3.0.0 547 2022-11-01T14:02:53Z 2022-11-01T14:02:53Z House HR 2019-01-15 116 [Congressional Record Volume 165, Number 8 (Tuesday, January 15, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. DAVID P. ROE of Tennessee:H.R. 547.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the United States Constitution.[Page H602]]]> hsvr00 Veterans' Affairs Committee House Standing Referred to 2019-01-15T15:01:15Z 2019-01-15 Referred to the House Committee on Veterans' Affairs. IntroReferral H11100 2 House floor actions hsvr00 Veterans' Affairs Committee 2019-01-15 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-01-15 Introduced in House IntroReferral 1000 9 Library of Congress R000582 Rep. Roe, David P. [R-TN-1] David Roe R TN P. 1 N Armed Forces and National Security Business records Cell biology and embryology Congressional oversight Department of Veterans Affairs Drug safety, medical device, and laboratory regulation Government ethics and transparency, public corruption Health information and medical records Health technology, devices, supplies Licensing and registrations Organ and tissue donation and transplantation Product safety and quality Public contracts and procurement Veterans' medical care Armed Forces and National Security 00 2019-01-15 Introduced in House 2020-02-06T14:21:16Z Biological Implant Tracking and Veteran Safety Act of 2019

This bill requires the Department of Veterans Affairs (VA) to adopt and implement a device identification system for use in identifying biological implants intended for use in medical procedures conducted in VA facilities. The VA may adopt the system developed by the Food and Drug Administration (FDA) or may develop its own comparable system. Additionally, the VA shall implement a compatible system for tracking the biological implants from human donor or animal source to implantation.

The bill requires the VA to implement compatible inventory controls so patients can be notified if they have received a biological implant in a VA facility that is subject to a recall.

The bill prescribes requirements for vendors from which the VA may procure biological implants of human and nonhuman origin.

Under the bill, 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.

In procuring biological implants, the VA must permit a vendor to use any of the accredited entities identified by the FDA as an issuing agency.

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 2019 Display Title Biological Implant Tracking and Veteran Safety Act of 2019 Official Title as Introduced To amend title 38, United States Code, to direct the Secretary of Veterans Affairs to adopt and implement a standard identification protocol for use in the tracking and procurement of biological implants by the Department of Veterans Affairs, and for other purposes. Introduced in House IH Short Title(s) as Introduced Biological Implant Tracking and Veteran Safety Act of 2019 Introduced in House IH Introduced in House 2019-01-15T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr547ih/xml/BILLS-116hr547ih.xml 2019-01-15 Referred to the House Committee on Veterans' Affairs. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.