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Outpatient Surgery E-Weekly

Malpractice Verdicts Often Favor Physicians

Physicians come out on the winning end of 80% of malpractice claims that end in jury verdicts, according to researchers at Massachusetts General Hos...

Study: CT Colongraphy Effective in Finding Polyps

A CT-scan-based, laxative-free "virtual colonoscopy" may be as effective as standard colonoscopy in finding potentially cancerous polyps, according ...

Wrong-Site Prevention Video Shows the Right Way

Wrong-site, wrong-patient and wrong-procedure surgery must be prevented at all costs. The 3 steps of the Joint Commission's Universal Protocol make ...

Archive > August, 2004 Vol. V, No. 8

Infection Prevention

SUD Reprocessing Update

Dan Mayworm

Dan Mayworm If you're reprocessing single-use devices (SUDs), take note. The FDA has revised the guidelines covering procedures and timeframes for reviewing the validation data submitted to the FDA for certain SUDs. The "Validation Data in Premarket Notification Submissions (5109(k)s) for Reprocessed Single-Use Medical Devices," which supersedes last year's document of the same name, is available at writeOutLink("www.fda.gov/cdrh/ode/guidance/1216.html",1). The 23-page guidance is a bit much to wade through, so here's what you need to know.

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Categories: Infection Control
Keywords:
Data; Device User Fee; FDA; Fee; MDUFMA; Medical Device User Fee; Modernization Act; Notification Submissions; Premarket Notification Submissions; SUDs; Submissions; User Fee; addendum; apply; areas; back; bit; body; calls; cleaning; complete; considered; contact; covering; critical; data; deemed; defines; designations; device; document; due; efficacy; ensure; equivalence; essentially; functional; guidance; guidelines; high-risk; hospitals; implementation; intact; list; made; makes; maximum; membranes; mucous; non-critical; number; penetrating; performance; phased; procedures; purposes; regula... show all keywords
Data; Device User Fee; FDA; Fee; MDUFMA; Medical Device User Fee; Modernization Act; Notification Submissions; Premarket Notification Submissions; SUDs; Submissions; User Fee; addendum; apply; areas; back; bit; body; calls; cleaning; complete; considered; contact; covering; critical; data; deemed; defines; designations; device; document; due; efficacy; ensure; equivalence; essentially; functional; guidance; guidelines; high-risk; hospitals; implementation; intact; list; made; makes; maximum; membranes; mucous; non-critical; number; penetrating; performance; phased; procedures; purposes; regulations; regulatory; reprocess; reprocessed; reprocessing; requirements; reviewing; revised; safety; seeks; semi-critical; separate; set; showing; single-use; sterile; sterilization; subject; submit; submitted; supersedes; timeframes; times; timetable; tissue; understand; updated; validation; wade; year's

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