Understanding the Medical Device Reporting Regulations

Understanding the Medical Device Reporting Regulations

April 11th, 2013 // 10:53 pm @

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April 11, 2013

Back in 2003, Endovascular Technologies, which made medical devices to treat some types of aortic aneurysms, pled guilty in federal district court to a shocking 10 felonies. The firm agreed to pay a staggering $92 million to settle both criminal and civil charges.

Nine out of 10 of these charges were related to the firm’s failure to report almost 2,000 AERs (adverse events) to FDA. This blockbuster case is a great example of the possible consequences if you do not comply with FDA’s MDR (Medical Device Reporting) regulation – 21 CFR Part 803. This regulation requires medical device firms to report to the agency any deaths or serious injuries with their products.

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FDA has stated in the past that the purpose of the MDR regulation is to give signals to FDA and the company that a medical device may have a potential safety problem, and that a corrective action may be needed to protect the public from harm.

FDA puts a good deal of its enforcement attention on complying with regulations on MDRs. In 2004 about 25% of all warning letters from Center for Devices included MDR violations. So, it is very important that all medical device companies understand their MDR responsibilities.

The Regulation Up Close

FDA mandates that you report AERs if the event in question meets the precise definition of an MDR-reportable event. However, this gets us quickly into murky waters. FDA’s definition is quite complicated and is very open to interpretation. FDA defines an MDR-reportable event as:

“An event about which the manufacturer or importer has received information that reasonably suggests that one of their devices may have caused a death or serious injury; or has malfunctioned…and may cause or contribute to a death or serious injury if the malfunction recurs.”

This definition sounds clear, no? Well, actually….the definition raises vital questions. When exactly does a manufacturer ‘become aware’ of an MDR? What exactly does it mean for a medical device to ’cause or contribute’ to a serious injury, or death? What is a serious injury? What is a malfunction? The regulation has definitions of each one of these items. But FDA’s meaning will often differ from how someone in industry would define each one. Let’s try to tease out the meaning for each one:

  • Become aware. Manufacturers will frequently miss an MDR deadline because they do not understand what ‘become aware’ means. In generally, you will be considered by FDA to have become aware of an MDR-reportable event when any employee in your company is aware of it. MDRs are usually due to the agency within 30 days of your firm ‘becoming aware.’ So, the clock on your response starts to tick as soon as someone becomes aware in your company of the event, NOT when regulatory finds out. This shows just how vital it is that all personnel be trained on the principles of MDRs and make sure they understand how important it is to send potential MDR-reportable information to regulatory to get it analyzed.
  • Caused or contributed. This means that a death/serious injury was, or may have been caused by a device. Or that the device could have been a factor in the death/serious injury. The FDA reg lists device failure, improper function, manufacture, bad design, user error and poor labeling as examples of what may cause a device to cause or contribute to a death/serious injury. Manufacturers often overlook the importance of analyzing the ‘contributed’ part of ’caused or contributed.’ So, the company may decide that the event is NOT reportable because the device didn’t directly contribute to the injury. But the information may reasonable suggest that the medical device MAY have been a factor. So the event is reportable. For instance, a device that failed right out of the box and was never used COULD contribute to the death or serious injury of a patient, IF the delay in trying to find a device that worked right was in part the cause for the AER.
  • Serious injury. We think of a serious injury as being badly hurt, and the FDA definition is like this, but it adds more to it. The MDR reg states that a serious injury is one that is life threatening, results in permanent impairment of a body function or body structure, and makes necessary medical/surgical intervention. Companies often neglect the latter aspect and focus on if the patient died or was injured. However, remember that MDR requires you to report if there was a medical/surgical intervention to prevent death/serious injury.
  • Malfunction. FDA states a device malfunctioned if it did not meet performance specs or otherwise did not perform as intended. Note that performance specs include not just technical operating specs, but all the claims made on the product label.

In our next article on MDRs, we’ll discuss how to set up your MDR system and how to avoid the common MDR landmines. For example, we will detail the importance of having a strong complaint-handling system.

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