ECRI Institute Research Underpins FDA Medical Device Servicing Report

Additional regulations for medical device servicing not needed, states ECRI Institute and FDA

May 21, 2018

PLYMOUTH MEETING, PA—ECRI Institute, an independent health research organization, provided conclusive research to help guide the U.S. Food and Drug Administration (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.

For more information about ECRI Institute's medical technology procurement and management programs, contact ECRI Institute at (610) 825-6000, ext. 5891; visit; e-mail; or mail to ECRI Institute, 5200 Butler Pike, Plymouth Meeting, PA 19462.

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About ECRI Institute
ECRI Institute (, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to discover which medical procedures, devices, drugs, and processes enable improved patient care. As pioneers in this science for 50 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. Strict conflict-of-interest guidelines ensure objectivity. ECRI Institute is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO is listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. Find ECRI Institute on Facebook ( and on Twitter (

For more information, contact:
Laurie Menyo, Director of Public Relations and Marketing Communications
(610) 825-6000, ext. 5310