During a joint FCC/FDA meeting, stakeholders disagreed on who should be tasked with developing standards for the environments in which wireless medical devices are tested. Some said it’s time for the government to step in, while others warned federal regulations could stifle innovation.
Stakeholders seem to be at odds over who should set standards for proper testing environments for wireless medical devices. While some say it is time for regulatory agencies to step in to provide more certainty for industry and patients, others are concerned government regulation could hamper innovation.
Industry, government officials and standards groups converged in Washington, D.C., at the Federal Communications Commission (FCC) headquarters on March 31 to talk about developing “test beds” for medical wireless devices. The meeting, co-hosted by FCC and FDA, exposed some of the confusion, frustration and rifts that stakeholders have on test beds that would be a platform to test wireless devices so they function securely and safely in different environments.
While some groups, in particular standards organizations, called for more government involvement to standardize test bed requirements, others were more wary and wanted industry to be able to develop its own standards.
“We have isolated test beds doing good work in their own entities but I think the industry needs a common place to go,” said Mick Conley, development manager for industry programs at the safety-standards group Underwriters Laboratories Inc. “I think there needs to be a critical sponsor, possibly the FDA, getting together a collection of member consensus-driven people that start prescribing use cases.”
Some attendees pointed to the Wifi Alliance
and its work to develop test beds for wireless devices more generally, but Conley noted that it took 15 years for the alliance to develop those standards. He said the alliance’s work to cover the large spectrum of manufacturers is a model that should be looked at but also points out it is important to develop test bed standards as soon as possible to support device safety. In addition, implementing standards sooner could save industry money, he suggested.
The two main applications of test beds are to provide assurance of interoperability between wireless medical devices and to allow other devices to coexist without interference, speakers at the meeting explained. “Test beds will provide us and consumers the assurance a device won’t break our system,” said Chris Riha, senior director at the Technology Services Group at Carilion Clinic Health System. “It’s not going to be a plug and play; it will hopefully be a plug and don’t break.”
Ed Cantwell, chief operating offering with the Center for Medical Interoperability compared current medical wireless systems to a “seven-dimension chess game” that have to take into consideration factors such as radio frequency, signal type and human behavior.
“The question is can we rise up, and is it time for U.S. healthcare to have a point of view on what wireless really means in a hospital,” he added. “[Regulators have] defined building automation, they’ve defined electricity, they’ve defined every other basic utility but wireless is still like this orchestra where there is no testing whether all the instruments play together.”
Riha said he would like to see a seal of approval similar to the European CE mark that states that a device follows certain approved protocols. But he shied away from endorsing government development of test bed standards, stating he is “philosophically opposed to government regulations.”
Rick Hampton, wireless communications manager with Partners Healthcare System, which includes Massachusetts General Hospital, argued that government regulation is sometimes necessary, especially when industry hasn’t come together to develop its own standards. Even internet providers want to see uniform standards because they are afraid of liability issues when medical devices connect to their portals.
Steven Baker, senior principal engineer with Welch Allyn, which has prioritized development of wireless capabilities for its hospital devices, says he stands somewhere on the spectrum between Riha and Hampton, and cautioned that while stakeholders are discussing developing test beds for wireless medical devices, new companies are continuously entering the healthcare system with devices that often fail in the hospital setting.
“I think we all agree we need a plan, so far industry hasn’t come together to create a plan,” he said. “So while I prefer the industry would do it, maybe there needs to be some government incentive to do it.”
Baker says he doesn’t want to see FDA and FCC to come up with test bed requirements without industry input but also noted getting that input is like herding a thousand cats.
Surjit Ahluwalia, director of Advanced Services at Cisco Systems, says he doesn’t think any single company can address the transformation of wireless medical devices on the market and suggests the answer may be to develop industry partnerships to come up with solutions in specific product areas.
“I believe this is a shared problem we all have to work together to address,” he said. “We can’t just put this on the regulators…because frankly if you overregulate it you’ll have companies stay away from it, you will stifle and stop the innovation that’s happening. And if you leave it open you’ll have all these other problems to deal with.”
The sentiments were echoed by Robert Jarrin, senior director of government affairs at Qualcomm Inc, who said he’d like to see the creation of a public-private partnership that FDA and FCC should oversee. The entity would gather information from companies on what testing tools they currently use and what issues are they facingandreport on how to improve wireless test beds, he proposed.
“The next step should be creating [a national medical wireless test bed] center which could be housed in many different places and the idea would be it would have expertise, it would have access to experimental licenses and tools to help those [who] are developing converged wireless medical devices,” Jarrin added.
Despite the contention over who should set test bed standards, speakers seemed to agree that manufacturers need access to a wide range of techniques to test their wireless medical devices in environments they are likely to be used in and based on risk level. Test beds also need to account for use of wireless medical devices by patients at home and the need for devices to be simple enough for use by people who are not tech savvy, some pointed out.
Test beds should also take into account how wireless medical devices are updated over time and any methodology used should be based on the lifecycle of the device, attendees stated.
Several speakers also emphasized the importance of not making standards too burdensome for smaller medical device companies.
Julius Knapp, head of FCC’s Office of Engineering and Technology, said he and Bakul Patel, associate director for digital health at CDRH, had absorbed the day’s discussion, emphasizing that the agencies do not want to overregulate the industry.
Via The Gray Sheet