Reusable medical devices that are designed to be used several times must be reprocessed correctly. The reprocessing of medical devices comprises in particular cleaning, disinfection, functional testing, packing, sterilisation and storage. Laws, standards and recommendations establish the requirements for correct reprocessing.
- Responsibilities for compliance monitoring
- Manufacturers' instructions for processing
- Reprocessing in healthcare institutions
- Further information concerning the reprocessing of medical devices in hospitals
- Instructions on the processes validation
- Swissmedic-specific note on further documents
Responsibilities for compliance monitoring
Swissmedic is the agency responsible for the compliance monitoring with regard to the maintenance and reprocessing of medical devices in hospitals. The cantons are responsible for compliance monitoring of all other professional bodies that use medical devices (e.g. medical practices, outpatient clinics, dental clinics).
The corresponding legal basis is Art. 24, para. 2 of the Medical Devices Ordinance.
Users in hospitals can contact Swissmedic if they have any questions about the reprocessing of medical devices: firstname.lastname@example.org
Any users that fall within the jurisdiction of the cantons can contact the cantonal Department of Public Health or the competent cantonal authority (either the Cantonal Pharmacist's Office or the cantonal Medicines Inspectorate depending on the canton) if they have any questions about the reprocessing of medical devices.
List of Public Health Departments, Cantonal Pharmacist's Offices, Cantonal Medical Officers or Medicines Inspectorates of the cantons:
Website of the Swiss Association of Cantonal Pharmacists: http://www.kantonsapotheker.ch
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.
Reprocessing in healthcare institutions
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 "Good practice for the reprocessing of medical devices" (GPA), 2016 version (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.
Swiss Guideline for the Validation and Routine Monitoring of Cleaning and Disinfection Processes for Medical Devices:
The reprocessing of low-germ or sterile medical devices used 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.
Announcement: In 2019, Swissmedic gives priority to the inspection of those 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, however, be used by healthcare institutions. The checklist will also be published in Italian and as an active PDF in the near future.
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.
Instructions on the processes validation
Reprocessing consists of various procedural steps whose efficacy (cleanliness, 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 will also be published in Forum 2/2018, the Journal of the Swiss Society for Sterile Supply (www.sssh.ch).
The following recommendation (in German, French and Italian) provides instructions on the validation of the steam sterilisation process 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.
Further Swiss guidance documents on the validation of other processes to be validated are currently being drafted and will be published in due course. Corresponding foreign guidelines on the validation of the cleaning and disinfection process and on the packaging process are currently referenced in the GPA (see Chapters 7.4.2 and 7.6.3).
Swissmedic-specific note on further documents
In view of the responsibilities for compliance monitoring mentioned at the start, the following documents that fall within the jurisdiction of the cantons have been transferred to the Swiss Association of Cantonal Pharmacists (KAV) -> http://www.kantonsapotheker.ch:
- Good practice for processing medical devices in medical and dental practices and by other users of small steam sterilisers
(MU530_00_001d_RL KlGAP / 30.04.2010)
- Guide with the key criteria to be considered when procuring a small steam steriliser
(Leitfaden zur Beschaffung eines Dampf-Klein-Sterilisators / 20.09.2005)
- Checklist to facilitate the determination of requirements when procuring a steam steriliser
(Beispiel einer Checkliste für die Beschaffung eines Dampf-Klein-Sterilisators / 27.11.2008)
Instructions for use for reusable and re-sterilisable medical devices (PDF, 381 kB, 10.07.2014)Checklists 2014 V. 1.0 based on EN ISO 17664 and EN ISO 14937