The whole idea of having to notify a government agency when you have an adverse report involving your device can leave a particularly unpleasant aftertaste. And each time you have to make the decision  to do it, it doesn’t seem to get any easier.

The Medical Device Reporting regulations went into effect in 1984 when the FDA realized that they might not learn of a death or serious injury associated with a medical device for up to two years or the time between inspections. There were no requirements for a company to have to notify the agency of a death or serious injury involving their device and if there was such an incident the day after an inspection ended, the FDA may not learn about it until their next visit.

The FDA felt they could not truly protect the public from possible death or serious injury if they did not know what was happening, at the time it was happening, in the field. So Congress gave the FDA the MDR regulations.

The last 15 years there have seen a lot of changes concerning the MDR regulations, the most recent change coming in 1997 with the issuance of the revised GMP (QSR) regulations.

Initially, the FDA had to determine what was important about the MDR regulations and what they should expect concerning the reporting of incidents. Most companies made a minimum number of reports fearing that notifying the agency of a death or serious injury could lead to a host of lawsuits. Companies did not want to air their "dirty laundry" in public; MDR reports were fair game under the Freedom of Information regulations. What great propaganda for your competitor to know that your device, which you claimed to be safe and to meet specifications and to be better than theirs, was now involved in a death.

From everything I can determine, companies have not experienced any additional lawsuits from reporting MDRs, but you can be sure that the MDR reports were used against them by the competition.

The FDA has made changes in the MDR requirements. The new QSR that was released in June 1997 made mention to the MDR reports. So, now MDRs are a "GMP" requirement and this makes them a legitimate FDA483 point (though the FDA has been reporting the lack of or incorrect MDR reports on 483 for years).

The FDA is expecting all reports to be made on the FDA Medical Device Experience Reporting form FDA. The time frame for reporting a death or serious injury or malfunction is 30 days from receiving the report. If you take a remedial action as a result of the event report, i.e. recall, you have 5 days to report.

Also, if the FDA has made a special notice concerning a particular product you would have 5 days to report any event involving that device.

So now you get a report of an incident of a death associated with the use of your device. What are you supposed to do? First of all you should follow your company’s quality system requirements concerning dealing with complaints and especially deaths. Usually that includes notifying the president of the company and for most companies the insurance carrier.

This situation is always serious, risking grave consequences if not handled correctly. You must get all the necessary information available concerning the incident, so that you can conduct a complete investigation. If you can show that your device was not the one involved in the death, then you will not have to report this incident to the FDA via the MDR requirements. But, you must be able to document your completion of a comprehensive investigation including the recording of any evidence you are able to uncover, that led to your making this determination.

While it is hard enough to report an isolated incident, try to visualize a situation where you have had several deaths or serious injuries reported close to each other.   Imagine if you could determine that these deaths or injuries could be traced to a specific lot of product or batch. What is the ramification for notifying the agency? First of all you have 30 days to report the initial report if that was your only reported incident. But, as you become aware of other incidents and you now decide to recall the product this now becomes a 5-day report.

mdi was involved with such a case recently. The company had 4 deaths and several serious injuries reported over a two-week period. The company decided to recall the product and notify the FDA of their intent. The company then made a 5-day report.

This seemed very much in order until the FDA conducted their follow up investigation as to both the root cause of this problem and into the company’s time frame in doing their investigations, making the MDR and deciding to recall the product. You must, let me repeat, must make sure that all complaints and subsequent investigations are fully documented. It is essential that you have complete justification for each decision, especially when such tragedies occur.

The FDA will determine whether the company took the correct actions in the appropriate time frames to ensure that no other deaths or serious injuries could occur. The FDA can make a case of negligence if they find that the quality system was not followed and that decisions were made to the detriment of the public for the sake of the product and profit. You must be very careful with how these things are handled.