Article prview reprinted from "The Gray Sheet" - February 1, 2009
FDA, device makers and others are struggling to identify the best way to regulate "interoperable" medical systems - such as an iPhone that receives blood glucose data - with some suggesting that a separate classification scheme might be needed. Read more...
"Plug And Play" Medical Systems Raise Complicated Regulatory Questions
Article prview reprinted from "The Gray Sheet" - February 1, 2009
FDA, device makers and others are struggling to identify the best way to regulate "interoperable" medical systems - such as an iPhone that receives blood glucose data - with some suggesting that a separate classification scheme might be needed.
Device firms, FDA regulators, information technology specialists and other stakeholders met at FDA headquarters last week to discuss a regulatory pathway for interconnected device and IT systems.
The Jan. 25-27 workshop on medical device interoperability issues was co-sponsored by FDA, the Center for Integration of Medicine & Innovative Technology (CIMIT) and Continua Health Alliance, an industry coalition focused on interoperability in health care.
When FDA announced the meeting last December, it posed questions around clinical uses of interoperable devices, pre- and post-market studies for the products and tools to assure the safety and effectiveness of interoperable systems.
"We at FDA believe the technology and the knowledge are currently available to design, develop and implement a safe and effective medical device interoperability system," CDRH Director Jeffrey Shuren told workshop attendees Jan. 25.
"What we need to do is pull it all together first, by answering several critical questions."
After three days of discussion, the group produced more questions than answers on these topics.
Regulatory Questions Abound
Systems of medical devices that link seamlessly to electronic medical records (EMRs) and to each other - no matter the manufacturer - are the goal, but the challenges are steep.
Potential benefits, beyond doing away with proprietary product interfaces and accessories, include the ability to create "safety interlocks" across devices, CDRH's Shuren said.
For instance, synchronized imaging and ventilator equipment could enable clinicians to disable a ventilator while performing an imaging scan, and then automatically power it back up to avoid any patient harm.
The greatest barriers to achieving these goals are not technology-based, workshop attendees agreed, but involve trust issues, company cultures and unclear regulatory pathways.
"Companies will say, 'There's no way I'm letting another manufacturer turn my ventilator off,'" workshop co-chair Julian Goldman, director of the Medical Device Interoperability Program at CIMIT, noted.
In addition, participants questioned how to write an intended-use statement for an interoperable device when the company may not know what other devices or systems it will ultimately interface with.
Further, it would be impossible to test and validate use of that device with every other connected system it might be used with, the workshop participants noted.
For these products, FDA and industry must move away from the full-system validation and clearance approach, one attendee said.
"The number of possible permutations is just too large, both for FDA to review permutation by permutation, and for the manufacturers to submit that."
"Some other means has to be developed," he added.
Questions were also raised about how much a firm could say in marketing materials for interoperable devices, and who would be responsible for reporting adverse events in a complex, interconnected system.
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