News | Cardiovascular Business | June 07, 2018

FDA Releases New Report Assessing Quality, Safety and Effectiveness of Medical Device Servicing

Agency concludes current available evidence is not sufficient to indicate widespread public health concern over device servicing; action steps seek to improve best practices

FDA Releases New Report Assessing Quality, Safety and Effectiveness of Medical Device Servicing

June 7, 2018 — A new report from the U.S. Food and Drug Administration (FDA) discusses the continued quality, safety and effectiveness of servicing of medical devices by original equipment manufacturers (OEMs) and third-party entities.

The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. The public workshop included broad participation by OEMs, independent service organizations, healthcare establishments, biomedical and clinical engineers, healthcare technology management professionals, and professional and trade associations. Based on the available information, the FDA believes the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements at this time.

The report also concludes:

  • The objective evidence indicates that many OEMs and third-party entities provide high-quality, safe and effective servicing of medical devices;
  • A majority of comments, complaints and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing”; and
  • The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.

The report also includes several actions that FDA intends on pursuing, such as:

1. Promote the adoption of quality management principles;

2. Clarify the difference between servicing and remanufacturing;

3. Strengthen cybersecurity practices associated with servicing of medical devices; and

4. Foster evidence development to assess the quality, safety and effectiveness of medical device servicing.

The FDA published the report as a required provision of the 2017 the Food and Drug Administration Reauthorization Act (FDARA).

For more information: www.fda.gov

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