A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.
As of July 26, the FDA has received only four comments. Those interested in submitting comments can do so here.
The comments thus far include feedback from U.S. PIRG Right to Repair Campaign Director Kevin O’Reilly.
“Thank you for issuing this draft guidance. Drawing a clear line between service and remanufacturing will help to ensure that health care providers and their patients can have full confidence in the medical devices they are using for treatment. We hope that this guidance will help to clarify the difference between ‘servicing’ and ‘remanufacturing,’ and reduce inaccurate arguments that medical device servicing is dangerous given FDA findings that the majority of adverse events and deaths can be attributed to remanufacturing,” O’Reilly writes. “We also applaud the draft guidance’s labeling recommendations. Equipping clinical engineers and biomedical repair technicians (biomeds) with technical, functional, performance and safety specifications is critical to their ability to effectively and safely repair medical devices when they break. Providing biomeds with recommended maintenance activities and schedules will allow them to keep equipment in fine condition, while descriptions of error codes will enable biomeds to quickly respond in the event of an unplanned problem. It is especially important that this information is included in labeling so that all biomeds can access it, regardless of whether they work for a health delivery organization (HDO), an independent service organization (ISO) or an Original Equipment Manufacturer (OEM).”
“In addition to this information, we encourage the FDA to include troubleshooting instructions and part lists, with specifications, in the labeling recommendations. These measures would help prevent unnecessary remanufacturing and the resulting safety risks and regulatory requirements,” he adds. “Troubleshooting could help identify problems with a repair that are causing the device to not meet performance or safety specifications. A descriptive list of parts would allow biomeds to ensure that any replacement they install matches the original as it was marketed. Matching an exact part should help to make sure that required specifications are met.”
Reilly says that a list of parts is just the beginning of what biomeds need.
“A complete list of parts alone, however, will not be much help without access to the parts themselves. A U.S. PIRG survey of biomeds published in February 2021 found that 76% of respondents were ‘denied access to parts or service materials for critical medical equipment by the manufacturer’ as COVID-19 cases were spiking,” he writes in the comments. “Making sure that HDOs and their chosen repair entities have access to OEM parts will help to avoid cases like that of Example E.5, where the use of a replacement tube with a different inner diameter led to performance changes that put the equipment out of specifications. Biomeds have reported instances in which they needed to promptly fix a medical device in order to save a patient’s life; without access to the parts they need to carry out that job, biomeds’ hands are tied while patient care suffers. We hope to see the above adjustments reflected in the final draft of the guidance, representing an important first step. Ultimately, however, decisive policies and regulations must be put in place to ensure change. Biomeds have sounded the alarm throughout the COVID-19 pandemic that they routinely face repair restrictions from OEMs – a problem that will continue as we emerge from the pandemic. The FDA should respond to calls from frontline healthcare professionals by undertaking rulemaking and other enforcement steps to ensure that OEMs provide qualified biomeds – regardless of their employer – with access to the materials they need to safely and efficiently fix medical equipment as soon as it breaks.”
More comments can be viewed online at https://www.regulations.gov/document/FDA-2018-N-3741-0044/comment.
While the Medical Imaging & Technology Alliance (MITA) has not posted comments to the draft guidance website. The group did issue responded to the publication of the guidance on June 20. Official comments from MITA and other groups are expected before the deadline.
“The guidance takes a step in the right direction by describing measures all servicers and manufacturers should take to ensure medical devices are functioning properly,” MITA Executive Director Patrick Hope said in June. “By detailing the importance of conducting risk analysis, ensuring proper documentation and education around remanufacturing and servicing, it is our hope that those entities performing unregulated and unaccountable third-party servicing can obtain a better line of sight into their work and regulatory responsibilities, especially when it veers into remanufacturing, which is often the case.”
“The FDA remanufacturing guidance underscores the need for the agency to provide clarity around to whom this draft guidance applies, what surveillance mechanisms are available to FDA to detect servicers who are performing remanufacturing activities and how this guidance will be enforced,” noted Hope. “MITA strongly believes all servicers and manufacturers should proactively adopt quality control measures to meet the same quality and safety standards. This can be assured by requiring servicing entities to register with the agency, report errors and demonstrate they have quality management systems in place. Patients deserve nothing less.”
The draft remanufacturing guidance was published in response to the May 2018 FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices in which the FDA stated that “a significant portion of the comments, complaints, and adverse event reports alleging inadequate servicing pertain to activities more accurately described as remanufacturing.”
“Given the findings of the 2018 FDA report, MITA remains concerned that the majority of third-party servicers are actually engaging in unaccountable remanufacturing activities that are not yet in view of the FDA,” added Hope.
MITA looks forward to working with the FDA to finalize its remanufacturing guidance and urges the agency to move quickly to address the other action steps they committed to taking in their 2018 report, including promoting the adoption of quality management principles, strengthening cybersecurity practices associated with servicing and fostering evidence development to assess servicing.
“The FDA needs data to reach conclusions and take action based on the 2018 recommendations. By refusing to register with the FDA, third-party service businesses continue to thwart the agency’s work – thereby increasing risks for patients, physicians, and technicians,” Hope concluded.
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