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This article was originally published in The Gray Sheet

Executive Summary

OST continues to develop protocols for cleaning, sterilizing, and assessing the performance of single use devices (SUDs) after reprocessing, the annual report notes. For evaluating SUD cleaning protocols, the office developed a "tenacious soil" that simulates biological debris, and formulated a method of chemically tagging biological soils. OST also has been investigating the effect of repeated resterilization with ethylene oxide on balloons and catheters, as well as testing metallic components of gastrointestinal devices for corrosion. Biopsy forceps are among devices on which OST has performed tests; studies by the office were cited in a recent agency letter denying a Boston Scientific citizen petition to revoke the 510(k) exemption for reprocessed SUD Class I biopsy forceps (1"The Gray Sheet" July 23, 2001, p. 26). Separately, the device center office has submitted to the Association for the Advancement of Medical Instrumentation a proposal for a "compendium of cleaning reusable medical devices for reprocessing," OST notes

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