H.R. 28 requires the Secretary of the Department of Veterans Affairs (VA) to: implement a standard identification protocol for biological implants that is consistent with FDA’s Unique Identification System and report to Congress in the event that such a system is not operational within 180 days of enactment; and procure biological implants only through competitive procurement processes from vendors who maintain a 10 year record retention policy and who procure their human tissue from properly accredited sources.
Scientific innovation and advanced technology has provided the opportunity for the VA to turn increasingly to biological implants for prosthetic limbs and other healing enhancements. According to the Committee on Veterans’ Affairs, there remains “significant risk to veteran health and safety involving possibly contaminated products and the inability of VA to reliably identify veterans with implants in the event of [a] recall.” FDA has utilized a Unique Device Identification (UDI) system consisting of certain labeling and data submission requirements for biological implants and other medical devices since 2013.
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Jan 3, 2017.
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)
Biological Implant Tracking and Veteran Safety Act of 2017
(Sec. 2) This bill directs the Department of Veterans Affairs (VA) to: (1) 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; (2) permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency; (3) implement (within 180 days after enactment of this bill) a compatible system for tracking implants from human donor or animal source to implantation; and (4) implement compatible 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.
If the biological implant tracking system is not operational within 180 days, the VA shall report to Congress explaining why the system is not operational each month until it is operational.
(Sec. 3) The bill prescribes requirements for vendors from which the VA may procure biological implants of human and non-human origin and for vendors from which the VA may procure biological implants of non-human origin. Such a vendor must: (1) use the standard identification system adopted or implemented by the VA under this Act; (2) be registered as required by FDA procedures; (3) consent to periodic VA inspections and audits regarding records and product handling; (4) agree to cooperate with all biological implant recalls conducted on the vendor's initiative, on the initiative of the original product manufacturer used by the vendor, or by FDA request or statutory order; (5) agree to notify the VA within 60 days of providing any adverse event report to the FDA or receiving any warning letter from the FDA; and (6) 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 unless they are not 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 making a biological implant procurement transaction with intent to avoid, or with reckless disregard of, the requirements of this bill 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.