Reusable medical devices that are being used several times must be reprocessed correctly. The reprocessing of medical devices comprises in particular cleaning, disinfection, functional testing, packaging, sterilisation and storage. Laws, standards and recommendations establish the requirements for correct reprocessing. Manufacturers of medical devices are obliged to provide precise instructions for reprocessing (see following section on "Manufacturers/Users"). Since the recommendations for correct reprocessing differ according to the area of use in question, two separate sections below provide information for small and medium-sized facilities such as medical or dental practices (see section on "Processing in medical and dental practices") and large facilities such as hospitals and clinics (see section on "Hospitals").
Manufacturers of reusable medical devices must provide users with the information they need to perform correct sterilisation. The following document is based on standard EN ISO 17664. It provides manufacturers and users with a checklist that they can use to verify whether the manufacturer's information satisfies the requirements of the standard.
Reprocessing in medical and dental practices and by other users
The following document describes the practical measures for reprocessing medical devices in accordance with current legal provisions and the state of the art in science and technology. It is intended for users such as general practitioners, dentists, doctors who perform outpatient surgical procedures, but also at podiatrists, providers of care outside hospitals, convalescent facilities, etc.
During sterilisation cycles, various checks must be performed for each batch. These must be documented, and the documentation must be filed. A template that can be used for batch release and for the corresponding section of the documentation is provided below.
The following guide describes the key criteria for procuring a small steam steriliser for use in medical or dental practices, for example.
A checklist that makes it easier to determine requirements when procuring a steam steriliser is also available:
The new, completely revised “Good practice for the reprocessing of medical devices for Swiss health facilities”, version 2016 is available online (in German, French and Italian). This document replaces, with immediate effect, the version of 2005. This document has to be considered as a directive for the reprocessing of medical devices in health facilities, such as hospitals, clinics, group practices, outpatient clinics or emergency services, care home, etc. Not only does it apply to the central sterilization services, but also for all areas where medical devices are reprocessed (operating theatres, nursing services, etc.).
Since sterilisation is a procedure whose efficacy cannot be confirmed by checking or inspecting the sterilised devices, sterilisation procedures must be validated beforehand. Furthermore, routine performance checks must be carried out and the equipment must be kept in good repair.
Swissmedic has repeatedly been asked who is permitted to validate sterilisation in a facility. The following document provides information on the subject:
Swissmedic is not responsible for questions concerning the transport by road of medical devices that are possibly contaminated. The Federal Roads Office (FEDRO) is responsible for such questions.
Manufacturers, distributors or hospitals can loan specific medical devices for specific surgical procedures. In such cases, problems can arise in connection with the reprocessing of the loaned instruments. Recommendations can be found in the following document: