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

Artificial intelligence, also called deep learning and machine learning, was the hottest topic at the 2018 Radiological Society of North America (RSNA)) meeting.

Artificial intelligence was the hottest topic at the 2018 Radiological Society of North America (RSNA)) meeting, which included a large area with its own presentation therater set asside for AI vendors.

Feature | Artificial Intelligence | January 10, 2019 | Dave Fornell, Editor
Hands down, the hottest topic in radiology the past two years has been the implementation of...
GE Submits Initial Public Offering Paperwork for Healthcare Division
News | Radiology Business | December 19, 2018
December 19, 2018 — As part of its plans to spin off its healthcare division into a separate company, GE reportedly s
Affordable Care Act Ruled Unconstitutional in Texas Federal Court
News | Radiology Business | December 17, 2018
A judge of the Federal District Court for the Northern District of Texas ruled the Affordable Care Act (ACA)...
RADxx Announces 2nd Annual Award Winners for Outstanding Leadership in Medical Imaging Informatics
News | Radiology Business | December 14, 2018
RAD Women (#RADxx), a networking group for the advancement of women in imaging informatics, recently announced the...
AHRA Names Daniel Kelsey Chief Executive Officer

Daniel Kelsey. Image courtesy of AHRA: The Association for Medical Imaging Management

News | Radiology Business | November 20, 2018
On November 15, AHRA: The Association for Medical Imaging Management announced the appointment of Daniel Kelsey, MBA,...
Merit Medical Completes Acquisition of Cianna Medical
News | Women's Health | November 14, 2018
Disposable device manufacturer Merit Medical Systems Inc. announced the closing of a definitive merger agreement to...
MDW Unveils First Radiology Blockchain Platform at RSNA 2018
News | Radiology Business | November 13, 2018
Medical Diagnostic Web (MDW) will debut the first radiology blockchain platform designed to connect all players in the...
An enhanced patient experience can reduce providers’ exposure to liability, increase care compliance and positively impact providers’ reputations in the care community.

An enhanced patient experience can reduce providers’ exposure to liability, increase care compliance and positively impact providers’ reputations in the care community.

Feature | Radiology Business | November 06, 2018 | By Casey Williams
Two unrelenting forces are on a crash-course in healthcare: The rising volume of patient out-of-pocket payments and i