Reprocessing of Single-use Medical Devices: Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Sixth Congress, Second Session ... June 27, 2000, Volume 4 |
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ADDM adverse events agency balloon biopsy forceps cardiac cardiac catheterization CDRH central retinal artery CHAIRMAN cleaning and sterilization Cleveland Clinic clinical Clorox CONGRES CONGRESS THE LIBRARY cost demonstrate designed device manufacturers disposable devices draft guidance electrophysiology electrophysiology catheters endoscopic Enforcement Priorities Guidance EP catheters essed exemption FDA Prioritization Scheme FDA Proposed Strategy FDA's FDC Act FEIGAL GAO report guidance document health care facilities healthcare hospitals informed consent intended issue labeled for single LIBRARY OF CONGRESS lumen MDR reports medical devices OEMs original equipment manufacturers oversight patient injuries patient safety performance premarket requirements PTCA public health regulation regulatory reproc reprocessed devices reprocessed single reprocessed SUDs reprocessing and reuse resterilization reusable devices Reuse of Single Risk Categorization safely reprocessed safety and effectiveness Senator COLLINS simulated reuse single use devices single-use medical devices specific standards sterilization studies submitted SUD reprocessing testing third-party reprocessors Warning Letter
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Page 131 - Allocate the Necessary Resources to Bring all Reprocessed Single Use Devices into Compliance with the Law Reuse of Single-Use Medical Devices: Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 106* Cong. (Feb.
Page 83 - The Honorable James M. Jeffords Chairman Committee on Health, Education, Labor, and Pensions United States Senate Washington, DC 20510-6300 Dear Mr. Chairman: Food and Drug Administration Rockvilte MD 20857 This is in response to your letter
Page 107 - Melinda K. Plaisier Associate Commissioner for Legislation The Honorable Edward M. Kennedy Ranking Minority Member Committee on Health, Education, Labor, and Pensions United States Senate Washington, DC 20510-6300
Page 106 - Honorable James M. Jeffords Chairman Committee on Health, Education, Labor, and Pensions United States Senate Washington, DC 20510-6300 Dear Mr. Chairman: Food and Drug
Page 170 - (2) that the physical characteristics or quality of the device will not be adversely affected by such processing; and (3) that the device remains safe and effective for its intended use after such reprocessing. 44 While the CPG appropriately recognized these three key criteria for ensuring
Page 9 - Feigal, Director of the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am very pleased to have the opportunity to be here today
Page 30 - we are going to be able to continue to assure the American people that the medical devices used by their doctors are safe and effective, we are going to have to learn a lot more than we know now about the reprocessing industry. And we are going to have to do a much better job of systematically collecting critical patient safety information.
Page 148 - at 28 (citation omitted); see also United States v. Diapulse Corp. of America. 748 F.2d 56,62 (2d Cir. 1984) (holding that FDA must act "evenhandedly" and may "not 'grant to one person the right to do that which it denies to another similarly situated.'"):
Page 6 - I understand the fiscal constraints hospitals are under. Between managed health care and reduced Medicare reimbursements, hospitals feel intense pressure to cut costs wherever possible. I look forward to working with you, Mr. Chairman, and with the rest of the distinguished Committee members to find a thoughtful solution to this problem. Thank you.
Page 106 - would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.'