VA Central Office Needs To Exercise Better Oversight of Cardiac Pacemaker Recalls
HRD-84-33
Published: Apr 16, 1984. Publicly Released: Apr 16, 1984.
Skip to Highlights
Highlights
GAO reviewed the actions taken by the Veterans Administration (VA) in response to recalls of defective pacemakers.
Recommendations
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| Veterans Administration | The Administrator of Veterans Affairs should direct the Chief Medical Director to establish criteria, as part of program guidance, to define when a recalled pacemaker should be considered critically unreliable. |
Closed – Implemented
Issuance of the circular containing the program guidance was delayed for technical details by the Chairman, DRD Council, and the Office of Acquisition and Material Management. It has been revised incorporating their changes and issued in May 1989.
|
| Veterans Administration | The Administrator of Veterans Affairs should direct the Chief Medical Director to revise program guidance to require that medical centers: (1) inform patients of pacemaker recalls unless the reasons for not informing the patient are documented in the medical record; and (2) document the actions taken in response to the recall in the patients' medical records. |
Closed – Implemented
The circular containing program requirements was issued in May 1989.
|
| Veterans Administration | The Administrator of Veterans Affairs should direct the Chief Medical Director to identify all VA patients using recalled pacemakers and ensure that: (1) they have been informed of the recall or that the reasons for not informing the patient are documented in the patients' medical records; and (2) all actions taken in response to the recalls are documented in affected patients' medical records. |
Closed – Implemented
The circular containing program requirements was issued in May 1989.
|
| Veterans Administration | The Administrator of Veterans Affairs should direct the Chief Medical Director to establish a timetable for development of the clinical pacemaker registry and, in the interim, take steps to improve the completeness and reliability of data contained in the existing registry. |
Closed – Implemented
The clinical registry has been developed and was placed in service in 1986. Operating instructions for the registry will be included in the revised circular. The revised circular was issued in May 1989.
|
| Veterans Administration | The Administrator of Veterans Affairs should direct the Chief Medical Director to establish a program to monitor the actions taken by medical centers in response to pacemaker recalls. |
Closed – Implemented
The program circular was issued in May 1989.
|
Full Report
Office of Public Affairs
Topics
Health care servicesMedical recordsMonitoringProsthetic devicesVeterans hospitalsHealth care centersVeteransPhysiciansCardiovascular diseasesMedical devices