Devices

Hold 3rd-Party Device Servicers Accountable: MITA

A new Medical Imaging & Technology Alliance (MITA) white paper, “Understanding Accountability in Medical Device Servicing,” calls on FDA to do more to hold third-party medical device servicing businesses accountable. The document gives an overview of the types of organizations and entities that perform medical device servicing and the degree to which they are held accountable by federal regulations, accreditors, and voluntary industry-established standards, according to a MITA statement.

The paper says that oversight mechanisms for original equipment manufacturers are developed by FDA, and include strict pre- and post-market requirements for device manufacturers such as registration, reporting of adverse events, and maintenance of a quality management system.

Servicers directly employed by healthcare organizations are held accountable primarily by rigorous accreditation systems such as those of the Joint Commission, it says.

In contrast, the paper says, third-party servicing businesses are not bound by any such accountability mechanism. “Beyond voluntary standards, third-party servicing businesses operate within a regulatory gray area that raises significant concerns for patient safety and device performance,” MITA says.

MITA executive director Patrick Hope says third-party servicing businesses should be held to certain minimum requirements, including the adoption of a quality management system that conforms to FDA regulations, registration with FDA, and reporting of notable malfunctions and any deaths and serious injuries.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome