Converging Medical Device and Enterprise Networks
On Thursday, May 21, 2009 WAV Distribution and and client Summit Data Communications are hosting a web seminar on Converging Medical Device and Enterprise Networks, with yours truly.
As automation converges ever closer to the point of care, medical device systems are increasingly coming to the attention of hospital IT departments. Applications like EMRs, alarm notification, and enterprise-wide deployments of medical device systems are all driving the convergence of private medical device networks with the hospital enterprise network.
Consolidating medical device networks onto the enterprise network eliminates “islands of information” and supports broad deployment of systems like smart infusion pumps and point of care diagnostic testing devices. Moving medical devices from private networks to enterprise networks, however, can prove challenging.
This webinar explores the special requirements medical device systems place on an enterprise networks and provides best practices for creating safe and effective converged networks. Topics covered include: regulatory issues, networking specifications, vendor selection, implementation and management for converged networks.
You can register for the webinar here. I’ll post links to the recorded webinar and a downloadable version after the event.
UPDATE: You can find the webinar listed at Wav Wireless Outfitter’s site, here, and view a stream of the recorded webinar here. You can also download a copy of just the presentation here (4.4Mb pdf).
Convergence Summit – Day One
I’m at the Wireless-Life Sciences Alliance conference, called the Convergence Summit, May 13 and 14. Held at the Estancia La Jolla hotel, today was a full house — standing room only. A few of us are also Twittering the event; you can search for #wlsa to pull up everyone’s posts. You can also see the Summit agenda and prestentors here.
During breakfast, I chatted with Michael Kurgan, CEO of start-up Service Wing Healthcare. They’re targeting the wireless gateway market to support body area networks. I mentioned a company I heard about yesterday, GainSpan and Michael had some great perspective on the challenges picking tech winners in immature markets. GainSpan has an ultra low power wireless SOC (system-on-chip) that includes an 802.11b radio and two ARM processors, one for the radio and one to drive whatever device the chip is enabling. In an immature market, just because a component comes from a big company does not mean that their component will have long term success. A much smaller competitor with a better solution may win, or the big company may acquire a better solution in order to be a big player in that market segment.
Rob McCray, chair of the Wireless-Life Sciences Alliance, kicked things off. Camille Sobrian was up next, touting San Diego as the biggest wireless hot spot in the world (perhaps for cellular wireless). She also mentioned the West Wireless Health Institute, and the upcoming TEDMED event. Dr. Paul Jacobs, CEO and chair of Qualcomm passed on introductory remarks and jumped right into things wireless.
Paul noted that what’s going on right now is convergence, and it’s those who understand both industries that can lead that convergence. He described the new mobile internet experience: networks, devices and applications in the cloud. Multiple air interfaces are a key enabling component. The newest radios are only a few percent more efficient, but they tend to support broader bandwidth to improve network performance. He mentioned a mobile WAN, and various wireless LANs and BANs. A future trend is where applications control the radio to optimize performance for that application.
In Europe, mobile broadband radio dongles for connecting laptops outsell all the 3G phones sold there. Paul defined convergence as the overlapping of computing devices, consumer electronics and wireless tech. Paul alluded to the Amazon Kindle, as a prototypical device for the future, where an embedded system includes a cell phone built in for connectivity. He also highlighted Snapdragon as a platform for mobile data processing, multimedia performance, 3G wireless connectivity and the low power consumption.
Final MDDS Rule Expected Soon
In an off the record conversation couple months ago I was assured by an FDA contact that they were indeed working on a final version of the MDDS rule. Then this past Friday, David Bowerman with VisICU said that he’d heard that the FDA was going to publish the final draft in a few months.
After some poking around, I came across this page on SoftwareCPR (by the time you visit the page, the 4/7/09 entry may have scrolled off the page). At the top was this intriguing bit:
At public conferences representatives of the FDA have indicated that the draft Medical Device Data System Classification rule was returned from FDA legal review for clarification of how public comments were addressed. This will delay release of the final rule perhaps 3 – 6 months but it is hard to estimate.
On the same page of news, I saw that John Murray, with the CDRH Software Compliance office, gave a presentation at the recent AAMI Standards Conference on what software is a medical device, how such software is classified, and whether pre market submissions are required or the quality system regulation applies. (An interesting presentation (pdf) that you can download here.) Thinking this may be one of the “public conferences” where “the FDA have indicated” the status and not too distant release of a final rule, I give John a call. Here’s what he said:
- FDA legal had indeed come back with a request to more fully address the public comments in the final rule.
- He described the majority of comments as focused on wanting a better understanding the proposed rule’s definitions.
- Consequently, the preamble will be expanded to include better definitions.
- That the basic rule itself will be unchanged.
- And yes, the final rule is close to being published.
When asked about the 3 to 6 month time frame to finish tweaking and publish the final rule, John declined to site a specific time frame.
Compliance Requirements
The proposed rule includes specific time frames for manufacturers to come into compliance. The draft MDDS rule states that vendors have 60 days after the final rule is published to register with the FDA as a medical device vendor and provide a list of their products. Manufacturers who fall under premarket notification (510k) have 90 days to submit, and 180 days to obtain final clearance. This is not a whole lot of time.
Since the draft rule was published, vendor reactions have ranged from “wait and see,” to accepting the MDDS rule as a foregone conclusion and moving towards compliance. This puts some vendors facing FDA regulatory scrutiny in a bit of a pickle.
GlobeStar Systems World Connex — Day Three
After a breakfast meeting, I caught Brenda Vollmer’s presentation on Improving Safety Through Automation. Grand River Hospital recently installed ConnexALL to integrate WatchMate patient wandering, Siemens fire panels and Delta Controls building automation systems.
According to Brenda the implementation of ConnexALL was initiated to better align with their hospital’s patient and staff safety goals. After installation they were able to consolidate much of the management and interaction of these three event driven systems into an automated and consolidated system using ConnexALL. Specific benefits included, improved reliability, managed group notification, reduction in manual interventions, automatic alarm escalation, increased mobility (no sitting at a workstation or watching a panel), quicker decision making, and a consolidated auditing capability.
WatchMate is used for wandering, patient elopement and infant abduction. The hospital’s security is based on the premise that it’s easier to contain (a potential security situation) than retrieve, and that it’s easier to catch someone in the act than is to try to find them after the fact. WatchMate provides notification to a user at a workstation. The hospital used switchboard operators to monitor WatchMate, since they’re usually at their desks. They had to recognize the alarm, look up who to notify, and ensure that notification is made. Now, ConnexALL automatically receives alarms, notifies appropriate staff, ensures alarm delivery (including necessary automatic retry), and escalates alarm notification when necessary. (After some googling, it seems that GlobeStar integrated with WatchMate even though the product is no longer sold by the manufacturer, Xmark.)
