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Preventing medical-device–borne outbreaks: High-level disinfection policy for duodenoscopes

Published online by Cambridge University Press:  14 December 2020

Preeti Mehrotra*
Affiliation:
Division of Infectious Diseases and Silverman Institute for Health Care Quality and Safety, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
David J. Weber
Affiliation:
Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina
Ameet Sarpatwari
Affiliation:
Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
*
Author for correspondence: Dr Preeti Mehrotra, E-mail: pmehrotr@bidmc.harvard.edu

Abstract

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Type
Commentary
Copyright
© The Author(s), 2020. Published by Cambridge University Press on behalf of The Society for Healthcare Epidemiology of America

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References

Rubin, ZA, Murthy, RK. Outbreaks associated with duodenoscopes: new challenges and controversies. Curr Opin Infect Dis 2016;29:407414.CrossRefGoogle ScholarPubMed
Infections associated with reprocessed duodenoscopes. US Food and Drug Administration website. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes. Accessed November 4, 2019.Google Scholar
High-level disinfection BoosterPak. The Joint Commission website. https://www.jointcommission.org/assets/1/6/TJC_HLD_BoosterPak.pdf. Accessed November 4, 2019.Google Scholar
Henwood, P. Imaging an outbreak: ultrasound in an Ebola treatment unit. N Engl J Med 2019;381:69.CrossRefGoogle Scholar
Senate Health, Education, Labor Pensions Committee Report. Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients. US Senate website. https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf. Accessed March l, 2020.Google Scholar
US Food and Drug Administration. Medical devices: validated instructions for use and validation data requirements for certain reusable medical devices in premarket notifications. Federal Register website. https://www.federalregister.gov/documents/2017/06/09/2017-12007/medical-devices-validated-instructions-for-use-and-validation-data-requirements-for-certain-reusable. Accessed November 23, 2020.Google Scholar
FDA webinar: duodenoscope sampling and culturing. US Food and Drug Administration website. https://www.fda.gov/media/112402/download. Accessed March 4, 2020.Google Scholar
FDA recommending transition to duodenoscopes with innovative designs to enhance safety. US Food and Drug Administration website. https://www.fda.gov/medical-devices/safety-communications/fda-recommending-transition-duodenoscopes-innovative-designs-enhance-safety-fda-safety-communication. Accessed March 4, 2020.Google Scholar
News release: FDA clears first fully disposable duodenoscope. US Food and Drug Administration website. https://www.fda.gov/news-events/press-announcements/fda-clears-first-fully-disposable-duodenoscope-eliminating-potential-infections-caused-ineffective. Accessed March 4, 2020.Google Scholar
Reprocessing medical devices in healthcare settings: validation methods and labeling guidance for industry and Food and Drug Administration staff document. US Food and Drug Administration website. https://www.fda.gov/media/80265/download. Accessed November 4, 2019.Google Scholar
ANSI/AAMI ST91:2015 Flexible and semi-rigid endoscope processing in healthcare facilities. American Association Medical Instrumentation website. https://my.aami.org/aamiresources/previewfiles/ST91_1504_preview.pdf. Accessed March 4, 2020.Google Scholar
Mary Ann Drosnock: AAMI overview, ST91 update, flexible scope reprocessing. Beyond Clean Podcast website. https://beyondclean.libsyn.com/mary-ann-drosnock. Accessed March 4, 2020.Google Scholar
Bringhurst, J. Special problems associated with reprocessing instruments in outpatient care facilities: physical spaces, education, infection preventionists, industry reflections. AJIC 2019;47:A58A61.Google Scholar
Basile, R. AAMI TIR 12 and the future of device processing instructions. Biomed Instrument Technol 2019;53:6769.CrossRefGoogle Scholar
Factors affecting quality of reprocessing. US Food and Drug Administration website. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/factors-affecting-quality-reprocessing. Accessed March 4, 2020.Google Scholar
522 postmarket surveillance studies. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm. Accessed June 30, 2020.Google Scholar
The Joint Commission. Clarifying infection control policy requirements. Perspectives 2019;39(4):15.Google Scholar
