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FEDERAL CONSTITUTION
MEDICAL DEVICES ORDINANCE
CODE OF OBLIGATIONS
FEDERAL LAW ON PRIVATE INTERNATIONAL LAW
LUGANO CONVENTION
CODE OF CRIMINAL PROCEDURE
CIVIL PROCEDURE CODE
FEDERAL ACT ON POLITICAL RIGHTS
CIVIL CODE
FEDERAL ACT ON CARTELS AND OTHER RESTRAINTS OF COMPETITION
FEDERAL ACT ON INTERNATIONAL MUTUAL ASSISTANCE IN CRIMINAL MATTERS
DEBT ENFORCEMENT AND BANKRUPTCY ACT
FEDERAL ACT ON DATA PROTECTION
SWISS CRIMINAL CODE
CYBERCRIME CONVENTION
COMMERCIAL REGISTER ORDINANCE
FEDERAL ACT ON COMBATING MONEY LAUNDERING AND TERRORIST FINANCING
FREEDOM OF INFORMATION ACT
FEDERAL ACT ON THE INTERNATIONAL TRANSFER OF CULTURAL PROPERTY
- I. General
- II. Requirements for reprocessing (para. 1)
- III. Quality management system (para. 2)
- IV. Reprocessing for third parties (paras. 3 and 4)
- V. Consequences of non-compliance
- Bibliography
- Materials
I. General
1 Art. 72 MedDO deals with the reprocessing of medical devices that are intended for multiple use. Such reusable medical devices must be distinguished from single-use devices, which are regulated by Art. 73 MedDO. Not least for reasons of sustainability and cost, medical devices that can be reprocessed are of interest to service providers (in contrast to single-use products). Art. 72 MedDO is based on the statutory maintenance obligation under Art. 49 TPA. According to Art. 49 TPA, anyone who uses a medical device commercially or on third parties must take all measures necessary for maintenance to preserve the performance and safety of this medical device. The TPA does not further define the term “maintenance,” but the MedDO contains a definition in Art. 4 para. 1 lit. d: Maintenance includes all measures such as servicing, software updates, inspection, repair, preparation for initial use, and reprocessing for reuse, in order to maintain or restore the functional condition of a medical device. In the MedDO, maintenance is regulated in detail by Art. 71. Reprocessing – which, according to the definition in Art. 4 para. 1 lit. d MedDO, is fundamentally part of maintenance – is regulated separately from maintenance in Art. 72 MedDO due to its relevance in practice.
2 However, Art. 71 and 72 MedDO cannot be completely separated from each other. According to Art. 71 para. 4 MedDO, Swissmedic may issue and publish guidelines on maintenance measures, which are then considered to represent the state of the art in science and technology. Since reprocessing is part of maintenance according to Art. 72 MedDO, Swissmedic's corresponding powers also extend to this area, enabling it to issue guidelines on measures that are then considered to represent the state of the art in science and technology. In the field of medical device reprocessing, the Swiss Good Practice for Medical Device Reprocessing (version 2022), which was developed jointly by the Swiss Society for Sterile Supply (SGSV), the Swiss Society for Hospital Hygiene (SGSH) and Swissmedic, is particularly relevant. Swissmedic bases its inspection activities on these guidelines and requires that any deviations be justified. In practice, healthcare facilities seem to have difficulty complying with the reprocessing regulations – the Swissmedic hospital inspection concerning medical devices in 2024 revealed numerous deficiencies in the area of reprocessing in the reprocessing units for medical devices (AEMP, central sterilization departments). It was found that individual reprocessing processes were affected by deficiencies, particularly the cleaning and disinfection process (92%), the packaging process (100%), the sterilization process (75%), and the storage of sterile instruments (67%). In addition, the AEMP's quality management system was affected by deviations in 75% of the inspections, with the main issues being missing or inadequate work instructions and interface agreements, as well as the lack of risk management.
