Guest guest Posted May 2, 2008 Report Share Posted May 2, 2008 The permanent injunction is the first step to clear the way for Physio to restart manufacturing: Physio-Control agrees to revamp defibrillator quality control By Ángel González Seattle Times business reporter Physio-Control said Monday it agreed with the U.S. Food and Drug Administration on a plan to revamp its manufacturing quality-control procedures to comply with federal regulations. The agreement was filed with the U.S. District Court in Seattle on Friday. If approved by the court, it will set a course for the Redmond medical-equipment maker to resume shipments of its external defibrillators. Physio-Control expects to comply with the terms of the consent decree within its current fiscal quarter, which ends in July, or shortly after, said spokeswoman Anne Devine. It can begin shipments once its final report on the changes gets a nod from the FDA. " We already completed a lot of the things [regulators] were concerned about, " Devine said. The agreement mandates that the company hire an independent expert to evaluate Physio-Control's procedures once a year. A third-party audit was recently completed, and there's " no requirement for one in the near future, " Devine said. The company voluntarily suspended the U.S. distribution of its products in January 2007, supplying only critical clients, after the FDA found shortcomings in its quality-control procedures. The suspension prompted a delay in a planned spinoff of the company from its corporate parent, Medtronic, and led to layoffs. Physio-Control continued to ship defibrillators to foreign markets, which accounted for about 40 percent of its pre-suspension revenue. But the accord forces it to restrict those sales as well until it fully complies with the FDA requests. " During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution, " said Physio-Control President Webster. " We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations. " Physio-Control competes with a Seattle-based unit of Philips for the top position in the external-defibrillator market. The devices can jolt a failing heart back into action with an electrical charge. Ángel González: or agonzalez@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2008 Report Share Posted May 2, 2008 Well, it may be the first step, but one wonders why the matter had to get this far. PhysioControl has a history of less than candid relations with its customers. FDA has been engaged with Physio for a long time over failures to maintain adequate manufacturing standards. The January 2007 order came only after months of attempts to get Physio to comply and to fix the problems with it's AEDs. People suffered from Physio's failures, and it has yet to admit even one mistake. Physio has seemingly used every technique it could think of to deter the implementation of regulations. The FDA is not famous for being on the cusp of concern for citizens who are affected by medical equipment failures. It only acts after situations become so egregious it cannot ignore them anymore. Physio has used its lawyers to delay, obfuscate, and pettifog the real issues: that Physio's manufacturing processes are flawed and that is has refused to fix them. Additionally, after the FDA stopped its shipments of AEDs to customers in the USA, it continued them to other countries who had not questioned its products. What does that say to you about the integrity of the company? It says to me that Physio is interested in money, not lives. It says to me that Physio's management is more interested in profits than it is in product quality. Now, that's just my personal opinion. I do not know the President of Physio. I probably wouldn't like him or her if I knew her or him. Maybe they'd surprise me, but I doubt it. So now it has been forced to enter into a consent judgment. People only do that then the government has got them by the balls. Physio is fighting for its life, but yet it cannot bring itself to overhaul its manufacturing processes, correct the culture of sales that has resulted in its promulgating lie after lie about the worth of its products, and take responsibility for the harm it has done. Go to its website and see what it says about all this. You'll be underwhelmed. There has to be a certain amount of trust in decisions to purchase medical hardware. Most of us are not electrical engineers, biomedical engineers, or anything but consumers dependent on what we're told by the vendors who sell us medical stuff. Ask your Physio rep for the facts. But take his responses with a grain of salt and QUESTION, QUESTION, QUESTION. If you are going to buy a monitor/defibrillator, it's incumbent upon you to search for the data on every product and make your decision based on all the available information. BTW, sales people are not all bad, but they tend to portray themselves and their products in the best possible light, and they attend courses to show them how to do that. It's up to you to ask them the hard questions about their products. It's up to you to know the questions to ask. It's not up to them to volunteer those questions and answers, although if they were ethical they would. But there is nothing in law that says that salesmen must be ethical. They can't commit outright fraud, but fraud is narrowly defined. So take what any salesman says with a grain of salt. Make them prove it and guarantee it. Learn to ask the hard questions and take no guff from somebody who is going to make a ton of money from your purchase of a piece of equipment. So if you're in the market for a monitor/defibrillator, consider what you're going to buy very carefully. GG > > The permanent injunction is the first step to clear the way for Physio to > restart manufacturing: > > Physio-Control agrees to revamp defibrillator quality control > > By Ãngel González > > Seattle Times business reporter > > Physio-Control said Monday it agreed with the U.S. Food and Drug > Administration on a plan to revamp its manufacturing quality-control > procedures to comply with federal regulations. > > The agreement was filed with the U.S. District Court in Seattle on Friday. > If approved by the court, it will set a course for the Redmond > medical-equipment maker to resume shipments of its external defibrillators. > > Physio-Control expects to comply with the terms of the consent decree within > its current fiscal quarter, which ends in July, or shortly after, said > spokeswoman Anne Devine. It can begin shipments once its final report on the > changes gets a nod from the FDA. > > " We already completed a lot of the things [regulators] were concerned > about, " Devine