Reporting Incidents in Europe (Part 1)

By Rene van de Zande

Rene van de Zande

The Medical Device Directive (93/42/EEC) has been mandatory since 1997 and stipulates that manufacturers have the legal obligation to report adverse events (Incidents and Near Incidents). Nine years later, according to European Competent Authorities, incident reporting is on the rise but is still at a level where underreporting is assumed to be widespread.

The issue of Incident Reporting remains a confusing subject for many manufacturers. What to report, what not to report, how to report—none have simple answers. This article, the first of two parts, will explain what types of Incidents and Near Incidents need to be reported to the European Competent Authorities, and which do not. While this two-part series will focus on regulations as they pertain to Europe, many of the same principles also apply to the Medical Device Reporting rules set forth by the FDA in 21 CFR Part 803 and 804.

To Report or Not to Report

Many manufacturers are reluctant to file Incident reports with Competent Authorities, as they may feel doing so is an implicit admission of guilt. But, in fact, the contrary is true. Filing an Incident Report is not a conclusion that the device caused or contributed to the Incident. In fact, your report should make a disclaimer noting this.

The overall purpose of the Incident Reporting process in Europe is not to allocate blame; it is to safeguard the public and prevent problems from (re-)occurring in the future. In Europe, companies are respected for reporting incidents, and this can be perceived as the mark of a responsible corporate citizen. Likewise, competent Authorities are more likely to take the viewpoint of trying to help the manufacturer fix a worrisome situation rather than ostracizing the company for perceived failure. The European system encourages manufacturers to take a more pro-active, rather than reactive, approach.   

Following are some triggers of incident and near-incident reports:

1. Failure of a device to perform its intended purpose, even though the manufacturer’s instructions were followed

2. A poor or inadequate design, or manufacturing of the device

3. Labeling or Instructions for Use that are unclear, poorly written or omit vital information needed to operate the device

4. A public health issue that becomes a large scale public concern (eg, AIDS, H5N1 bird flu)

5. New information that becomes available from testing, scientific research, etc

6. User error

Of these issues, user errors account for the vast majority of Reports. They, in turn, MIGHT have been caused by improper or poorly translated Labeling and Instructions for Use, but many users do not take the time to read the labeling enclosed, especially if they are repeat users. Therefore, it is crucial for the manufacturer to explicitly state the proper way to use the device as intended, as well as any precautions, warnings, etc.

What Needs to Be Reported?

Aside from the exceptions listed below, any Incident that leads to (or could have caused—that is, Near Incident) death or serious injury must be reported. It should also be noted that Incidents can include omissions of information. For example, if the manufacturer omits a critical step in the Instructions for Use, and failure to perform this step could lead to death or serious injury (even if it has not yet), that is considered a Near Incident and must be reported. One cannot simply reprint the IFU and hope nothing happens with those items already placed on the market.  

Sometimes, not enough information will immediately be available to decide whether an event is reportable. For example, perhaps a distributor calls you, the manufacturer, and says a hospital called to report a patient injury related to the use of your product. It is the manufacturer’s (or its Authorized Representative’s, depending on the contract!) responsibility to find out from the hospital the nature of the injury, how it occurred and so on.

The Competent Authority will not accept the argument that the manufacturer was unable to determine if the Incident was reportable because you could not reach an English-speaking person at the hospital in Greece, where the product was used. Enlist the support of your distributor or European Authorized Representative, if needed! You must make a reasonable effort to obtain additional information and do everything possible to retrieve the device.

In any case, you need to take into account the opinion of any healthcare provider that may have been involved, evidence of previous similar incidents and, of course, the results of your own preliminary assessment of the situation in determining whether reporting is needed.

What Does NOT Need to Be Reported?

The following occasions do not require you to report the problem to Competent Authorities:

1. Problems found by a user before the device is used on a patient, except if failure to make such an observation could have led to damage to the patient. This also means deficiencies that would always be detected by a user prior to use—for example, a missing connector on a catheter that would prevent its use.

2. Incidents caused by a patient or user. However, you must be able to prove that the device operated as intended and therefore did not cause the Incident or Near Incident (user error). However, if too many similar user errors happen, this should lead to a reappraisal of the risk analysis and perhaps to a reformulation of the label contents.

3. Expired shelf life or service life. If the Incident was caused because the device exceeded its serviceable life or shelf life,  and that limit was clearly specified, there is no need to report.

4. Malfunction protection worked as  planned. If your device has a built-in design feature that prevents a malfunction from becoming a hazard, and no death or serious inquiry resulted, you don’t need to report it (this is known as “single fault”).

5. Expected side effects stated in the labeling text. If your device may lead to expected and foreseen side effects and they are clearly noted to the user, you do not need to report incidents resulting from those side effects as long as the device functioned properly.

6. You have already issued an Advisory Notice. In most cases, you do not need to file individual reports but only need to provide summary reports as determined by the Competent Authority.

How Much Time Do You Have to Report?

In Europe, the general rule of thumb is that you have 10 calendar days to file an Initial Report to the Competent Authority for an Incident that involves death or serious injury. Near Incidents need to be filed within 30 calendar days.

The clock starts ticking the day the manufacturer or his AR (not the distributor) receives notice of the Incident or Near Incident, even if that happens to be on Friday afternoon at 2 p.m. By Monday morning, you’re already on Day 4 and it’s 4 p.m. in Europe. Act fast.

But let’s not forget: If the product caused death or serious injury, it becomes a  moral obligation to report it IMMEDIATELY so no further harm comes to others, if possible. You are also required to submit a final report to the Competent Authority within 30 days of the initial report submission. If a product is privately labeled by an OEM, the manufacturer is considered the manufacturer and responsible for Incident reporting.  

What Happens If You Do Not Report?

Member States of the European Union have different criminal regimens in place for manufacturers that violate the reporting time limits, or intentionally underreport. Contrary to the United States, financial penalties are severe, and France, Germany and the United Kingdom have given jail sentences to repeat or serious first time offenders.

The next article (in the July/August issue of Medical Product Outsourcing) will walk you through procedures you should have in place for Incident Reporting, how to communicate them to Distributors and your European Authorized Representative, dealing with recalls and preventing future incidents. In addition, the demarcations of responsibilities between these parties with regard to Reporting requirements compliance will be addressed.

To see dozens of real-life examples of reportable and non-reportable incidents, refer to European Guidance Document MEDEV 2.12-4, which can be found on-line at www.europa.eu or by e-mailing me at the address below.

Rene van de Zande is president and CEO of Emergo Group, a consulting firm that provides quality assurance, regulatory affairs and distribution services. Emergo Group has offices in the US, Europe, Canada and Australia. Rene can be reached at [email protected].