Organizations across the life sciences landscape are devoting a tremendous amount of time and resources to reverse the current upward trajectory of health care costs. New innovations for getting more mileage out of medical devices are one area that is having a significant impact on this endeavor.

There are multitudes of medical devices with differing technologies, levels of complexity, intended users, and use environments. Many devices are designed for long-term use, which require ongoing maintenance throughout their life cycles. In contrast, there are devices categorized as single-use devices that are used once and discarded. More and more of these single-use devices are able to be remanufactured and put back into action. Medical device servicing and remanufacturing involve different processes that apply to prolonging the life of devices. Still, medical device companies that perform servicing and remanufacturing are not always clear about how their products should be classified. This leads to confusion about which regulatory requirements they need to comply with.

In May 2018, the U.S. Food and Drug Administration (FDA) published the white paper “Evaluating Whether Activities are Servicing or Remanufacturing.” This document takes a deeper dive into determining which activities constitute servicing and which are considered remanufacturing. In the report, the FDA used the following high-level definitions to distinguish between the two activities:

Service – Repairs, preventive/routine maintenance of one or more parts on a finished device, but no changes to the safety, performance specifications, or intended use of the device.
Remanufacture – Process, condition, renovate, repackage, restore, or any other act done to a finished device that changes the finished device’s performance, safety specifications, or intended use.

To illustrate, the white paper includes a flowchart that helps distinguish whether the activity on a legally marketed device is servicing or remanufacturing. In summary, if the activity performed on a device includes the addition or removal of components that directly or indirectly contact body tissues or fluids, changes the performance or safety specifications, or introduces a new or modified risk, it is categorized as remanufacturing. The flowchart addresses only the most common and important considerations that should be evaluated when identifying servicing or remanufacturing. It’s also designed to help guide organizations in determining when additional evaluations (such as testing and/or conducting a risk assessment) are necessary.

Why a Quality Management System Is Pivotal in Both Processes

The FDA’s draft guidance “Remanufacturing of Medical Devices” states that the agency continues to apply the guidelines identified in the Food, Drug, and Cosmetic (FD&C) Act — that all devices must have a reasonable assurance of safety and effectiveness. Ultimately, both servicing and remanufacturing processes are intended to return a medical device to the safety and performance specifications established by the original equipment manufacturer (OEM).

Stakeholder groups providing feedback on the draft guidance spoke of the importance of having a quality management system (QMS) and how it can be beneficial to ensuring the quality and safety of both serviced and remanufactured devices. Commenters noted that high quality service and remanufacturing under a quality management program can help maintain device conformance with its original specifications and performance standards.

The FDA touts the use of a QMS in device servicing and remanufacturing to help identify, prevent, track, and monitor safety hazards and reduce risks. This is necessary to set up a quality framework for organizations to ensure they apply effective risk management, that personnel are appropriately trained and qualified, and that all activities on devices are accurately documented.

Risk Management

The FDA recommends the guidelines in ISO 14971 as a benchmark for risk management. The guidelines in the standard are intended to assist manufacturers of medical devices to identify the hazards associated with the device, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls. Risk estimation, acceptability, analysis, and assessment of hazards and hazardous situations are all concepts that can be applied during servicing and remanufacturing activities.

Training

Given the level of complexity of the design and functionality of medical devices, it’s a regulatory requirement that personnel are adequately trained to perform the necessary servicing or remanufacturing processes.

In the “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices,” stakeholder groups acknowledged that poor quality servicing may lead to poor device performance, device malfunction, and clinical adverse events. That said, it’s important that staff work on only those devices for which they have specific knowledge and experience. Using your QMS to track and keep staff training current helps ensure compliance with this regulation.

Documentation

When deciding whether an activity is servicing or remanufacturing, the FDA recommends that companies document in sufficient detail their rationale for the determination. The documentation should also include relevant data to support the decisions — specifically, why the activities do or do not significantly change the performance or safety specifications or intended use of the device. In-depth documentation assists with the justification of decisions in the event of an inspection.

Conclusion

In addition to lowering the cost of health care, not to mention reducing the environmental footprint within the medical device industry, the availability of timely, cost-effective, quality maintenance and repair of medical devices is critical to the efficient functioning of health care. Still, all medical devices must adhere to the FDA’s core guidelines of quality, safety, and efficacy. Whether a medical device organization focuses on servicing or remanufacturing, leveraging connected, digital technology that integrates all the components of the QMS is essential to complying with the regulations of both processes.

Matt Lowe, chief product and marketing officer at MasterControl, provides a unified vision for the marketing and product teams. He brings a unique understanding of both product and customer knowledge to develop MasterControl’s go-to-market strategies. Lowe is a medical device expert with experience in product development and product management at Ortho Development Corp. and Bard Access Systems, a subsidiary of BD. Lowe has successfully launched more than a dozen medical devices and has five patents issued and one pending. Since joining MasterControl in 2006, Lowe has held several executive roles. He has a bachelor’s degree in mechanical engineering from the University of Utah and an MBA from Indiana University.