said. > > The agreement mandates that the company hire an independent expert to > evaluate Physio-Control' evaluate Physio-Control'<wbr>s procedures once a > recently completed, and there's " no requirement for one in the near future, " > Devine said. > > The company voluntarily suspended the U.S. distribution of its products in > January 2007, supplying only critical clients, after the FDA found > shortcomings in its quality-control procedures. The suspension prompted a > delay in a planned spinoff of the company from its corporate parent, > Medtronic, and led to layoffs. > > Physio-Control continued to ship defibrillators to foreign markets, which > accounted for about 40 percent of its pre-suspension revenue. But the accord > forces it to restrict those sales as well until it fully complies with the > FDA requests. > > " During the last year, we've made significant investments and improvements > to our quality systems and we are pleased to have a plan that formalizes the > path to resume full distribution, path to resume full distribution,<wb > Webster. " We have the right people in the organization to execute to the > plan and we are working with the FDA to expedite resumption of full > operations. " > > Physio-Control competes with a Seattle-based unit of Philips for the top > position in the external-defibrilla position in the external-defibril > failing heart back into action with an electrical charge. > > Ãngel González: or agonzalez@seattletiagonzal > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 3, 2008 Report Share Posted May 3, 2008 I would like to see a poll on our perfered cardiac monitors. Olney EMS = Zoll E Series-2 Perfer LP12 " Bledsoe, DO " wrote: The permanent injunction is the first step to clear the way for Physio to restart manufacturing: Physio-Control agrees to revamp defibrillator quality control By Ángel González Seattle Times business reporter Physio-Control said Monday it agreed with the U.S. Food and Drug Administration on a plan to revamp its manufacturing quality-control procedures to comply with federal regulations. The agreement was filed with the U.S. District Court in Seattle on Friday. If approved by the court, it will set a course for the Redmond medical-equipment maker to resume shipments of its external defibrillators. Physio-Control expects to comply with the terms of the consent decree within its current fiscal quarter, which ends in July, or shortly after, said spokeswoman Anne Devine. It can begin shipments once its final report on the changes gets a nod from the FDA. " We already completed a lot of the things [regulators] were concerned about, " Devine said. The agreement mandates that the company hire an independent expert to evaluate Physio-Control's procedures once a year. A third-party audit was recently completed, and there's " no requirement for one in the near future, " Devine said. The company voluntarily suspended the U.S. distribution of its products in January 2007, supplying only critical clients, after the FDA found shortcomings in its quality-control procedures. The suspension prompted a delay in a planned spinoff of the company from its corporate parent, Medtronic, and led to layoffs. Physio-Control continued to ship defibrillators to foreign markets, which accounted for about 40 percent of its pre-suspension revenue. But the accord forces it to restrict those sales as well until it fully complies with the FDA requests. " During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution, " said Physio-Control President Webster. " We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations. " Physio-Control competes with a Seattle-based unit of Philips for the top position in the external-defibrillator market. The devices can jolt a failing heart back into action with an electrical charge. Ángel González: or agonzalez@... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 4, 2008 Report Share Posted May 4, 2008 I look forward to them emerging from this issue and getting free from Medtronic...PC was slated to be let go on their own before this occurred...will be interesting to see what happens when the monitor/defib maker gets out from under the company that is more interested in other " profitable " product lines... Dudley Re: Physio I would like to see a poll on our perfered cardiac monitors. Olney EMS = Zoll E Series-2 Perfer LP12 " Bledsoe, DO " wrote: The permanent injunction is the first step to clear the way for Physio to restart manufacturing: Physio-Control agrees to revamp defibrillator quality control By Ãngel González Seattle Times business reporter Physio-Control said Monday it agreed with the U.S. Food and Drug Administration on a plan to revamp its manufacturing quality-control procedures to comply with federal regulations. The agreement was filed with the U.S. District Court in Seattle on Friday. If approved by the court, it will set a course for the Redmond medical-equipment maker to resume shipments of its external defibrillators. Physio-Control expects to comply with the terms of the consent decree within its current fiscal quarter, which ends in July, or shortly after, said spokeswoman Anne Devine. It can begin shipments once its final report on the changes gets a nod from the FDA. " We already completed a lot of the things [regulators] were concerned about, " Devine said. The agreement mandates that the company hire an independent expert to evaluate Physio-Control's procedures once a year. A third-party audit was recently completed, and there's " no requirement for one in the near future, " Devine said. The company voluntarily suspended the U.S. distribution of its products in January 2007, supplying only critical clients, after the FDA found shortcomings in its quality-control procedures. The suspension prompted a delay in a planned spinoff of the company from its corporate parent, Medtronic, and led to layoffs. Physio-Control continued to ship defibrillators to foreign markets, which accounted for about 40 percent of its pre-suspension revenue. But the accord forces it to restrict those sales as well until it fully complies with the FDA requests. " During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution, " said Physio-Control President Webster. " We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations. " Physio-Control competes with a Seattle-based unit of Philips for the top position in the external-defibrillator market. The devices can jolt a failing heart back into action with an electrical charge. Ãngel González: or agonzalez@... Quote Link to comment Share on other sites More sharing options...
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