Dockets Management Staff
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
September 20, 2021
Docket No. FDA-2018-N-3741: Remanufacturing of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff, issued on June 24, 2021 (the “Draft Guidance”)
Dear Sir/Madam:
This document is to submit comments to the Draft Guidance referenced above.
I. Introduction of Alliance
Before providing information and comments, please allow us to introduce the Alliance for Quality Medical Device Servicing (the “Alliance”). The Alliance is an informal coalition of seven leading independent medical device service organizations which support healthcare delivery organizations (“HDOs”) across the United States, namely TRIMEDX, Sodexo, Crothall, ABM, Agiliti, the InterMed Group, and TKA.
Alliance members collectively employ tens of thousands of associates across all fifty states and actively service and maintain millions of medical devices. The Alliance members, as independent service organizations (“ISOs”), offer to their HDO customers not only safe and effective service, but also an equipment agnostic perspective focused on improving safety, reliability, and efficiency.
The Alliance’s mission is to advance policy solutions that will result in lowering health care costs, reducing downtime, enhancing patient outcomes, and ensuring the safety and availability of medical devices for hospitals nationwide. The Alliance is working to continue to make ISOs a cost effective solution for providers, which ultimately improves the quality of patient care.
II. General Comments
The Alliance commends the FDA for creating and releasing the Draft Guidance. We are aware that the FDA has been working to gain additional perspectives on the distinction between servicing and remanufacturing and has undertaken several efforts to help promote clarity. As noted in the 2018 FDA Report on Device Servicing, a majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertained to “remanufacturing.” For this reason, additional clarity on this topic is important. However, even with the additional guidance and specific examples, we believe that the “significant change” distinction can be subjective and subject to significant discretion. We are also concerned about the scope of the service assessment process described in the Draft Guidance, including its interpretation and cumbersome nature. Finally, our comments raise questions about illogical exemptions set out in the Draft Guidance, as well as the FDA’s anticipated enforcement process.
III. Comments on Sections III (Scope) and IV (Definitions)
With respect to the Scope, we kindly remind the FDA that the Draft Guidance should be applicable to any parties who endeavor to service or potentially remanufacture medical devices. While there seems to be a focus on non-OEM ISOs, often referred to as third parties, in-house HDO teams and OEM multi-vendor service teams also engage in identical activities. There is no rational basis to distinguish work done by ISOs from identical work performed by these other groups.
The Definitions section, as modified to reflect updated understanding and practice, offered helpful clarifications. However, as noted above, the definition of Third Party Servicers and ISOs specifically excludes HDOs and OEMs, even though HDOs perform the same activities as ISOs and some OEMs operate exactly as ISOs through their multi-vendor service arms. We do not understand the FDA’s position on exempting entities which perform the exact same functions.
Some OEMs and their trade associations have suggested to exempt HDOs because they are “regulated” by FDA’s sister agency, the Centers for Medicare & Medicaid Services (CMS) or licensed by state agencies. First, CMS does not have authority to regulate HDOs; it can only require HDOs to comply with the Conditions of Participation – CoP (42 CFR 482) whenever they voluntarily participate in the Medicare or Medicaid programs (e.g., the VA and military hospitals are not required to comply with the CoPs because they don’t participate in those programs). Furthermore, neither CoPs (or accreditation standards established by CMS-deemed organizations) or state licensing codes explicitly require HDOs to refrain from remanufacturing activities. Finally, if “regulated” by CMS were an acceptable justification, all the servicing entities that are contracted by HDOs that participate in the Medicare or Medicaid programs and required by contractual terms to comply with the CoPs should also be excluded from this guidance.
The Draft Guidance states “[t]his draft guidance discusses whether activities performed by OEMs and third parties on such devices are likely remanufacturing.” However, it states in section VI.B. that “FDA does not recommend evaluation with Figure 1 when an activity is performed on behalf of, or otherwise explicitly authorized by, the OEM and the activity returns the legally marketed device to its original performance and safety specifications, and intended use.” This statement basically exempts all OEMs from complying with this guidance when servicing devices they produced.
The Alliance does not believe OEMs should be exempt simply because their service staff are performing activities on behalf of the OEMs. We are aware of the fact that OEMs are regulated through the Quality System regulation – QSr (21 CFR 820). However, other than including remanufacturing into manufacturing, there are no clear, specific requirements in the QSr to determine whether any servicing activities performed by OEM staff strayed into remanufacturing intentionally or unintentionally. Section 820.200 – Servicing only requires: (a) “… verifying that the servicing meets the specified requirements;” (b) “… analyze service reports with appropriate statistical methodology…” Furthermore, while the service reports are required to have identification of the individual(s) servicing the device, there is no requirement for anyone else to review and sign off confirming that the servicing did not venture into remanufacturing.
We urge the FDA to revise this guidance to state that that it applies to any entities engaging in these activities.
IV. Comments on Section V (Guiding Principles)
The Alliance certainly agrees with the notion that remanufacturing should be treated differently than servicing, as the FDA has clearly laid out in the Draft Guidance. We also appreciate that the FDA has attempted to clarify which activities constitute remanufacturing, in part by providing specific examples. Nevertheless, the determination/evaluation process to determine what constitutes a “significant change” remains vague and highly subjective. We are concerned that the proposed service assessment process is not well defined, potentially adds additional burden to the HDOs (not only increased servicing costs, but also equipment inventory to compensate for slower service response and increased downtime) without resulting benefit, and will be difficult to interpret. This is particularly true for the many organizations (including ISOs, in-house HDO teams and OEM multi-vendor service teams) that only intend to perform service and do not intentionally seek to change the safety or performance specifications of a finished device. Indeed, the Draft Guidance could be interpreted to require parties to prove they are not engaged in remanufacturing as opposed to servicing, placing an undue burden on those purely performing device servicing. We believe the better approach is to clearly define what constitutes remanufacturing and apply that guidance.
