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 firstname.lastname@example.org.
- 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.
As service revenue is 100% profit. Manufacturers have managed to maximise profit with poor quality of service while cutting corners and not following Clinical Engineering principles on patient safety and quality of service. I wonder how a company with 5 service technicians can have the contract of all linear accelerators in a country like Canada… Good Paper Bensing.
Perhaps the reason is to make repairs made by third party service groups more difficult.
I was thrilled to see this article throwing LASER manufacturer’s under the bus. Their attempts to limit and secure service are succeeding in violation of the FDA.
Wow! Well said Mr Wang. I do think the more light that shines on this topic, the more likely we will see positive movement on this.
HTM, seems to be getting collectively more aware of the issues. Our cause is right and just. HTM is often the gateway to sales for many of the same OEMs that are working in opposition to R2R. I think HTM can drive change by modification of purchasing habits and policies. I don’t think HTM has the momentum to also drive positive regulatory changes just yet in the same way OEMs have tried. But, HTM has demonstrated ability to resist anti competitive, OEM sponsored, regulatory changes. but maybe that too can improve in time as HTM leadership becomes more conversant on the topic. Individual BMETs and HTM managers have a key role to play at the point in the device life cycle when the salesman is trying to bring the device into the hospital thru the Biomed shop door. This is the key moment to leverage manuals and favorable support level agreements. The OEM trade association is formidable but, we did see the much hailed Pittsburg snatch defeat from the jaws of victory while the Vikings snatched victory from the jaws of defeat with new Orleans this past weekend so one can believe anything is possible…
I believe the current state of medical equipment manufacturers’ service philosophies is a case analogous to Jack killing the Golden Goose for a tasty meal. The service and parts departments raise the revenue of their divisions at the cost of future sales. Hospitals push capital expenditures ever further into the future, placing more burden on the clinical engineering department to “keep ’em running”.
Training costs, service manuals that instruct the in-house service personnel to send critical equipment to a depot for repair, and service keys that are unobtainable have driven CE costs through the roof. Contracts only provide a known expenditure, not a reduction of expenditure. Hospitals are beginning to realize that shifting costs from capital expenditure to service expenditure is false economy.
There is no brand loyalty as I knew it 30 years ago. (Coincidently, about 30 years ago is when service was moved from a “cost” center to a “profit” center.) Now, whomever can provide the best price for equipment with an extended maintenance contract wins the RFQ battle. Never mind that no one in the facility is familiar with the equipment or the service group. Never mind that at the end of the “sweet deal” the next contract will try to recoupe the losses of the OEM in the first contract. Never mind that when the inflated new contract is rejected the in-house guy is faced with maintenance and repairs by hook or by crook. Never mind that used parts are installed to mitigate the cost of obscenely priced new OEM parts. Never mind that service training for CE departments is ever more difficult to fund. Never mind that OEM’s are declaring EOL on six year old equipment. Never mind that OEMs, faced with now declining revenue because of misguided attempts to control the service market, are having to reduce their service groups to ridiculously few people to cover large geographic areas.
The future of medical equipment maintenance for most hospitals in the next decade is going to be one of extended down times, best-guess repairs, and outrageous costs.
The internal resistance has to be broader than on a device-by-device basis. Don’t talk to salespeople whose companies don’t give you what you need, don’t clear demo units, tell management that XYZ is working against you rather than with you, etc. Buyers should not deal with sellers that don’t give them what they need.
I agree that any institution using these medical devices should be able to obtain the needed information to properly service and calibrate the equipment, however there has to be some type of of liability transfer if an institution chooses to perform their own service or farm that service out to a third party. Anytime that their is an incident and someone is harmed, the legal team tries to name everyone, particularity the manufacturer, in the lawsuit along with everone that ever drew a breath of air around said device.
Binseng, thank you for your clear analysis of the current problem.
However, I have been listening to variations of this same concern for more decades than I care to admit. In my opinion, the problem comes down to we are preaching to ourselves, rather than the people who can make a difference.
