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Day: December 13, 2005

Networked Medical Device Study Group Adjourns, Plans Next Steps

It seems that something like the existing ISO 14971 risk management standard for medical device manufacturers will be used to address networked medical devices. Several major revisions will be required, not the least of which is the kind of risk. The potential harm that ISO 14971 tries to mitigate is risk of injury to patients. Medical device connectivity entails this risk, as well as others. Another difference is that 14971 applies to the development of new medical devices, and much of connectivity entails the integration of legacy medical devices. And of course, as noted before, the connectivity risk management standard will “pierce the veil of commerce” and apply to users as well as manufacturers. As a group we reviewed the following concerns; stepping on other’s regulatory toes, the decree of proscriptiveness, getting input and participation from users, scalability of the standard so it works as well for a 50 bed hospital as it does one with 500 beds, the costs that might be incurred by implementing this standard, and how the standard might disrupt care or negatively impact clinical practice. All these topics were discussed and resolved. We started working on a scope, but didn’t make much progress. One thing that vendors desired was that the standard not apply to vendor “products” that include general purpose computing components (like servers, PCs and network gear) as long as they are...

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Virtual ICU Network Plans Expansion

Quality Health Systems which operates a virtual ICU at three hospitals in the Milwaukee, Wisconsin area is considering expanding its services to other local hospitals. Quality Health Services officials say they have capacity to add more hospital beds to their system and that they likely will sell access to smaller hospitals in southeastern Wisconsin. “We want to identify interested health care organizations in regional areas that share the same ideas in value and efficiency of health care services,” said Rick Born, CEO of Quality Health Services Each virtual ICU bed is equipped with a camera, speaker and microphone. Providers at a command center in Menomonee Falls, Wis., monitor patients and communicate with ICU staff at each hospital. [Hat tip:...

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Visitors to This Site Break 20,000

Wow, I just noticed this morning that my visit counter rolled over to 20,000 some time yesterday (the counter is at the bottom of the right hand column). Thanks to everyone for visiting, especially those of you who reach out with emails and comments. Presently my average visits per day are at 147, and average visit length is a whopping 2 minutes, 56 seconds. Page views are almost 50,000, not surprising for a site like this where most of the information is on the home page. I'm very proud of the regular readers (and clients) who check in every few days. You can get a glimpse into the stats for this site here. There are now almost 500 posts on this site, many more than can fit on the home page or category pages. To find some of this buried information use the Google search box near the bottom of the right column. Be sure to click the “This site” radio button. Results that have a date or end in a number will provide the most direct information. For some reason Google indexes pages that scroll the oldest posts off the page as new entries are made, so the info you're looking for may or may not still be there. You might also find the map in the lower left column interesting. ClusterMaps tracks the location of visitors and...

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