Biological Implant Tracking and Veteran Safety Act of 2015
Latest action. Read twice and referred to the Committee on Veterans' Affairs.
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.
The summary continues for 2 more paragraphs. Read it in full on Congress.gov
Written by analysts at the Congressional Research Service and published on Congress.gov, not by Civibrief. Summarized at the "Introduced in Senate" stage on November 30, 2015. It describes the bill, it is not the legal text.
Where is it in the process, and what happens next?
4 steps remain before this bill could become law.
The record's latest action, on November 30, 2015: Read twice and referred to the Committee on Veterans' Affairs.
- Clearing the committees it was referred to, and being scheduled for a floor vote
- Passage by the Senate
- Passage by the House
- The President's signature. If the President vetoes it, two-thirds of both chambers must vote to override.
How likely is it to become law?
Civibrief does not forecast outcomes and this page has no opinion about this one. What the record supports is a base rate, which is a fact about the whole pile, not a prediction about this measure.
In the 114th Congress (2015-16), 329 of the 10,233 bills and joint resolutions introduced became law, about 3.2 percent. That count covers every measure at every stage, including the many that never left committee.
This one is not there yet: 4 steps are still outstanding, listed above.
Has anyone actually voted on it?
No. No roll call in this Congress cites this measure. That is the ordinary outcome: most measures never reach a recorded floor vote, and a committee ends most of them simply by not acting.
A vote is not the only thing that happens to a measure. Hearings, markups, and referrals are all recorded actions, and none of them is a vote of the full chamber.
Who is behind it?
Bill Cassidy (R-LA) introduced it on November 30, 2015, and 1 member has since signed on as a cosponsor.
They are 1 Democrat.
Cosponsoring is a formal signature on the text. It is not a commitment to vote for the measure, it does not bind anyone's party, and a long list of cosponsors is a measure of attention rather than of prospects.
How long has it been in play?
It was introduced on November 30, 2015, 3937 days ago. The most recent recorded action was 3937 days ago, on November 30, 2015.
Measures do not carry over. Anything the 114th Congress has not finished by January 3, 2017 dies when the term ends, and has to be introduced again from the start in the next Congress.
Every answer above is assembled from this measure's own record on Congress.gov and from published counts of what Congress has passed before. Civibrief does not predict outcomes and takes no position on any measure.
Vote history
- SenateIn committee, no floor vote yet
- HouseAwaits Senate passage
- PresidentAwaits both chambers