DOTmed News has received some e-mail in response to last week's report "Defibrillators Recalled at Alarming Rate." (For more information on the Journal of the American Medical Association research that was the basis of the article, go to http://jama.ama-assn.org/cgi/content/full/296/6/655. To read the FDA's take on it, go to http://www.fda.gov/bbs/topics/NEWS/2006/NEW01429.html)

Some letters are reprinted below and we look forward to your continuing input of expert comments on industry news.

**


I read with great interest your recent article in DOTmed (Defibrillators Recalled at an Alarming Rate, August 10, 2006.)

I was with you right up until the message that "manufactures should develop a way to determine failure issues before they occur." Such a
program does indeed exist.

Most, if not all, patient contact electronic device manufacturers recommend that the equipment be seen by a qualified biomedical technician at least yearly. Some recommend every six months. However, many end users, in particular the non-medical related users, do not want to spend the money to have these inspections performed. The cost for such an inspection is approximately $140.00 to $160.00 per unit per inspection.
The test is very detailed, and follows the manufacturers guidelines.

Our company, TECH+MED, knows from first hand experience how many patient related issues are prevented because a problem was found and
corrected during a routine device inspection procedure that we performed for an end-user customer.

Very truly yours,

Richard Sapp
President-CEO
Tech+Med Industries, L.P.
Maverick Investment Corporation
Indianapolis, Indiana

**


Hello,
As an EMS practitioner and an AED instructor I was very interested in the above cited article. Having a definite interest in promoting the use of AEDS I felt this article might help arm me with information which would assist me in fielding questions from members of the public.

Many people have an inherent fear of machines. Many corporate CEOs are
afraid of liability issues should one of their employees use an AED. This article, although interesting, was not informative.

It would have greatly assisted not only instruction, but confidence if the article had defined what malfunctions occurred. The Medtronics Lifepack 500 had a recall issued for its adamant refusal to shock, other units had been recalled due to their not being able to register proper dates. These malfunctions and problems, although serious in the case of the Lifepack 500, are not as terrifying for the public as the suspicion a unit may erroneously shock a patient.

A layperson, or even an instructor with limited experience (many part time first aid instructors, who appear to give up on CME when certified) might interpret this article to mean AEDs are computerized killers stalking our streets. (A wee bit of melodrama there). I have audited quite a few classes where the instructor has not understood the principles behind defibrillation, and was not in a position to answer the simplest questions from the students.

All in all I love receiving DOTmed emails and find them informative and
timely. In this instance, however I feel a slight disservice was done in not printing statistical data.

Brian Phaneuf
Executive Officer, Operations
Immediate Action Services

More Voices