Is Increased Regulation Coming Soon for the Medical Device Maintenance Industry?

Right to Repair vs. OEM restrictions. Remanufacturing vs. servicing. FDA regulations for OEMs vs. 3rd-party manufacturers and Independent Service Organizations (ISOs).

Since 2016, stakeholders have zeroed in on the complex regulatory landscape of the medical device maintenance industry. The relationship between regulatory agencies, healthcare providers, OEMs, independent service providers, and biomedical repair professionals results in a confusing and sometimes contentious environment.

Problems completing essential repairs during the height of the COVID-19 pandemic in 2020 turned the industry's regulatory issues into national headlines and spurred a movement calling for "Right-to-Repair" legislation across the country. At the same time, many OEMs have buckled down on equipment repair restrictions. High-profile media outlets have facilitated much debate between some special interest groups. But those players don't necessarily speak for the majority on either side of the Right-to-Repair question, and such statements don't always reflect the realities involved in biomedical device repair.

So, what kind of regulatory change is in store for independent service providers and 3rd-party parts companies? And which stakeholders stand to benefit from those changes? What about the effect on patient safety and clinical outcomes?

Before answering these questions, let’s explore the current regulatory landscape.

Regulatory Inconsistencies and Right-to-Repair

Simple isn't a word that applies to either of those topics. They aren't mutually exclusive either, although some louder voices in the industry claim them in opposition.

In a nutshell, proponents of increased regulation focus on the FDA requiring OEMs to maintain a quality management system (QMS) that complies with the strict guidelines in the 21 CFR 820 Quality System Regulations, yet these standards are voluntary for 3rd-party businesses.

Some companies choose to register with the FDA and maintain ISO 13485 certification, requiring a robust QMS. Others choose not to do this — however for optimal quality and performance, it is critical to depend on USA manufactured non-OEM parts with FDA Registered and ISO certified 3rd party companies.

Furthermore, some OEMs assert that the gap in regulatory policy affects the quality of 3rd-party repairs and parts, which compromises patient safety and device effectiveness. However, as explained later in this article, the evidence doesn't fully support this assertion.

The Right-to-Repair movement seeks to lift policy and OEM restrictions that act as barriers to performing independent service and repairs on equipment. The movement encompasses all industries. In the medical sector, Right-to-Repair advocates are driven by factors such as:

• Economic factors: Repair costs for large health networks, smaller healthcare facilities, rural and regional hospitals
• Practical concerns: OEM restrictions limit access to manuals, parts, and tools, yet OEM repairs often take longer, increasing asset downtime and impacting patient care.
• Device repair networks: In reality, partnerships drive the medical device repair industry. OEMs aren't equipped to service every device they produce. Rather Hospitals, OEMs, and ISOs typically work together to keep Biomedical asset fleets up and running.

Right-to-Repair legislation has been introduced in at least 25 states. These laws will continue to affect regulatory policy.

Previous FDA actions taken include:

• 2016 FDA Notice calling for information and comments on 3rd-party healthcare and medical device entities that "refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices."
• 2018 FDA Report concludes that "objective evidence indicates that many OEMs and 3rd-party entities provide high quality, safe, and effective servicing of medical devices," and states that the majority of adverse event comments pertain to "remanufacturing" rather than servicing.
• 2021 FDA Draft Guidance clarifying which activities performed on devices are considered to be remanufacturing and calls for comments

The FDA intends to publish its final guidance in 2022. That document will cover much detail and nuance between the new definitions laid out in the draft guidance.

Will the FDA regulate 3rd-party repair services?

Not anytime soon. The 2018 report concluded that the evidence was insufficient to warrant new formal regulation for medical equipment servicing. The report stated the FDA would take action to promote the adoption of quality management systems, strengthen cybersecurity measures associated with servicing, and "foster evidence development" to assess the safety and quality of device servicing.

Who will benefit from this?

Stakeholders who will directly benefit from these laws include:

• 3rd-party servicing: organizations will avoid the costs and potential limitations of regulatory compliance. Depending on the progress of Right-to-Repair laws, they may also benefit from increased access to service manuals and tools.
• Health systems and hospitals: organizations that contract with ISOs will continue to enjoy lower repair costs, faster repairs, increased device lifespan, and the operational benefits associated with these advantages. Smaller rural and regional hospitals depend on 3rd-party service providers because OEM servicing often isn't accessible in the region, and out-of-warranty OEM repair fees are too costly.
• Clinical staff and patients: faster and more cost-effective repairs reduce asset downtime and allow more devices to be deployed to meet ongoing care demands. That means clinical staff experience fewer workflow interruptions and can more readily provide effective care. In the final analysis, all these benefits add up to better care for patients and enhanced clinical outcomes.

Although OEMs may lose some revenue as independent service providers become more equipped to complete service and repairs, the evidence in the 2018 report suggests that most players stand to benefit from Right-to-Repair laws. In fact, focusing on partnerships between OEMS, ISOs, and 3rd Party Companies can significantly benefit all parties.

Will the FDA regulate 3rd-party medical device manufacturers?

This is still unclear, but the draft guidance highlights why increased regulation for manufacturers of replacement parts makes sense. Complaints cited in the 2018 report that fall under the definition of “remanufacturing” includes references to 3rd party replacement parts not meeting OEM specifications. The FDA defines “remanufacturing” as a process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications or intended use. Such parts may contribute to decreased device lifespan, equipment failure, and adverse patient events, leading to recalls.

Regulation of 3rd party companies would ensure that their establishments maintain compliance with 21CFR820 like the OEM manufacturers. It is also important to investigate and qualify your 3rd party replacement part company. Other questions to consider: Where do they manufacture? How is their QMS? Are they FDA Registered? Are they ISO 13485:2016 and ISO 9001:2015 certified?

The Takeaway: Collaboration is the Best Path Forward

Ultimately, Right-to-Repair and increased regulatory standards are methods of achieving the same goal: effective medical care and patient safety. Spokespeople from industry associations that support increased regulation have suggested that greater collaboration between stakeholders is the key to making the medical device maintenance industry as safe and effective as possible. The most realistic and strategically advantageous path forward is a future vision that recognizes OEMs, ISOs, and qualified 3rd party companies as trusted partners.

Elite Biomedical Solutions, a certified ISO 13485:2016 and ISO 9001:2015, FDA-registered business, proudly manufactures medical replacement parts in the USA.

To learn more about how we ensure the highest quality standards, read our related post, “Manufacturing Biomedical Device Parts: The Nuts and Bolts of Quality Control”.