Storage of gastrointestinal endoscopes: when is the safe time for re-use?

to identify the safe storage time for the use of flexible gastrointestinal endoscopes after high-level disinfection, as well as the defining criteria for this time.

Methods:

an integrative literature review was carried out in the Virtual Health Library, PubMed, Scopus, and Web of Science, considering original articles published since 2000.

Results:

eleven articles were selected, whose storage times ranged from 1 to 56 days, with a predominance of one to seven days (73%). Several criteria were used to define this time, predominantly the premise of efficient processing (100%), use of alcohol flush (64%), use of drying cabinets (18%), among others.

Conclusions:

the criteria for determining the storage time did not show a consensus for clinical practice. Expanding the discussion of this theme with the definition of the minimum necessary conditions is of fundamental importance for the reduction of risks and safety of the procedure and the patient.

Descriptors:
Endoscopes; Gastrointestinal; Disinfection; Equipment Contamination; Equipment Reuse; Patient Safety

Reference Outline Level of Evidence	Types of Endoscopes Sample Size	Criteria adopted to define shelf life	Outcomes	Suggested storage time
Riley et al.(²⁴24 Riley R, Beanland C, Bos H. Establishing the shelf life of flexible colonoscopes. Gastroenterol Nurs. 2002;25(3):114-9. https://doi.org/10.1097/00001610-200205000-00006 https://doi.org/10.1097/00001610-2002050... ) 2002, Prospective observational Level 3	1 colonoscope 30 samples	Bacterial growth: Up to 5 CFU/ml - acceptable; 5-20 CFU/ml moderate; > 20 CFU/ml high.	Within 24 hours of storage, there was no microbiological growth. In 168 hours, there was growth in two samples of 1 CFU/ml of coagulase negative Staphylococcus and 1 CFU/ml of Micrococcus sp.	7 days
Rejchrt et al.(²¹21 Rejchrt S, Cermák P, Pavlatová L, Micková E, Bures J. Bacteriologic testing of endoscopes after high-level disinfection. Gastrointest Endosc. 2004;60(1):76-8. https://doi.org/10.1016/S0016-5107(04)01313-6 https://doi.org/10.1016/S0016-5107(04)01... ) 2004, Prospective observational Level 3	10 endoscopes (gastroscope, duodenoscope and colonoscope) Total of 135 samples	Acceptable microbiological growth of commensal microorganisms	Positive culture: 3%. Corynebacterium pseudodiphteriae (2nd day) Staphylococcus epidermidis (2nd and 3rd day at two different points) He did not mention the amount of colony forming units found.	5 days
Osborne et al.(²³23 Osborne S, Reynolds S, George N, Lindemayer F, Gill A, Chalmers M. Challenging endoscopy reprocessing guidelines: a prospective study investigating the safe shelf life of flexible endoscopes in a tertiary gastroenterology unit. Endoscopy. 2007;39(9):825-30. https://doi.org/10.1055/s-2007-966766 https://doi.org/10.1055/s-2007-966766... ) 2007, Prospective observational Level 3	23 endoscopes Total of 194 samples Gastroscope, 101 Echoendoscope, 8 Colonoscope, 74 Duodenoscope, 11	Acceptable microbiological growth of microorganisms without clinical importance	Overall contamination rate: 15.5%. Coagulase-negative Staphylococcus and Micrococcus were the most common microorganisms (6.7% and 3.1%). Bacillus, Corynebacterium, fungus, Streptomyces (n = 29) 12.9% - 1st day 10% - Between 1st and 2nd day 17.2% - Between 2nd and 3rd day 25% - Between 3rd and 4th day 37.5% - Between 6th and 7th day Yeast between the 5th and 6th day of storage	5 days
