Reprocessing

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 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 in healthcare insitutions


New medical devices regulations came into force on 26 May 2021. An information meeting was held (in French and German) on 2 September 2021 to explain the impact of the new regulations on the different players in the Swiss medical devices sector.

Information on the new medical devices regulations (French and German only):

One presentation dealt with healthcare institutions and the new requirements facing them, particularly as regards reprocessing. This presentation is available on the Swissmedic website:

Presentation on requirements pertaining to healthcare institutions:

The completely revised "Good practice for the reprocessing of medical devices for Swiss health facilities" (GPA), 2022 version (replaces the 2016 version, available in German, French, Italian) should be viewed as a directive for the reprocessing of medical devices in healthcare institutions, primarily in hospitals.  It applies not only to the central sterilisation service department, but also to all areas in which medical devices are reprocessed (surgical areas, endoscopy departments, nursing services, etc.).

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


Hospitals should consider GPA as a work of reference that provides 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 current practice and literature. The mandatory requirements listed in GPA must be implemented in hospitals, and Swissmedic will verify compliance, particularly during inspections. Any deviations must be justified accordingly.

The following two presentations (only in german and french), which were given at the Swiss Symposium on Sterilization in June 2022, explain the most important updates and amendments introduced along with the GPA 2022 and answer important questions on reprocessing that were brought to Swissmedic's attention.

The following checklist is based on the 2022 version of “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.

Inspections by Swissmedic have shown that the reprocessing of thermolabile endoscopes can cause certain problems in hospitals. Swissmedic uses the following checklist as an aid when inspecting hospitals to verify correct implementation of the reprocessing process for thermolabile endoscopes. It can also be used by healthcare institutions for internal audits.


Instructions on the processes validation


Swiss Guideline for the Validation and Routine Monitoring of Cleaning and Disinfection Processes for Medical Devices:

Medical devices to be used in aseptic or sterile condition must be reprocessed 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.

Swiss Guideline for the Validation and Routine Monitoring of Cleaning and Disinfection Processes for Medical Devices:

Medical devices to be used in aseptic or sterile condition must be reprocessed 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 sterilisation 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 on the Transport of Contaminated and Reprocessed Medical Devices


The way in which contaminated and/or reprocessed medical devices (MDs) are transported between different hospital facilities or between an external processing unit and that unit’s customer establishments may have a critical impact on patient and user safety. The aim of this document (which is only available in German or French) is to give facilities that reprocess reusable medical devices the information they need to transport MDs safely and in accordance with the current state of the art in science and technology.

This document is a complementary guideline to "Good practice for the reprocessing of medical devices for Swiss health facilities".


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.


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.