Accidents relating to permanently installed medical devices
If a medical device permanently installed in the patient in a healthcare unit is not as safe as it can be expected to be and causes a personal injury to its carrier, the injured party can be compensated under the Patient Insurance Act. The time when the device was released on the market, the foreseeable level of use of the device and other factors are considered when assessing the device’s safety.
The device must be installed on or after 1 January 2021.
For the injured party to be eligible for compensation, the device must have been installed on 1 January 2021 or after. Compensation for defects and issues with safety for devices installed before this date should be sought from the manufacturer in accordance with the Product Liability Act.
Medical devices installed permanently
The most common medical devices that are installed permanently in the patient are artificial joints, pacemakers, materials used to fix bone fractures, and different kinds of implants. The devices are installed in a patient with a surgical procedure or by another medical method, and they are intended to be left in place permanently or for a longer period after the procedure. A device is permanently installed if part of it is external to the body or when some part of it can be replaced if necessary by undergoing a new procedure. This includes, for example, a device that releases medicine in the person’s body.
The Act does not apply to medical devices intended for short-term use or that are easily detachable. Such devices include removable or dissolvable materials used to close wounds, external hearing devices, teeth alignment devices, or removable dental prostheses, prosthetic limbs or orthopaedic supports.
The device is not safe
Medical devices must be safe. They must be suitable for their intended purpose and, if used properly, they must achieve their planned functionality and level of performance. If a device does not meet these requirements and the use of the device causes a personal injury, compensation can be obtained from patient insurance.
The device is not safe if it clearly falls short of its intended service life. When assessing the service life, the patient’s state of health and other characteristics as well as the expected level use for the device are considered. For example, the service life of a very active person’s joint prosthetic may be shorter than the service life of a similar joint prosthetic installed in a less active person.
A device is not defective on the grounds that a device with better features enters the market after the device’s installation.
The final compensation liability remains with the manufacturer of the device
Patient insurance is used to pay compensation for personal injuries caused by a device that is defective in terms of safety. The compensation is not intended to be ultimately covered by patient insurance and healthcare services. The Patient Insurance Centre has the right to claim the compensation paid for the device malfunctions from the manufacturer, importer or marketer of the device.