By John Wallace
Medical device service professionals maintain and repair a variety of equipment, including many devices that save lives on a daily basis. The quality of the work done by these unsung heroes is important. Their work is literally a matter of life and death for many health care patients.
The work of medical device servicers (biomeds, clinical engineers, healthcare technology management [HTM] professionals) continues to be a hot topic. A new white paper from the Medical Imaging & Technology Alliance (MITA), titled “Understanding Accountability in Medical Device Servicing” served as a spark once again igniting conversation and debate throughout the industry.
MITA – which describes itself as the leading organization and collective voice of medical imaging and radiopharmaceutical manufacturers, innovators and product developers – says the white paper provides an overview of the types of organizations and entities that perform medical device servicing and the degree to which they are held accountable by federal regulations, accreditors and voluntary industry-established standards.
“As this white paper makes clear, when servicing complex medical devices, crystal-clear accountability is indispensable to ensuring the devices’ ongoing safety and efficacy,” MITA Executive Director Patrick Hope said in a press release. “Servicers employed by device manufacturers are held to account by the U.S. Food & Drug Administration. Health care facilities are held accountable by accreditation systems. Unfortunately, no authority – public, private or otherwise – holds third-party servicing businesses accountable for their actions or the quality and safety of their work. When interacting with highly complicated medical devices designed to detect life-threatening disease, this is troubling, to say the least.”
TechNation reached out to the FDA regarding the MITA white paper. Questions posed to the FDA included queries regarding a 2018 report on the quality, safety and effectiveness of servicing of medical devices. The FDA was asked if the finding “that there is insufficient evidence to justify additional regulations” remains accurate in 2021.
“The FDA’s 2018 Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices continues to reflect the agency’s thinking as it pertains to the quality, safety and effectiveness of servicing medical devices,” FDA Press Officer Lauren-Jei McCarthy replied via email. “As stated in our report to Congress on the servicing of medical devices, we believe that multi-stakeholder engagement and collaboration is key to addressing the challenges associated with delivering high quality, safe and effective servicing of medical devices. As a stakeholder, FDA works closely with interested stakeholder groups and remains willing and interested to be engaged.”
MITA’s white paper does not represent a consensus opinion about all medical device service professionals. In fact, many within the HTM community disagree with MITA’s white paper.
The International Association of Medical Equipment Remarketers and Servicers (IAMERS) membership is worldwide and represents companies ranging from the largest OEMs to smaller highly specialized companies that sell, service and finance pre-owned medical imaging devices.
IAMERS President Diana Upton expressed concern regarding the white paper.
“We are disappointed by MITA’s white paper claiming a lack of servicer accountability and sadly MITA’s apparent continued efforts to portray the hard-working women and men who undertake independent servicers as not accountable. This really gives short shrift to the highly trained HTMs and the hospital EOCs,” Upton wrote in an email to TechNation after being asked about the white paper. “In an industry in which so much of the progress is evidence based, we would expect MITA’s renewed move for further regulation to at least acknowledge that the incidence of service-related adverse events is under 1% as reflected in the ECRI study of the FDA MAUDE reports cited in the 2018 Servicing Report. I fear that MITA’s zeal for further regulation of independents is but another attempt by an organization of large companies to gain further dominance. I hope my concerns are misplaced.”
The ECRI Institute is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services.
A 2018 FDA report includes a summary of an analysis performed by ECRI Institute (section 5.3). “ECRI Institute searched over two million records, including the publicly available FDA Manufacturer and User Facility Device Experience (MAUDE) database; in addition, we analyzed our private databases of hazards and recalls and our investigations of hospital-based incidents. We concluded that there is no safety problem that is associated with the servicing, maintenance, and repair of medical devices either by the OEM or by third-party maintenance organizations,” according to the report.
There are many voices from varied backgrounds in the ongoing debate. Original equipment manufacturers (OEMs) employ medical device servicers. Many health care facilities employ their own in-house team of service professionals. Other non-OEM service professionals include those employed by large corporations who staff departments that work within hospitals and other facilities. There are also independent service organizations that provide professionals who can be called upon to service equipment within a hospital or at a company’s facility.
MITA Senior Director of Strategic Operations and Policy Peter Weems was asked to explain the difference between third-party servicers and in-house hospital servicers.
