Maintenance / reconditioning

Maintenance

Anyone who uses medical devices commercially or for third parties must take all maintenance measures necessary to maintain the performance and safety of the medical device (Art. 49 TPA). The term "maintenance" includes measures such as servicing, software updates, inspection, repair, preparation for reuse, to maintain or restore the functional condition of a device.

The specialist using the device must ensure that maintenance and the associated tests are carried out in accordance with the regulations (Art. 71 MedDO). Maintenance must be carried out in accordance with the principles of a quality management system, must be appropriately organized and documented and is based in particular on

a. in accordance with the manufacturer's instructions;

b. according to the risk inherent in the device and its use.

For devices with a measuring function, test procedures may be provided for in accordance with the Ordinance on Measuring Instruments.

Reprocessing

Medical devices that are intended for multiple use and are used several times must be maintained and reprocessed in accordance with the regulations. Proper reprocessing - in particular proper cleaning, disinfection, functional testing, packaging, sterilization and storage - eliminates the risk of infection so that the reprocessed product is "safe" for reuse.

Before each use, the healthcare professional must ensure that the device is checked for functionality and reprocessed in accordance with the state of the art in science and technology, taking into account the manufacturer's instructions and hygiene requirements. For reprocessing, procedures must be used that are suitable and validated according to the state of the art in science and technology and whose proven effectiveness is ensured in a traceable and reproducible manner as part of a quality management system (Art. 72 MepV).

In addition to the legal requirements, standards, guidelines and recommendations define further requirements for professional reprocessing. For reprocessing in medical and dental practices and for other users of small steam sterilizers, the following guidelines / position papers should be observed in particular:

• Good practice for the reprocessing of medical devices in medical and dental practices and for other users of small steam sterilizers
• Creutzfeldt-Jakob disease: CJKV and Epidemics Ordinance
• Guide to the procurement of a small steam sterilizer
• Checklist for the procurement of a small steam sterilizer
• Guideline 001: Requirements for a quality assurance system (QAS) for the reprocessing of sterile medical devices
• Guideline 002: Minimum requirements for the documentation and operation of small steam sterilizers
• Guideline 003: Operational requirements for the reprocessing area for medical devices in medical and dental practices and for other users

These and other guidelines / position papers can be downloaded from the website of the Cantonal Pharmacists' Association.

Single-use devices and reprocessing

Article 73 MepV regulates the reprocessing of single-use devices. The reprocessing and reuse of used single-use devices is prohibited (unused, non-sterile single-use devices may, however, be reprocessed before use in accordance with the manufacturer's instructions). The use and distribution of single-use devices reprocessed abroad is also prohibited.

Reprocessing for third parties (external reprocessing)

The specific requirements for service providers who reprocess for third parties are set out in Art. 72 para. 4 MedDO. In addition to fulfilling the basic requirements for reprocessing in accordance with the state of the art in science and technology, the provider of reprocessing services to third parties must essentially have a suitable quality management system certified in an accredited certification program in accordance with nationally or internationally recognized standards (usually SN EN ISO 13485).

The ordering healthcare facility that uses the product shall ensure that the functionality is tested before each use and that the external reprocessing has been carried out in accordance with the regulations.

Healthcare facilities that provide reprocessing services for other healthcare facilities do not have to meet the requirements of Art. 72 para. 4 MedDO, provided they belong to the same organization as the client and are affiliated to the same quality management system.

Maintenance and reprocessing in hospitals

Detailed information on maintenance and reprocessing in hospitals can be found on the Swissmedic website.