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 isolated and standalone. Any time general purpose computing components are included in a solution, whether it is a “medical device” (a closed vendor supplied system) or integrated onto the hospital’s network and tied to other systems, connectivity problems can arise. This preference will probably remain because more and more hospitals are refusing to buy standalone systems (islands of information), and there’s nothing to prevent buyers from including the risk management process in negotiations for standalone systems – whether required by the standard or not.
So why is this standard being contemplated? The objective is to provide the key stakeholders (regulators, vendors, users, third parties) with a common tool to facilitate communications, coordinate efforts and manage risk when medical devices are integrated into the highly variable general purpose computing environment. I think the resulting standard will be a boon to all stakeholders, and especially users. The standard should provide a framework for detailed information and capabilities to negotiate with vendors at the point of sale, establishing responsibilities and service level agreements (SLAs) for things like component obsolescence, operating system patches and other connectivity issues.
Next steps will be to capture the problems, hazards and risks to be managed by the process, and to write a scope. There are two subsequent meetings planned, one in Frankfurt, Germany in March and another somewhere in the “lowland countries” in September. My next focus will be to tease out problems, hazards and risks. Any suggestions, observations or input is appreciated.
You can read about the first day of this meeting here, and some pre-meeting background here.
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.
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: iHealthBeat]
Grand Rounds
Grand Rounds 2:12 are up at Pipeline, a Corante weblog. Happy reading!
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 plots them on a map in 30 day increments, so that as the month goes by you can see where visitors are coming from. I recently upgraded from a free account so you can click on a continent and better see the distribution of visitors. In North America, you can see that Atlanta, Kansas City, North Carolina, New York and Massechusetts are big hot spots.
Thanks again, to everyone. I encourage you all to share your questions and knoweldge with everyone via the comments or by emailing me directly at tim@medicalconnectivity.com.