“Third-party medical device service businesses compete with manufacturers and each other to win contracts to service medical devices. Third-party service businesses are currently not regulated by the FDA and are not required to meet any accreditation requirements,” Weems explained. “Health care facilities often employ in-house staff charged with the management and maintenance of medical devices. To participate in the Medicare or Medicaid programs, health care organizations must meet certain Conditions of Participation (CoPs). Health care organizations can be accredited as meeting applicable CoPs by accrediting organizations such as The Joint Commission. Under the Joint Commission’s Standards, a health care facility must meet certain Environment of Care (EC) Elements of Performance (EP) requirements, including inspecting, testing and maintaining imaging and radiologic equipment in accordance with the manufacturers’ recommendations.”
Standards and Accountability
The MITA press release announcing the white paper discusses how the different types of medical device service professionals are held accountable.
“For OEMs, the principal oversight mechanisms are developed by the Food & Drug Administration (FDA) and include strict pre- and post-market requirements for device manufacturers such as registration, reporting of adverse events, and maintenance of a quality management system,” the press release announcing the white paper states. “Servicers directly employed by health care organizations are held accountable principally by rigorous accreditation systems such as those implemented by the Joint Commission.”
Weems was asked if reports of adverse events could include information about third-party servicers.
“FDA recently added a new question to Form FDA 3500A: ‘Was this device serviced by a third-party?’ followed by a checkbox for ‘Yes’ and a checkbox for ‘No.’ MITA supported the addition of this question to the reporting form. Increasing accountability and transparency of the third-party service industry is an important step to ensuring the safe and effective operation of all devices,” Weems replied. “Very little is currently known about unregulated third-party medical device servicing businesses. Nonmanufacturer, third-party servicer businesses do not even have to register with the FDA, and they are not held to any quality, safety and regulatory requirements. In May 2018, the FDA estimated that ‘total number of firms performing medical device servicing in the U.S. is between 16,520 and 20,830,’ but said the ‘precise number of entities that perform servicing of medical devices in the U.S. is not known.’ Why do third-party medical device servicers refuse to make themselves known to the FDA?”
Along those lines, IAMERS General Counsel Robert J. Kerwin was asked about a section of the white paper that states: “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). Third-party service businesses are not held accountable by any AHJ for training their personnel, implementing quality or safety controls, sourcing qualified parts, tracking complaints, or reporting deaths or serious injuries.”
“The white paper sadly omits reference to the accountability practices already in place in the health care ecosystem,” Kerwin stated. “One only needs to look at the length of the typical contract between the hospital and ISO to see the many contractual commitments.”
“By declining to highlight the many checks and balances, I agree with Diana that it diminishes the hardworking HTMs, hospital EOC committees and the yearly reviews by medical physicists,” he added. “It also omits reference to the servicers who file reports with the FDA as to the assembly of diagnostic X-ray equipment under 21 C.F.R.”
In addition, Kerwin pointed out that “were there to be across the board OEM training programs and cooperation, the white paper might be better received. But, right now, we have a pretty common situation where some OEMs are on the one hand not providing training programs and service keys and on the other hand complaining that the quality is a safety issue.”
Kerwin also pointed out that the OEMs frequently use IAMERS members to support their multi-vendor service programs. He asks, “If these independent servicers were really ‘damaged goods,’ why would the manufacturers be using them to service devices?”
Joseph Haduch, senior director of clinical engineering for UPMC BioTronics, also questioned the white paper.
“Despite, on multiple occasion, being unable to make a case for regulation of third-party and potentially in-house service organizations MITA continues to falsely define the medical equipment service narrative,” Haduch said. “Unable to have their standards adopted by ANSI, unable to convince the FDA of the need for additional regulation and despite the FDA determining that ‘the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system’ MITA continues to lobby the FDA for additional regulation of the medical equipment service industry. Some of the facts associated with the MITA narrative are strangely absent. While MITA condemns third-party service and asks them to ‘come out of the dark’ they are profiting from the very type of service strategy they condemn. The major OEMs in MITA all have multi-vendor service solutions and perform service without access to OEM training and OEM diagnostics. There are many ways MITA, as an organization, can help improve the medical equipment service industry which they claim is their primary concern.”
Haduch lists the following as ways MITA can improve the medical device service industry:
- Train all equipment service providers
- Make proprietary documentation available to all service providers
- Make proprietary service tools available to all service providers
- Collaborate with all service providers in establishing industry standards and protocols.
