As the RSNA annual meeting wound down last Thursday in Chicago, medical equipment OEMs, third-party servicers, clinical engineers and industry associations came together at the Swissotel Chicago hotel to discuss the FDA report on equipment service and seek consensus on the road ahead.
Dubbed the Summit on Safety, Quality and Effectiveness of Servicing Medical Devices
, the event was held in response to the FDA's call for Collaborative Communities to work together addressing challenges and ambiguities in the service arena. Hosted by the Alliance for Quality Medical Device Servicing, a group of independent third-party service providers, the meeting also looked ahead to the December 10-11 FDA Workshop
to address the distinctions between servicing and remanufacturing.
The all-day event focused on four key points of interest identified in the report:
Service versus remanufacturing
- Clarify the Difference Between Servicing and Remanufacturing
- Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices
- Promote the Adoption of Quality Management Principles
- Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing
Although attending OEMs, providers and third-parties all described feeling confused as to which term a specific action falls under, "servicing" or "remanufacturing", most agreed that the distinction must lie in the extent of the changes made.
“If the change is made so that it goes back to the way it was originally labeled and marketed, that doesn’t constitute a change significantly. Otherwise, that would warrant a title change,” said David Francoeur, senior director of brand and quality for Sodexo Clinical Technology Management. “If a change has been done that alters the original intent, then I think we should label it as something that needs to be looked at differently.”
A white paper entitled “Evaluating Whether Activities are Servicing or Remanufacturing”
was issued by the FDA in conjunction with the workshop announcement in October and provides additional insight into how they are approaching the discussion surrounding these two terms.
Comments concerning the white paper are being accepted at https://www.regulations.gov
in Docket No. FDA-2018-N-3741 until January 25, 2019.
Improving cybersecurity as it relates to servicing medical devices was an area where everyone agreed there is much work to be done, and standardization is key. Currently, there are no standards or required actions in place for how to systematically address cyberattacks.
Speakers emphasized particular areas where standards were needed, such as sharing information related to identified security vulnerabilities; the securing of legacy devices; enhanced training and avoidance of careless actions; and the need to better understand and simplify approval processes.
“From an equipment perspective, we just don’t have the ability with our equipment that’s on the network at this time to do any automatic port control, as well as encryption,” said Mike Busdicker, system director of clinical engineering at Intermountain Healthcare, indicating the challenges faced by many front line healthcare providers.
Busdicker also stressed the need for equipment suppliers to assist providers with changing passcodes internally in order to mitigate the threat of security breaches.
Quality management principles
Establishing quality management principles, and ensuring their effectiveness, is a core objective of the FDA and equipment stakeholders in the wake of the service report. Such wide-reaching protocols would impact the training of technicians; sharing of information; reporting of issues; and following of certification practices, to name a few.
Katrina Jacobs, a biomedical engineer for the U.S. Department of Veteran Affairs, said that she would like to see an agreed-upon source of guidance to help organizations determine the best partners to collaborate with for safe and effective servicing of their devices.
“A lot of our folks in the contracting business will say ‘Why are you going to the OEM when this independent is offering a cheaper price? What about this independent versus this independent? What’s wrong with going with the cheaper option?',” she said. “There should be some sort of agreed-upon best practice or guidance widely available to help those people to make that decision and understand the important principles.”
Fostering evidence development
Establishing a standard set of quality management principles is confounded by the lack of baselines to quantify safety, effectiveness or quality and demonstrate positive impacts made on servicing.
Identifying data sets on these matters and understanding how to use them, along with the environment and performance of the devices and services, and the potential outcomes of any particular failure, is an area of interest that also leaves more questions than answers.
“Regulation drives compliance. You need to determine the key points. What’s the common vernacular? What’s the nomenclature?,” said Kate O’Rourke, director of sales at ECRI Institute. “The data collection for determining that is in place not just within ECRI but in other places. People are hesitant to share it, however. Having an agreement in some kind of collaborative like this to share that type of data from its different sources would be a great initiative.”
Further and more in-depth discussions of these topics are expected to take place at the FDA workshop next week at FDA headquarters in Silver Spring, Maryland.