US Congress Senate Bill 2334 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on November 30 2015 - 25% progression, died in committee
Action: 2015-11-30 - Read twice and referred to the Committee on Veterans' Affairs.
Pending: Senate Veterans' Affairs Committee
Text: Latest bill text (Introduced) [PDF]

Biological Implant Tracking and Veteran Safety Act of 2015 This bill directs the Department of Veterans Affairs (VA) to: adopt the unique device identification system developed for medical devices by the Food and Drug Administration (FDA), or implement a comparable standard identification system, for identifying biological implants intended for use in VA medical facilities; permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency; implement a compatible system for tracking implants from human donor or animal source to implantation; and implement inventory controls compatible with such tracking system so that patients who have received a biological implant in a VA medical facility subject to FDA recall can be appropriately notified. The bill also prescribes requirements for vendors from which the VA may procure biological implants of human origin, and for vendors from which the VA may procure biological implants of non-human origin. Such a vendor must: use the standard identification system adopted or implemented by VA under this Act; be registered as required by FDA procedures; consent to periodic VA inspections and audits regarding records and product handling; agree to cooperate with all biological implant recalls conducted on the vendor's own initiative, on the initiative of the original product manufacturer used by the vendor, or by FDA request or statutory order; agree to notify the VA within 60 days of any adverse event report it provides to the FDA, or of any FDA warning letter issued to the vendor; and agree to retain all records associated with the procurement of a biological implant by the VA for at least 10 years. The VA shall: (1) procure such implants under General Services Administration Federal Supply Schedules if they are available under such Schedules, (2) accommodate reasonable vendor requests to undertake specified outreach efforts to educate VA medical professionals about the use and efficacy of implants, and (3) procure biological implants that are unavailable under such Schedules using competitive procedures in accordance with the Federal Acquisition Regulation. Any VA procurement employee responsible for a biological implant procurement transaction with intent to avoid, or with reckless disregard of, the requirements of this Act shall be ineligible to hold a certificate of appointment as a contracting officer or to serve as the representative of an ordering officer, contracting officer, or purchase card holder. Certain biological implants may be temporarily procured by the VA without relabeling under the standard identification system.

Biological Implant Tracking and Veteran Safety Act of 2015

Sen. Bill Cassidy [R-LA]

Sen. Jon Tester [D-MT]

Date	Chamber	Action
2015-11-30	Senate	Read twice and referred to the Committee on Veterans' Affairs.

HB1016 (Related) 2015-04-21 - Forwarded by Subcommittee to Full Committee in the Nature of a Substitute (Amended) by Voice Vote .
HB2256 (Related) 2015-07-22 - Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.
SB2921 (Related) 2016-05-16 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 467.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/senate-bill/2334/all-info
Text	https://www.congress.gov/114/bills/s2334/BILLS-114s2334is.pdf