Shown below are the most common allegations made by some OEMs and their trade association against the Right to Repair for medical equipment. Also shown are the evidence (facts) against those allegations (myths).
SAFETY
MYTH: Some OEMs claim services provided by third parties are unsafe for patients
FACTS: In its 2018 report to the Congress[1], FDA conducted an extensive review of the safety and quality of services provided by 3rd-parties (aka independent service organizations - ISOs) and concluded:
The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time;
Rather, the objective evidence indicates that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices;
A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to remanufacturing” and not “servicing”; and
The continued availability of third party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.
[1] Available at https://www.fda.gov/media/113431/download
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REGULATORY OVERSIGHT
MYTH: Some OEMs claim third parties are not regulated by the FDA and, thus, pose risks to public health
FACTS:
In its 2018 report to Congress (see footnote [1]), the FDA stated “FDA’s authority to regulate the servicing of medical devices by any entity, including OEMs and third party servicers, is grounded in the agency’s authority to regulate medical devices and radiation-emitting electronic products under the FD&C Act.” => FDA CAN regulate 3rd parties if it wishes.
Third parties contracted by hospitals are typically required by the latter to comply with the Conditions of Participation (CoPs) enforced by the FDA’s sister agency Centers for Medicare & Medicaid services (CMS) through state agencies and accrediting organizations.
Several OEMs also provide services on equipment manufactured by other OEMs (aka multivendor service – MVS) thereby blurring the differentiation between OEMs and third-party service providers.
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INTELLECTUAL PROPERTY - IP
MYTH: Some OEMs claim 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.
FACTS:
Hospital staff and third parties are focused on providing maintenance and repairs to healthcare delivery organizations (HDOs) and are not interested in producing competitive products.
Furthermore, most IP are protected by patents, copyrights, trademarks and other legal tools.
The fact that both EU and China have RtR requirements for medical devices for many years (>33 [2] and >10 [3], respectively) and these same OEMs have continued to conducting business there prove that IP infringement is not a valid concern, especially in the USA.
[2] Available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042 and https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745
[3] Available only in Chinese at https://www.nmpa.gov.cn/ylqx/ylqxfgwj/ylqxbmgzh/20151021120001725.html. See also https://english.nmpa.gov.cn/2019-10/11/c_415402.htm
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CYBERSECURITY
MYTH: Some OEMs claim providing access to equipment diagnostic and calibration software would allow servicers to introduce malware and, thus, pose cyber risks.
FACTS:
Most cyber-attacks are perpetrated by hackers or persons seeking monetary gains. Servicers have nothing to gain from ransomware attacks.
While vulnerabilities in medical devices have been demonstrated by researchers and some cybersecurity companies have reported that malware have been uncovered in some medical devices, no evidence of any attack perpetuated through medical devices has been documented.
Furthermore, third party servicers are required through contract by hospitals to monitor and address promptly cyber vulnerabilities and attacks being onsite and in close contact with the equipment.
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REMANUFACTURING
MYTH: Some OEMs claim servicers often exceed the limits of servicing and ended up remanufacturing devices, thus violating FDA regulations.
FACTS:
The 2018 FDA Report (see footnote [1]) found a small number of cases involving complaints related to device remanufacturing
It is possible that some of those remanufacturing activities were committed due to the lack of access to device specifications and service materials.
FDA issued in 2024 a guidance [4] to clarify the distinction between servicing and remanufacturing but has not required the OEMs to release device specifications and service materials.
[4] Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remanufacturing-medical-devices
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ASSEMBLY, INSTALLATION, ADJUSTMENT AND TESTING (AIAT) INSTRUCTIONS
MYTH: Some OEMs claim there is no need for RtR because OEMs already provide IFUs and the AIAT information” per FDA regulation.
FACTS:
AIAT requires instructions for installation and inspection ONLY for X-ray emitting equipment, not complete service material for all medical devices (see below)
21CFR820.170(a) Each manufacturer of a device requiring installation shall establish and maintain adequate installation and inspection instructions, and where appropriate test procedures…
21CFR1020.30(g) Manufacturers [of X-ray equipment] … shall provide to assemblers … instructions for assembly, installation, adjustment, and testing…
21CFR1020.30(h) Manufacturers of X-ray equipment shall provide to purchasers… manuals or instruction sheets which shall include the following technical and safety information:
(ii) A schedule of the maintenance necessary to keep the equipment in compliance with this section…
…
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COMPETENCY
MYTH: Some OEMs are concerned about the competency of the 3rd party (and HDO) staff because they are not licensed by states or subject to FDA regulations like OEM staff (21 CFR 820.25).
FACTS:
Like other professionals who do not directly provide services to the public, licensure does not exist for ISO staff—nor HDO and OEM staff.
However, HDOs that participate in (and thus receive reimbursements from) the Medicare and/or Medicaid programs are required by CMS and its accrediting organizations to evaluate periodically the quality and effectiveness of contracted services, including staff performance, competency and training.
Some ISO (and HDO) staff have gone beyond and sought professional certification at various levels.
Furthermore, several ISOs have adopted and registered for the ISO 13485:2016 international standard on Quality Management System, which is the foundation of the new FDA regulation for OEMs (QMSR) effective February 2, 2026 [5].
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LIABILITY
MYTH: Some OEMs are concerned about their liability exposure when equipment serviced by unauthorized parties are involved in patient injury lawsuits.
FACTS:
In theory, one would expect that a thorough investigation will reveal the true guilty party(ies) of any medical device failure that caused patient harm or death: OEMs for design and manufacturing defects, hospitals for not providing proper care, doctors for malpractice, and service companies for improper maintenance or repair.
Unfortunately, the American legal system is quite convoluted. Plaintiff attorneys typically take the “shotgun approach” (aka shotgun pleading or complaint [6]) of naming everyone (institution or person) who are likely to have some money (“deep pocket”) as defendants, regardless of who actually caused the harm. This is because lawsuits seldom proceed to the court for jury decision. It is typically settled by almost all defendants (regardless of innocence or guilt) pitching some money into the “settlement pool” because legal costs are often more expensive than settlement. In essence, everyone related to the failed device is exposed to liability regardless of actual culpability.
Servicing by unauthorized parties does not increase the OEM’s liability exposure, as OEMs are automatically named by the plaintiff’s attorneys.
By providing access to service material, OEMs could actually decrease their liability exposure because the servicers are less likely to make mistakes due to the lack of service material.
[6] See, e.g., https://www.findlaw.com/legalblogs/eleventh-circuit/11th-circuit-clarifies-how-not-to-write-a-shotgun-complaint/