Author Archives: IAMERS

AdvaMed and MITA exit collaboration with non-OEM service stakeholders

May 20, 2020
by Gus Iversen, Editor in Chief  DOTmed

In a setback for improved cooperation between different medical equipment service stakeholders, two of the leading manufacturer trade groups, the Medical Imaging & Technology Alliance (MITA) and AdvaMed, have announced they will no longer be participating with in-house and independent service organizations in FDA-recommended Medical Device Servicing Collaborative Communities (MDSCC). 

The collaborative community was called for in a highly anticipated 2018 FDA report, which capped off a two-year investigation finding evidence “not sufficient” to warrant increased regulation of non-OEM medical equipment service organizations. The communities were intended as an opportunity for different groups to forge ahead addressing the unique challenges they face, working together to resolve them. 

“While we appreciated and supported FDA’s aim of bringing together third-party servicers and manufacturers to address issues surrounding the safety of third-party servicing of medical 

devices, ultimately we did not feel the group made sufficient progress in basic organizational or other areas to justify AdvaMed’s continued participation,” an AdvaMed spokesperson told HCB News. 

In response to that statement, David Francoeur, senior vice president of marketing and sales at Tech Knowledge Associates, and a member of the MDSCC representing the non-OEM service viewpoint, said AdvaMed’s reason for leaving mischaracterizes the FDA’s aim in forming the collaboration to begin with, noting that the FDA was addressing quality and safety related to maintaining medical equipment as a whole — not third-party specifically. 

In its own statement, MITA also commended the FDA’s efforts, but added that “despite over a year of regular meetings and numerous attempts to find consensus, It has become clear that progress is unlikely any time soon, given the divergence of opinions held by participants, as well as the time constraints imposed on industry by the COVID-19 pandemic.” 

The divergence of opinion referenced by MITA has been well documented since 2016, when the FDA first launched its investigation. 

By and large, OEMs have taken the position that non-OEM service lacks oversight and represents a safety hazard. In a 2018 opinion piece for HCB News, Patrick Hope, the executive director of MITA, wrote, “While we agree with many FDA findings, we reach a far different conclusion on this one,” and called for ending the “regulatory void” by passing legislation in Congress that would increase third-party oversight. 

In-house and independent service groups, on the other hand, generally argue that the biggest threat to safety is the lack of cooperation they get from OEMs regarding access to manuals, passcodes and other necessary information. In a response to Hope’s article, Arif Subhan, then president of the American College of Clinical Engineering (ACCE), observed that reporting of adverse events is the job of facilities (not servicers) and asserted, “it is grossly misleading to suggest servicers are held to a lower standard when clearly it makes no sense to hold servicers to manufacturing-specific regulations.” 

The clashing viewpoints are comparable to high-profile right-to-repair controversies concerning consumer products like smartphones and tractor-trailers, where manufacturers like Apple and John Deere have argued that a robust service market for their products would open the door to safety and security concerns. 

“In reality, AdvaMed and MITA have been stalemating progress in the collaborative communities for over a year,” said Francoeur. “They couldn’t agree on antitrust-focused language, and they couldn’t agree on voting rights.” 

Although COVID-19 has put the MDSCC on hold, Francoeur said that “mini groups” have been formed within the alliance to concentrate on specific topics (training materials, definitions, QMS solutions, and key performance indicators) and he expects those groups to continue their work despite the departure of MITA and AdvaMed. 

The International Association of Medical Equipment Remarketers and Servicers (IAMERS), another MDSCC member representing non-OEM viewpoints, echoed that sentiment. “IAMERS is disappointed that AdvaMed and MITA will not be continuing with the Medical Device Servicing Collaborative Communities initiative,” Robert Kerwin, general counsel for the organization, told HCB News. “Like other stakeholders, we have devoted many hours to the MDSCC initiative and will continue to pursue this and other collaborative initiatives.” 

The need for better partnerships between medical equipment OEMs and service teams has been highlighted by the COVID-19 pandemic. In April, five state treasurers called upon device manufacturers to increase the availability of ventilator service manuals for service technicians on the front lines. “In a public health crisis, every second counts. There shouldn’t be a single ventilator sitting in a closet because a hospital, already under extreme pressure, isn’t able to make necessary repairs to it,” wrote Pennsylvania State Treasurer, Joe Torsella. “I call on manufacturers of this lifesaving equipment to release this information and remove this barrier that hospitals are facing.”

