The Top 10 Health Technology Hazards list is updated each year based upon the prevalence and severity of incidents reported to ECRI Institute by healthcare facilities nationwide; information found in the Institute’s medical device problem reporting databases; and the judgment, analysis, and expertise of the organization’s multidisciplinary staff. Many of the items on this year’s list are well-recognized hazards with numerous reported incidents over the years.If one honestly looks at the number of saves versus the number of deaths from defibrillators, I wonder how many of this highly esteemed group of "multidisciplinary staff" of the ECRI might reconsider.
Clearly, most of them have never been in a code situation.
-Wes
h/t: Wall Street Journal Health Blog
Dr. Wes,
ReplyDeleteIt is hard to imagine how such a life saving invention like hospital based difibrillators could be protrayed as being so hazardous.
In a previous blog post a couple of years ago ("A Conversation I Never Want to Have") you wrote about a potential conversation with a patient over which ICD manufacturer's device they would receive. In that article you mentioned that if the patient didn't want a device from any of the US manufacturers that,
"...you can alternatively have us special-order you a device from Germany called a Biotronik device. It might cost you a bit more and I'm not sure there will always be a rep available to help check the device, but hey, we want to keep you well informed about ALL possibilities. Any preference?"
Just curious as to why you think that you have to "special order" Biotronik devices from Germany? Are all of their devices special ordered from Germany? Do they not have a US sales and distribution team with devices in the US already? Are there devices more expensive than US based manufacturers? Someone told me that Biotronik actually makes and/or assembles a larger portion of their devices in the US as compared to the US based manufacturers which utilize facilities in the Dominican Republic, Costa Rica, etc.
Thanks
Failure of the defibrillator is the listed problem. Haven't seen that myself, but it would be an issue during an urgency.
ReplyDeleteJohn Mallery
Grass Valley, California
Anony 09:55 -
ReplyDeleteYour question is off topic. In regards to the prior post referring to an imaginary patient and scenario from March 2008, back then Biotronik had a fledgling US sales force then but has grown market sales since. They do sell and market devices in the US but, in our area, have a much smaller number of sales and support staff. Many reputable centers use their device (our center does not implant them, but we do follow patients with these devices). This is not to say they are not effective.
Again, we are talking in this post about external defibrillators, not implantable ones. Sorry I got your knickers in a twist from my earlier post some two and a half years ago.
'nuf said.
John -
While you are correct that a defibrillator not working in the heat of a cardiac arrest would be of concern, I would bet many more injuries occur to hospital workers from, say, kitchen griddles causing grease burns. Selection bias is likely responsible for defibrillators being added to these guys' list rather than their malfunction being a serious problem.
Too bad they fail to mention the potential flaws with the the development of their "Top Ten" medical device hazard list.