I also found the article disturbing. Some of the facts in the article
don't quite add up.
They sampled a small percentage. Obviously (I hope) they chose a sample
size based on the number of defective assemblies they were seeing that
would ensure the problem caps would be detected if present. I assume
this was after the fact was discovered. The article states that they did
not find any bad caps. Was not the sample size large enough, or is the
problem something else? I am assuming there are capacitors from the bad
lot still available for inspection.
All of the bashing of Guidant's processes is not only unprofessional,
but also very suspicious. These processes are carefully monitored by
medical quality auditors. If the problem was in product released by
Guidant and still being manufactured by Boston Sci, how come they did
not find the problem, either?
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Steve Gregory
Sent: Tuesday, June 27, 2006 8:03 AM
To: [log in to unmask]
Subject: Re: [TN] Bad capacitors in Boston Scientific Defibrillators and
Pacemakers...
Hi Susan!
Thanks for the link, but it still doesn't say who made the capacitors,
or exactly what the nature of the problem is. There were a few
statements in the article that raised my eyebrows:
-"Guidant had reduced the rigor of its quality- control programs,
contributing to the rash of product recalls..."
-"There used to be more testing. There used to be more checking. They
used to do process development in parallel with product development. For
whatever reason, they got away from some of those kind of things, and I
think you're starting to see the result of that..."
-"The new problem involves a failure of a capacitor, a tiny part that
stores electrical charges, Boston said. Tobin said Guidant didn't find
flaws in a small percentage of the capacitors, built by a supplier whose
name wasn't disclosed.
-"These capacitors were clearly out of spec. That should never have
happened, and it happened. Batch after batch after batch, and now we're
paying the price."
-"Guidant was cutting corners basically to advance its product line,
keep its technology fresh or whatever it was."
-An independent panel named by Guidant to investigate the quality
problems in its cardiac rhythm business concluded that they stemmed in
large part from lax oversight by management, understaffing of product
engineering positions and failure to involve medical experts in
assessing questions of patient safety.
As details of this incident are disclosed, you really shake your head.
How does something like this happen with a implantable medical device
company? I have an uncle who wears a pacemaker. He's had his in for
quite a few years, so hopefully his pacemaker doesn't have a problem.
But can you imagine the stress you would be having if you were a patient
that just had one of these devices put inside you to keep you alive?
-Steve Gregory-
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Susan Mansilla
Sent: Tuesday, June 27, 2006 7:43 AM
To: [log in to unmask]
Subject: Re: [TN] Bad capacitors in Boston Scientific Defibrillators and
Pacemakers
Here is a link to this morning's update in the Indianapolis paper
describing the problems.
Susan Hott
http://www.indystar.com/apps/pbcs.dll/article?AID=/20060627/BUSINESS/606
270421
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