Uncritical, semi-critical and critical medical devices
In some countries, such as Germany, medical devices fall into so-called risk categories:
- “Non-critical” medical devices include those that are in contact with unbroken skin only (e.g. ECG electrodes). There are no enhanced requirements for reprocessors.
- “Semi-critical” medical devices are those that have been in contact with mucous membranes or pathologically affected skin. Reprocessors have to comply with enhanced requirements (e.g. the use of a special machine).
- “Critical” medical devices comprise those in contact with blood, blood tissue or organs and other sterile medicinal products that permeate the skin or mucous membrane. When reprocessing those medical devices, enhanced requirements can include the special training of personnel or even the certification of the quality management system by a notified body.