3 But what exactly does the term “reprocessing” mean from a legal perspective? Art. 4 para. 1 lit. e MedDO contains a definition of this term: Reprocessing is defined as a process to which a used product is subjected so that it can be safely reused; this process includes cleaning, disinfection, sterilization, and similar procedures, in particular packaging, transport, and storage, as well as testing and restoring the technical and functional safety of the used product. This definition corresponds to that in Art. 2 para. 39 of Regulation (EU) 2017/745 (“EU MDR”), although in Art. 4 para. 1(e) MedDO, unlike the European definition, the “similar processes” are specified in a list of examples. The aim of reprocessing medical devices is to eliminate all risks of infection that may arise from these products, and the reprocessing procedure must ensure that these products are sterile or disinfected.
4 The reuse of medical devices in everyday medical practice is commonplace. For example, surgical instruments such as clamps and forceps, ventilators, and endoscopes are used multiple times. The proper reprocessing of reusable medical devices is crucial in practice to prevent infections caused by contaminated medical devices.
II. Requirements for reprocessing (para. 1)
A. Introduction
5 Professionals who use medical devices that are intended for repeated use shall ensure that the functionality of the device is checked and that it is reprocessed in accordance with the state of the art and technology, taking into account the manufacturer's instructions and hygiene requirements (Art. 72 para. 1 MedDO). Art. 72 para. 1 MedDO stipulates a duty of care in connection with the repeated use of medical devices, which applies to the specific user of such a product. This duty of care applies to the professional who uses such a product in a specific case. Specialists are defined as members of the healthcare professions, such as doctors and dentists, but also nurses and physiotherapists. Although the wording of Art. 72 para. 1 MedDO refers exclusively to specialists, Swissmedic also applies this provision to healthcare facilities. On its website, Swissmedic states that “hospitals must regard the GPA (including corrigendum) as a reference work that provides guidelines for the correct operation of a reprocessing unit. It contains mandatory requirements that must be followed on the basis of the applicable laws and standards, as well as recommendations based on current practice and literature.” Due to the clear wording of Art. 72 para. 1 MedDO (“specialist”), it is questionable whether this extension to healthcare facilities is permissible by the supervisory authority, as there is no legal basis for such an extension. In substance, however, Swissmedic's view is of course understandable, as the duties of care under Art. 72 para. 1 MedDO should also apply to healthcare facilities, not just to professionals – but from the point of view of legal certainty, a better wording of Art. 72 para. 1 MedDO would have been desirable. It therefore remains to be seen whether Swissmedic's decisions against healthcare facilities for violating Art. 72 MedDO will stand up in court.
6 The reprocessing of medical devices must be carried out in accordance with the state of the art in science and technology, taking into account the manufacturer's instructions and hygiene requirements (Art. 72 para. 1 MedDO). Since reprocessing is part of maintenance, Swissmedic may, on the basis of Art. 71 para. 4 MedDO, issue guidelines in this regard which are considered to represent the state of the art in science and technology. Swissmedic considers the Swiss Good Practice for the Reprocessing of Medical Devices (version 2022) to be such a requirement within the meaning of Art. 74 para. 1 MedDO and designates it as a guideline for the reprocessing of medical devices in healthcare facilities, which must be observed in all areas of the healthcare organization (central sterilization, operating rooms, endoscopy departments, etc.). These guidelines contain both mandatory requirements that must be followed on the basis of applicable laws and standards, as well as recommendations based on current practice and literature.
