The Food and Drug Administration (FDA) filed a court order against the large scale production and sale of Medtronic’s Synchromed II drug Infusion system. The order comes after several warnings by FDA regulators were made, noting that years’ worth of problems found within the Infusion Pump were left uncorrected.
The Synchromed II is an implantable Drug Infusion device that injects small doses of medication directly into the spine. It is used to treat patients with cancer, chronic pain, and severe muscle spasms. Five inspections at the company’s neuromodulation plant in Columbia Heights were carried out between 2006 and 2014, which resulted in Medtronic receiving three warning letters containing major violations under the Food, Drug, and Cosmetic Act.
The FDA cited Quality Control, failure to document design changes, and failure to meet product design specifications as the major reasons for ordering a halt in large-scale production of the device. Cases of battery power failure and injections with incorrect dosages were also reported.
The FDA’s Consent Decree was filed in the U.S. District Court of Minnesota, where it awaits the signature of a federal judge. A consent decree is a legal settlement that requires a company to agree to court-ordered actions without admitting fault or guilt.
According to Medtronic, the agreement allows the company to make the drug pumps available to physicians on a limited basis. Patients using the device were advised to refrain from having the devices removed, unless they were proven to be failing. The company has also announced that no new recalls or safety alerts will be made about the product.
Once the decree is approved, the FDA will be given the right to oversee design changes for the Synchromed pump and the company’s manufacturing quality control systems. Medtronic will also be required to hire an outside expert to validate the correction plans and submit regular audit reports on the new processes.
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