The complexity and cost of medical devices are escalating, and with it, the stakes for maintaining these assets efficiently and compliantly are increasing. In some cases, this requires complex and comprehensive repairs that may involve major components of the asset being rebuilt or upgraded. As organizations strive to prolong the safe, useful lifespan of their medical assets while curtailing capital expenditure, they face a new challenge: adhering to the U.S. Food & Drug Administration’s (FDA) latest guidance issued in May 2024.
This guidance has profound implications for healthcare organizations involved in medical equipment servicing, from in-house healthcare technology management teams to third-party service providers. Proper understanding of the complexities of the regulations and documentation of servicing activities has never been more critical.
Why the New Guidance?
The FDA issued this guidance to assist service organizations in distinguishing between “service” activities and “remanufacturing” activities. This distinction is critical, as certain modifications can alter a device’s capabilities, potentially allowing it to operate outside its original safe parameters. While the guidance is categorized as “non-binding,” it aims to ensure that medical equipment maintains its original safety and performance standards, thereby increasing confidence in its reliability.
Prompted by concerns raised by various industry groups, the guidance looks to address inconsistent regulation of third-party servicing compared to original manufacturers. The primary issue lies in the lack of regulatory oversight, which could result in equipment failing to meet the safety and performance specifications established by the original equipment manufacturer (OEM). Since OEMs are regulated by ISO 13485, ISO 90001, and other U.S. laws and regulations, the FDA leveled the playing field with this new guidance.
This guidance pertains to specific assets in the healthcare ecosystem; service organizations should refer to section 201(f) of the FD&C Act to get clarity on what assets are affected.
What should be done?
All organizations involved in servicing and maintaining medical equipment should thoroughly review the published guidance to understand the distinction between servicing and remanufacturing. The definitions outlined in the document should serve as the standard for categorizing activities within service operations. For instance, while terms like “rebuilding” and “remanufacturing” are often used interchangeably, they represent distinctly different processes. Clearly understanding these differences can help prevent regulatory violations by your service teams.
Processes, policies, and procedures should be updated to incorporate the new terminology and ensure proper documentation that clearly defines each activity within one of the FDA’s classifications. This is especially important because the FDA’s qualifications for activities differ from those of original equipment manufacturers (OEMs). The FDA evaluates servicing organization activities independently of the device’s classification as Class I, II, or III, making accurate categorization and compliance essential.
Service, Repair, or Remanufacture?
The FDA has established six guiding principles to help organizations determine whether an activity qualifies as servicing or remanufacturing. These principles provide a structured framework for evaluation, ensuring that activities align with regulatory requirements and maintain device integrity.
- First, assess whether the activity results in a change to the intended use of the device.
- Next, evaluate whether the activity, either individually or cumulatively, significantly impacts the safety or performance of the finished device.
- Then, it’s crucial to determine if the changes necessitate a new marketing submission to the FDA.
- Additionally, compare any modifications to components, parts, or materials with the original equipment manufacturers’ (OEM) specifications to ensure compatibility and compliance.
- Also, a risk-based approach should be employed to identify and address any changes that did not exist in the original device design.
- Finally, organizations must meticulously document the process used to classify an activity as either servicing or remanufacturing, including validation data and all supporting evidence.
On page 11 of the guidance, the FDA includes a decision-process diagram accompanied by clarifying language to assist organizations in determining whether an activity qualifies as servicing or remanufacturing. Notably, the FDA often categorizes software changes as remanufacturing due to their potential impact on the device’s architecture and data processing. Additionally, certain activities are automatically classified as remanufacturing because of their significant influence on the device’s functionality and safety. These include changes to the device’s sterilization methods, reprocessing instructions, control mechanisms, operating principles, or energy type. Separately, software changes must be evaluated against the list on page 16 of the guidance, where general OEM software upgrades and cybersecurity activities are classified as servicing, while custom modifications like creating batch files are classified as remanufacturing.
The FDA’s 2024 guidance represents a significant step toward ensuring the safety, reliability, and compliance of medical device servicing activities. By providing clear distinctions between servicing and remanufacturing, along with detailed evaluation criteria, the guidance empowers organizations to align their practices with regulatory standards. For healthcare providers, third-party service entities, and in-house teams alike, adapting to these requirements is not only essential for regulatory compliance but also critical to maintaining the integrity and performance of medical devices. As the complexity of medical equipment continues to grow, adhering to this guidance will play a vital role in supporting patient safety and optimizing the lifecycle of these critical assets.
About Margaret Nardini
Margaret Nardini is a Senior Healthcare Product Manager at Accruent. With a robust background in the healthcare industry, Margaret has designed and delivered a variety of software solutions, including data warehousing, claims processing monitoring and review tools, analytic tools, and patient self-service tools. Before joining Accruent, Margaret ran her own software consulting business, helping companies design, develop, and implement technical solutions tailored to their organizational needs.
