Medical device experts and their devices converse at Boston conference

I’m looking forward to Medical Device Connectivity conference this week at Harvard Medical School. It’s described by one of the organizers, Shahid N. Shah, as an “operational” conference, focused not on standards or the potential of the field but on how to really make these things work. On the other hand, as I learned from a call with Program Chair Tim Gee, many of the benefits for which the field is striving have to wait for changes in technology, markets, FDA regulations, and hospital deployment practices.

For instance, Gee pointed out that patients under anesthesia need a ventilator in order to breath. But this interferes with certain interventions that may be needed during surgery, such as X-Rays, so the ventilator must be also sometimes turned off temporarily. Guess how often the staff forget to turn the ventilator back on after taking the X-Ray? Often enough, anyway, to take this matter out of human hands and make the X-Ray machine talk directly to the ventilator. Activating the X-Ray machine should turn off the ventilator, and finishing the X-Ray should turn it back on. But that’s not done now.

Another example where Gee pointed out the benefits of smarter and better networked devices are patient-controlled analgesia (PCA) pumps. When overused, they can cause the patient’s organs to slow down and eventually cause death. But a busy nurse or untrained family member might keep the pump going even after the patient monitors issue alarms. It would be better for the monitor to shut off the pump when vital signs get dangerously low.

The first requirement for such life-saving feedback loops is smart software that can handle feedback loops and traverse state machines, as well as rules engines for more complex scenarios such as self-regulating intravenous feeds. Standards will make it easier to communicate between devices. But the technologies already exist and will be demonstrated at an interoperability lab on Wednesday evening.

None of the functions demonstrated at the lab are available in the field. They require more testing by manufacturers. Obviously, devices that communicate also add an entirely new dimension of tasks to hospital staff. And FDA certification rules may also need to be updated to be more flexible. Currently, a manufacturer selling a device that interoperates with other devices must test every configuration it wants to sell, specifying every device in that configuration and taking legal responsibility for their safe and reliable operation. It cannot sell into a hospital that uses the device in a different configuration. Certifying a device to conform to a standard instead of working with particular devices would increase the sale and installation of smart, interconnected instruments.

Reading the conference agenda (PDF), I came up with three main themes for the conference:

The device in practice

Hospitals, nursing homes, and other institutions who are current major uses of devices (although they’re increasingly being used in homes as well) need to make lots of changes in workflow and IT to reap the benefits of newer device capabilities. Currently, according to Gee, the output from devices is used to make immediate medical decisions but are rarely stored in EHRs. The quantities of data could become overwhelming (perhaps why one session at the conference covers cloud storage) and doctors would need tools for analyzing it. Continuous patient monitoring, which tends to send 12 Kb of data per second and must have a reliable channel that prevents data loss, has a session all its own.

Standards and regulations

The FDA has responded with unusual speed and flexibility to device manufacturers recently. One simple but valuable directive (PDF) clarified that devices could exchange information with other systems (such as EHRs) without requiring the FDA to regulate those EHRs. It has also issued a risk assessment standard named IEC80001, which specifies what manufacturers and hospitals should do when installing devices or upgrading environments. This is an advance for the FDA because they normally do not regulate the users of products (only the manufacturers) but they realize that users need guidance for best practices. Another conference session covers work by the mHealth Regulatory Coalition.

Wireless networks

This single topic is complex and important enough to earn several sessions, including security and the use of the 5 GHz band. No surprise that so much attention is being devoted to wireless networking: it’s the preferred medium for connecting devices, but its reliability is hard to guarantee and absolutely critical.

The conference ends with three workshops: one on making nurse response to alarms and calls more efficient, one on distributed antenna systems (good for cell phones and ensuring public safety), and one on the use of open source libraries to put connectivity into devices. The latter workshop is given by Shah and goes more deeply into the topic he presented in a talk at O’Reilly’s Open Source convention and an interview with me.

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