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# Stakeholders Want QS Regulation on Refurbished Devices
- URL: https://www.fdaweb.com/stakeholders-want-qs-regulation-on-refurbished-devices/
- Published: 2016-06-08T12:00:00.000Z
- Updated: 2026-09-14T21:08:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135874

Baxter says that unauthorized third-party services who refurbish, recondition, rebuild, remarket, remanufacture, and service medical devices “generally lack the product and process knowledge and controls of the original equipment manufacturer. Unauthorized service activities, therefore, may create significant risks for patients, despite the best intentions and efforts of the third-parties performing the service activities.” The company [statement](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0436-0166) responded to an FDA request for comments on the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices performed by third-party entities and original equipment manufacturers.

Baxter also says that as devices and service activities increase in complexity, so does the potential risk and harm to patients. “Unfortunately,” it says, “Baxter’s experience has been that unauthorized service activities can and do lead to device malfunctions, which may render a device inoperable or may adversely impact the safety of the device.” The company says that in 2015 it identified 87 instances in which unapproved components were used, components were swapped between different machines without required testing, or unapproved service operations were performed on its devices. “In each of these,” it claims, “safe operation of the pump was potentially compromised, creating risk for inaccurate infusion of high-alert medications.”

The company says there is a role for third parties, including healthcare providers, in the servicing of medical devices and that certain authorized service activities can safely and efficiently be performed by third parties who are appropriately trained, provided with detailed instructions and approved parts, and included in any communications about changes to the device, component, or service procedures.

Writing on behalf of 11 professional and trade organizations, Sidley Austin [says](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0436-0150) that all persons and organizations engaged in the activities FDA sought comment on “should be regulated in a consistent manner. We do believe that all of these activities can only be performed by original equipment manufacturers. Many third parties, including hospital service teams, independent service organizations and others, currently provide excellent service. Our desired outcome is to ensure that all third-party servicing of medical equipment consistently results in the safe and effective operation of medical devices, including medical imaging equipment.” It suggests that the best way to ensure this outcome would be to extend Quality System requirements to all entities that engage in the activities. It also suggests that all such entities be subject to registration requirements.

The 501(k) Coalition [says](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0436-0146) it wants to be sure that the agency docket is not intended to address the reprocessing of single-use or reusable medical devices. “We do not support expanding the scope to address the regulation of these practice,” it declares. “The reprocessing of single-use devices is a complex question that presents significant public health and regulatory issues. Additionally, most companies who have products that require replacement parts, calibration, preventive maintenance, etc., qualify the service centers for their devices and identify them as ‘authorized service providers.’ These entities are monitored through supplier quality oversight processes.

The coalition says that FDA should leverage existing quality systems to the maximum extent possible when addressing the issues at the heart of the public notice.

Bayer Medical Care associates its [position](https://www.regulations.gov/?ref=fdaweb.com#!documentDetail;D=FDA-2016-N-0436-0178) with those calling for extending the Quality System Regulation to all entities engaged in the specified activities. It says that many third parties currently perform excellent service and says that performance of service activities should always result in the safe and effective operation of medical devices.

Finally, Johnson & Johnson says it supports the AdvaMed position on the proposed definitions of third-party and original equipment manufacturer for the activities described. It also submitted more than 60 pages of redacted data in response to the FDA question on evidence that exists about actual problems with the safety and/or performance of devices resulting from the specified activities.