Maintenance / Reprocessing

Maintenance

Anyone who uses a medical device commercially or applies it to third parties is subject to a legal duty to maintain it, as set out in Art. 49 of the Therapeutic Products Act (TPA). To this end, all maintenance measures that are necessary to ensure the correct functioning and safety of the medical device must be in place. Furthermore, Swissmedic can issue and publish requirements for maintenance measures. These requirements will be deemed to constitute the current state of technology and science (Art. 71 MedDO and Art. 64 IvDO).

According to Art. 4 MedDO and Art. 4 IvDO, the term “maintenance” comprises measures such as mechanical maintenance, software updates, inspection, repair, preparation for first use and reprocessing for reuse or measures to keep a product in functional condition or restore it to such condition. “Reprocessing” is part of maintenance and comprises cleaning, disinfection, sterilisation and similar procedures, such as packing, transport and storage, testing used devices and restoring a device’s technical and functional safety.

Processing

The legal requirements pertaining to reprocessing are set out in Art. 72 of the Medical Devices Ordinance (MedDO). Medical devices intended for multiple use or single-use that are not supplied in sterile condition must be reprocessed before use in accordance to the current state of technology and science, taking account of the manufacturer’s instructions and the requirements of good hygiene. Suitable methods must be used for reprocessing, which generally comprises cleaning, disinfection, functional inspection, packing, sterilisation, transport and storage. These methods must have been validated in accordance with the state of technology and science, and their efficacy must have been demonstrated and be transparently and reproducibly guaranteed within the framework of an appropriate quality management system.

Laws, standards and recommendations establish the requirements for correct reprocessing. Reprocessing requirements published by Swissmedic are deemed to be the current state of science and technology (Art. 71 MedDO).

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

• Gute Praxis zur Aufbereitung von Medizinprodukten in Arzt- und Zahnarztpraxen sowie bei weiteren Anwendern von Dampf-Klein-Sterilisatoren
• Creutzfeldt-Jakob-Krankheit: CJKV und Epidemienverordnung
• Leitfaden zur Beschaffung eines Dampf-Klein-Sterilisators
• Checkliste für die Beschaffung eines Dampf-Klein-Sterilisators
• Leitlinie 001: Anforderungen an ein Qualitätssicherungssystem (QSS) zur Aufbereitung steriler Medizinprodukte
• Leitlinie 002: Minimale Anforderungen an die Dokumentation und den Betrieb für Dampf-Klein-Sterilisatoren
• Leitlinie 003: Betriebliche Voraussetzungen an den Aufbereitungsbereich für Medizinprodukte in Arzt- und Zahnarztpraxen sowie bei weiteren Anwendern

These and other guidelines / position papers are available for download on the Website of the Kantonsapothekervereinigung.

Single-use devices and their reprocessing

Article 73 MedDO and Article 17 EWR-MepV set out the provisions governing the reprocessing of single-use devices. It is forbidden to reprocess and reuse used single-use devices. However, unused single-use products supplied in non-sterile condition but intended for sterile use have to be reprocessed in accordance with the manufacturer’s instructions before use. It is also forbidden to use or distribute single-use products that have been reprocessed abroad.

Reprocessing for third parties (service reprocessing)

Art. 72 para. 4 MedDO lists the specific requirements to be fulfilled by service providers who reprocess medical devices for third parties. In addition to fulfilling the primary requirement for reprocessing according to the state of science and technology, providers of reprocessing services for third parties must essentially have a suitable quality management system that has been certified to nationally or internationally recognized standards (generally SN EN ISO 13485) under an accredited certification programme.

Prior to each use, the healthcare institution that uses the product and has had it processed by a service provider must ensure that it is properly functional and that service reprocessing has been carried out in accordance with requirements

Healthcare institutions that provide reprocessing services for other healthcare institutions do not have to fulfil the requirements of Art. 72 para. 4 MedDO if they belong to the same organisation as the ordering party and are attached to the same quality management system.

Maintenance and reprocessing in hospitals

Detailed information regarding maintenance and reprocessing in hospitals is described on the Website of Swissmedic.