Summary: H.R.4374 — 113th Congress (2013-2014)All Information (Except Text)

There is one summary for H.R.4374. Bill summaries are authored by CRS.

Shown Here:
Introduced in House (04/02/2014)

Biological Implant Tracking and Veteran Safety Act of 2014 - Directs the Secretary of Veterans Affairs 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 medical procedures conducted in Department of Veterans Affairs (VA) medical facilities; (2) implement a compatible system for tracking the implants from donor to implantation; and (3) implement inventory controls compatible with such tracking system so that all patients who have received, in a VA medical facility, a biological implant subject to a recall by the FDA can be notified of the recall.

Authorizes the Secretary to procure biological implants only from vendors that meet specified conditions, including that the vendor uses the standard identification system, consents to periodic VA inspections and audits, is registered with the FDA, and maintains national accreditation specific to biological implants. Requires the Secretary to: (1) procure such implants under General Services Administration (GSA) Federal Supply Schedules, (2) accommodate reasonable vendor requests to undertake specified outreach efforts to educate VA medical professionals about the use and efficacy of implants that are listed on such Schedules, and (3) procure biological implants that are unavailable for procurement under such Schedules using competitive procedures in accordance with the Federal Acquisition Regulation.

Makes any VA procurement employee found responsible for a biological implant procurement transaction with intent to avoid, or with reckless disregard of, the requirements of this Act 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.