The care and servicing of medical devices is a subject that rightly commands much attention, particularly as the accessibility and availability of critical medical devices became a focused topic during the COVID-19 pandemic. Some of this attention increased calls for right to repair legislation pending in some states as well as similar legislation introduced in the last Congress. Under this backdrop, the National Electrical Manufacturers Association’s Medical Imaging & Technology Alliance (“NEMA/MITA”) published in February a “White Paper on Understanding Accountability in Medical Device Servicing,” referred to herein as the “MITA Paper.”
The MITA Paper purports to “clarify” how different entities are held accountable for their medical device servicing activities. While we applaud NEMA/MITA for the zealous advocacy on behalf of its membership, the MITA Paper contains several misleading characterizations and suggests conclusions that are simply inaccurate or do not reflect the reality of the medical device servicing landscape.
About the Alliance
The Alliance for Quality Medical Device Servicing (the “Alliance”) is an informal coalition of six leading independent medical device service organizations which support health care providers across the United States. The members of the Alliance are TRIMEDX, Sodexo, Crothall, ABM, Agiliti, and the InterMed Group.
The Alliance represents some of the largest participants in the Independent Service Organization (“ISO”) segment of the U.S. medical device service industry. 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 ISOs, offer to their healthcare delivery organization (“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 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.
The MITA Paper
The MITA Paper attempts to address the framework currently in place with respect to medical device servicing, broken down into direct regulation, accreditation requirements and standards. While many of the categorical descriptions are accurate, certain conclusions suggested are misleading and even factually inaccurate.
The MITA Paper includes the following statement about ISOs: “Third party service businesses are currently not regulated by the FDA and are not required to meet any accreditation requirements. Third-party service businesses are not held accountable for their work’s quality or safety by any authority having jurisdiction (“AHJ”).” Further, the MITA Paper claims that “No AHJ holds third-party servicing businesses accountable for their actions or the quality or safety of their work.”
The MITA Paper paints the entire ISO industry with a broad brush. While the Alliance cannot speak for all ISOs in the industry, just as MITA does not speak for all original equipment manufacturers (“OEMs”), the Alliance collectively represents a significant portion of ISO business, in particular on-site work outsourced by hospitals, so we presume the MITA Paper’s claim about a lack of accountability is at least partially directed at us.
Are ISOs accountable?
The MITA Paper attempts to draw distinctions between in-house hospital teams and ISOs with respect to accountability. However, a primary feature of the Alliance members’ business models is on-site management of hospitals’ internal biomed departments. In effect, Alliance members serve in an outsourcing capacity while functioning as an internal department of the HDO. In many cases, ISOs such as the Alliance members serve as the hospital biomed team in its entirety. As such, the Alliance members and similarly-situated ISOs step into the shoes of their hospital customers to ensure that all applicable regulatory and accreditation requirements are satisfied.
These requirements include regulation by state licensing agencies (not mentioned in the MITA Paper), which can vary significantly among states. These state laws are sometimes even stricter than Centers for Medicare & Medicaid Services (“CMS”) requirements or accrediting organizations’ standards. Alliance Members adhere to, on behalf of their hospital customers, all state requirements respecting medical device servicing. Alliance members also perform services that meet or exceed hospital system accreditation requirements and elements of performance. We are seamlessly held to and measured by CMS and all “deemed status” accrediting agencies standards without any consideration for our role as subcontractors. In situations where an HDO elects not to participate in an accreditation program, state agencies will act as surveyors for CMS.
Further, medical device incident reporting for Alliance members falls under the umbrella of the hospital customers’ Safe Medical Devices Act (“SMDA”) reporting process as mandated by the FDA. The SMDA helps ensure the FDA is aware of injuries associated with equipment failures and the reporting is by the HDO, regardless of who is providing the service, such that all servicers whether OEMs, third parties, or hospital employees, are held to the same reporting standard.
The MITA Paper seems to suggest that OEMs are held to a higher standard. However, much of the regulatory standard to which OEM’s are held deals with the design of the device, not service. Many ISOs have quality management systems and/or meet the rigorous standards described in the MITA Paper. In addition, OEMs often engage ISOs to perform work on their behalf as their entire authorized service partner, to perform recall work and device upgrades.
With respect to standards, the Alliance agrees that each ISO should establish its own quality system, as recommended by the FDA in its 2018 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (the “FDA Report”)1. Each Alliance member has adopted a robust quality system appropriate to its particular customer requirements and industry focus. These quality systems hold Alliance members to a similar degree of rigor as OEMs. In addition, not all standards are “voluntary.” Once adopted by an AHJ, a standard become mandatory. For example, several NFPA standards have been adopted by states.
