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How to handle medical device vigilance cases with European competent authorities.

The European Commission's MED-DEV 2.12/1, which is a guidance document that covers the Medical Devices Vigilance System, describes how a manufacturer should communicate with competent authorities about vigilance cases--which are triggered when there is an incident with a device. A competent authority is a body with authority to act on behalf of the member state government to ensure that member state government transposes requirements of medical device directives into national law and applies them. This particular MEDDEV provides a Manufacturer Incident Report. While this document may look as if there is not much freedom in how to report, there is. And manufacturers should try to make good use of this. As an inspector of medical technology at the Dutch Healthcare In spectorate, I saw many reports. It probably doesn't come as a surprise, but there were big differences in reports--even when the Manufacturer Incident Report was used--and those differences could affect how cases were handled.

This column will share five secrets about how competent authorities typically handle vigilance cases, and how you can improve the way your cases are handled.

Remember, however, that this is not a guide for how to mislead a competent authority. On the contrary, this is a guide on how to make sure you are clearly understood when you report an incident.

First Secret

Competent authority staff behave just like normal people. Brace yourself. This may come as a surprise: Competent authorities are manned by normal people. Their behavior will not differ significantly from your own. And what's more, the working population at the competent authority probably will be quite similar to yours. That means you will have to take into account that your report will be read by an "average" staff member who often is junior level. Even worse, if your report ends up in the hands of senior staff, or even the head of the organization, that will usually mean bad news. That junior staff member most likely will not fully appreciate the subtle wordings of a senior legal consultant. And if your report is not fully understood, it may not be handled correctly.

Second Secret

They have no idea about your device. Another surprise to you may be that most competent authorities have no idea what your device is about. That is not due to lack of expertise or interest, but to the fact that there are thousands of different devices out there, and most competent authorities simply don't have the manpower to go into details about all of the devices that are distributed under their responsibility. They only will do that when needed. Under normal circumstances, it is not always a good thing if a competent authority spends time looking into your device. That means when you write your report, you should make sure you are clear about your device.

It won't hurt if you describe the intended use of your device clearly in your incident report by answering the following questions:

* What does your device do?

* How does it work?

* What is the patient population?

* Who is the intended user?

* What are the criteria for use?

* What are the criteria for exclusion?

* What are the start and stop criteria?

* What are the specific risks?

In some reports, the box for Class IIa was ticked, so my first guess was that these were invasive devices targeting natural orifices. But into which orifice should the devices be inserted? Sometimes the answer to such a question means the difference between a low risk, standard case and a case that would demand immediate attention. So, be clear about the nature of your device, even if it seems to be extremely evident to you. You will help the competent authority staff member who does the first selection immensely.

Third Secret

Not all cases get the same priority. Typically, manufacturers are expected to deal with vigilance cases. The compulsory reporting according to the MEDDEV only is done to give competent authorities an opportunity to see if manufacturers take this responsibility. If a case is considered serious, competent authorities may want to act independently from the manufacturer. That means incoming reports get priority, and most of the time that will be a low priority. Again, if your report gets high priority, this usually means bad news. The only thing worse would be a situation where your report is considered to be low risk, while it should have been high risk. The competent authority may get the idea you didn't inform well. I can strongly recommend avoiding such a situation. It is important for manufacturers to understand the importance that the competent authority gives the right priority to your report as soon as possible.

Fourth Secret

On every desk there are three piles. Competent authority staff handling vigilance cases typically will use a system with three piles of work on their desk. On one side there is a small stack of cases. These are the complex, high-risk cases, often handled by senior staff.

On the other side there is a higher pile with low-risk, easy cases. These cases mainly will be handled by junior staff and handled by the manufacturer. These cases are just waiting for the final incident report. If enough boxes have been ticked, the cases will be closed and filed.

Finally, there is the pile in the middle. These are the cases in which the level of risk is unclear. Although most of these cases are expected to be low risk, each one needs good risk assessment and careful consideration to make that determination. Such cases often demand a lot of communication to and from the manufacturer to make clear what exactly the risk is. Sometimes several letters and emails are used at this stage, compared to the actual handling of the case. All time and energy spent on these cases is only spent to get the cases in the correct pile. Therefore, it is strongly recommended that you make sure your competent authority has all the information to make a good risk assessment of your case.

Fifth Secret

There is room for extra information. The formal Manufacturer Incident Report doesn't leave much room for extra information. The form is designed in such a way that all the information automatically can be uploaded into a database. This makes the incident report form a difficult piece of reading. You can try to make the answers you supply on the form clear and easy to understand, but the effect of this is quite limited. There is another option to add extra information, however. The incident report form is always sent by email to the competent authority. You have enough room in this email to include a comprehensive summary. Here you can help the junior member of staff understand the nature of your device as well as the incident you are reporting. Here you can summarize all that important information scattered all over the incident report form. And if you think that your case is a high-risk or complicated case, this is the moment to mention your worries.

Vigilance cases take up a lot of time for competent authorities, mainly because manufacturers' devices are not completely understood by competent authority staff. Being clear about the nature of your device and your reported event helps a lot. Don't hesitate to use all the room available to add extra information or to summarize.

Ronald Boumans is senior global regulatory consultant at Emergo Group. He previously served as Inspector for medical technology at the Dutch Healthcare Inspectorate.
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Title Annotation:Regulatory Perspectives
Author:Boumans, Ronald
Publication:Orthopedic Design & Technology
Date:Jan 1, 2014
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