An eBay search for medical devices (listed under the medical equipment category) is likely to yield various types of used medical equipment—magnetic resonance imaging machines, for example, negative pressure wound therapy systems, X-ray machines, infusion pumps, and heart-lung machines, among others.

For many years, the U.S. Food and Drug Administration (FDA) has sought to clarify its regulatory requirements and expectations under 21 CFR Part 820 to entities servicing, refurbishing, rebuilding, reconditioning, remarketing, and remanufacturing medical devices. In addition, FDA medical device regulations mandate that device manufacturers establish and maintain instructions and procedures for servicing. However, in the Dec. 4, 1998 Federal Register (63 FR 67076), medical devices were excluded from compliance with the 1997 Quality System Regulation.

Since then, the FDA has established some regulatory requirements for refurbished/serviced medical equipment. The Electronic Product Radiation Control requirements of the Food, Drug and Cosmetic Act (Pub. L. 90-602, amended by Pub. L. 103-80), include provisions specific to manufacturers and assemblers of certified X-ray components. Under 21 CFR Part 1020.30(c), manufacturers of diagnostic X-ray systems are responsible for providing assembly instructions adequate to ensure compliance of their components with the applicable performance standards when installed properly. Furthermore, under 21 CFR Part 1020.30(d), assemblers are required to assemble, install, adjust, and test the certified components according to the instructions of their respective manufacturers. The FDA has previously issued guidance on these topics, including an Assembler’s Guide to Diagnostic X-ray Equipment and Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems. Under the EPRC provision in 21 CFR 1040.10(h)(1)(i), manufacturers of laser products must provide instructions for assembly, operation, and maintenance, including warnings and precautions on how to avoid exposure, and maintenance schedules to ensure the product complies with standard requirements.

Yet the current regulations are unsatisfactory for many medtech executives and policymakers. The FDA, for example, is concerned that third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices could use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment. The agency also worries about adequate documentation of the work and potential public health issues arising from these activities. Some specific concerns are:

1. Improper device operation
2. Faulty device safety systems
3. Ineffective recalls 

Earlier this year, the FDA issued a docket to request feedback from the industry, particularly those involved in the activities previously noted or who utilize refurbished, reconditioned, rebuilt, remarketed, remanufactured, or third-party serviced and repaired medical devices. The docket, FDA claims, was triggered by concerns about the quality, safety, and continued effectiveness of used medical devices handled by original equipment manufacturers (OEM) and third parties, including healthcare establishments. The docket asks for input on the following proposed definitions:

1. Recondition: Restores and/or refurbishes a medical device to the OEM’s original specifications. Under limited circumstances, the medical device may be restored and/or refurbished to current specifications.
2. Service: Maintenance or repair of a finished device after distribution for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use. Servicing cannot change the intended use(s) of the device from its original purpose(s).
3. Repair: Return the device or component to original specifications, including replacing non-working components or parts outside of routine or periodic upkeep for the  current owner of the device.
4. Refurbish: Restore device to a condition of safety and effectiveness that is comparable to when new. This includes reconditioning, repair, installation of certain software/hardware updates that do not change the intended use of the original device, and replacement of worn parts.
5. Remanufacture: Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications, or intended use.
6. Remarket: The act of facilitating the transfer of a previously owned device from one party to another by sale, donation, gift, or lease.

Besides requesting comments on these definitions, the FDA wants feedback about their associated benefits and risks. Feedback is welcomed on the following questions: 

1. Who are the different stakeholders involved with the medical device activities listed previously? What are their respective roles?
2. What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities? Specific examples should be submitted.
3. What are the potential risks (patients/users) and failure modes (devices) introduced as a result of performing the previously defined activities on medical devices? Please speak to issues common to all devices as well as specific risks with specific devices.
4. These activities are performed by OEMs and various third-party entities, including hospitals and humanitarian organizations. Are the risks different depending on who performs the previously mentioned activities?
5. We are interested in knowing if these activities are more difficult or riskier to perform on certain devices versus others. Please cite specific examples in your response, along with an explanation of the source of this particular complexity.
6. What information do third-party entities need in order to perform these activities in a way that results in safe and effective operation of the medical device? Provide specific examples.
7. What additional challenges do stakeholders encounter with devices that result from these activities?

