In its most narrow sense, the Right-to-Repair movement refers to the debate over whether ownership of an instrument should be associated with the unrestricted right to repair it. More specifically, this debate has focused on the third-party repair and maintenance (service) organizations that perform repairs on instruments.

In the healthcare industry, there are two distinct sides in this debate: Those who favor regulation of the repair organizations to ensure they meet the same standards as the original manufacturers and those who believe repair organizations should have the right to access parts and manuals. Of course, neither of these makes sense by itself: How can you follow the same standards as the original manufacturer if you don’t know what standards they follow? And why should you have a right to repair medical instruments if you don’t want to follow the rules?

The fact is medical instruments are being repaired by more or less sophisticated service companies, and the real question is whether (and how) we should regulate them. (This discussion was brought up again at the 2025 AAMI eXchange in New Orleans, where Binseng Wang, ScD, CCE, and Wayne Moore, CHTM, discussed the issue.)

A Diverse, Unregulated Industry

Medical instrument repairs cover a very broad spectrum of different practices that are unregulated (with a few exceptions)—and this is exactly the challenge. If I buy a pair of surgical scissors, I should obviously be able to get them sharpened by a third-party repair shop. However, the same repair shop probably offers repairs of $60,000 endoscopes, including the replacement of parts. Neither activity is regulated, and the repair company doesn’t even have to be FDA registered or ISO certified.

Moreover, there are no industry standards for the performance of the repaired instruments, no standardized training, and no professional self-regulation. There is very little transparency about repair costs and quality, and while original manufacturers service their own instruments, there is no information sharing between repair companies and original manufacturers. When third-party repair companies replace parts of a flexible endoscope, reassemble it, and test it (without knowing manufacturer specifications), we have a problem. We need to put some guardrails in place.

The challenge is how to make the distinction between sharpening a pair of scissors and repairing an endoscope. Hospitals rely on small repair companies to come in and sharpen their instruments. If such businesses were to be regulated like manufacturers, these services would become prohibitively expensive. Moreover, FDA oversight over these activities would be an almost impossible task. Historically, FDA has shied away from regulation, probably due to the large diversity of activities involved and the variability among actors involved.

However, FDA has indicated its general support of medical device repairs. More specifically, FDA recognizes the importance of third-party medical device repair companies in maintaining the functionality and availability of medical equipment within the healthcare system. While acknowledging the potential cost savings and other benefits of using third-party services, FDA also emphasizes the need for these companies to adhere to quality standards and safety protocols to ensure patient safety. The agency distinguishes between “servicing” (maintenance and repair) and “remanufacturing” (significant changes to the device) and provides guidance to clarify these definitions and their implications for regulatory compliance.

In other words, FDA emphasizes that third-party servicers play a crucial role in maintaining the quality and safety of medical devices; however, they need to adhere to the original manufacturer’s specifications and intended use, and ensure devices function as intended. Also, crucially, repair personnel should have the necessary training and expertise to service medical devices safely and effectively.

Reprocessing and Remanufacturing

In a broader sense, the Right-to-Repair movement in healthcare is reflective of an increasingly strong argument for device and instrument reuse in healthcare. Historically, healthcare has had a throw-away mindset based on the idea that the more we throw away, the less infection risk is involved, and the safer the patient. Concerns about the cost of medical instrument and device use in the 2000s, increasing focus on the environmental impact of single-use instruments in the 2010s, and the post-pandemic focus on supply chain resilience have begun to change this mindset.

Single-use medical device reprocessing and recent developments in robotic instrument remanufacturing are the strongest examples of how device and instrument re-use have begun to change this healthcare mindset. In contrast to medical device repair (another form of re-use), both these areas are heavily regulated, and they could serve as case studies in how to handle regulation in the broader service industry.

In U.S. healthcare, we have regulated single-use device reprocessing since 2000, when FDA regulation started to demand reprocessing companies become FDA registered and an FDA clearance would need to be granted for each device the companies wanted to reprocess and make available to hospitals for an additional use. FDA essentially put a regulatory regimen in place that demanded the same from the reprocessor that was demanded from the manufacturer: The reprocessor had to provide evidence that the reprocessed device could be cleaned, tested, and sterilized to the point where it was substantially equivalent to a new device and added no patient risk. Thanks to such strict requirements, the single-use reprocessing industry has an impeccable safety record, and the industry’s participants are highly sophisticated, technologically savvy, and regulatorily advanced organizations.

It is important to note that prior to regulation, reprocessing of single-use devices was a common practice: Hospitals would simply send their used single-use devices down to the Sterile Processing Department, have the device re-sterilized, then use them in another patient. Or they would send the used single-use device to a third-party reprocessor, who would essentially do the same. In other words, prior to regulation, single-use device reprocessing closely resembled the current medical instrument repair industry in terms of transparency, consistency, guidance, quality, and patient safety.

However, single-use labeled devices are regulated differently from reusable devices. The label is placed on the devices by the manufacturer because, from a design perspective, it is unsafe to use more than once. Only under certain specific circumstances (described previously) can it be reused. Reusable devices come with cleaning instructions from the original manufacturer, and they are designed to be reused.

Over the past couple of years, healthcare companies have received the industry’s first FDA clearances to remanufacture robotic instruments (arms). This represents a second example of regulated reuse—this time in the reusable instrument industry.

A robotic instrument is reusable, but its reuse is limited: You cannot simply use the instrument until it doesn’t work anymore (such as a pair of scissors). The instructions for use from the robotic company prescribe a limited number of re-uses (typically 10-15 times), after which the instrument has to be replaced. If a repair company wants to make a robotic instrument available for reuse, it has to achieve an FDA clearance to remanufacture the instrument. This is because the steps involved in resetting the instrument significantly alter the instrument and bring robotic instruments into the regulatory area of “remanufacturing.” Essentially, getting an FDA clearance to remanufacture an instrument is similar to getting an FDA clearance to reprocess a single-use device: You have to demonstrate substantial equivalence to a new device.

Moving Forward with Regulation

The case of remanufactured robotic instruments can be educational in terms of how we move forward in the discussion about the Right to Repair in healthcare and the challenges associated with such a diverse practice and such a fragmented industry. There is no doubt that regulation is needed in medical instrument repair, but regulation needs to be limited to instruments and practices that require such regulation. These include:

• Instruments that are reusable but “limited-use” (i.e., specify a certain number of uses)—This includes robotic instruments, but also (for example) cables used in different procedures. The limited use is usually determined by the manufacturer based on instrument integrity and wear-and-tear over time. It is meaningful to regulate who can “remanufacture” or “reprocess” these.
• Instrument repairs that involve the replacement of critical parts—This includes robotic instrument remanufacturing, but also potentially endoscope repair. We find little difference between the alteration of a robotic instrument and the alteration of an endoscope under repair; however, one is regulated, and one is not.
• Instruments of a certain level of design complexity—Medical devices and instruments are becoming more and more advanced. As a result, they are becoming more and more difficult to repair. Certain types of instruments would require specialized training, specific standards, etc. Such instrument repair should fall under regulation.

FDA needs to refine its categorization of different instrument types and develop regulatory frameworks that match these. Specifically, we are in need of a broader “remanufacturing” category that captures devices that should have tighter FDA oversight, such as endoscopes or surgical cables.

Recall what regulation did to the single-use device reprocessing industry? It became regulated, and as a result, the practice became more sophisticated, professionalized, consistent, and safe. Doesn’t that sound like a good outcome for the medical instrument service industry?