B. Requirements relating to personnel and premises
7 Swiss Good Practice for the Reprocessing of Medical Devices (Version 2022) contains guidelines on the correct operation of a reprocessing unit, including premises, personnel, equipment, and information management systems. With regard to personnel and responsibilities, Swiss Good Practice for the Reprocessing of Medical Devices (Version 2022) sets out various requirements. A manager must be appointed for the reprocessing unit, as well as a person responsible for the quality assurance system for the reprocessing of medical devices. Both persons must have appropriate professional experience and training in the reprocessing of medical devices. The person responsible for the quality assurance system must also have appropriate training and experience in quality management. In small healthcare facilities, both functions can be performed by the same person. If this is the case, however, the internal audits must be carried out by a qualified third party, who must also write the corresponding reports. The manager of the reprocessing unit must write an annual activity report and submit it to the management of the healthcare facility. In addition, (i) all personnel involved in the reprocessing of medical devices must be listed in the operational organization chart, (ii) the activities of these personnel must be included in a job description, and (iii) all tasks related to the reprocessing of medical devices may only be performed by selected, competent employees who have received appropriate training. The Swiss Good Practice for the Reprocessing of Medical Devices (version 2022) contains further regulations relating to personnel on pages 32 to 34, which must be observed.
8 The Swiss Good Practice for the Reprocessing of Medical Devices (Version 2022) also contains various requirements relating to premises that must be observed by healthcare facilities. In principle, the layout of the premises must allow for the physical separation of the following areas: (i) area designated for receiving and cleaning work (cleaning zone), (ii) area for packaging work (clean zone), and (iii) area available for removing medical devices from sterilizers and for storing sterile goods (sterile zone). The premises and the process flow must be designed in such a way that any risk of confusion between sterile and non-sterile medical devices can be ruled out. The Swiss Good Practice for the Reprocessing of Medical Devices (Version 2022) also contains various other requirements that must be met with regard to the premises, e.g. with regard to lighting (Chapter 5.2.2), noise pollution (Chapter 5.2.3), maintenance (Chapter 5.2.5), ventilation and indoor air quality (Chapter 5.3), medical compressed air (Chapter 5.4), water (Chapter 5.5) and materials (Chapter 5.6). For details regarding these requirements, please refer directly to the relevant chapters of the Swiss Good Practice for the Reprocessing of Medical Devices (Version 2022).
C. Requirements relating to the reprocessing of medical devices
9 Reprocessing must be carried out in accordance with the manufacturer's instructions (see Art. 72 para. 1 MedDO). According to Annex I, no. 23.4(n) of the EU MDR, in order to comply with the essential requirements, the manufacturer is obliged to provide the following information in connection with the labeling and instructions for use of reusable medical devices: Information on suitable reprocessing procedures, e.g. for cleaning, disinfection, packaging and, where applicable, the validated procedure for re-sterilization in accordance with the Member State(s) in which the product is placed on the market. It must be made clear how to recognize that the product should no longer be reused, e.g., signs of material wear or the maximum number of permitted reuses. Pursuant to Art. 6 para. 2 MedDO, these provisions of Annex I of the EU MDR also apply to Switzerland.
10 A manufacturer of medical devices must therefore describe in detail how a user must reprocess the product in question and how they can determine whether the product is still suitable for further reprocessing. The manufacturer is obliged to provide objective evidence that the specified reprocessing procedures lead to the desired result. Further specific standards relating to the information to be provided in connection with reprocessing procedures can be found in ISO standard 17664, in particular in the sixth chapter, which deals with the information to be provided by the manufacturer to the user. This manufacturer information must be provided for all reprocessing steps, including, for example, information on the validation parameters (such as temperature, time, water quality) and the process chemicals. In principle, machine reprocessing procedures are preferable to manual procedures due to their standardization and reproducibility.
11 Compliance with the manufacturer's specifications is not mandatory. This already follows from Art. 72 para. 3 lit. a no. 2 MedDO with regard to reprocessing by third parties. The Swiss Good Practice for the Reprocessing of Medical Devices (version 2022) also states that anyone who deviates from the manufacturer's instructions when reprocessing medical devices must analyze and evaluate the new risks that arise as a result and assess the acceptability of the residual risks. This risk assessment must be documented accordingly. However, for liability reasons, it is recommended that the manufacturer's instructions, if available, regarding the reprocessing of medical devices be followed.
