Over the past several years, some original equipment manufacturers (OEMs) and associated trade associations have made sweeping claims towards the work of medical device third-party service providers. The following fact-based responses to those claims were assembled by the Alliance for Quality Medical Device Servicing.
- SAFETY: Services provided by third parties are unsafe for patients.
- In its 2018 report to Congress, FDA stated “… the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” Further, The FDA Report highlighted an ECRI Institute analysis indicating a statistically insignificant number of issues related to service and repair of medical devices.
- Onsite staff provided by third parties can respond swiftly, while waiting for offsite service technicians may impede timely patient care, as clearly evidenced during the COVID-19 pandemic.
- REGULATORY OVERSIGHT: Third parties are not regulated by the FDA and, thus, pose risks to public health.
- Third parties are contracted by hospitals, which are licensed by respective states and required to comply with the Conditions of Participation (CoPs) enforced by CMS through state agencies and accrediting organizations. Those requirements are typically transferred by the hospitals to the third parties, so effectively the third parties are indirectly regulated by FDA’s sister agency, CMS.
- The 2018 FDA Report emphasized that “…the currently available objective evidence is not sufficient … that would justify imposing additional/different burdensome regulatory requirements at this time.”
- Several OEMs also provide services on equipment manufactured by other OEMs thereby blurring the differentiation between OEMs and third party service providers.
- INTELLECTUAL PROPERTY (IP): Providing service materials (technical specifications, service manuals, diagnostic and calibration software access, proprietary parts and test tools, etc.) would require OEMs to reveal trade secrets and IP.
- We are not aware of any third party service providers interested in securing IP to produce competitive products. Servicers are focused on safely and effectively servicing devices, not manufacturing.
- CYBERSECURITY: Providing access to equipment diagnostic and calibration software would allow servicers to introduce malware and, thus, pose cyber risks.
- Most cyber-attacks are perpetrated by hackers or persons seeking monetary gains. Servicers have nothing to gain from ransomware attacks. Furthermore, third party servicers are required by hospitals to monitor and address promptly cyber vulnerabilities and attacks being onsite and in close contact with the equipment.
- REMANUFACTURING: Servicers often exceed the limits of servicing and end up remanufacturing devices, thus violating FDA regulations.
- The 2018 FDA Report found a small number of cases involving complaints related to device remanufacturing and FDA has committed to issue a guidance to clarify the distinction between servicing and remanufacturing, with input from many stakeholders including the Alliance. It is possible that some of those remanufacturing activities were committed due to the lack of access to device specifications and service materials.
- Since 1993, OEMs are required by the European Union to release “… all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times.” In contrast, such requirements only exist in the US for medical lasers (21 CFR 1040.10) and for assembly, installation, adjustment and testing of diagnostic X-ray systems (21 CFR 1020.30).
