Medical Device Safety: How FDA Regulates the Reprocessing of Supposedly Single-use Devices : Hearing Before the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, Second Session, September 26, 2006, Volume 4
U.S. Government Printing Office, Jan 1, 2006 - Disposable medical devices - 99 pages
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additional AdvaMed adverse event reports adverse events agency Ascent Healthcare Solutions associated with reprocessed biopsy forceps bundling catheters CDRH Center for Devices Chairman TOM DAVIS clinical cost CUMMINGS defibrillators device safety device types Device User Fee Devices and Radiological devices labeled Director electrophysiology catheter Endoscopy FDA regulation Fee and Modernization Food and Drug forceps Government Reform GUTKNECHT infection issue labeled for single legally marketed MDMA MDR Report MDUFMA Medical Device User MedWatch Modernization Act October 22 OEMs original device manufacturers original equipment manufacturers original manufacturer patient safety percent post-market pre-market submission reproc reprocessed devices reprocessed medical devices reprocessed single Reprocessed Single-Use Devices reprocessed SUDs requires reprocessors reusable reuse risk safe and effective safely reprocessed SCHMIDT SCHULTZ Selvey September 26 single use devices single use label specific staff submit validation data substantially equivalent Testimony of Ascent Thank third-party reprocessors TOUSSAINT Waxman