In recent months, the Food and Drug Administration (FDA) and members of the medical imaging community have been taking a close look at the topic of what defines servicing as opposed to the remanufacturing of imaging devices. While the period for public comment and a two-day workshop examining differences are over, the heated discussion around this subject continues.
First, here’s a little bit of background regarding why this became an issue.
In 2016, the Food and Drug Administration (FDA) began looking into third-party servicing of medical imaging systems. In early 2018, it released an initial report noting that while there are differences of opinions among stakeholders, including original equipment manufacturers (OEMs) and independent third-party service organizations (ISOs), there was no evidence to suggest a public health concern requiring regulatory oversight.
The FDA found the majority of complaints surrounding adverse clinical events involved the remanufacturing of devices rather than the servicing of medical imaging systems. This led to the question: what separates servicing activities from remanufacturing?
A very general description of these tasks can be found in a blog post from the Association for the Advancement of Medical Instrumentation (AAMI). Matt Dummert, director of healthcare technology management at Froedtert & The Medical College of Wisconsin, describes it this way:
“Servicing returns a device to its original intended use without compromising the safety and performance specified by the OEM. Servicing includes repair, refurbishing, reconditioning, rebuilding, and remarketing. If an activity significantly changes the device’s performance, safety specifications, or intended use, then it is considered remanufacturing.”
While that seems simple enough, it can apparently get much more complicated, depending on who you ask. Dummert goes on to explain why:
“The key is that the distinction between servicing and remanufacturing greatly depends on the OEM-defined procedures, the available specifications, and the perspective of the individuals determining what is considered significant risk.”
The topic of servicing vs. remanufacturing was one of the issues the FDA continues to explore with the help of industry input and officials from associations including the Medical Imaging and Technology Alliance (MITA) and its parent organization, the National Electrical Manufacturer’s Association (NEMA). Representing the engineers and ISOs in the debate is the International Association of Medical Equipment Resellers (IAMERS).
You can read more about the different stakeholders, their opinions, and likely motivations in our article about the debate on FDA oversight for medical imaging equipment.
A two-day public workshop exploring the details of servicing vs. remanufacturing took place in December 2018, and it was followed by an extended period allowing for public comment. Links to view recorded webcasts of the workshop are available on the FDA.gov website.
Ahead of that workshop, the FDA released a white paper for the topic of discussion in which it lists its view of how to delineate between servicing and remanufacturing medical imaging equipment. While the white paper is by no means an official ruling, the FDA created a flowchart to help imaging engineers and others in healthcare technology management (HTM) make a determination.
DirectMed Imaging recreated that flowchart below for use as a visual aid that should help imaging engineers and their employers understand whether it is more likely the task they are working on represents servicing or remanufacturing.
Flowchart: Is it Servicing or Remanufacturing?
What’s Happening with Servicing and Remanufacturing Now?
Since the release of the white paper and subsequent public workshop, different sides of the industry continue to make recommendations and debate what constitutes servicing as opposed to remanufacturing. There are also efforts to establish best practices for ISOs and engineers who service imaging equipment outside of the OEM’s oversight.
NEMA and MITA recently released their own quality management system (QMS) requirements for servicing medical imaging devices. The NEMA/MITA QMS document is available to download online. MITA’s executive director and the director of policy told Healthcare Business News these standards were needed.
“Until now, there have not been any QMS Standards developed specifically for servicing of medical imaging devices. MITA saw this as a critical gap that needed to be filled in order to protect patient safety and device integrity.”
Those on the other side of the debate aren’t so willing to immediately accept standards that were developed by agencies representing the OEMs. An attorney for IAMERS says others should be consulted before any specific guidelines are identified or enforced.
“The MITA Service standard did not get approval by the HTMs and ISOs. Stakeholders should recognize that it was not endorsed, as it was based on the FDA QSR regulation pertaining to manufacturers and did not adequately address training and calibration of equipment.”
For now, ISOs, OEMs, and the medical community have to wait to see what conclusions the FDA makes regarding definitions and standards for servicing and remanufacturing medical imaging devices. The agency has yet to announce a date when it will respond.
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