Prendre note que dans le reportage, on indique que malgré le fait que
PhysioControl a cessé la distrubution de ses produits aux EUA, pour des
raisons de problèmes dans les processus de fabrications de ses
différents modèles de défibrillateurs (automatisé ou autres), la
distrubution de ces mêmes produits se poursuit dans les autres pays,
dont bien sûr le Canada et l'Europe.
Stéphan Gascon
Redmond defibrillator firm considers layoffs
Physio-Control employs about 800 on Eastside
By ANDREA JAMES <mailto:[EMAIL PROTECTED]
<mailto:andreajames%40seattlepi.com>>
P-I REPORTER
One week after Physio-Control stopped shipping products to U.S. customers,
the Redmond company that makes Lifepak-brand defibrillators has told its
employees that it is considering layoffs, the Seattle P-I has learned.
The firm's Minneapolis-based parent, Medtronic Inc., announced in December
that it would spin off Physio-Control into an independent company. However,
those plans were put on hold last week when the company announced problems
with Physio-Control's manufacturing processes. No products are being
recalled, the company said.
"We've told our employees that we may, in fact, have to reduce the size of
the force," Medtronic spokesman Rob Clark said Monday. "Clearly with the
suspension of operations, the work is scaled back. That will have an effect
on the resources that we need during this period."
Although the company has voluntarily stopped shipping its products to U.S.
locations, it still ships to its overseas customers. Medtronic will be
reaching out to the regulatory bodies in other countries, Clark said.
The scope of the role that the Food and Drug Administration has played in
the decision to cease shipment is unclear; however, Medtronic said that both
FDA and the company have identified "system issues."
"We found a number of things in our quality-control systems back in our
plant in Redmond that concerned us and concerned the FDA," Clark said.
U.S. sales account for two-thirds of Physio-Control's business, according to
a Prudential Equity Group research report issued Sunday. The report predicts
a 70 percent decline in sales at the plant and gives revised earnings
estimates for Medtronic assuming that the company can cut 30 percent of its
fixed costs at Physio-Control and that U.S. sales resume within one year.
Medtronic officials do not yet have a timeline for any potential layoffs,
Clark said. Physio-Control employs 1,200 people, about 800 of them in
Redmond.
The FDA sent warning letters to Medtronic about the Lifepak defibrillators
in 2000 and 2005, notifying the company about several violations the agency
had found during its inspections. Among the complaints outlined in a letter
dated June 9, 2005, were that Medtronic did not follow proper procedures on
a complaint involving a patient death.
Those issues have since been resolved and are not related to the current
problem, Clark said. The current problem is a "quality systems related
issue," not affecting any particular product on the market. But it could
take awhile to fix, he said.
"We're working very quickly to try to resolve it," Clark said. "We
understand that we have employees that are anxious to know."
Medtronic still plans to spin off Physio-Control once business is back to
normal, though the spinoff likely won't meet its October deadline, the
company said. Physio-Control brings in about $400 million per year, Clark
said, which represents about 3.5 percent of Medtronic's $11.3 billion annual
revenue.
Physio-Control makes automatic external defibrillators that are found in
schools, airports and other public areas and are used to shock hearts back
into rhythm. It also makes manual defibrillators used by hospital and
emergency workers.
Founded in 1955, Physio-Control has been a part of Redmond since it was a
sleepy Northwest town. Today, it is one of Redmond's 20 largest employers,
according to the city. In 1992, the company shut down its manufacturing,
sales and marketing because of alleged violations of good manufacturing
practices found by the FDA.
"Physio-Control is one of my favorites -- it's been in Redmond for several
decades on Willows Road," Redmond Mayor Rosemarie Ives said Monday. "Even
before Nintendo, there was Physio-Control and those defibrillators."
P-I reporter Andrea James can be reached at 206-448-8124 or
[EMAIL PROTECTED] <mailto:andreajames%40seattlepi.com>.
John Sinclair, Fire Chief
Emergency Manager
Kittitas Valley Fire & Rescue
2020 Vantage Highway
Ellensburg, WA 98926
509-933-7235 Station 2-1 Office
509-962-7274 Station 2-9 Office
509-856-7714 Mobile
509-925-6501 Home
Chair, International Director
IAFC EMS Section
253-973-1606 Cell_._,___
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