American Medical Association — 2000 — "The AMA supports the Food and Drug Administration (FDA) guidance titled 'Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals' that was issued on August 2, 2000." "The AMA supports the development of device-specific standards for the reuse and reprocessing of single-use medical devices involving all appropriate medical and professional organizations and the medical device industry."…more
Hospitals for a Healthy Environment — June 24, 1998 — "…affirm the Congressional goals and principles set forth in the Pollution Prevention Act …particularly the goal of reducing the generation of pollution at its source, preferentially to [recycle]." " …will reduce the waste disposal costs …more
United States Congress — Oct. 26, 2002 — The Medical Device User Fee and Modernization Act of 2002 …provided new regulatory requirements for reprocessed single-use devices (SUDs)."…more
Food & Drug Administration — "[Dr. David Feigal to Congress] FDA does have the tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed SUDs." "Third-party reprocessors are subject to the same regulatory requirements as other manufacturers, including premarket requirements."…more
Food and Drug Administration — Sept. 26, 2006 — [Dr. Daniel Schultz to Congress] "Available data show that SUDs can be reprocessed with a reasonable assurance of safety and effectiveness. FDA believes that reprocessed SUDs that meet FDA's regulatory requirements are as safe and effective as a new device. The law and regulations in place are designed to protect the public health by assuring that the practice of reprocessing and reusing SUDs is based on sound science. FDA continues to monitor the performance of these devices and to assess and refine our ability to regulate these devices appropriately." …more
ANA- American Nurses Association — 2010 (House of Delegates) — “The American Nurses Association supports best practices for the various reprocessing methods and the safety of single-use devices for patients and healthcare workers.”…more