Manufacturer’s instructions for use- addressing conflicts amongst IFUs for different equipment and products: frequently asked questions. The Joint Commission website. https://www.jointcommission.org/standards/standard-faqs/hospital-and-hospital-clinics/infection-prevention-and-control-ic/000002252/. Updated April 2020. Accessed November 23, 2020.Google Scholar
Information about automated endoscope reprocessors and FDA’s evaluation. US Food and Drug Administration website. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/information-about-automated-endoscope-reprocessors-aers-and-fdas-evaluation. Accessed March 4, 2020.Google Scholar
Olympus Investor Day 2017: medical business strategy. Olympus website. https://www.olympus-global.com/ir/data/pdf/id_2017e_03.pdf. Accessed July 5, 2020.Google Scholar
Rutala, WA, Weber, DJ. Disinfection, sterilization, and antisepsis: an overview. AJIC 2019;47(5):A3A9.Google Scholar
Rutala, WA, Kanamori, H, et al. What’s new in reprocessing endoscopes? Are we going to ensure the needs of the patient come first by shifting from disinfection sterilization? AJIC 2019;47(5):A62A66.Google Scholar
Spaulding, EH. Chemical disinfection of medical and surgical materials. In: Lawrence, C, Block, SS, eds. Disinfection, Sterilization and Preservation. Philadelphia: Lea & Febiger; 1968:517531.Google Scholar
Rutala, WA, Weber, DJ. CDC guideline for disinfection and sterilization in healthcare facilities. Centers for Disease Control and Prevention website. https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf. Accessed July 6, 2020.Google Scholar
Ethylene oxide. Environmental Protection Agency website. https://cfpub.epa.gov/ncea/iris2/chemicalLanding.cfm?substance_nmbr=1025. Accessed July 6, 2020.Google Scholar
Rabin, RC. To prevent deadly infections, FDA approves the first disposable ‘scope.’ The New York Times, December 13, 2019.Google Scholar
Statement on concerns with medical device availability due to certain sterilization facility closures. US Food and Drug Administration website. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions. Accessed July 6, 2020.Google Scholar
Muthusamy, VR, Bruno, MJ, Kozarek, RA, et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol 2019;19:3126131263.Google Scholar
Sherman, JD, Raibley, LA, et al. Life-cycle assessment and costing methods for device procurement: comparing reusable and single-use disposable laryngoscopes. Crit Care Resusc 2018;127:434443.Google ScholarPubMed
Davis, NF, McGrath, S, Quinlan, M, et al. Carbon footprint in flexible ureteroscopy: a comparative study on the environmental impact of reusable and single use ureteroscopes. J Endourol 2018;32:214217.CrossRefGoogle ScholarPubMed
Sorenson, BL, Gruttner, H. Comparative study on environmental impacts of reusable and single use bronchoscopes. Am J Environ Protect 2018;7:5562.CrossRefGoogle Scholar
Seavey, R. Using a systematic approach for adopting new technologies in sterile processing departments and operating rooms. AJIC 2019;47(5):A67A71.Google Scholar
FDA innovation challenge 1: identify new sterilization methods and technologies. US Food and Drug Administration website. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-1-identify-new-sterilization-methods-and-technologies. Accessed March 4, 2020.Google Scholar
Investigating decontamination and reuse of respirators in public health emergencies. US Food and Drug Administration website. https://www.fda.gov/emergency-preparedness-and-response/mcm-regulatory-science/investigating-decontamination-and-reuse-respirators-public-health-emergencies. Accessed April 30, 2020.Google Scholar
FDA Innovation Challenge 2: Reduce Ethylene Oxide Emissions. US Food and Drug Administration website. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/fda-innovation-challenge-2-reduce-ethylene-oxide-emissions. Accessed March 4, 2020.Google Scholar
EPA Seeks Input on strategies to reduce ethylene oxide emissions from commercial sterilizer operations. US Environmental Protection Agency website. https://www.epa.gov/newsreleases/epa-seeks-input-strategies-reduce-ethylene-oxide-emissions-commercial-sterilizer. Accessed July 10, 2020.Google Scholar
Bang, JY, Sutton B Hawes R, et al. Concept of disposable duodenoscope: at what cost? Gut 2019;68:19151917.CrossRefGoogle ScholarPubMed
Incineration and treatment. Sharps Compliance website. https://www.sharpsinc.com/high-temperature-incineration. Accessed July 6, 2020.Google Scholar
Stericycle 2019 corporate social responsibility overview. Stericycle website. https://www.stericycle.com/white-papers/corporate-social-responsibility-2019. Accessed April 30, 2020.Google Scholar