By Binseng Wang, ScD, CCE
One of the questions the U.S. FDA asked in its 2016 Request for Comments, titled Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, (Docket No. FDA–2016–N–0436) was: “What information do third-party entities need in order to perform these activities in a way that results in the safe and effective operation of medical devices?”
Not surprisingly, both manufacturers and “third parties” (including in-house and external service organizations) responded that service manuals and software keys—in addition to replacement parts—are essential for safe servicing and, thus, operating medical devices. However, some manufacturers refuse to release such information—citing various reasons in an attempt to defend their actions.
The same issue is also coming up in several states where the “Right to Repair” (aka: “Digital Right to Repair”) legislation is being considered it their respective state assemblies, following the successful passage of “Automotive Owner’s Right to Repair” statutes in several states. (For more information regarding the right to repair, read 24×7 Magazine’s January cover story about the issue here.)
So, let’s examine the most common reasons manufacturers are citing when refusing to release service manuals. Here are the top three:
- “We Don’t Publish Service Manuals.”
Some manufacturers decline requests for service manuals, alleging that they don’t produce them. However, this allegation is a clear violation of the FDA”s Quality System regulation, which states (20 CFR 820.200(a)): “Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.”
Some manufacturers get around this requirement by stating that their device or component is not serviceable, such as an ultrasound probe or MRI coil, even though some third parties have found ways to do so. The worst violators, however, are laser manufacturers, who refuse to provide service manuals despite knowing that there is a specific FDA regulation regarding it: 21 CFR 1040.10(h), reproduced below.
“Informational requirements—1) User information. Manufacturers of laser products shall provide as an integral part of any user instruction or operation manual, which is regularly supplied with the product, or, if not so supplied, shall cause to be provided with each laser product:
(i) Adequate instructions for assembly, operation, and maintenance, including clear warnings concerning precautions to avoid possible exposure to laser and collateral radiation in excess of the accessible emission limits in tables I, II-A, II, III-A, III-B, and VI of paragraph (d) of this section, and a schedule of maintenance necessary to keep the product in compliance with this section and 1040.11.”
In both cases, clinical engineering professionals should consider filing a formal complaint with the Allegations of Regulatory Misconduct Branch within the FDA’s Division of Analysis and Program Operations.
- “We Already Provide the AIAT Information.”
Some radiation-emitting device manufacturers decline to provide service manuals, claiming that they have already provided the assembly, installation, adjustment, and testing (AIAT) instructions. However, a careful reading of the relevant regulatory requirements reproduced below shows that—unlike in the case of lasers—only maintenance schedules, without the service instructions (aka: “procedures”), are actually included in AIAT, (21 CFR 1020.30(g) and (h) with irrelevant information omitted):
“(g) Information to be provided to assemblers: Manufacturers of components listed in paragraph (a)(1) of this section shall provide to assemblers subject to paragraph (d) of this section and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for assembly, installation, adjustment, and testing of such components adequate to assure that the products will comply with applicable provisions of this section and 1020.31, 1020.32, and 1020.33, when assembled, installed, adjusted, and tested as directed.
Such instructions shall include specifications of other components compatible with that to be installed when compliance of the system or subsystem depends on their compatibility.
(h) Information to be provided to users: Manufacturers of x-ray equipment shall provide to purchasers and, upon request, to others at a cost not to exceed the cost of publication and distribution, manuals or instruction sheets, which shall include the following technical and safety information:
- All x-ray equipment. For x-ray equipment to which this section and 1020.31, 1020.32, and 1020.33 are applicable, there shall be provided:
(ii) A schedule of the maintenance necessary to keep the equipment in compliance with this section and 1020.31, 1020.32, and 1020.33.…(6) Displays of values of AKRand cumulative air kerma. For fluoroscopic x-ray systems manufactured on or after June 10, 2006, the following shall be provided:
(i) A schedule of maintenance for any system instrumentation associated with the display of air kerma information necessary to maintain the displays of AKR and cumulative air kerma within the limits of allowed uncertainty specified by 1020.32(k)(6) and, if the capability for user calibration of the display is provided, adequate instructions for such calibration.”
- “We Need to Protect Proprietary Information.”