“All of these would help advance MITA’s claimed goal,” Haduch said. “So, why haven’t they taken these steps? They alone have the power to make all of this happen and advance their cause. Because the goal isn’t better quality service, which the FDA previously determined isn’t an issue. The goal is to protect service margin and market share. OEMs profit from OEM service, they profit from in-house service, they make nothing from ISOs. Which solution do they deride?”
MITA Objective
The MITA white paper does not conclude with a conclusion or call to action. Weems said the objective of the white paper is to show that MITA supports “policy reforms that would protect patient safety by requiring third-party servicing businesses to also meet the basic requirements that OEMs are currently meeting.”
He described those basic requirements as:
- Registration: Medical device servicing businesses should be required to register with the FDA.
- Quality Management System: Medical device servicing businesses should be required to adopt and maintain a quality management system that ensures devices are returned to safe and effective condition.
- Reporting of Adverse Events: Medical device servicing businesses should be required to report adverse events to the FDA when they encounter death, serious injury or device malfunction.
Weems said interested parties can provide comments regarding the white paper at NEMA.org/about/contact.
FDA Requests Collaborative Approach
MITA’s call for non-OEM service professionals to register with the FDA is not in line with the FDA’s own recommendation after an examination of medical device service professionals.
The FDA recommended a collaborative approach to medical device service in 2018 when it agreed with ECRI regarding a lack of evidence for increased regulation of service providers.
ECRI shared the news on its website stating, “On May 15, 2018, FDA released FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices. This report was written to address concerns that have been raised about the quality of service provided by third-party organizations – that is, organizations other than original equipment manufacturers (OEMs). These third parties include hospitals and independent service organizations (ISOs). In developing the report, FDA held hearings and allowed for public comment about the issues. The main findings are:
- FDA will not issue additional regulatory requirements regarding the servicing of medical equipment, as there is insufficient evidence to justify additional regulations.
- The evidence that is available shows that many organizations other than the OEM who service medical equipment are providing ‘high-quality, safe and effective servicing of medical devices.’
- Most of the events that have been attributed to service issues were actually associated with the ‘remanufacturing’ of medical equipment (defined by FDA as any ‘act to a finished device that significantly changes the finished device’s performance or safety specifications or intended use’) and not with its servicing.
- Third-party service providers are essential to ensure the safe operation of the U.S. health care system.”
ECRI deemed this an “important announcement” explaining that if FDA were to conclude that only OEMs could service medical equipment, it would potentially more than double the cost of equipment service (which, during the life of the equipment, may already equal the acquisition cost).
The report from ECRI also pointed out that service issues would take longer to correct causing additional expenses to health care facilities. Service and repair delays could also postpone the delivery of health care as well as increase the cost of health care as additional expenses could be passed on to patients.
“Moreover, equipment would be unavailable for longer times than is currently the case, as the hospital would have to wait for the OEM to send repair staff. (Most hospitals have staff on-site to maintain and repair equipment.) Some hospitals would therefore need to purchase additional equipment to use while their current equipment is out of service, further increasing the cost of health care without improving service delivery,” the ECRI report states.
Last year, manufacturer trade groups AdvaMed and MITA sent emails a week apart informing members of the FDA-recommended Medical Device Servicing Collaborative Community (MDSCC) that they will no longer participate. At the time, a few of the remaining members provided feedback regarding AdvaMed and MITA’s exit. David Francoeur, senior vice president of marketing and sales for TKA, and Upton expressed disappointment regarding the departure of the two groups.
“The Medical Device Servicing Collaborative Community (MDSCC) has been actively working through continuous opportunities since its inception in January of 2019. The group consists of 25 individuals made up of a comprehensive representation across the industry consisting of; Healthcare Delivery Organizations (HDOs), Independent Service Organizations (ISOs), regulatory/industry agencies and Original Equipment Manufacturers (OEMs),” Francoeur explained at the time.
The MDSCC was intended to bring all entities representing the industry together to discuss issues in an effort to find opportunities/solutions related to establishing a baseline, verify tools/key performance indicators (KPIs) that demonstrate and, where possible, raise the level of quality, safe maintenance of medical equipment. At the time, the MDSCC reported that it had not made the progress it hoped/envisioned, however, progress has been made, and the membership is encouraged and engaged.
For more regarding this topic, be sure to review a panel discussion and continuing education opportunities at the MD Expo in Dallas scheduled for April 16-17. Find out more at MDExpoShow.com.
