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REDMOND, Wash. -- Rebuked by the FDA for quality control issues, Redmond's Physio-Control has been limited for almost a year to selling its LIFEPAK defibrillators in the United States to emergency service providers, such as paramedics and emergency medical technicians.
Now, Chelmsford, Mass.-based Zoll Medical, a major competitor, is aggressively going after that market, questioning why emergency service providers are continuing to purchase Physio-Control's products when the FDA has banned them from being sold to other customers.
In a survey of paramedics and emergency medical technicians, conducted by an independent firm but paid for by Zoll, most respondents said they had not heard of Physio-Control's travails. But half of the respondents who said they planned to buy Physio-Control's products said they knew about the company's troubles with the FDA.
"The marketplace does not seem to be aware of it and those (that) are aware of it seem to be under the impression that it's really not that big of a deal," said Julie Gelfand, an executive vice president at Harrison LeiferDiMarco Public Relations, which is representing Zoll.
Jennifer Roth, a spokeswoman at Physio-Control, a division of Medtronic, said she was unaware of the survey but questioned its validity since Zoll, who she described as a "major competitor," had paid to conduct it.
But she said emergency service providers were standing by Physio-Control's defibrillators, despite the troubles with the FDA and competitor sales pitches.
"Our customers are extremely loyal. We've been selling quite a bit of product," she said.
Roth said business was mostly steady because the emergency responder market consisted mostly of replacements.
Overall, Physio-Control's sales continue to fall. In fiscal year 2008, the company's revenue was $329 million, compared with $412 million in 2006. The company can still ship its defibrillators abroad and do repairs. By contrast, Zoll's sales reached record levels last quarter of $100 million, which included defibrillators and related software.
During a 2006 visit to Physio-Control's Redmond plant, FDA inspectors found 11 violations and concluded that the company's defibrillators were both "adulterated" and "misbranded." Many of the violations were similar to those discovered by the FDA on other inspections in 1992, 2000, 2003 and 2005.
In January 2007, Physio-Control voluntarily suspended all shipments of its defibrillators in the United States. That August it resumed shipping some defibrillators to the emergency responder market.
As part of an agreement reached with the FDA in May of this year, Physio-Control is banned from selling defibrillators, except to emergency service providers, until the company complies with federal law and hires an independent expert to conduct inspections, among other remedies.
Roth said Physio-Control, which employs 950 workers in Redmond, has hired an independent inspector whose work should be complete by late summer or early fall, she said. She said it was possible that the FDA would have to inspect the facility before it could start manufacturing defibrillators for all markets again.