The Food and Drug Administration recently notified executives at medical device manufacturer Medtronic that its efforts at rectifying significant issues within its diabetes business are falling short. “In summary,” the agency said, “your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training will prevent reoccurrence of the identified deficiencies.”
The letter comes as Medtronic was slapped with a Class I recall over its MiniMed insulin pumps. Over 320,000 of the devices were recalled after it was discovered that a faulty component within the pumps could cause them to either over- or under-deliver insulin to the wearer. The Class I recall is reserved for the agency’s most urgent matters where continued use of the device could cause serious injury or death. The MiniMed device has been blamed for at least one patient death and over 2,100 additional injuries.
Consumer advocates note that the letter, in conjunction with Medtronic’s spotty record when it comes to quality assurance and patient safety, is cause for concern. “In looking through this letter, I think this is on the very high level of serious, severe violations by Medtronic,” says Public Citizen director Dr. Michael Carome. “The violations, as described, would have put patients at risk for potential serious harm. The violations are very serious and what makes them the most concerning is a pattern that spans years and multiple violations over that period.”
The list of products recalled by Medtronic is significant. From heart catheters and insulin pumps to tracheostomy tubes and even defibrillator leads, few medical device manufacturing companies are as synonymous with recalls and aftermarket troubles as Medtronic. And now, with this latest letter, it appears that the company might not even be able to properly rectify a situation even after it has been brought to their attention.