ECRI Institute has provided conclusive research to help guide the U.S. FDA in its new report, FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. The FDA report addresses concerns raised about the quality of service provided by third-party organizations. The report concurs with ECRI Institute recommendations that additional regulatory requirements regarding the servicing of medical equipment by entities other than original equipment manufacturers (OEMs) are not necessary.
“If FDA were to conclude that only OEMs could service medical equipment, it would potentially more than double the cost of equipment service,” says ECRI Institute’s David Jamison, executive director, health technology evaluation and safety. “We are pleased that FDA has investigated this issue and come to the same conclusion as we have—the servicing of medical devices is safe, and there is no need for additional regulation,” adds Jamison.
The FDA report includes a summary of an analysis performed by ECRI Institute of more than two million records, including the publicly available FDA Manufacturer and User Facility Device Experience (MAUDE) database, as well as ECRI’s private databases of hazards and recalls, and investigations of hospital-based accidents.
ECRI Institute concluded that there is no safety problem associated with the servicing, maintenance, and repair of medical devices either by the OEM or by third-party maintenance organizations. View ECRI Institute’s publicly released statement.
