Re: Update on welding with implanted defibrillator

On Jan 13, 12:40 am, Don Foreman <dfore...@xxxxxxxxxxxxxxxxxxxx>
wrote:
Summary:   not lookin' promising.

I've had contact with some good people:  a  senior fellow engineer at
a major ICD mfr, a former employee (engineer) of a major ICD mfr  and
friend of many years,  my wife's niece who is a former cardiac nurse
of 30+ years experience, and helpful others.

Findings:

There are reported cases of weldors returning to work with ICD's but
the reports are sketchy on details. One report mentions a minimum
distance of 24" between weldor and cables, work and torch.  That ain't
how I weld:  my face is right in there with 2 diopter lenses in my
mask.  

The experience of having a defib misfire has been variously described
as being hit by lightning and being kicked in the chest by a mule. I'd
rather skip that experience.  Welding is fun, being kicked in the
chest by a mule very probably isn't.        

I can't seem to get data on acceptable field strengths (E-field and H
or B field) that won't cause an ICD to malfunction.  I opined that
this is probably because the goddamned lawyers make this data highly
proprietary.  That was confirmed by the engineer (and friend) formerly
employed by a major mfr.  Goddamned lawyers.    

So I'm about SOL here, not being up for a mule kick in chest while
experimenting, candyass that I am.  

Helluvit is that I have no friends who can do TIG and MIG, though Karl
Townsend's son "the kid" may be a savior.  Neither of my sons are at
all interested.  One daughter is, and she's done some nice work with
MIG  but she lives in Brooklyn NY so she's not exactly local.

Mar, bless her hawrt, has volunteered that she might do a Vo-Tech
course in TIG and MIG.  She'd be a natural, that based on her
precision quilting and prowess with handgun, both hand-eyes
coordination activites.  TBD how that goes, but whatta teammate for
even considering it, eh?  Hey, she severely aced ground school for
pilot licence for previous hub in the bad old days. Highest score
they'd ever seen if I recall correctly.  What a fool he was for doing
her wrong, what good luck for me and eventually us. Goin' on 30 years
now and it just keeps getting better.      

Most folks are quite happily "weld free" in their dotages, right?
Still, it's a bit of a lump to be prohibited from practicing a skill
and activity I've enjoyed developing over decades and frequently find
useful in my shop.  Oh *** oh dear, poor me.

I intend to wallow in this for a while, *** you if you can't take a
joke.  I'm not happy about this, but it's no secret  that gettin' old
ain't for sissies.    

Hey Don, you might want to read this.

TMT

http://news.yahoo.com/s/ap/20090115/ap_on_he_me/med_medical_devices

High risk medical devices escaped close review
By RICARDO ALONSO-ZALDIVAR, Associated Press Writer Ricardo Alonso-
zaldivar, Associated Press Writer Thu Jan 15, 6:35 pm ET
WASHINGTON – Some medical devices for sensitive uses, from certain hip
joints to a type of defibrillator, have won government approval
without a close scientific review, congressional investigators said
Thursday.

Although Congress ordered the Food and Drug Administration years ago
to resolve the issue, the agency approved 228 medical devices without
a full scale review from 2003-2007, the Government Accountability
Office said in a report.

Some devices approved under the less rigorous process have been
recalled because of malfunctions and other problems, according to the
consumer group Public Citizen. One device was an external
defibrillator to assist heart attack victims.

The report comes as the FDA's Center for Devices and Radiological
Health is the subject of allegations that scientists were pressured to
approve medical machinery against their professional judgment. Nine
FDA scientists wrote the Obama transition team last week complaining
that a "corrupted" review process is putting public health at risk.

The allegations are a separate matter from the concerns raised in
Thursday's report. But taken together, they probably will raise the
level of congressional scrutiny over the FDA's medical devices branch.

"GAO's investigation confirms my concerns that the approval process
for medical devices is woefully inadequate," said Rep. Frank Pallone,
who heads the House Energy and Commerce Committee's health panel. "For
years, Congress has required high-risk medical devices to undergo
stringent premarket review, but GAO's findings show that is simply not
happening in every case."

Pallone, D-N.J., said he intends to hold hearings on the FDA's
oversight of medical devices. The GAO did not look into whether any
patients were harmed as a result of devices that got less government
scrutiny.

The root of the problem seems to be that the FDA never fully carried
out the intent of a decades-old change in the law.

Medical devices include everything from tongue depressors to silicone
breast implants and pacemakers. In 1976, Congress set up a three-
tiered classification system for devices.

Manufacturers of low-risk devices such as bandages and reading glasses
could get cleared by notifying the FDA before going to market. High-
risk devices such as pacemakers and heart valves would have to go
through tighter scrutiny, and their manufacturers were required to
provide evidence of safety and effectiveness. Devices classified as
high-risk tended to be ones that are implanted in the body or could
spell the difference between life and death.

An exception was carved out for new versions of high-risk devices
already on the market.

Manufacturers could get approval by convincing the FDA that these
devices were "substantially equivalent" to their precursors. In 1990,
Congress ordered the FDA to end the practice, but it has continued
even as generations of technology have come and gone.

The report urged the FDA to promptly resolve the problem, either by
carrying out full reviews or reclassifying some devices as lower risk,
if appropriate.

The FDA acknowledged the problem, but has not set a timetable for
resolving it. "In general, we agree with the conclusions and
recommendations," said spokeswoman Karen Riley. "We are considering
legal and procedural options to accomplish this objective."

The GAO report found that two-dozen distinct types of devices approved
without close scrutiny, including metal hip joints, external
defibrillators, and electrodes for pacemakers.

"It all adds up to less-than-rigorous device review, and it's placing
tens of thousands of Americans at risk," said Peter Lurie, deputy
director of Public Citizen's health research group.

___

On the Net:

GAO report: http://tinyurl.com/73nyhl

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