<span id="midArticle_start"/>(Adds details of consent decree, background)
<span id="midArticle_0"/>April 27 (Reuters) - Medtronic Plc has agreed toresolve U.S. regulators' allegations it violated qualitystandards for making its SynchroMed implantable drug pump, whichdelivers medications to cancer patients and others with chronicpain.
<span id="midArticle_1"/>Medtronic failed to correct problems that could lead to apatient receiving too much or too little medication, the U.S.Department of Justice said in a statement on Monday.
<span id="midArticle_2"/>The medical device maker and two top executives agreed toterms of a consent decree with the U.S. Food and DrugAdministration requiring changes to the product's manufacturingprocess, the DOJ said. The agreement includes Medtronic ChiefExecutive Omar Ishrak and Thomas Tefft, head of theneuromodulation division that makes the pumps.
<span id="midArticle_3"/>Medtronic, the world's largest standalone medical devicemaker, has agreed to stop manufacturing and distributing theSynchroMed pumps except in extraordinary cases where a physiciancertifies the product is medically necessary for treatment.
<span id="midArticle_4"/>The proposed consent decree also requires Medtronic toretain an expert to help the company correct the regulatoryviolations.
<span id="midArticle_5"/>Medtronic said it is focused on implementing design changesto the pump and improving its neuromodulation quality system. The implanted pump sends pain medication directly to the fluidaround the spinal cord.
<span id="midArticle_6"/>The company said it is not required to retrieve any productscurrently in use, and patients using the system do not need tochange their course of therapy or have the pump removed.
<span id="midArticle_7"/>The problems were uncovered between 2006 and 2013 during FDAinspections at the company's Columbia Heights, Minnesota,manufacturing plant, the DOJ said. Among the violations wereproblems involving design controls and complaint handling.
<span id="midArticle_8"/>The DOJ filed a complaint and the consent decree in U.S.district court in Minnesota, which must approve the agreement. (Reporting by Susan Kelly in Chicago; Editing by Ted Botha)
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<span id="midArticle_0"/>April 27 (Reuters) - Medtronic Plc has agreed toresolve U.S. regulators' allegations it violated qualitystandards for making its SynchroMed implantable drug pump, whichdelivers medications to cancer patients and others with chronicpain.
<span id="midArticle_1"/>Medtronic failed to correct problems that could lead to apatient receiving too much or too little medication, the U.S.Department of Justice said in a statement on Monday.
<span id="midArticle_2"/>The medical device maker and two top executives agreed toterms of a consent decree with the U.S. Food and DrugAdministration requiring changes to the product's manufacturingprocess, the DOJ said. The agreement includes Medtronic ChiefExecutive Omar Ishrak and Thomas Tefft, head of theneuromodulation division that makes the pumps.
<span id="midArticle_3"/>Medtronic, the world's largest standalone medical devicemaker, has agreed to stop manufacturing and distributing theSynchroMed pumps except in extraordinary cases where a physiciancertifies the product is medically necessary for treatment.
<span id="midArticle_4"/>The proposed consent decree also requires Medtronic toretain an expert to help the company correct the regulatoryviolations.
<span id="midArticle_5"/>Medtronic said it is focused on implementing design changesto the pump and improving its neuromodulation quality system. The implanted pump sends pain medication directly to the fluidaround the spinal cord.
<span id="midArticle_6"/>The company said it is not required to retrieve any productscurrently in use, and patients using the system do not need tochange their course of therapy or have the pump removed.
<span id="midArticle_7"/>The problems were uncovered between 2006 and 2013 during FDAinspections at the company's Columbia Heights, Minnesota,manufacturing plant, the DOJ said. Among the violations wereproblems involving design controls and complaint handling.
<span id="midArticle_8"/>The DOJ filed a complaint and the consent decree in U.S.district court in Minnesota, which must approve the agreement. (Reporting by Susan Kelly in Chicago; Editing by Ted Botha)
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