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).
Article 73 MedDO sets out the provisions governing the reprocessing of single-use products. It is forbidden to reprocess and reuse used single-use products (however, unused single-use products supplied in non-sterile condition can 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 in healthcare insitutions
The completely revised "Good practice for the reprocessing of medical devices for Swiss health facilities" (GPA), 2016 version (replaces the 2005 version, available in German, French, Italian) should be viewed as a directive to the reprocessing of medical devices in healthcare institutions (hospitals, clinics, group practices, outpatient clinics or emergency services, nursing homes, etc.). It applies not only to the central sterilisation service department, but also to all areas in which medical devices are reprocessed (surgical areas, nursing services, etc.). The GPA was prepared in conjunction with the Swiss society for sterile materials provision (SGSV), the Swiss society for hospital hygiene (SGSH) and Swissmedic, the Swiss Agency for Therapeutic Products.
Hospitals should consider the GPA as a work of reference that issues guidelines on the correct operation of a reprocessing unit. It contains both mandatory requirements that must be fulfilled on the basis of the applicable laws and standards plus recommendations based on the current practice and literature. The mandatory requirements listed in the GPA must be implemented in hospitals, and this is checked, for example, during an inspection by Swissmedic. Any deviations must be justified accordingly.
The following checklist is based on the 2016 version of the “Good Practice for the reprocessing of medical devices” (GPA, available in German, French, Italian). Swissmedic uses the checklist as an aid when inspecting hospitals. It can also, however, be used by healthcare institutions to conduct gap analyses of their current situation in comparison to requirements as per the "Good practice" document and for internal audits, etc. The checklist is published as an active PDF for this purpose.
Announcement: In 2019, Swissmedic gives priority to the inspection of the units that reprocess thermolabile (flexible) endoscopes in hospitals.
During the last hospital inspections performed by Swissmedic, it became obvious that the reprocessing of thermolabile endoscopes can cause certain problems. Swissmedic uses the following checklist as an aid when inspecting hospitals to verify the correct execution of the reprocessing process of thermolabile endoscopes. It can also be used by healthcare institutions.
Instructions on the processes validation
Reprocessing consists of various procedural steps whose efficacy (cleanliness, no contamination with microorganisms, sterility) cannot be completely confirmed by in-process controls or product testing. Consequently, documented evidence of the constant and reproducible efficacy of the processes is needed. This is established by validation of the critical procedural steps. The GPA describes the validation of the processes of cleaning and disinfection, packaging and sterilisation of medical devices according to the corresponding standards as a binding precondition for correct reprocessing (see Chapter 5.6 of GPA).
The aim of the following document is to provide information, which is necessary in order to define responsibilities and qualifications of the personnel involved in the process of validation of the different reprocessing procedures of medical devices in healthcare facilities. This article was also published in Forum 2/2018, the Journal of the Swiss Society for Sterile Supply (www.sssh.ch).
Swiss Guideline for the Validation and Routine Monitoring of Cleaning and Disinfection Processes for Medical Devices:
The reprocessing of medical devices to be used low-germ or sterile must be carried out using suitable validated procedures, taking into account the manufacturer's specifications.
The following document serves as a guideline for the practical implementation of the minimum requirements for the validation and routine monitoring of cleaning and disinfection processes in Switzerland. This guideline specifies the requirements listed in the GPA for the validation of cleaning and disinfection processes and is divided into several parts. The guideline was developed in conjunction with the Association for Reprocessing in Healthcare (IG WiG), the Swiss Association of Dental Assistants (SVDA), the Swiss Society for Sterile Materials Provision (SGSV), the Swiss Society for Hospital Hygiene (SGSH), and Swissmedic.
The following document provides instructions on the validation of moist heat sterilization based on SN EN ISO 17665, taking account of, and applying, the contents of SN EN 285.” It applies to healthcare institutions that operate large steam sterilisers according to SN EN 285; it can also be applied, by analogy, to sterilisation processes in small steam sterilisers according to SN EN 13060.
Swiss Guideline for the Transport of Contaminated and Reprocessed Medical Devices
The following document is only available in German or French.
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.
Further information concerning the reprocessing of medical devices in hospitals
What are the challenges and requirements in the reprocessing of flexible endoscopes from Swissmedic's point of view? The following document (in German and French) was presented at various conferences in 2018 and 2019.
What are the principal new requirements of the GPA 2016? A presentation on this topic was given at the 8th H-Forte Conference, held on October 27, 2017 in the University Hospital of Zurich (in German).
What are the results of the controls in the field of reprocessing that Swissmedic has conducted in Swiss hospitals? The following document (in German and French) was presented at the 13th Swiss Symposium on Sterilisation “Eye to Eye”, held on June 21 – 22, 2017 in Biel.
Manufacturers’ instructions for processing
Manufacturers of reusable medical devices are required to provide users with the information they need to perform correct sterilisation. The following document is based on standards EN ISO 17664 and EN ISO 14937. It provides manufacturers and users with a checklist that they can use to verify whether the manufacturer's information satisfies the requirements of these standards.