By K. Richard Douglas
Much has been made in modern-day politics about the burden or significance of regulations. One political party has always supported more regulation and the other seeks less. Is the U.S. over-regulated? Does regulation do more harm than good? What is the trade-off between regulations and public safety and economics, household income, economic expansion or economic contraction?
The petroleum, electric, nuclear power, banking, insurance, brokerage, legal, real estate and coal industries are heavily regulated; and these regulations protect consumers, workers and investors.
The term “garbage in, garbage out,” was popularized during the early days of computer science, indicating that flawed input data can result in faulty output.
The same can be said for regulations. During the rulemaking process, Congress needs to be working with accurate data before a member proposes a bill and before it becomes a law. A law must be based upon good data, including any negative impact it might have, before it goes to regulators for enforcement.
It is very important to those subject to regulations that both the lawmakers and the regulators are fully informed during the entire process by sources with reliable data.
Health care is also one of the most regulated industries. Just as compliance officers are important in financial services, they are an important part of health care.
Health care facilities are regulated by the Department of Health and Human Services (HHS), which has oversight over the Centers for Medicare and Medicaid Services (CMS) as well as regulation by state agencies in every state. Additional federal agencies with regulatory oversight over health care include the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).
These agencies publish and enforce the regulations that impact all those who work in health care and ultimately; patients.
Sometimes regulations can be as burdensome to clinical staff as they are beneficial to patients. These clinicians spend so much time pursuing regulatory compliance that it can take them away from patient care. It can be a two-edged sword.
With the broader impact of regulation on health care as an industry, the question of regulations that impact HTM have been highlighted the past couple of years.
How does government intervention impact the future of the HTM community, the safe practice of medical equipment servicing and patient safety? Are decisions made in a vacuum, using reasonable advice or consultation or just purely bureaucratic?
Do biomeds who are not affiliated with an OEM provide a standard of maintenance that is up to the task? That was the impetus for the creation of the FDA-supported Medical Device Servicing Collaborative Communities (MDSCC).
When regulations impact the HTM community, it is important that the bills passed by Congress, that are the basis for the regulations, are sound and based on accurate data.
The Creation of a Collaborative Community
The evolution and formation of the Medical Device Servicing Community (MDSC) grew out of the Medical Device Servicing Collaborate Community (MDSCC).
The MDSC has continued its work, breaking areas of focus into four subgroups. Some background on the formation of the MDSCC in 2018 and its focus then and now follows.
“The MDSCC was formed over the course of two years. Efforts started when the Medical Imaging Technology Alliance (MITA) approached Congress and stated individuals servicing medical devices that are not employed by, and/or trained/sanctioned by the original equipment manufacturer (OEM) are delivering low-quality, unsafe maintenance on medical equipment,” says Dave Francoeur, senior vice president of marketing and sales, TKA.
Francoeur says that the non-OEM individuals consist of independent service organizations (ISOs) and healthcare delivery organizations (HDOs) in-house groups.
“When Congress was approached to look into, vote on whether MITA’s claim was valid, fortunately IAMERS organization had sent their legal council representative to the hearing of Congress where the vote was to take place stating non-OEM servicing individuals would no longer be able to provide service on medical equipment as they have in the past. Robert J. Kerwin, IAMERS legal counsel was able to stop Congress from passing the bill,” Francoeur says.
Congress then asked the FDA to look into MITA’s claims.
“FDA put out a formal request for information (RFI) where they asked the industry for data and input so they could make a determination as to if there was any validity to MITA’s claim. After many organizations and individuals responded to the RFI as well as a two-day forum for discussions and presentations on this topic, the FDA responded with an official notice, while there does not seem to be evidence that non-OEM servicing entities deliver less quality or less safe maintenance of medical device servicing, there also was not enough evidence to say they do not deliver less quality and less safe servicing of medical devices,” Francoeur adds.
Francoeur says that after a meeting set by the FDA in December of 2018, individuals representing OEMs, ISOs, HDOs, industry associations and regulatory bodies participated in exercises that provided a platform to work together in an attempt to bring unity to the profession and help establish good working practices.
He says that from this effort, the MDSCC was established and the basis for its formation and structure were developed.
It was determined that the group would have a steering committee and that it would consist of representation across all impacted parties throughout the profession.
“Today that has been decided to be 25 or so individuals; approximately five per group – regulatory/associations, OEMs, ISOs, HDOs, patients,” Francoeur says.
The group has met in person or via the phone for just over a year.
Francoeur says that there were three areas during the year that the group could not seem to reach consensus on. Those areas were antitrust activities, a charter and a voting process.
MITA, AdvaMed and Philips decided to remove themselves from the MDSCC.
“Ironically, they stated it was because of the lack of progress being made by the group. Yet the lack in progress was created because they objected to everything the group wanted to do in regards to the areas on non-consensus (antitrust activities, charter, voting process),” Francoeur says.
MDSC: Current Initiatives
At the time of this writing, none of the work done by the subgroups has been reviewed or approved by the steering team, so the recommendations listed are proposals.