Regardless whether providing on-site outsourcing services, on-call (aka time and material) or depot services, ISOs are also held accountable through their customer contractual arrangements, many of which require adherence to the regulations, laws and standards previously described. Further, ISOs are certainly not immune from legal liability in the event their actions are negligent and cause harm.
Does additional regulation ensure greater accountability?
As described above, ISOs such as the Alliance members are held to the regulatory, accreditation and contractual requirements of their hospital customers. Nevertheless, we believe the MITA Paper confuses “accountability” with “regulation.” Merriam Webster defines accountability as “an obligation or willingness to accept responsibility or to account for one’s actions,” whereas it defines regulation as a “rule or order issued by an executive authority or regulatory agency of a government and having the force of law.” In other words, regulation does not ensure accountability or even public/patient safety.
Indeed, examples abound of regulation not ensuring safety. The metal-on-metal hip implant issues showed FDA device regulations were insufficient to ensure patient safety, much less accountability of the respective manufacturers. Similar challenges exist for medical equipment. The high and increasing number of device recalls, particularly infusion pumps and automatic external defibrillators, provide confirmation of this point. There are numerous examples in other industries of large companies showing little regard for public safety despite the presence of strict regulation.
The MITA Paper implies that additional regulation is needed beyond the existing state and federal regulatory framework and accreditation standards to which many ISOs adhere on behalf of their hospital customers. The Alliance continues to agree with the FDA Report that there has been insufficient evidence of a problem or widespread health concern related to servicing of medical devices to support additional, burdensome regulation. We believe the current regulatory framework is sufficient to ensure patient safety, as evidenced by a lack of data to support safety issues arising from device servicing.
As earlier noted, Alliance members generally must meet the applicable regulatory framework and accreditation requirements on behalf of their hospital customers and are accountable to those same hospital customers through contractual requirements. In some cases, OEM’s have multi-vendor service arms that serve hospital customers in a similar fashion to Alliance members and can certainly attest to the great degree of compliance rigor required on behalf of hospitals.
These issues were carefully considered In the FDA Report in concluding that additional regulation was not warranted. The MITA Paper appears to challenge this conclusion, but presents no evidence to support the position that a problem exists.
Is there a patient safety issue?
The MITA Paper’s accountability argument also implies there is a patient safety issue that must be addressed, yet provides no support to suggest that this is the case. Indeed, available data suggests the opposite; that there is not a patient safety issue based on whether an OEM or third party entity services a medical device. Quite simply, the data do not support the notion that medical device servicing by ISO’s is less safe than service performed by others.
The FDA Report cited an ECRI Institute analysis, based on searches of numerous relevant records (including over two million records in FDA’s MAUDE database) which concluded that it does not believe a safety problem exists with the servicing maintenance, and repair of medical devices by either third party organizations or OEMs. Based on an FDA search of complaints and allegations of regulatory misconduct related to the servicing of radiation-emitting devices since 2009, only 40 complaints alleged inadequate servicing, including 29 complaints alleging inadequate servicing by OEMs and 10 by ISOs. The FDA concluded that there may be isolated instances of poor quality by OEMs or third party entities.
Rather, after research, public comment and review of existing data, the FDA concluded that “objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices” and that “the continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.”
In sum, it is unclear what problem MITA is seeking to correct, nor how it believes an additional regulatory scheme would serve the existing healthcare system other than to add complexity and cost.
Collaboration and cooperation are critical to ensure patient safety and cost-effective healthcare
We continue to believe that open communication between all stakeholders is important, whether to address potential concerns or to seek a greater understanding of challenges faced by others in the industry. Accordingly, the Alliance has embraced the collaborative community framework suggested by the FDA and continues to actively participate and provide feedback through the Medical Device Servicing Community. This framework includes a variety of stakeholders such as ISOs, OEMs, end users/hospitals, and industry associations. Unfortunately, MITA and some OEMs decided to withdraw from this collaborative process. We welcome this kind of collaboration to advance the industry, address perceived problems, and to ensure that patient safety is always held at the forefront of what we do.
The Alliance believes it is critical for HDOs to have choices in how they service and maintain their medical devices and also that materials (e.g., parts, manuals, training, etc.) are readily available to an HDO’s chosen service provider or in-house team. Indeed, the Alliance applauds the Federal Trade Commission’s (“FTC”) recent report on anticompetitive practices related to repair markets, including the medical device market. 2 As the FTC noted, there is “scant evidence to support manufacturers justifications for repair restrictions.” We stand behind the right of medical device owners to choose competent personnel to service and maintain their devices as they see fit without unjustified interference by OEMs that often result in unacceptable delays and higher costs for the device owners and patients. We also stand ready to work with all stakeholders to ensure that medical device service is delivered in a safe, reliable, and cost effective manner.
- May 2018 FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices in accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA)
- Nixing the Fix: An FTC Report to Congress on Repair Restrictions, Federal Trade Commission, May 2021