the entire decontamination proc- tive cleaning and processing of reusable medical devices that
ess for reusable medical devices. This can improve cleaning safeguards patient health e quo vadis? Sci Total Environ 2023;900:
and disinfection/sterilization validation methods, improve 165673.
T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98 97
[14] Srinivasan A, Wolfenden L, Song X, Mackie K, Hartsell T, Jones H, [35] Alfa M. Biofilms on instruments and environmental surfaces: do
et al. An outbreak of Pseudomonas aeruginosa infections asso- they interfere with instrument reprocessing and surface dis-
ciated with flexible bronchoscopes. N Engl J Med 2003;348:221e7. infection? Review of the literature. Am J Infect Control
[15] Muscarella L. Reassessment of the risk of healthcare-acquired 2019;47:A39e45.
infection during rigid laryngoscopy. J Hosp Infect 2008;68:101e7. [36] Vickery K, Hu H, Jacombs A, Bradshaw D, Anand D. A review of
[16] Chang A. Hospital policy eyed in L.A. outbreak. Associated Press; bacterial biofilms and their role in device-associated infection.
21 December 2006. Healthcare Infect 2013;18:61e6.
[17] Cabronne A, Thiolet JM, Fournier S, Fortineau N, Kassis- [37] Otter J, Cickery J, Walker J, deLancy Pulcini E, Stoodley P,
Chikhani N, Boytchev I, et al. Control of a multi-hospital outbreak Goldenberg S, et al. Surface-attached cells, biofilms and biocide
of KPC producing Klebsiella pneumoniae type II in France, Sep to susceptibility: implications for hospital cleaning and disinfection.
Oct 2009. Euro Surveill 2010;15:19734. J Hosp Infect 2015;89:16e27.
[18] Williams D, Dignley J, Jones C, Berry N. Contamination of lar- [38] International Organization for Standardization. ISO 15883-1.
yngoscope handles. J Hosp Infect 2010;74:123e8. Washer-disinfectors e Part 1. General requirements, terms and
[19] Kovaleva J, Peters F, van der Mei H, Degener J. Transmission of definitions and tests. Geneva: ISO; 2006.
infection by flexible gastrointestinal endoscopy and brochoscopy. [39] International Organization for Standardization. ISO/DIS 15883-1.
Clin Microbiol Rev 2013;26:231e54. Washer-disinfectors e Part 1. General requirements, terms and
[20] Lowman W, Venter LSJ. Bacterial contamination of re-usable definitions and tests. Geneva: ISO; 2021.
laryngoscope blades during course or daily anaesthetic practice. [40] International Organization for Standardization. ISO 15883-5.
S Afr Med J 2013;103:386e9. Washer-disinfectors e Part 5. Performance requirements and test
[21] Negri de Sousa A, Levy C, Freitas M. Laryngoscope blades and method criteria for demonstrating cleaning efficacy. Geneva:
handles as sources of cross-infection: an integrative review. ISO; 2021.
J Hosp Infect 2013;83:269e75. [41] Cloutman-Green E, Canales M, Zhou Q, Ciric L, Hartley J,
[22] Magill S, Edwards J, Stat M, Bamberg W, Beldavs Z, Dumyati G, McDonnell G. Biochemical and microbial contamination of surgi-
et al. Multistate point-prevalence survey of health care- cal devices: a quantitative analsyis. Am J Infect Control
associated infections. N Engl J Med 2014;370:1198e208. 2015;43:559e661.
[23] Kola A, Piening B, Pape U, Veltzke-Schlieker W, Kaase M, [42] Kremer T, Bancroft R, Patel Z, Owen M, McDonnell G.
Geffers C, et al. An outbreak of carbapenem-resistant OXA-48- A standardized method for evaluating test soils used to demon-
producing Klebsiella pneumoniae associated to duodenoscopy. strate cleaning efficacy. J Hosp Infect 2022;126:52e5.
Antimicrob Resist Infect Control 2015;4:8. [43] Kremer T, Tortora A, Yeung Y, McDonnell G. Material adhesion
[24] Marsh J, Krauland M, Nelson J, Schlackman J, Brooks A, comparison of test soils for reusable device cleaning efficacy.
Pasculle A, et al. Genomic epidemiology of an endoscope- Zentral Steril 2021;29:166e72.
associated outbreak of Klebsiella pneumoniae carbapenemase [44] Kremer T, Kulkarni K, Ratanski C, Floyd L, Anderson C. Con-
(KPC)-producing K. pneumoniae. PLoS One 2015;10:e0144310. necting across competencies: leveraging best practices for pro-
[25] Ofstead C, Wetzler H, Doyle E, Rocco C, Visrodia K, Baron T, et al. cessing. Biomed Instrum Technol 2021;55(Suppl. 3):6e11.
Persistent contamination on colonoscopes and gastroscopes [45] Kremer T, Kimble A, Ratanski C. Improving protein assay methods
detected by biologic cultures and rapid indicators despite to more accurately assess medical device cleanliness. Biomed
reprocessing performed in accordance with guidelines. Am J Instrum Technol 2023;57:122e8.