At the vast majority of hospitals, decisions about the medical devices to be acquired are almost always made by a combination of the equipment users (physicians, nurses, imaging technologists, respiratory therapists, etc.) and the administrators who control the budget. While the total cost of ownership is sometimes tangentially discussed, it is often a nebulous concept. I have never heard a sales representative come to our hospital and say: “Our device may be a little more difficult to use than our competitors and it gives slightly worse clinical results and our purchase price is just about the same, but, our total cost of ownership is 50% lower than our competitor’s model because our parts last longer and they are much easier to replace when then do break.” Instead, assuming the upfront costs are roughly equivalent, users care much more about ease of use and clinical results, with one exception. Another important consideration is the cost of any disposables associated with the equipment. For example, if a hospital is purchasing an infusion pump that requires a proprietary infusion set, the unit cost of that set will definitely be an important part of that purchasing decision. But in general, when it comes to the availability service manuals, that appears so far down on the list of considerations that I suspect virtually no decisions about medical equipment are made because of that.
For better or worse, the FDA does not see it as a priority in their world. Further, the influence of the FDA in hospitals is extremely limited. My suggestion is that instead of looking to the FDA for “salvation,” we as clinical engineers and biomedical equipment technicians, and our professional associations should work closely with the regulatory agency that matters to our hospital leaders: CMS (The Centers for Medicare and Medicaid Services). If CMS included a requirement in its Conditions of Participation that made Medicare and Medicaid funding contingent on a hospital only purchasing equipment that came with a comprehensive service manual, I suspect that manufacturers would quickly provide them.
Once CMS adopted such a regulation, all of the accreditation agencies that enjoy “deemed status” (such as The Joint Commission, DNV and HFAP), as well as the individual state departments of health, who act as CMS’s surrogates, would need to enforce that regulation. If a hospital were threatened with loss of its accreditation, there is not a hospital in the US that would even think about buying a device that did not have a complete service manual available.
So that is where I suggest we put our emphasis. Not on the FDA. But on CMS. Our professional associations need to help us understand how to work with CMS to encourage the inclusion of just such a requirement in a future edition of the CoPs.
I currently service CT, MRI, and Gamma Cameras for large Hospital System in the Mid east. I’ve serviced all Radiology Imaging modality’s over the past 30 years. I’ve found working with the OEM’s to obtain Expert Service contracts and specializing provides the best return on investment. I’ve learned working with the OEM’s service documentation and technical support provides enough to be very successful at reducing downtime and service cost. The biggest obstacle to the success of In-House Imaging service is the system. Systems rarely understand the Importance of the system approach to providing Imaging service. They tend to talk the talk but not walk the walk. In other words hospitals that are part of a system tend to work against the system not for it. The problem is when you invest 50 to 100K in training a specialist you have to protect your investment. Understanding the need to allow a specialist to service as much equipment as possible is Important. Use it or lose it. Exposure to more problems increases confidence and success. Necessary for them to retain knowledge and hone skills. They must be provided the financial tools necessary (A Corporate Credit Card with a large level of revolving credit with no restrictions!). This is required to find competitively priced parts and still meet the demands required to increase uptime ($100.00 to $1500.00 power supply, video cards, CD drive, hard drive or detector modules verses the $5,000.00 to $12,000.00 OEM part). Specialist need to be trusted to use these tools and the system structured to verify there use. The need to be competitive when it comes to pay is required to retain staff. Systems need to purchase the same equipment to facilitate this approach. Not only for in-house service but also for shared Radiology staff. I am lucky that I work for a system that has taken years to learn the benefits of the system approach to Imaging service and knows from experience what I can do for them. Good luck and God Bless.
Interesting but circuitous. Calibration is not the same as repair. I can understand a manufacturer refusing software access to a systems ianards but I am certain they all provide calibration info. If not, do not purchase products from them.
The Automotive Industry used to be 30 years ahead of the early Electronics Industry when it came to POE-“Planned Obsolescence Engineering”, AND, things like purposeful “Suicide Chips”, …
But these days, every single sector of ALL manufacturing Industries, …, that provide stuff to consumer’s do NOT supply any Service/Repair Manuals.
The damage alone, to our environment, caused by this forced upon throw-away society is tragically so ironic.
Our Governments are just puppets for these Corporations, hence why our Democracy has been replaced with Corporatocracy today.