D. Testing of functionality
12 Art. 72 para. 1 MedDO requires the professional using the product to test its functionality before each use. The legislator thus imposes a specific duty of care on the professionals using the product – e.g., the physician who uses a (re)processed medical device during an operation – when handling (re)processed medical devices. It is not possible to say in general terms what this check should entail; rather, it depends on the medical device in question and also on the manufacturer's specifications. Failure to comply with this duty of care may – provided that the other conditions for liability are met – result in liability on the part of the responsible professional.
III. Quality management system (para. 2)
13 According to Art. 72 para. 2 MedDO, procedures that are suitable and validated according to the state of the art in science and technology must be used for (re)processing. Their proven effectiveness must be guaranteed in a traceable and reproducible manner within the framework of a quality management system (“QMS”). Reprocessing consists of various process steps whose effectiveness cannot be fully confirmed by in-process controls and product testing. Therefore, documented evidence of the consistent and reproducible effectiveness of such a reprocessing process is necessary, which is achieved by validating the critical process steps. Validation is a documented procedure for generating, recording, and interpreting the results required to prove that a process consistently delivers products that meet the specified requirements. A healthcare facility must therefore develop a QMS for the (re)processing of medical devices, document it in writing, implement it, keep it up to date, and ensure its long-term effectiveness. The QMS must cover all processes involved in the reprocessing of medical devices. The following steps may be part of the reprocessing process: sorting, preparation, pre-cleaning, cleaning, disinfection, cleanliness control and functional testing, packaging, sterilization, batch release, transport and storage, and provision. Swiss Good Practice for the Reprocessing of Medical Devices recommends a QMS based on the concepts described in the ISO 9000 series of standards. However, a specialist is free to apply other concepts, in which case the legal requirements must also be met. With regard to the specific requirements and design of a QMS and the validation of the reprocessing procedure, reference is made to Swiss Good Practice for the Reprocessing of Medical Devices (version 2022) and the Swiss Guideline for the Validation and Routine Monitoring of Cleaning and Disinfection Processes for Medical Devices.
IV. Reprocessing for third parties (paras. 3 and 4)
14 Para. 3 of Art. 72 MedDO deals with the reprocessing of medical devices for third parties. Due to staff shortages and cost pressures faced by many healthcare facilities and professionals, they are increasingly outsourcing the reprocessing of medical devices to specialized service providers. Service providers wishing to undertake reprocessing for hospitals must meet the requirements of Art. 72 para. 3 and 4 MedDO. Even if the reprocessing is outsourced to a service provider, the overall responsibility under Art. 72 para. 1 MedDO remains with the professional who uses the product. It is therefore in the interest of the outsourcing healthcare facility and professional to carefully select the service provider and to set out the requirements that the service provider must comply with, as well as information and control rights, in a contract.
15 Anyone who reprocesses a medical device for third parties must declare, in accordance with Art. 72 para. 3 lit. a MedDO, that the product has either (a) been reprocessed in accordance with the manufacturer's instructions, or (b) been reprocessed using their own reprocessing procedure that is equally safe and effective as the procedure specified by the manufacturer, and that this equivalence has been demonstrated by means of a risk analysis and a validation procedure. This declaration must include the identification of the product and the name and address of the service provider (Art. 72 para. 4 MedDO). Furthermore, according to Art. 72 para. 3 lit. b MedDO, the service provider must have a suitable QMS certified according to nationally or internationally recognized standards (usually ISO 13485). In addition, according to Art. 72 para. 3 lit. c MedDO, the service provider must provide evidence that the reprocessing is carried out in suitable premises in accordance with recognized scientific and technical rules and that hygiene requirements are met. Finally, in accordance with Art. 72 para. 3 lit. d MedDO, they must document that the product has been reprocessed in accordance with Art. 72 para. 3 lit. a MedDO.
16 With regard to the individual elements of para. 3, reference is made to the comments on paragraphs 1 and 2. However, it should be noted that, in the context of reprocessing for third parties, additional factors must be taken into account compared to in-house reprocessing, e.g., transport to and from the service provider and, if necessary, external storage. These additional elements must be taken into account by the healthcare facility with overall responsibility within the framework of Art. 72 para. 2 MedDO.
