I had the opportunity to attend the December FDA public workshop, which focused on the distinction between medical device servicing and remanufacturing activities. I do not intend to cover all the specifics of the workshop here. My goal is to inform those in the health technology industry who are not clear on the history of these efforts or have disengaged from the topic. You will be impacted. The extent and nature of that impact has yet to be determined and will ultimately be influenced by the individuals who are at the table.
My curiosity in the topic is multidimensional. For the past eight years, I’ve managed an “in house” medical equipment services operation at a healthcare organization. Prior to that, I worked for eight years with two independent service organizations (ISOs), and I spent a short time working for a manufacturer. Apart from my industry experience, I’m a biomedical engineering educator. This topic not only impacts how I do my work but also how I educate my students.
During the FDA’s previous workshop in 2016, I observed a distinct division of perspectives for what the outcome of the efforts should look like. I wondered if the various parties involved were trying to solve the same problem. We all packaged the topic as “quality and safety,” but the definition and flavor of quality is very different based on your business and role. We all had patient safety and effective care at the top of our minds, but I believe there is a misunderstanding about how each branch of the medical device industry operates so the solutions proposed tend to be solving different problems.
The outcome of the 2016 workshop was summarized in a report from the FDA indicating that there is no available evidence of a systemic quality problem related to servicing medical equipment, regardless of whether the service is performed by an original equipment manufacturer (OEM), an ISO, or a healthcare technology management (HTM) entity. To the casual observer, the focus seemed to have shifted to the safety and quality of activities under “remanufacturing” rather than “servicing.” Those working in healthcare-based HTM operations may have disengaged from the topic because they did not associate themselves with “remanufacturing.” However, it was clear to me that it is not yet possible to fully separate servicing from remanufacturing.
What is servicing versus remanufacturing? 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.
Consider the following example. The host computer on a computed tomography (CT) scanner fails. The hospital service technician, who attended OEM-provided service training for this system, traced the issue to a failed hard drive.
Option 1 is to order the entire host computer from the OEM at a cost of $70,000. As part of the OEM’s quality system, they are only able to service the CT as defined in their published service procedures. The OEM will not sell the hard drive as a replacement part since, per their procedures, it is not considered a field replaceable unit.
Option 2 is to order a replacement hard drive from a computer supplier at a cost of $450. The new hard drive is the same specification as the hard drive found in the host computer. In either option, the hospital service technician will need to reload the software which was covered in the OEM training and is published in the OEM service documentation.
The hospital would consider this to be “servicing” since they have returned the CT to its original use and based on their knowledge and experience have introduced minimal risk. The OEM may claim a significant risk was introduced since the OEM did not qualify the hard drive. The OEM may also suggest that the hospital technician would not have been able to qualify the repair, since they do not have the procedures and specifications available to the manufacturing technicians when they test the full host computer. This would move this “servicing” activity into “remanufacturing.”
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. Forcing the hospital technicians or ISOs to only use OEM-provided replacement units would have profound negative impacts on the HTM industry. Forcing the OEM to define detailed procedures and validations for every possible hard drive, cable, or screw is probably not realistic, either.
This leads to one of the fundamental complexities of this discussion: How do we find ways to help each other improve the safety and effectiveness of our patients while satisfying the regulatory and business needs of the medical device industry?
Prior to the 2018 workshop, the FDA provided a reference white paper to help guide the discussion. The workshop was very well facilitated, and the engagement of the participants was outstanding. We covered the definitions of remanufacturing vs servicing, training and technical materials, collaboration across the medical device industry, and development of quality systems that could apply to all servicers. Servicing was clearly still on the table for discussion.
It is worth noting that the panel sessions were primarily populated by OEM and ISO representatives. Some participants also represented various trade or professional organizations. I am careful not to be too critical of the lack of HTM representatives employed by healthcare providers, as some of the ISO and professional organizations do share much of the in-house perspective. However, I encourage all HTM professionals to participate in the discussion of this important topic.
The workshop is over, but the efforts will carry on through various workgroups and collaborative activities. You can still weigh in! The FDA is taking comments at www.regulations.gov (docket number FDA-2018-N-3741) until Feb. 25, 2019.
Matt Dummert is director of healthcare technology management at Froedtert & The Medical College of Wisconsin and a member of the BI&T Editorial Board.