Some manufacturers have also declined to provide service manuals by alleging their need to protect trade secrets, intellectual property, and confidential information. Case in point: Many manufacturers refuse to provide access to proprietary service software (i.e., release the soft-keys).
In the case of radiation-emitting devices, the FDA agreed—albeit partially—with such manufacturers when it issued a formal response to an inquiry from the Medical Imaging & Technology Alliance of the National Electrical Manufacturers Association, as shown below.
“There are limits on the information that 21 CFR 1020.30(g) and 21 CFR 1020.30(h) require the manufacturer of the original system to provide. The manufacturer of the original system is not required to disclose trade secrets or confidential information.
Also, the manufacturer of the original system may provide the user or its own service personnel with additional documentation or enhanced software programs, with privileged access codes. This additional documentation or enhanced software programs may operate in conjunction with other proprietary accessories or functions.
Such additional documentation, enhanced software, proprietary accessories, or functions may increase the value of the system to the user. The manufacturer of the original system is not required to disclose proprietary accessories or functions, additional documentation, or enhanced software programs to third parties unless this information is part of the AIAT instructions specified in 21 CFR 1020.30(g) or part of the user information specified in 21 CFR 1 020.30(h).”
Notice that in the statement above, the FDA clearly states that manufacturers can decline to disclose proprietary information unless a regulation requires them to do so— for instance, 21 CFR 1020.30(g) or (h) in case of radiation-emitting devices and 21 CFR 1040.10(h) in case of medical lasers. Unfortunately, other categories of equipment—such as non-radiation-emitting imaging, biomedical, laboratory, and radiation therapy devices—are not covered.
The last paragraph brings up a very curious fact: Why do only lasers and x-ray machines have such requirements—even though the latter is only for AIAT and maintenance scheduling—while other more critical—or “high-risk” as The Joint Commission prefers—equipment, such as ventilators, radiation therapy machines, defibrillators, and automated clinical laboratory analyzers, do not? Doesn’t the FDA profess to regulate medical devices “based on the degree of risk they present?”
Even more curious is the fact that if we look across the pond, the European Union (EU) clearly spells out such requirements in the European Medical Device Directive. Under the directive’s “Essential Requirements” section 13.6(d), the EU says that medical device manufactures must supply the following information before marketing a product in the continent: “Where appropriate, the instructions for use must contain…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.”
I really wish a reader smarter than me—as I’m an underprivileged (but legal, so please don’t call ICE!) immigrant from Asia and Latin America—can explain why the same manufacturers who are already releasing maintenance information in the EU are allowed to decline to do in the U.S.
Could it be because Americans 1. are not smart enough to properly use the maintenance manuals; 2. do not understand documents written in the “proper” King’s English; 3. do not respect intellectual property and will use maintenance information to create “fake” devices; 4. will leak this information to North Korea, allowing them to use it for their weapons of mass destruction; or 5. will do something else that I cannot even fathom?
Having worked most of my professional career for private, for-profit companies, I fully appreciate every company’s desire and need to generate revenue, not only to survive but also to be able to invest in new technologies or services for their own benefit, as well as for the society (through their current and prospective customers).
However, protecting their service revenue by refusing to release service manuals (and selling replacement parts) seems to be a very short-sighted approach. It only increases the cost of healthcare for everyone, as well as the risks of maintenance-related harm— thus ultimately marring their brand, decreasing American competitiveness, and reducing the health of Americans. Using a probably inadequate analogy, I feel like watching a bunch of people fighting for the biggest slices of a cake on a ship that is slowly sinking into the ocean.
Binseng Wang, ScD, CCE, fAIMBE, fACCE, is director, quality and regulatory affairs with Greenwood Marketing LLC (formerly WRP32 Management, Inc.). The views expressed in this article are solely those of the author. For more information, contact chief editor Keri Forsythe-Stephens at [email protected].
- https://www.fda.gov/downloads/MedicalDevices/Resourcefulness/Industry/UCM385149.pdf. Accessed 5/25/2017.
- How to Study and Market Your Device. Accessible at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. Accessed 5/25/2017.
- European Union Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. Available at http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31993L0042.