V. Consequences of non-compliance
17 From a civil law perspective, inadequate reprocessing of medical devices may result in liability on the part of the specialist or healthcare facility towards the injured patient, provided that the other conditions for liability (adequate causal link between the breach of duty and the damage, as well as fault) are met in the specific individual case. The conditions for liability must be proven by the patient concerned (Art. 8 CC), although it may not be easy to prove that the reprocessing was inadequate. For this reason, there is a case for easing the burden of proof if the patient can prove an infection for which a contaminated medical device is a possible cause. In this case, the specialist or healthcare facility must prove that they have fully complied with the duties of care set out in Art. 72 MedDO (reversal of the burden of proof).
18 From an administrative law perspective, Swissmedic is the enforcement authority responsible for market surveillance and the enforcement of medical device regulations (Art. 66 para. 1 TPA) . Market surveillance controls include, among other things, checking that economic operators are fulfilling their obligations (Art. 75 para. 1 MedDO) and, consequently, that they are implementing the obligations arising from Art. 72 MedDO. The range of administrative measures available to remedy such deficiencies is not limited in principle, as Art. 66 para. 1 TPA provides that all administrative measures necessary for the enforcement of the TPA may be taken. Art. 66 para. 2 TPA contains a non-exhaustive list of measures that may be ordered by Swissmedic. In any case, the measures ordered must comply with the principle of proportionality.
19 From an (administrative) criminal law perspective, it should be noted that, according to Art. 86 para. 1 lit. e TPA, anyone who intentionally violates the maintenance obligation for medical devices is punishable by imprisonment of up to three years or a fine. Negligent acts are punishable by a fine, and in particularly minor cases by a penalty (Art. 86 para. 4 TPA). In this context, the authorities are likely to focus primarily on the person in charge of the reprocessing unit and the person responsible for the quality assurance system, as they bear responsibility for maintenance within their organization. The maintenance obligations are governed by Art. 49 TPA in conjunction with Art. 71 ff. MedDO. Under certain circumstances, however, the healthcare facility itself may also be convicted (cf. Art. 89 TPA). In cases where a breach of duty in connection with the reprocessing of medical devices leads to the death of a patient or to bodily injury, it is also conceivable that the criminal offense of negligent homicide (Art. 117 SCC) or negligent bodily injury (Art. 125 SCC) has been committed.
Bibliography
Frédy Cavin/Rafael Moreno/Nicola Franscini, Verantwortlichkeiten und Qualifikationen der Personen, die an der Validierung von Wiederaufbereitungsverfahren für Medizinprodukte beteiligt sind, Société Suisse de Stérilisation Hospitalière, forum 2 (2018).
D. Diedrich et al., Angaben der Hersteller zur Aufbereitung von Medizinprodukten, Zentralsterilisation 3/2018, S. 176.
Meier Andreas L./Cortizo Juan, Kommentierung zu Art. 49, in: Eichenberger Thomas/Jaisli Urs/Richli Paul (Hrsg.), Basler Kommentar, Heilmittelgesetz, 2. Aufl., Basel 2022.
Suter Benedikt A./Pieles Yvonne, Kommentierung zu Art. 86, in: Eichenberger Thomas/Jaisli Urs/Richli Paul (Hrsg.), Basler Kommentar, Heilmittelgesetz, 2. Aufl., Basel 2022.
Materials
Bundesamt für Gesundheit, Erläuternder Bericht zur Totalrevision der Medizinprodukteverordnung und Verordnung über klinische Versuche mit Medizinprodukten, Juli 2020 («BAG, Erläuternder Bericht»).
Schweizerische Gesellschaft für Sterilgutversorgung (SGSV), Schweizerische Gesellschaft für Spitalhygiene (SGSH) und Swissmedic, Schweizerische Gute Praxis zur Aufbereitung von Medizinprodukten, Version 2022.