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ENDOSCOPES REPROCESSING

 

The risk of infection associated with endoscopic procedures can be effectively controlled through an adequate reprocessing process [1].Infections related to endoscopy may be endogenous or exogenous in origin. A recent review by Kavoleva et al. [2] indicates that, in most cases, the source of infection is endogenous, meaning it originates from the patient’s own microbial flora.The microorganisms most frequently isolated include:Escherichia coliKlebsiella spp.Enterobacter spp.enterococciEndogenous infections cannot be prevented by the endoscope reprocessing process.The exogenous microorganisms most commonly associated with infections include:Pseudomonas aeruginosa and Salmonella spp. during flexible gastrointestinal endoscopyPseudomonas aeruginosa or mycobacteria during bronchoscopyContamination of endoscopes may occur during endoscopic procedures or may result from improperly maintained automated endoscope reprocessors (AERs) or contaminated processing water, facilitating the spread of microorganisms.These types of infections can be prevented through strict adherence to reprocessing and storage procedures.However, the safety margin required to ensure an effective reprocessing process is limited [3]. The internal channels of gastrointestinal endoscopes, including duodenoscopes, may harbor up to 10⁷–10¹⁰ (7–10 log) enteric microorganisms.
The cleaning phase can reduce the microbial load by approximately 4 log, while high-level disinfection provides an additional 4–5 log reduction.The incidence of infections associated with endoscopic procedures is estimated to be approximately 1 infection per 1.8 million procedures [4].Clusters of infection or colonization caused by carbapenem-resistant Enterobacteriaceae (CRE) have been associated with the use of duodenoscopes during ERCP (endoscopic retrograde cholangiopancreatography) [5].A literature review showed that between 1975 and 2010, ERCP procedures were associated with only 23 reported outbreak clusters, mainly caused by Pseudomonas aeruginosa and only rarely by enterobacteria.However, in September 2013, an outbreak occurred in a hospital in Chicago in which 10 patients were infected and 28 were colonized by carbapenemase-producing Klebsiella pneumoniae following an endoscopic procedure. The cause was attributed to structural features of the duodenoscope’s elevator channel, which made effective cleaning and disinfection difficult.Microbiological surveillance of the reprocessing process is an important strategy to:identify potential systemic errors in reprocessing procedures;detect micro-damage or defects in endoscope channels that may facilitate biofilm formation.

 
 
References

[1] CDC HIPAC. Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPAC. 2018
[2] Kavoleva J et al. Transmission of Infection by Flexible Gastrointe stinal Endoscopy and Bronchoscopy, Clinical Microbiology Reviews; 2013, 26(2): 231–254. 
[3] Rutala WA, Weber DJ. Outbreaks of carbapenem-resistant Enterobacteriaceae infections associated with duodenoscopes: What can we do to prevent infections? American Journal of Infection Control, 2016,Volume 44, Issue 5, Supplement, 47-51.
[4] Government of Canada. Part IV: Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy – Issues related to reprocessing flexible endoscopes. 2011 
[5] Casini B et al. Il ricondizionamento degli endoscopi: punti critici del processo e interventi di miglioramento. Gimpios 2016;6(4):136-143


 
For further reading
 

Evidence and Reviews

 

Official Documents, Reports and Guidelines

 

Regulatory Framework

Medical Devices:
Decreto Legislativo 24 febbraio 1997, n. 46 - Attuazione della direttiva 93/42/CEE, concernente i dispositivi medici" e s.m.i.
REGOLAMENTO (UE) 2017/745 DEL PARLAMENTO EUROPEO E DEL CONSIGLIO del 5 aprile 2017 relativo ai dispositivi medici, che modifica la direttiva 2001/83/CE, il regolamento (CE) n. 178/2002 e il regolamento (CE) n. 1223/2009 e che abroga le direttive 90/385/CEE e 93/42/CEE del Consiglio.

Reprocessing Process
UNI/TR 11662:2016 Ricondizionamento dei dispositivi medici – Guida al ricondizionamento degli endoscopi termolabili.
UNI/TR 11408:2011 Guida alla progettazione, allo sviluppo e al controllo del processo di ricondizionamento dei dispositivi medici riutilizzabili (DM) sterilizzabili mediante vapore.

Automated Endoscope Reprocessors
UNI EN ISO 15883-1: 2014 –Apparecchi di lavaggio e disinfezione – Parte 1: Requisiti generali, termini e definizioni e prove.
UNI EN ISO 15883-4: 2019 Apparecchi di lavaggio e disinfezione – Parte 4 Requisiti e prove per apparecchi di lavaggio e disinfezione che utilizzano la disinfezione chimica per gli endoscopi termolabili.
UNI CEN ISO/TS 15883-5: 2006 Apparecchi di lavaggio e disinfezione - Parte 5: Metodo di prova dello sporco per dimostrare l efficacia di pulizia.

Endoscope Storage Cabinets
UNI EN 16442:2015-Armadi di stoccaggio ad ambiente controllato per endoscopi termolabili condizionati.
 

 

Links

 

[Last update February 2025]

Content and updates curated by Daniela Accorgi