The documentation requirement could be particularly burdensome when considering a wide variety of routine servicing activities. We suggest that some thresholds be applied so that any such assessments focus on activities which could most easily be construed as remanufacturing. To complicate matters regarding assessments, many OEMs continually fail to provide service documentation to many servicing entities, including HDOs and their chosen ISO partners, making any assessments to determine whether an activity constitutes service or remanufacturing that much more difficult.
Moreover, it is unclear how the guidance on remanufacturing will be enforced. Will it be subject to audit by the FDA? If so, will servicing entities be required to produce some type of documentation as suggested in the Draft Guidance? We urge the FDA to clarify the auditing and enforcement processes, and any resulting requirements placed on servicing entities.
V. Comments on section VI (Relevant considerations to determine if activities are remanufacturing)
Again, we applaud the FDA for providing this additional guidance and particularly the specific examples in Appendices A and B. While the examples are indeed helpful, it remains somewhat unclear how the validation testing and/or risk-based assessment will lead to conclusive determinations. Furthermore, validation testing is virtually impossible unless OEMs release the operating principles and design specifications and risk assessment is also challenging because both “new risks” and changes in harm probability and severity require lengthy and detailed studies by subject matter experts not typically found among servicing staff regardless of the type of employer.
Indeed, even the Figure 1 flowchart, which leads to conclusions of “Likely Manufacturing” or “Likely Not Remanufacturing,” highlights the very fact-sensitive nature of these determinations. As noted above, the Draft Guidance could be construed to require servicers to prove a negative, i.e., that they are not engaged in remanufacturing. We are concerned as to how the service assessment process described in the Draft Guidance will add more certainty to this process, especially given the significant additional work that may be required by servicers. We urge the FDA to elaborate on the proposed assessment process, including some parameters around when the process should be conducted and/or documented. Alternatively, we suggest that the FDA accept a policy statement from servicers that they will not exceed servicing and venture into remanufacturing and train their staff accordingly.
VI. Comments on Section VII (Changes involving software)
Regarding software changes, we appreciate the clarifications that certain activities such as assessing for viruses and malware and installing cybersecurity updates authorized by the OEM do not constitute remanufacturing. Unfortunately, as noted in our response to FDA’s June 2021 discussion paper on Strengthening Cybersecurity Practices Associated with Servicing Medical Devices, many OEM’s are often very slow or even refusing to release needed software patches to address known vulnerabilities, adding challenges to keeping devices safe.
VII. Comments on Labeling
As recognized in the Draft Guidance, “[u]intentional remanufacturing can occur when entities do not have the instructions necessary to return a device to its original performance and safety specifications.” Therefore, it is not enough for the FDA to “encourage” OEMs “ as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices…” If the FDA truly wants to eliminate unintentional remanufacturing, it must require OEMs to release servicing instructions, along with proprietary parts and tools, and keys to the software locks (“privileged access”). If OEMs were to allege that current regulation (21 CFR 801.109(c)) exempt them from providing adequate directions for use for prescription devices—which include most hospital-grade equipment—FDA should emulate the European Union which has been requiring the inclusion of service information in the “information for use” (IFU) since 1993 through the Medical Device Directive (MDD) and reiterated it in the Medical Device Regulation (MDR) that became effective earlier this year. Furthermore, there are already precedents for such a requirement for lasers, ultrasound therapy products, and in-vitro diagnostic instruments as the FDA stated in the White Paper: Evaluating Whether Activities are Servicing or Remanufacturing (Docket No. FDA-2018-N-3741).
VIII. Conclusions and Recommendations
We thank you for the opportunity to provide comment. The Draft Guidance represents an important step to clarify the distinctions between servicing and remanufacturing.
We respectfully make the following recommendations to improve the guidance document and, ultimately, safe and effective servicing of medical devices for patient care:
- We urge the FDA to reconsider the overly narrow scope. Again, we believe this guidance should be applicable to all parties involved in servicing that may venture into remanufacturing knowingly or unintentionally.
- We also believe that the proposed service versus remanufacturing assessment will be difficult and cumbersome to implement. Instead, we suggest that the FDA recommends each servicing entity to establish a clear policy whether remanufacturing is allowed and, if allowed, register with the FDA and establish appropriate procedures to ensure compliance with applicable FDA regulations. Servicing entities that opted for not allowing remanufacturing should train its servicing staff on how to avoid it, including instructions on when and how to seek guidance and approval in case of doubt before initiating those questionable activities. Instead of using all those 6 guiding principles, they should follow a simple and clear “cardinal principle” which basically asks, “has the device’s performance or safety specifications, or intended use been significantly changed?” (i.e., a combination of the guiding principles 1 and 2 presented in the Draft Guidance). This is analogous to the time-tested X-ray assembly post-installation testing (21 CFR 1020.30) that has worked well. In case of doubt, the flowchart in figure 1 would be a good tool to resolve any uncertainties. By adopting this suggested approach, we believe it will reduce device downtime and, thus, saving HDOs significant additional capital investments and reduce patient care delays and possible diversions.
- We urge FDA to follow EU’s example in requiring the inclusion of service information in the IFU, so servicing entities can perform the appropriate tests to prove that the safety and performance specifications have not been unintentionally changed.
- Finally, we suggest that FDA clarify in its final guidance how it will be used within FDA’s enforcement and auditing mechanisms.
The Alliance is pleased to provide these comments and we hope that the FDA finds them useful. We are interested in, and available for, further communication with the FDA on this important topic.
Sincerely yours,
The Alliance for Qualify Medical Device Servicing
