Legis Daily

Biological Implant Tracking and Veteran Safety Act of 2017

USA115th CongressHR-28| House 
| Updated: 1/4/2017
David P. Roe

David P. Roe

Republican Representative

Tennessee

Health Subcommittee, Veterans' Affairs Committee, Veterans' Affairs Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
(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.

Bill Text Versions

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Timeline
Jan 3, 2017
Introduced in House
Jan 3, 2017
Referred to the Subcommittee on Health.
Jan 3, 2017
Referred to the House Committee on Veterans' Affairs.
Jan 3, 2017
Mr. Roe (TN) moved to suspend the rules and pass the bill.
Jan 3, 2017
Considered under suspension of the rules. (consideration: CR H31-33)
Jan 3, 2017
DEBATE - The House proceeded with forty minutes of debate on H.R. 28.
Jan 3, 2017
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H31-32)
Jan 3, 2017
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H31-32)
Jan 3, 2017
Motion to reconsider laid on the table Agreed to without objection.
Jan 4, 2017
Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.
  • January 3, 2017
    Introduced in House


  • January 3, 2017
    Referred to the Subcommittee on Health.


  • January 3, 2017
    Referred to the House Committee on Veterans' Affairs.


  • January 3, 2017
    Mr. Roe (TN) moved to suspend the rules and pass the bill.


  • January 3, 2017
    Considered under suspension of the rules. (consideration: CR H31-33)


  • January 3, 2017
    DEBATE - The House proceeded with forty minutes of debate on H.R. 28.


  • January 3, 2017
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H31-32)


  • January 3, 2017
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H31-32)


  • January 3, 2017
    Motion to reconsider laid on the table Agreed to without objection.


  • January 4, 2017
    Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.

Armed Forces and National Security

Related Bills

  • S 115-23: A bill 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.
Business recordsCell biology and embryologyCongressional oversightDepartment of Veterans AffairsDrug safety, medical device, and laboratory regulationGovernment ethics and transparency, public corruptionHealth information and medical recordsHealth technology, devices, suppliesLicensing and registrationsOrgan and tissue donation and transplantationProduct safety and qualityPublic contracts and procurementVeterans' medical care

Biological Implant Tracking and Veteran Safety Act of 2017

USA115th CongressHR-28| House 
| Updated: 1/4/2017
(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.

Bill Text Versions

View Text
2 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Jan 3, 2017
Introduced in House
Jan 3, 2017
Referred to the Subcommittee on Health.
Jan 3, 2017
Referred to the House Committee on Veterans' Affairs.
Jan 3, 2017
Mr. Roe (TN) moved to suspend the rules and pass the bill.
Jan 3, 2017
Considered under suspension of the rules. (consideration: CR H31-33)
Jan 3, 2017
DEBATE - The House proceeded with forty minutes of debate on H.R. 28.
Jan 3, 2017
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H31-32)
Jan 3, 2017
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H31-32)
Jan 3, 2017
Motion to reconsider laid on the table Agreed to without objection.
Jan 4, 2017
Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.
  • January 3, 2017
    Introduced in House


  • January 3, 2017
    Referred to the Subcommittee on Health.


  • January 3, 2017
    Referred to the House Committee on Veterans' Affairs.


  • January 3, 2017
    Mr. Roe (TN) moved to suspend the rules and pass the bill.


  • January 3, 2017
    Considered under suspension of the rules. (consideration: CR H31-33)


  • January 3, 2017
    DEBATE - The House proceeded with forty minutes of debate on H.R. 28.


  • January 3, 2017
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.(text: CR H31-32)


  • January 3, 2017
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H31-32)


  • January 3, 2017
    Motion to reconsider laid on the table Agreed to without objection.


  • January 4, 2017
    Received in the Senate and Read twice and referred to the Committee on Veterans' Affairs.
David P. Roe

David P. Roe

Republican Representative

Tennessee

Health Subcommittee, Veterans' Affairs Committee, Veterans' Affairs Committee

Armed Forces and National Security

Related Bills

  • S 115-23: A bill 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 Committee
  • On Floor
  • Passed Chamber
  • Enacted
Business recordsCell biology and embryologyCongressional oversightDepartment of Veterans AffairsDrug safety, medical device, and laboratory regulationGovernment ethics and transparency, public corruptionHealth information and medical recordsHealth technology, devices, suppliesLicensing and registrationsOrgan and tissue donation and transplantationProduct safety and qualityPublic contracts and procurementVeterans' medical care