The subgroup that Francoeur chairs, is the standardize benchmarking, data collection and analytics (BDCA) group. Its focus is to establish a framework for assessing quality of medical equipment servicing and establish a baseline to assess the effectiveness of improvements to quality and patient safety.
The BDCA subgroup’s objectives include the establishment of industry KPIs and benchmarks for those KPIs, with the resulting benefits being the continuous improvement of the quality and safety of medical equipment maintenance. One goal is the standardization of quality and safety metrics.
The group’s assumptions are outlined as: All parties have a vested interest in validating quality and safety baselines; all parties want to improve/ensure quality and safety of medical equipment maintenance.
Constraints include: Any stakeholder segments unable/unwilling to participate may limit the outcomes. Money to implement program. Differences in data, data gathering, data manipulation and nomenclature among stakeholder groups.
“The team has landed on several key performance indicators that they believe represent measurements that demonstrate service/maintenance being performed on medical equipment by any entity will provide evidence of quality and safety. These are to be presented to the MDSC for consideration,” Francoeur says.
He says that today, the group has listed the KPIs that would represent quality and safety, defined the numerator and denominator of each KPI and clearly detailed components for each numerator and denominator.
The chair of the cross-stakeholder education group is Samantha Jacques, Ph.D., FACHE, vice president of McLaren Clinical Engineering Services (MCES) at McLaren Health.
The focus of the subgroup is to establish a base understanding of each industry involved in the servicing community such as HDOs, OEMs, ISOs, regulatory bodies and accrediting organizations.
“Each subgroup has been directed to develop a slide deck to inform the other subgroups related to the regulations and processes in place related to servicing and how they ensure quality and safety in medical devices,” she says.
“Presentations from the HDO and associations representing the industry (AAMI, DNV and FDA) have been presented to the subgroup. The ISO group is slated to present its slides the first week of September. The group is still looking for additional OEM representatives who would participate and develop their education slides,” Jacques adds.
Kerwin chairs the best practices for servicer training subgroup. The focus of the group is to develop high-level training best practices to establish industry-wide expectations for servicing personnel.
The fourth subgroup is the best practices for quality management systems. It seeks to establish quality management system principles specific to medical device servicing. Presently, a chair for this group is being sought.
Once all presentations are complete, the subgroups are tasked with identifying a method to disseminate the education to the larger MDSC.
Trade Associations Seek Other Regulatory Frameworks
The members who left the group continued their work while representing their stakeholders. Both AdvaMed and MITA offered follow-up statements indicating their current focus, as well as their stance; post-MDSCC.
“Patient safety is the medical technology industry’s number one priority, which is why the proper servicing of complex, life-saving and life-sustaining medical devices is so vital. We are concerned that unregulated third-party servicers continue to be allowed to work on these highly sophisticated medical devices without having to follow the strict patient safety regulations FDA requires of OEMs and their authorized servicers,” says a spokesperson from the Advanced Medical Technology Association (AdvaMed).
“This has clearly harmed patients: The FDA itself estimated in May 2018 that there were up to 21,000 companies servicing medical devices, and reported that more than 4,300 negative incidents involving medical devices, including 40 deaths and 294 serious patient or device user injuries, had occurred – all the result of unregulated third-party servicers attempting and failing to repair complex medical devices,” the spokesperson adds.
MITA also stated its position.
“The challenges presented by the COVID-19 pandemic have been a major area of attention for MITA as it seeks to guarantee ongoing patient access to safe and effective medical imaging technologies. We have been working with FDA, CMS, Congress and others to implement policies that ensure expedient delivery of our technologies, help patients return to care, and secure the ongoing viability of radiology practices and departments across the country,” says Peter Weems, MITA senior director of strategic operations and policy.
He says that early in the pandemic, they decided that the nascent and ineffective Medical Device Servicing Collaborative Community (MDSCC) was not an area where they could dedicate concerted attention given its lack of governance and progress toward shared goals.
“We are open to considering new approaches to ensuring patient safety and device performance in the future,” Weems says.
“It is outrageous, however, that unregulated independent servicing businesses have decided to exploit the pandemic for their own business interests by championing self-serving and irresponsible ‘smash and grab’ legislation such as the Critical Medical Infrastructure Right-to-Repair Act of 2020. This, while they continue to avoid any responsibility for quality controls, FDA registration or filing Medical Device Reports (MDRs) – especially considering the lack of any evidence that medical imaging technologies have gone un-serviced during the public health emergency,” Weems adds.
“One must wonder what these organizations wish to hide if they will not even make themselves known to the FDA. Instead they have resorted to expansive demands for their competitors’ proprietary information without committing to taking any responsibility for putting necessary quality control systems in place. Are these third-party servicing businesses afraid that they won’t stand up to even basic scrutiny?” Weems asks.
More to Follow
While the pandemic has thrown a wrench in many ongoing endeavors, the work being done by the MDSCC or MDSC will continue. While there are competing interests and varying viewpoints, the resulting product of the various stakeholders will impact the future of HTM and future regulations. Decisions that result from good data and historic evidence will play an important role in the process.
“There’s a lot more that could be communicated to the industry and the industry should be aware of what’s going on that will have an impact on them,” Francoeur says.
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