May 22, 2018

ECRI Institute research helped guide FDA report on medical device servicing

By: Judy Mathias
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Editor’s Note

The ECRI Institute on May 21 announced that it had provided conclusive research to help guide the Food and Drug Administration’s (FDA) new “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.”

The FDA report, which addresses concerns about the quality of service provided by third-party organizations, concurs with ECRI Institute recommendations that additional regulations for medical device servicing are not needed.

The ECRI Institute concluded that there is no safety problem associated with the servicing, maintenance, and repair of medical devices by the original equipment manufacturer or third-party maintenance organizations.

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