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US Food & Drug Administration (FDA)

Request for A Mandatory Unique Device Identifier

APIC and a coalition of organizations (AHA, Federation of American Hospitals, VHA, CHA, AARP, AAMC, JCAHO) have urged the Food and Drug Administration to develop a mandatory unique device identifier (UDI) system for medical devices, similar to the National Drug Code used for pharmaceuticals. The system is designed to improve patient safety, reduce medical errors and increase efficiency.  A UDI system would facilitate the management of more than 600 device annual recalls by the FDA.  Electronic searches could be conducted, enabling hospitals to swiftly and accurately notify and treat patients who have received a recalled device. This would make it more difficult to counterfeit medical supplies. To view the letter sent to the FDA, click here.

Testimony of Tammy Lundstrom, MD, JD, Provided to the Food and Drug Administration (FDA) 

Nonprescription Drugs Advisory Committee on October 20, 2005 to discuss the merits of alcohol-based consumer hand hygiene products.

To view Dr. Lundstrom's testimony, click here.

Reprocessing of Single Use Devices: FDA Review and Determination 11/04

The FDA completed a review of supplemental validation data submitted by firms that reprocess medical devices originally intended for single use only (SUDs). The FDA allowed certain types of previously cleared reprocessed SUDs to be marketed, however supplemental data for cleaning, sterility and functionality had to be submitted to the FDA for review to determine if certain reprocessed SUDs were safe for use. The FDA's review determined that although many reprocessed SUDs can continue to be legally marketed, there are a number that can no longer be commercially distributed for use. The list of No Longer Legally Marketed Devices and Legally Marketed Devices from the FDA regarding this issue accompanies this notice.

Related Documents

• APIC’s Position on Reprocessing of Single Use Medical Devices, 8-31-07 (PDF)
• GAO Report , Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does not Indicate That Use Presents and Elevated Health Risk(PDF), January 23, 2008.
• FDA Talking Points (Word Doc)
• Complete List of both legally and not legally marketed devices (Excel Spreadsheet)