This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51242 

HSCC Legacy Medical Device Task Group Aims to Mitigate Cyber Threats

May 13, 2020 By Robert J. Kerwin

This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/51199 

In April, the FBI reported a global increase in malicious cyberactivity targeting U.S. Healthcare providers, noting that the cyberactivity was exploiting fear derived from the COVID-19 pandemic, including targeted phishing attempts with subject lines and content related to COVID-19. This increase in cyberactivity is part of a general rise in cyber threats and data breaches as reported by HHS’s Civil Rights Division. In light of the increased incidence of healthcare cybersecurity issues, it is heartening to know that efforts are ongoing to protect medical devices. 

A public-private partnership of companies, nonprofits and industry associations known as the Healthcare & Public Health Sector Coordinating Councils (HSCC) has formed a Legacy Medical Device Task Group to develop planning guidance to mitigate cyber and physical risks. HSCC is pursuing this initiative in the wake of the Cybersecurity Act of 2015 and presidential executive order [PPD-21], which directed the secretary of Homeland Security, among others, to undertake public-private engagements with critical infrastructure sectors to identify cyber and 

physical risks for security and resiliency. HSCC has compiled impressive deliverables in its short existence, including a technical volume 1 and volume 2 for small and medium/large hospitals. 

Legacy medical devices have been recognized as particularly vulnerable to cyber threats as cybersecurity for these devices may not have been considered in the initial device design. Replacing technologies is not always feasible. This challenge will no doubt be compounded by the financial challenges hospitals are experiencing as they resume non-urgent care. 

Cybersecurity risk-benefit analyses will likely be weighed with the primary goal of patient safety. An effort will be underway to identify compensating controls which may be able to provide a security baseline level of protection. This effort may include mechanisms for updates and patches to be maintained over a device’s clinical useful life. Topics could include whitelisting, hardening and micro-segmenting a network. 

One of the leads in the Legacy Medical Device Task Group, Mike Powers, a clinical engineer from Delaware, summarized his hope for the Task Group by noting his wish to help “create an environment or platform where devices which are currently unsupported, can, in fact, become supported”. Reacting to the launch of the Task Group, West Virginia based Radon Medical Imaging Corporation’s president Tim Martin commented, “We are interested in the takeaways. We are committed to cybersecurity. It is on our mind today and every day.” 

There were also expressions of caution concerning the Task Group endeavors. IAMERS president Diana Upton offered, “we are hearing increased reports that when cyber patches and upgrades are being applied, some are not able to continue maintenance, as the software permits only the original manufacturer thereafter to undertake service. Given the frequency of patches, the system interdependencies and the number of modalities to be supported, we hope cybersecurity support solutions could be safely developed which still give hospitals cost- effective choices.” 

The Task Group members include an array of representatives from industry manufacturers, HDOs, trade associations and other stakeholders. We await their recommendations for greater cybersecurity for legacy devices. 

About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers, and a member of the HSCC Legacy Medical Device Task Group. 

Implementation of the EU MDRs Delayed Until 26 May 2021

IAMERS continues its role, albeit virtually, as an official observer to the European Commission Medical Device Coordination Group. IAMERS has been participating in the MDCG Subgroup on the MDR regulations on Post Market Surveillance and Vigilance. Under these regulations, manufacturers will be furnishing to member country regulators no less than annually reports on the safety of all medical devices. Due to the COVID-19 pandemic the implementation of the applicable regulations has been delayed to 26 May 2021.

IAMERS Joins Healthcare Sector Coordinating Council Cybersecurity Working Group

IAMERS has joined on behalf of its members the Healthcare Sector Coordinating Council. The HSCC is a private-sector organized and managed council created to establish a process to coordinate improvements to the security of critical infrastructure. The U.S. Department of Homeland Security is required to engage and consider the advice of the Sector Coordinating Councils. This Sector Council engages in planning, collaboration and decision making efforts for the purpose of strengthening the security and resiliency of the sector’s delivery of services and assets essential for the health of U.S. citizens. IAMERS is currently participating on two HSCC cybersecurity initiatives: HSCC’s Legacy Medical Device Task Force; and Model Contracts. For more information about HSCC see https://healthsectorcouncil.org/hscc-cybersecurity-working-group-charter/.

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