Vergis et al.(²⁸28 Vergis AS, Thomson D, Pieroni P, Dhalla S. Reprocessing flexible gastrointestinal endoscopes after a period of disuse: is it necessary?. Endoscopy. 2007;39(8):737-9. https://doi.org/10.1055/s-2007-966644 https://doi.org/10.1055/s-2007-966644... ) 2007, Multiphase observational Level 3	4 duodenoscopes and 3 colonoscopes Phase 1 and 2 70 samples Stage 3 14 samples	Acceptable culture of microorganisms of no clinical importance; did not detail the types.	Phase 1: (6/70) positive culture ranging from 10 to 200 CFU/ml. Predominant growth in the first 5 days. Phase 2: No growth Phase 3: Sample collection in 24 hours and 7 days Positive culture on the 7th day - 700 CFU/ml. All positive cultures recovered Staphylococcus epidermidis.	7 days
Alfa et al.(⁴4 Alfa MJ, Sepehri S, Olson N, Wald A. Establishing a clinically relevant bioburden benchmark: a quality indicator for adequate reprocessing and storage of flexible gastrointestinal endoscopes. Am J Infect Control. 2012;40(3):233-6. https://doi.org/10.1016/j.ajic.2011.02.023 https://doi.org/10.1016/j.ajic.2011.02.0... ) 2012, Prospective Level 3	5 gastroscopes 9 colonoscopes 6 duodenoscopes Total of 383 samples	Acceptable microbiological growth < 200 CFU/ml	5.7% (22/383) contaminated samples after 48 hours: (9/22) Bacillus gram-positive 10 CFU/ml; (11/22) Gram-positive Coccus: Highest microbiological load found 170 CFU/ml. (1/22) Gram-negative Bacillus Pseudomonas luteola 10 CFU/ml; (1/22) Fungi 10 CFU/ml;	2 days
Ingram et al.(²⁵25 Ingram J, Gaines P, Kite R, Morgan M, Spurling S, Winsett RP. Evaluation of medically significant bacteria in colonoscopes after 8 weeks of shelf life in open air storage. Gastroenterol Nurs. 2013;36(2):106-11. https://doi.org/10.1097/SGA.0b013e318288c715 https://doi.org/10.1097/SGA.0b013e318288... ) 2013, Longitudinal prospective Level 3	4 colonoscopes Total of 32 samples	Clinically important microorganism growth^ Staphylococcus aureus, Enterobacteriaceae, Pseudomonas sp., Stenotrophomonas maltophilia, Acinetobacter sp., Candida sp; *	Recovery of Staphylococcus epidermidis and Staphylococcus hominis with a maximum of 2 CFU/ml in two samples collected on the 14th day of storage. And recovery of ≤ 1 CFU/ml of Staphylococcus epidermidis on the 42nd day.	56 days
Grandval et al.(²²22 Grandval P, Hautefeuille G, Marchetti B, Pineau L, Laugier R. Evaluation of a storage cabinet for heat-sensitive endoscopes in a clinical setting. J Hosp Infect. 2013;84(1):71-6. https://doi.org/10.1016/j.jhin.2013.01.013 https://doi.org/10.1016/j.jhin.2013.01.0... ) 2013, Experimental Level 2	10 gastroscopes 11 colonoscopes 4 duodenoscopes 41 samples for each type of storage	< 5 CFU/ml (acceptable level) between 5 and 25 CFU/ml (alert level) > 25 CFU/ml or growth of any potentially pathogenic microorganism^ Staphylococcus aureus, Enterobacteriaceae, Pseudomonas sp., Stenotrophomonas maltophilia, Acinetobacter sp., Candida sp; (action level)	Drying cabinet: 56.1% without contamination 43.9% < 5 CFU/ml Coagulase-negative Staphylococcus, Micrococcus sp., Bacillus sp. Conventional closet: 41.4% without contamination 46.8% < 5 CFU/ml 5% between 5 and 25 CFU/ml Coagulase-negative Staphylococcus, Micrococcus sp., Bacillus sp. (6 and 7 CFU/ml) 7% > 150 CFU/ml Strenotrophomonas Maltophilia, Enterobacter cloacae and Serratia odorifera	3 days
Brock et al.(²⁷27 Brock AS, Steed LL, Freeman J, Garry B, Malpas P, Cotton P. Endoscope storage time: assessment of microbial colonization up to 21 days after reprocessing. Gastrointest Endosc. 2015;81(5):1150-4. https://doi.org/10.1016/j.gie.2014.09.053 https://doi.org/10.1016/j.gie.2014.09.05... ) 2015, Prospective observational Level 3	4 duodenoscopes 4 colonoscopes 2 gastroscopes Total of 96 samples	Growth ≤ 100 colony forming units (CFU)/ml	Global contamination rate: 29.2% Cultures: Coagulase-negative Staphylococcus, Micrococcus, Bacillus Corynebacterium and Propionibacterium acnes. Maximum of 49 CFU/ml Microorganisms with pathogenic potential: Aureobasidium pullulans (1st day); Enterococcus (7th day); a-hemolitic Streptococcus (14th day); Candida parapsilosis (day 21) All with growth ≤ 1 CFU/ml	21 days
