Setting Up Your Bulletproof MDR File, and How to Avoid Landmines

Setting Up Your Bulletproof MDR File, and How to Avoid Landmines

April 12th, 2013 // 8:27 pm @

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As we noted in our earlier article, medical device firms usually have to report an MDR event within 30 days of ‘becoming aware’ of it (remember – this means 30 days from the FIRST knowledge it occurred by any employee of the company). However, manufacturers need to report the event within FIVE workdays if remedial action is urgently needed to prevent serious risk to public health, or if FDA asks in writing that a 5 day report is submitted for the event.

You also will need to send in FDA Form 3417 the first time you send in an MDR for a new device model/family. The baseline report gives basic information about the device and will need to be updated each year if there are any changes in baseline device information.

Your MDR files need to be maintained in your MDR event files. Your event files need to have documentation of your firm’s decision making about the reportability of the event in question. The files have to include MDR form copies and all information related to anything submitted to FDA. You can keep MDR event files as part of your complaint files.

LANDMINE – A very important and often ignored part of the MDR regulations is the mandate that all device firms follow written MDR procedures. You need to have a system for IDing events that might be MDR reportable events. Procedures must also exist for a standard review process to determine if an event has to be reported, and to make sure all MDRs are sent to FDA within required timelines. FDA OFTEN cites companies for failing to have written MDR procedures in place.

How to Avoid Common MDR Problems and Landmines – 21 CFR 803

As we have seen in the Endovascular Technology case, not reporting MDR events properly can be a total disaster. We find that most noncompliance with these MDR regs is due to failures with complaint handling (21 CFR 803), improper MDR procedures, poor documentation of the process for making MDR decisions, and poor training for personnel on MDR.

  • Complaint Handling. Your complaint handling is the main way your company will document if an event is MDR reportable. The FDA complaint file regulations require that complaints are reviewed and evaluated to see if the events are reportable. FDA notes that a common problem is that firms do not investigate complaints enough to see if they should be reported. It is very important that you complaint handling employees are trained to do complete investigations.
  • Assume Errors and Malfunctions Will Repeat. FDA mandates that an event be reported if the device could cause serious injury or death IF the event were repeated. A very common landmine is to determine an MDR event is not reportable because it is not likely to recur. But if you assess the likelihood that the event will recur, you are not really following the regulation! The reg tells us to assume that the malfunction WILL happen again, and to see if the malfunction could cause death or serious injury.
  • Do Not Dismiss Human Error. A common 483 observation is a company not reporting an event because the death/serious injury was caused by clinician error. But the regulation states that events are reportable that are due to user error. Your product may need better labeling and instructions.
  • Be Very Consistent. A common FDA observation on a warning letter is when a company is not consistent in reporting all adverse events. If your device malfunctioned 20 times and you reported only 10 MDRs, FDA is going to dig deeper. You need to report all serious injuries or deaths. A good idea is to have a summary log of all related events that have happened that were and were not reported.

Filling Out the MDR Report – Form FDA-3500A

Both 30 day and 5 day FDA MDR report forms are available. Make sure that you follow the instructions in detail, as noted in FDA’s Instructions for Completing the MedWatch Form 3500A. You should fill out all MedWatch forms with fact based language that does not speculate. Remember that while submitting the report does not constitute any admission that anyone or thing cause the event, you still should not make unneeded, speculative admissions of guilt on this form.

Last note – do not say on the form that remedial action was taken if you didn’t take it. This is a common mistake in Section H7.

Note that we will have a good Webinar on the topic of complaint handling and MDR reporting in late May. We’ll update you with the details once we have the date in place.

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