News | Radiology 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

Related Content

The Current Direction of Healthcare Reform Explained by CMS Administrator Seema Verma
News | Radiology Business | June 11, 2019
June 11, 2019 — Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma addressed the American Med
ASTRO Applauds New Prior Authorization Legislation
News | Radiation Therapy | June 07, 2019
The American Society for Radiation Oncology (ASTRO) released a statement applauding Congress’s introduction of...
Applications Open for ASRT Foundation and Canon Medical's Safety FiRsT Grant Program
News | Radiation Dose Management | May 31, 2019
The ASRT Foundation and Canon Medical Systems are now accepting applications for the 2019 Safety FiRsT grant program,...

Photo courtesy of Philips Healthcare

Feature | Radiology Business | May 31, 2019 | By Arjen Radder
Change is a consistent theme in our world today, no matter where you look.
Life Image and Bialogics Analytics Partner to Deliver Imaging Business Intelligence
News | Analytics Software | May 21, 2019
Life Image and business intelligence analytics provider Bialogics Analytics have formed a strategic partnership that...
3 Recommendations to Better Understand HIPAA Compliance
Feature | Information Technology | May 17, 2019 | Carol Amick
According to the U.S.
ITN reached 90,000 unique Facebook users with content during the week of the visit to Central DuPage Hospital

ITN reached 90,000 unique Facebook users with content during the week of the visit to Central DuPage Hospital.

News | Radiology Business | May 10, 2019
Imaging Technology News (ITN) earned an Honorable Mention at the 2019 National Azbee Awards of Excellence in the Cross-...
An illustration of radiology department analytics data showing GE Healthcare's business analytics software.
Feature | Radiology Business | May 03, 2019 | April Wilson
According to IBM, the world creates 2.5 quintillion bytes of data daily.