Scanlon et al.(²⁶26 Scanlon P, Flaherty K, Reilly EA, Barth EG, Potter-Bynoe G, Cardini J, et al. Association between storage interval and contamination of reprocessed flexible endoscopes in a pediatric gastrointestinal procedural unit. Infect Control Hosp Epidemiol. 2017;38(2):131-5. https://doi.org/10.1017/ice.2016.260 https://doi.org/10.1017/ice.2016.260... ) 2017, Transverse Level 3	6 gastroscopes 2 duodenoscope 1 colonoscope Phase 1 27 samples Level 2 131 samples	Microbiological growth ≤ 100 CFU/ml	Phase 1 - Positive cultures: 11.1%. All ≤ 100 CFU/ml. Coagulase-negative Staphylococcus (On the 69th and 85th day of storage) Micrococcus (69th day of storage) Phase 2 - Positive cultures: 5.3%. All ≤ 100 CFU/ml. Coagulase-negative Staphylococcus (7th, 14th, 28th, 42nd day of storage) Neisseria subflava (28th day of storage) Bacillus species (42nd and 56th day of storage) Viridans group streptococci (28th day of storage) Candida albicans growth: 10 CFU/ml on the 14th day of storage.	56 days
Singh et al.(³⁰30 Singh H, Duerksen DR, Schultz G, Reidy C, DeGagne P, Olson N, et al. Impact of cleaning monitoring combined with channel purge storage on elimination of escherichia coli and environmental bacteria from duodenoscopes. Gastrointest Endosc. 2018;88(2):292-302. https://doi.org/10.1016/j.gie.2018.02.018 https://doi.org/10.1016/j.gie.2018.02.01... ) 2018, Experimental Level 2	3 duodenoscopes Total of 119 samples	Any growth of Escherichia coli or Enterococcus faecalis and/or ≥100 CFU/ml of any other microorganism is not acceptable. Inoculated suspension of E. Coli and E. faecallis at an approximate concentration of 108 CFU/ml before applying the designed protocols.	Protocol 1 - Cleaning and disinfection without alcohol flush (n = 69) Enterococcus faecalis < 9 CFU/ml - 17 samples 10-99 CFU/ml - 20 samples ≥ 100 CFU/ml - 5 samples Other microorganisms ≥ 100 CFU/ml - 9 samples Protocol 2 - Cleaning and disinfection followed by an alcohol flush (n = 20) Enterococcus faecalis < 9 CFU/ml - 4 samples 10-99 CFU/ml - 7 samples ≥ 100 CFU/ml - 4 samples Other microorganisms ≥ 100 CFU/ml - 1 samples Protocol 3 - Cleaning + extra cleaning and disinfection without alcohol flush (n = 30) Enterococcus faecalis < 9 CFU/ml - 6 samples 10-99 CFU/ml - 13 samples ≥ 100 CFU/ml - 2 samples Other microorganisms ≥ 100 CFU/ml - 9 samples Other microorganisms identified in duodenoscopes were: Bacillus spp., Paenibacillus spp., Brevibacillus spp., Neisseria spp., Streptococcus spp. and Kocuria spp.	1 a 3 days
Mallete et al.(²⁹29 Mallette KI, Pieroni P, Dhalla SS. Bacterial presence on flexible endoscopes vs time since disinfection. World J Gastrointest Endosc. 2018;10(1):51-5. https://doi.org/10.4253/wjge.v10.i1.51 https://doi.org/10.4253/wjge.v10.i1.51... ) 2018, Prospective observational Level 3	19 gastroscopes 24 colonoscopes 5 duodenoscopes Total of 164 samples	Microbiological results below 200 CFU/ml.	There was no growth > 200 CFU/ml within 7 days. Type of microorganism not evaluated. There was no description of all growths per day of storage. 18 contaminated samples. 80 CFU/ml (highest microbiological load found). There was no significant difference comparing the microbiological growth from 1, 2, 3, 4, 5, 6 days to 7 days.	7 days

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[1] Corresponding author: Naiara Bussolotti Garcia, E-mail: bussolottin@gmail.com