The following three excerpts were extracted from the more than 175 comments submitted thus far to the FDA. The full list of comments is available at bit.ly/mpo161250.

Comment Excerpt (1) 
In the industry of third-party ultrasound equipment repair, a wide range of interpretations and definitions exist about how to restore and/or refurbish ultrasound medical devices back to a quality healthcare facilities expect. Third parties attempt to remanufacture critical parts of the medical device, but to a specification they believe to be standard operational conditions. For example, a critical part may be remanufactured to a specification that they feel matches performance needs; however, the holistic characteristics such as ergonomics, temperature control, HIPOT, leakage, and form factor are often ignored. These issues are the same for third-party companies attempting to make any changes to medical devices to a newer specification.

Using non-OEM measuring devices to analyze transducers is also a common practice with some repair facilities. These devices are ultrasound machine simulators that provide snapshots and do not properly capture intermittent issues that require more intensive testing. This method is fine when used in conjunction with the intended testing machines the devices are used on, but cannot be used solely as a substitute. There are certain features, such as thermal monitoring and electromechanical control mechanisms, that can only be properly tested for functionality or faults on a native ultrasound machine.

The customer is often unaware of the low-quality remanufactured components inside ultrasound transducers because they are encased inside the outer body shell. This poses an ethical issue of disclosing what the customer is ordering relative to the OEM part number requested. If the transducer does not have OEM parts and materials, it should be disclosed at the time of sale to the hospital. This disclosure provides the opportunity to avoid unnecessary safety risks.

Comment Excerpt (2)
In over 25 years of laser service, we have not had any safety or performance issues reported as a result of our technicians servicing equipment. I do recall a recent occasion in which a customer called us to service a laser that was one year old, just out of warranty, in which they were having problems with. The OEM had serviced the unit and found no problem. Our technician found a factory defect in which metal shavings were left in the articulated arm, causing focusing issues for the customer. The OEM technician was not able to find the problem, but our technician did.

We require our technicians have formal electronic or biomedical training. There are multiple OEMs that subcontract us to perform service on their behalf.

Comment Excerpt (3)
If there is a lack of uniform performance, its genesis may be the failure of some original equipment manufacturers to readily supply AIAT [Assemble-Install-Adjust-Test] information. IAMERS [International Association of Medical Equipment Remarketers and Servicers] has continually expressed concerns that some original equipment manufacturers have consistently failed to fulfill disclosure requirements. Under the relevant regulations, including those in Title 21 of the Code of Federal Regulation, Parts 820.170 and 1020.30, OEMS are required to provide certain information to third-party servicers and installers. As the FDA has noted, “...it is the FDA’s responsibility to hold OEMs accountable for providing required information to third parties where appropriate for ensuring the safe and effective operation of medical devices.”

Conclusion
In researching this column and reading many of the comments submitted to the FDA, several key issues became obvious:

• OEMs and third-party service organizations have a clear point of view about servicing and repairing refurbished or reprocessed devices.
• The FDA‘s concerns about device service and repair by OEMs and third-party service organizations have not changed in 20 years.
• The patient must be the main concern of any organization involved in servicing medical equipment.

Third-party service organizations provide a critical service, particularly in cases when OEMs announce the end of life for their medical equipment. Although many users will upgrade—which is almost always an option—many may not, especially users who cannot afford to update to the most current technology. Thus, the current level of regulatory oversight is concerning to many organizations.

I sincerely hope the FDA issues additional regulatory requirements for third-party service organizations and OEMs that service their own equipment. An update is long overdue. 

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James A. “Jim” Dunning’s consulting career began in 2001. He has provided quality and regulatory consulting services for various companies ranging from Fortune 500 medical device firms to startups. Dunning’s passion, however, lies with startups and small companies, especially those in regulatory distress. He has amassed significant experience in preparing 510(k) applications, developing complete Quality Management Systems, providing Quality System Training, and advising on quality, business, and leadership issues. Dunning is a senior member of the American Society for Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS). He can be reached at jdunning@qpcservices.com