Obligation of operators and users to report in the event of suspected serious incidents involving medical devices

Medical device legislation regulates the safety of medical devices and the health protection of patients, users and third parties. To ensure that unexpected risks from medical devices are identified at an early stage, operators and users, in particular doctors and dentists, are obliged to report suspected serious incidents involving medical devices to the BfArM. This is intended to ensure that the Federal Institute for Drugs and Medical Devices (BfArM) is informed and can assess the incident. This ensures that manufacturers of medical devices react to such risks in good time and take measures to avert the risk of further incidents and improve product safety.

What is a suspected serious incident?

“An incident where it cannot be excluded that it is due to an undesirable side effect of a device, a malfunction, a deterioration in the characteristics or performance of a device, including errors in use due to ergonomic features or an inadequacy in the information provided by the manufacturer, and which has had or could have had, directly or indirectly, any of the following consequences:

1. the death of a patient, user or other person,

2. the temporary or permanent serious deterioration in the state of health of a patient
   condition of a patient, user or other person, or

3. a serious risk to public health.”

Reportable incidents are, for example

• Mechanical problems (e.g. breakage of electrodes, catheters, implants)

• Functional failures and lack of alarms (e.g. infusion pump stops due to a malfunction, but does not sound an alarm; ventilator does not sound an alarm)

• Electrical faults (e.g. short circuit, electric shock, power supply failure, premature battery fatigue)

• Deficiencies in labeling and instructions for use (e.g. missing warnings)

• (Potential) non-sterility/contamination (e.g. damaged sterile packaging)

• Software problems (e.g. computer tomography is not interrupted although scan stop function was used)

• Measurement errors (e.g. incorrect scaling on syringes)

When must be reported?

A suspected serious incident must be reported immediately by the operator, i.e. without culpable delay.
Who must be notified?
The report must be sent electronically to the Federal Institute for Drugs and Medical Devices (BfArM). The notification form can be found at:
http://www.bfarm.de -> Medical devices -> Report incident -> Notification by professional users, operators, distributors.

What happens to the medical device in question?

The medical device including accessories must be stored and, if necessary, labeled as contaminated until the risk assessment has been completed by the BfArM and, if necessary, the product has been examined by the manufacturer.

Procedural instructions

In order to be able to react immediately in the event of an incident, a procedural instruction should be drawn up in each facility. This should contain at least the person responsible, the reporting deadline, the Internet address of the BfArM and the regulations for storing the medical device/accessory in question.

Translation of Meldepflichten