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MEDICAL DEVICE SERVICING VS. REMANUFACTURING



Each are distinct processes, but both rely on quality management.







Matt Lowe, Chief Product and Marketing Officer, MasterControl05.04.22


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.


--------------------------------------------------------------------------------



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