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PubMed · 10683222

Methodology of reprocessing one-time use accessories.

C M Wilcox
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Abstract

The current climate of falling reimbursements has prompted evaluation of reusing single use (disposable) endoscopic accessories. A number of different accessories have undergone study of both function and sterility after reuse. These studies, albeit limited in number, do show that selected equipment can be sterilized without impairment of function. Nonetheless, despite the data, widespread adoption of accessory reuse remains hampered by lingering concerns over cross-contamination and medical and legal risks.

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Disposable EquipmentEndoscopes, GastrointestinalEquipment ContaminationEquipment SafetyHumansInfection ControlInfectionsSensitivity and SpecificitySterilizationUnited StatesJournal ArticleReview

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BibTeXRIS

C M Wilcox. 2000. Methodology of reprocessing one-time use accessories.. https://pubmed.ncbi.nlm.nih.gov/10683222/

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PubMed2006

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.

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