Infect Control 2015;43:794e801. [46] German Society for Hospital Hygiene (DGKH), German Society for
[26] Davis J. Retained bioburden on surgical instruments after Sterile Supply (DGSV), Working Group Instrument Preparation
reprocessing: are we just scraping the surface? Pennsylvania (AKI). Hygiene requirements for the reprocessing of medical
Patient Safety Advisory 2017;14:71e5. devices. Federal Institute for Drugs and Medical Devices: Bonn,
[27] Rauwers A, Voor In ’t Holt A, Buijs J, de Groot W, Hansen B, Germany; 2012.
Bruno M, et al. High prevalence rate of digestive tract bacteria in [47] Department of Health. Health Technical Memorandum 01-01.
duodenoscopes: a nationwide study. Gut 2018;67:1637e45. Management and decontamination of surgical instruments (med-
[28] Rahman M, Perisetti A, Coman R, Bansal P, Chhabra R, Goyal H. ical devices) used in acute care. London: DoH; 2016.
Duodenoscope-associated infections: update on an emerging [48] Kremer T, Olsen D, Summers C, Patel A, Hoover J, Cieslak M,
problem. Dig Dis Sci 2019;61:1409e18. et al. Assessing detergent residuals for reusable device cleaning
[29] Shenoy ES, Pierce WM, Walters MS, Moulton-Meissner H, Lawsin A, validations. Biomed Instrum Technol 2021;55:165e70.
Lonsway D, et al. Transmission of mobile colistin resistance (mcr- [49] Association for the Advancement of Medical Instrumentation.
1) by duodenoscope. Clin Infect Dis 2019;68:1327e34. ANSI/AAMI ST98 Cleaning validation of health care products e
[30] Ofstead C, Buro B, Hopkins K, Eiland J, Wetzler H, Lichtenstein D. requirements for development and validation of a
Duodenoscope-associated infection prevention: a call for cleaning process for medical devices. Arlington, VA: AAMI;
evidence-based decision making. Endosc Int Open 2022.
2020;8:E1769e81. [50] Kremer T, Patel A, Summers C, Quin M, Lemons K, McDonnell G.
[31] Okamoto N, Sczaniecka A, Hirano M, Benedict M, Baba S, Protein residuals on reusable medical devices and patient safety
Horino Y, et al. A prospective, multicenter, clinical study of impact. Zentral Steril 2019;27:178e83.
duodenoscope contamination after reprocessing. Infect Control [51] Lappalainen S, Gomatam S, Hitchens V. Residual total protein and
Hosp Epidemiol 2022;43:1901e9. total organic carbon levels on reprocessed gastrointestinal (GI)
[32] Nicholson W, Munakata N, Gorneck G, Melosh HSP. Resistance of biopsy forceps. J Biomed Mater Res B Appl Biomater
bacillus endospores to extreme terrestrial and extraterrestrial 2009;89:172e6.
environments. Microbiol Mol Biol Rev 2000;64:548e72. [52] International Organization for Standardization. Medical devices e
[33] Roberts C. The role of biofilms in reprocessing medical devices. application of risk management to medical devices. Geneva: ISO;
Am J Infect Control 2013;41:S77e80. 2019. p. 14971.
[34] Alonso V, Goncalves M, de Brito F, Barboza G, Rocha L, Silva N. [53] Kremer T, Carfaro C, Klacik S. Effects of time, temperature, and
Dry surface biofilms in the food processing industry: an overview humidity on soil drying on medical devices. Biomed Instrum
on surface characteristics, adhesion and biofilm formation, Technol 2023;57:58e66.
detection of biofilms, and dry sanitization methods. Compr Rev [54] Association for the Advancement of Medical Instrumentation. ANSI/
Food Sci Food Saf 2023;22:688e713. AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated
98 T. Kremer et al. / Journal of Hospital Infection 145 (2024) 88e98
Text). Comprehensive guide to steam sterilization and sterility [59] Michels W, Roth K, Eibl R. Assessment of cleaning efficacy based on
assurance in healthcare facilities. Arlington, VA: AAMI; 2020. the proteinesurface relationship. Central Service 2013;3:212e5.
[55] Bancroft R, Spencer W. Practical issues with instructions for use [60] Kremer T, Felgar F, Rowan N, McDonnell G. Validation of the
(IFU) for reusable medical devices. Zentral Steril 2022;30:97e101. device feature approach for reusable medical device cleaning
[56] Alfred M, Catchpole K, Huffer E, Fredendall L, Taaffe K. Work evaluations. Biomed Instrum Technol 2023;57:143e52.
systems analysis of sterile processing: decontamination. BMJ Qual [61] Alfa M, Degagne P, Olson N. Worst-case soiling levels for patient-
Saf 2020;29:320e8. used flexible endoscopes before and after cleaning. Am J Infect
[57] Association for the Advancement of Medical Instrumentation. Control 1999;27:392e400.
AAMI TIR12:2020. Designing, testing, and labeling reusable med- [62] Garvey M, Meade E, Rowan N. Effectiveness of front line and
ical devices for reprocessing in health care facilities: a guide for emerging fungal disease prevention and control interventions and
medical device manufacturers. Arlington, VA: AAMI; 2020. opportunities to address appropriate eco-sustainable solutions.
[58] Southworth P. Infections and exposures: reported incidents Sci Total Environ 2022;851:158284.
associated with unsuccessful decontamination of reusable surgi- [63] Garvey M, Rowan N. Pathogenic drug resistant fungi: a review of
cal instruments. J Hosp Infect 2014;88:127e31. mitigation strategies. Int J Mol Sci 2023;24:1584.