Reporting system for incidents with medical devices

Updated 07 February 2019

The reporting system makes it possible to detect errors, failure and defects in medical devices and systematically ensure that they are corrected in all the places where the device is used.

We administer the legislation governing medical devices, including the reporting system for incidents with medical devices. 

We receive incident reports from:

  • Danish users and healthcare professionals
  • Manufacturers (Danish and foreign)
  • Foreign authorities.

Reports from Danish users are based on serious incidents and accidents involving use of medical devices.

Manufacturers report serious incidents involving the use of devices in Denmark. In addition, they inform us of any preventive measures taken to avoid similar incidents, e.g. withdrawal or improvement of a product.

Reports from foreign authorities concern any preventive measures most often taken as a result of serious incidents. The purpose of these measures is to prevent similar incidents and thus improve patient safety.

The exchange of information between authorities ensures that the preventive measures are taken where the devices are marketed and not only in the country where the incident took place.

Incidents and accidents with medical devices

The safety and performance of medical devices have great and direct impact on patient safety. Errors, failure and defects in medical devices may have serious consequences for patients and healthcare professionals.

When we receive an incident report, we must make sure that the manufacturer investigates the reason for the incident and makes any required technical investigations of the device. The investigation can detect any defects in the performance and safety of the device. We make sure that the required changes of the product are implemented and that products are withdrawn from the market, if necessary. The users of the device are warned or informed of important product information.

Consequently, the reporting system is a constructive cooperation between the Danish Medicines Agency, the users and the manufacturer of the device. The aim is to improve product and patient safety.

Our national reporting system forms part of a European surveillance cooperation, which means that we can build comprehensive knowledge of product safety and measures that may also have an impact on Danish users.

We receive and investigate incidents with medical devices

Each individual serious incident report is investigated as soon as possible in collaboration between the Danish Medicines Agency, the manufacturer of the product and the user who experienced the incident. In many of these cases, the manufacturer is aware of the incident and is investigating the possible technical causes. If this is not the case, we will ask the manufacturer to start the investigation and obtain further details from the user.

As part of the investigation, the need for any preventive measures is considered. There may be a need for improving the safety of the device, the design of the device, the production method or for clarification of the instructions for use.

We decide on any required preventive measures

Information from healthcare professionals, manufacturers and other European countries is obtained so that we can discover errors and defects in a specific product. Knowledge of incidents in other European countries gives us a possibility to ensure that the required safety measures are also taken in Denmark.

In addition, the reporting system helps us compare the frequency of a type of incident, nationally and in Europe, with the number of products in the market. Based on this information and the seriousness of the incident, we can decide on any required actions.

We implement the required measures

Information aimed at those who use the device secures the most efficient implementation of required measures. The manufacturer provides information on the placement and number of products marketed. Consequently, we can act on the manufacturer's information about the product and make sure that the required measures are implemented by all those who use the affected device.

The Danish Medicines Agency publishes field safety notices (in Danish only) from manufacturers of medical devices. The notices communicate information about correct use, the need for modification, or instructions to dispose of or return medical devices.

Here are some examples of measures that may be required as a result of a reported incident. Usually, the manufacturer implements the measures in practice:

  1. The device is withdrawn due to a production error, e.g. a packaging process that led to leaking sealing of the bags for sterile hypodermic needles. The manufacturer sends an explanation of the withdrawal and instructions to all users and the Danish Medicines Agency. Finally, the manufacturer sends an account to the Danish Medicines Agency of the number of products delivered and the number of products that have been returned.
  2. The incident is caused by a poor construction of the wheels on a wheelchair, which implies that the wheels break easily. The manufacturer changes the design and sends new wheels for replacement on all wheelchairs. The manufacturer sends a report to the Danish Medicines Agency, which supervises that the required changes are implemented.
  3. The incident indicates incorrect use of the device, a user error, but the investigation shows that the instructions for use are insufficient. The manufacturer makes an improved version of the instructions for use and sends this version to all those who use the device. The manufacturer may also include supplementary notes to the instructions for use to specify how to use the device correctly.

Incidents with medical devices must also be reported to the Danish Patient Safety Database of the Danish Patient Safety Authority

Healthcare professionals who experience an error related to a medical device must report it as an incident to the Danish Patient Safety Database. This includes any errors occurring in connection with surgery, prescription or other processes related to a medical device.

Patients and relatives can also report incidents to the Danish Patient Safety Database. The reported incidents are used to enhance learning in the health service to prevent incidents from happening to someone else.

Why do I have to submit two reports?

You must report the incident to both the Danish Medicines Agency and the Danish Patient Safety Database. The reports to the Danish Medicines Agency are important for our monitoring of medical devices, and we can respond immediately to submitted reports, for example by involving manufacturers.

The reporting of incidents to the Danish Patient Safety Database is to ensure the health service learns from the errors being made. The incidents are firstly used for local learning at the place they occurred. They are then depersonalised and reported to the Danish Patient Safety Authority where they are used to enhance learning throughout the health service.

Guidelines

Read more about the reporting requirements and which incidents to report:

Guidelines on manufacturers' reporting of incidents with medical devices (in Danish)

Guidelines on healthcare professionals' and users' reporting of incidents with medical devices

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