The purpose of MDR reporting is to provide a means to collect data that may indicate the presence of a safety problem. MDR reporting can be confusing and it is certainly an area where mistakes are abundant. Some mistakes however will garner more scrutiny from the FDA. In extreme instances incorrect reporting or lack of appropriate reporting can lead to criminal charges.
Throw a Wide Net
Incorrect data collection is a result of a larger failure of the post market surveillance system. Complaint handling procedures are an obvious source but companies should also gather data from studies utilizing their device, published papers, users groups or customer surveys. The service organization is another source of data which needs to be reviewed and trended.
Any outsourcing should be governed by quality agreements which include a clear provision for reporting responsibilities. This is especially true if complaint handling is outsourced. The level of training and the background of the individuals receiving the information needs to be tightly controlled. This becomes more difficult if they aren’t your employees.
Other Dangers
Inadequate investigations are another area where companies struggle. Procedures need to be clearly defined. Companies must demonstrate that issues are investigated and trended in a similar fashion each time. Timeliness is key as the deadline for reporting looms. Predefined questions are useful to gather the appropriate information in a reproducible manner. Investigations should not languish with little to no activity documented. The final investigation should tell the entire story and make it clear for an auditor to follow.
Medical affairs should be included on the review of some incidents to determine reportability. It depends on the nature of the complaint and the training and background of the individuals gathering and interpreting the complaint.
Some events will require CAPA or some kind of field activity. It is important to scope the CAPA correctly and completely implement the solution. This is followed by effectiveness monitoring through trending activities. This ensures a closed loop system.
Documentation
Looking at the appropriate measures of the MDR system is important. It is one thing to say that MDRs were filed on time it is another to say whether they were accurate, well investigated and documented. Any abnormalities should be reported back to the complaint handling unit as possible improvement opportunities. The records and forms should be filled out in a manner that demonstrates consistency in the investigation and the decision making process. It is harder to explain when you have six of the same issue - why only three were reported. Finally, the details in the MDR should be consistent with the original complaint.
Making Ends Meet
The importance of accurate MDR reporting cannot be underestimated. Cutting corners here can lead to the need for arduous look-backs and many late MDRs filed. Issues with non-compliance are usually due to inadequate complaint and MDR procedures. It also follows that inadequate training is a contributing factor. The complaint handling system is the main portal to collect potential reportable events but all post market surveillance procedures must be comprehensive enough to maintain a robust, reproducible system.