Cost Utility of Competing Strategies to Prevent Endoscopic Transmission of Carbapenem-Resistant Enterobacteriaceae

Almario, Christopher V.; May, Folasade P.; Shaheen, Nicholas J.; Murthy, Rekha; Gupta, Kapil; Jamil, Laith H.; Lo, Simon K.; Spiegel, Brennan M.

doi:10.1038/ajg.2015.358

Cited by 44 publications

(25 citation statements)

References 28 publications

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“…A cost-utility study suggests that at currently reported rates of endoscope associated infections, neither of these methods is cost-effective. 32 …”

Section: Discussionmentioning

confidence: 99%

Adenosine triphosphate bioluminescence for bacteriologic surveillance and reprocessing strategies for minimizing risk of infection transmission by duodenoscopes

Sethi

Huang

Barakat

et al. 2017

Gastrointestinal Endoscopy

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Background/Aims Recent outbreaks of duodenoscope-transmitted infections underscore the importance of adequate endoscope reprocessing. Adenosine triphosphate (ATP) bioluminescence testing allows rapid evaluation of endoscopes for bacteriological/biological residue. In this prospective study we evaluate the utility of ATP in bacteriological surveillance, and the effects of endoscopy staff education and dual cycles of cleaning and high-level disinfection (HLD) on endoscope reprocessing. Methods ATP bioluminescence was measured after pre-cleaning, manual cleaning and HLD on rinsates from suction-biopsy channels of all endoscopes and elevator channels of duodenoscopes/linear echoendoscopes after use. ATP bioluminescence was re-measured in duodenoscopes (1) after re-education and competency testing of endoscopy staff, and subsequently (2) after 2 cycles of pre-cleaning and manual cleaning and single cycle of HLD, or (3) after 2 cycles of pre-cleaning, manual cleaning and HLD. Results The ideal ATP bioluminescence benchmark of <200 relative light units (RLUs) after manual cleaning was achieved from suction-biopsy channel rinsates of all endoscopes, but 9 of 10 duodenoscope elevator channel rinsates failed to meet this benchmark. Re-education reduced RLUs in duodenoscope elevator channel rinsates after pre-cleaning (23218.0 vs 1340.5 RLUs, p<0.01) and HLD (177.0 vs 12.0 RLUs, p<0.01). After 2 cycles of manual cleaning/HLD, duodenoscope elevator channel RLUs achieved levels similar to sterile water, with corresponding negative cultures. Conclusions ATP testing offers a rapid, inexpensive alternative for detection of endoscope microbial residue. Re-education of endoscopy staff and 2 cycles of cleaning and HLD decrease elevator channel RLUs to levels similar to sterile water and may therefore minimize the risk of transmission of infections by duodenoscopes.

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“…A cost-utility study suggests that at currently reported rates of endoscope associated infections, neither of these methods is cost-effective. 32 …”

Section: Discussionmentioning

confidence: 99%

Adenosine triphosphate bioluminescence for bacteriologic surveillance and reprocessing strategies for minimizing risk of infection transmission by duodenoscopes

Sethi

Huang

Barakat

et al. 2017

Gastrointestinal Endoscopy

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“…The enhanced pre-cleaning steps add to the complexity of duodenoscope washing, and as such, may be at risk for errors of omission and commission. In addition, some of the current methods of duodenoscope-related infection control (duodenoscope culture and 48-hour sequester, and ethylene oxide gas sterilization) may result in unacceptably increased capital and labor costs 5. Similarly, liquid and gas-based sterilants have crucial technical and environmental considerations and limitations, including occupational health hazards from ethylene oxide gas, the potential for cosmetic or functional damage, and the ineffectiveness of the gas- and liquid-based chemical sterilants in penetrating biofilm and blood barriers (Centers for Disease Control and Prevention, Vital signs: Carbapenem-resistant enterobacteriacae [2013].…”

Section: Introductionmentioning

confidence: 99%

A novel adjunctive cleansing method to reduce colony-forming units on duodenoscopes

Kwok

Chang

et al. 2016

Endosc Int Open

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Background and study aims: Endoscopic retrograde cholangiopancreatography-related infections are of increasing global concern due to the emergence of multidrug-resistant bacteria such as carbapenem-resistant enterobacteriaceae (CRE), with bacterial biofilm production postulated as one cause of persistent infection from such virulent organisms. Because N-acetylcysteine (NAC) has been shown to possess antibacterial and biofilm-disruption properties, we aimed to evaluate if NAC would demonstrate clinical utility in reducing the colony forming units (CFU) at the elevator end of a duodenoscope, one of the hardest areas to clean. Patients and methods: This was a pilot study of 16 procedures involving the use of a duodenoscope. After use, the elevator tip of a duodenoscope was cultured and submerged for 30 minutes, either in 20 % NAC (200 mg/mL, intervention) or in sterile water (control). After 30 minutes, the elevator tip was re-cultured. Results: Submersion of the distal end of a duodenoscope in 20 % NAC (200 mg/mL) for 30 minutes resulted in a statistically significant reduction in bacterial colony forming units compared to control (average reduction 41.6 % vs 8.8 %, P = 0.001). There was no visible damage and no optical distortion to the duodenoscope after submersion in NAC. Conclusions: In summary, NAC may be a safe, simple, and useful adjunct to currently available methods of duodenoscope reprocessing. Further research may better define NAC’s role in duodenoscope reprocessing, either broadly or specifically after procedures suspected to produce a high risk of bacterial contamination (e. g. choledocholithiasis).

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“…In addition, a medical device should be designed in a way that healthcare personnel can both fastidiously clean and successfully disinfect or sterilize the device, throughout the device's designated use life [ 211 ]. If a company does not properly validate their reprocessing method, then the FDA is likely to send them a warning letter.…”

Section: Medical Devicesmentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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Cost Utility of Competing Strategies to Prevent Endoscopic Transmission of Carbapenem-Resistant Enterobacteriaceae

Cited by 44 publications

References 28 publications

Adenosine triphosphate bioluminescence for bacteriologic surveillance and reprocessing strategies for minimizing risk of infection transmission by duodenoscopes

Adenosine triphosphate bioluminescence for bacteriologic surveillance and reprocessing strategies for minimizing risk of infection transmission by duodenoscopes

A novel adjunctive cleansing method to reduce colony-forming units on duodenoscopes

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

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