Day two started bright and early with a breakfast talk sponsored by GE Healthcare. The topic that got me out of bed early was the relationship between IT and biomeds. Some time ago I wrote a post about the efforts GE was offering IT training for biomeds - which is pretty cool. The session this morning was about Yadin David's experience holding a number of training sessions at St Lukes in Houston. Actually Yadin has done a lot more than the training to foster a productive working relationship with IT, and ensure that his department was positioned to be able to discharge their responsibilities as new technologies stream into their hospital. A classic contrast of biomeds and IT was presented: biomeds like to be on-site (among clinicians and patients), while IT likes to be on-line (doing everything via computer from their desk). A number of techniques were discussed, along with this GE training session that both biomeds and IT participated in together.
As an aside, after another session, Brian Fitzgerald of the FDA was telling me about a recent regulatory/standards meeting in Frankfurt, Germany. After the meeting they received a VIP tour of the brand new high tech University of Heidelberg Hospital. The entire hospital was designed and built from the ground up for the extensive use of wireless everything. Many of the medical devices are wireless, along with wireless VoIP, handheld computers, anything else you can imagine. As any biomed can imagine, designing and implementing this wireless capability along with building the hospital was an extensive, painstaking process. The hospital's original CIO couldn't take it and left to work outside of health care. In fact, IT was so resistant to the efforts required to assuring patient safety, that they had to move the IT department under clinical engineering. They now have one department called Medical Physics and Information Technology - of course in German it's one word 30 letters long. Draeger supplied the patient monitors, running on OneNet.
I was writing my "AAMI day one" post and unfortunately missed Eric Rosow's presentation on dashboards (nice new website). But I managed to catch "Disseminating Successfully Integrated Data: Who Needs It and How Do They Get It?" The short answer of course is not many, and not easily - but the situation's improving. Johnathan Gaev talked about the schizophrenic nature of medical device connectivity projects, being part biomedical and part IT (there's that theme again). He rightly noted how hard it is to change workflow, especially across organizational silos in hospitals. He also noted that workflow evaluations are more meaningful to clinicians than explanations of features and functionality. Jennifer Jackson presented three examples of connectivity projects at Brigham & Women's - successful but not easy projects. Finally, Todd Cooper talked about the IHE PCD and the work he's leading to bring about improved connectivity between devices and information systems. Salil Balar from Beaumont Services talked about something or other they've done. It sounded very interesting (and I'd like to learn more about it) but he had no presentation, and didn't have much time.
Next it was off to the day's keynote (and free lunch). The speaker was Donna-Bea Tillman, Director, Office of Device Evaluation, Center for Devices and Radiological Health, FDA, who talked about the "Myth of the "Premarket." Her point was that with the increasing rate of scientific knowledge and technological change, and the resulting product improvements, even released products are in some phase of "premarket" development and approval. She also talked about one of my favorite topics, combination products, and how everyone's still adjusting and learning the most efficient ways to deal with these types of products. She also presented some data: premarket applications have been running between 8,000 and 9,000 per year for the past several years; MDRs and product recalls are both trending up.
Every year at AAMI for the past few years there has been an impassioned debate of the merits of ISM versus WMTS for telemetry. (Here's a post on last year's dust up.) This year broke the trend. However the session after lunch was standing room only and "RF Wireless in Healthcare (Part I)" was the most exciting session of the conference. This was a high powered panel presentaiton emceed by Don Witters (FDA) and including Julius Knapp (FCC), David Whitlinger (Continua Health Alliance), Rick Hampton (Partners), and Jan Wittenberg (Philips). Don mentioned that the FDA's going to be releasing a guidance document this fall on the wireless enablement of medical devices. His cautious statements about wireless medical devices brought Jim Welch out of his chair to note that properly designed, deployed, and managed, wireless can be virtually as reliable as wired connections. Julius Knapp reminded the audience that when the new WMTS bands were designated it was with the understanding that many locales would only be able to use one or two of the three bands (that why they designated three bands). He noted that most vendors implemented 608-614 MHz, and that there are only 5 products approved for use in 1.4 MHz. There was also a great overview of MICS, the band designated for implantable devices. Dave Whitlinger introduced the audience to Continua Health Alliance, a non-profit industry group dedicated to fostering medical device and IT interoperability. Currently, they're targeting unregulated devices and regulated devices for home health - don't be surprised if success in home health quickly migrates into the hospital. Rick Hampton talked about how they've gotten IT and biomeds working together at Partners, and delved into the mysteries of the "hidden node" problem. Rick also shared all his secrets to managing wireless at Partners. Perhaps I can convice him to share some of his secrets here, for the the broader good. Finally Don Witters had his say, noting that EMI has lead to patient death and serious injury in the past. (He also pointed out the FDA man for primary and secondary alarms, whom I'll be bugging mercilessly in the near future.)
When the session wrapped up, the floor was opened for questions. Right out of the chute, someone asked if vendors were going to abandon the 608 band, leaving hospitals with millions recently invested from converting 460 MHz telemetry systems to WMTS. The problem driving this speculation is side lobe interference from digital TV stations 36 and 38. With no adjacent channel interference, the 608 band should support around 240 telemetry channels. If you add a digital TV station on either side, your capacity for telemetry units drops considerably. The sad truth is that most TV markets with have both channels 36 and 38 occupied before analog TV goes away in 2009. This will be a problem.
Well, the next session, "RF Wireless in Healthcare: Part II" will have to wait. I've got another half day of IHE PCD tomorrow and falling asleep in front of your peers is embarrassing...
Pictured right is Draeger's new TeleSmart (not approved by the FDA - not for sale).