Hygiene requirements in the healthcare sector
In this article, we summarize the most important legal requirements and the central guidelines for health protection and hygiene safety in the healthcare sector for you - in a compact and clear format.
Legal requirements of the federal government
Federal Act on Work in Industry, Trade and Commerce (Labor Act, ArG):
Health protection in the workplace is regulated by the Labor Act. Employers are responsible for the health of their employees:
Art. 2:
“The employer must take all measures necessary to maintain and improve health protection and to ensure the physical and mental health of employees”.
The Ordinance on the Protection of Workers from Exposure to Microorganisms also states:
Art. 8, para. 4:
“The employer must take hygiene measures to ensure that microorganisms neither endanger the employees concerned nor are transmitted to persons outside the workplace.”
To the full text of the law
Ordinance on the Control of Communicable Diseases in Humans (Epidemics Ordinance, EpV):
Art. 25: Prevention of Creutzfeldt-Jakob disease during surgical and medical procedures
- To reduce the risk of transmission of all forms of Creutzfeldt-Jakob disease, hospitals and clinics must sterilize reusable invasive medical devices that are to be used in sterile condition, in particular surgical instruments, before each use:
- decontaminate and disinfect according to the state of the art and taking into account the manufacturer's instructions; and
- sterilize at 134°C in saturated pressurized steam for 18 minutes.
- Medical devices that are damaged by the sterilization process according to the manufacturer's instructions may not be reused if they can be replaced by comparable medical devices that can withstand the process.
- Healthcare facilities other than hospitals and clinics, in particular medical practices, must treat medical devices used for neurosurgical, ophthalmologic, otorhinolaryngologic or maxillofacial procedures in accordance with paragraphs 1 and 2.
To the full text of the law
Federal Act of December 15, 2000 on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA), SR 812.21
The aim of this Act is to ensure that only high-quality, safe and effective therapeutic products are placed on the market. Therapeutic products include both medicinal products and medical devices.
The term “duty of care” (Article 3, TPA) stipulates that users of medical devices must take all measures required by the state of the art in science and technology to avoid endangering human and animal health. This can be achieved with the aid of current standards and the use of enforcement aids such as guidelines, instructions and recommendations from associations.
To the complete legal text
Medical Devices Ordinance (MedDO) of October 17, 2001, SR 812.213
This ordinance is intended to ensure the safe handling of medical devices. It regulates the placing on the market, product monitoring and the subsequent inspection of medical devices and their accessories by the authorities.
An important component is the maintenance obligation, which obliges the user to regularly service and maintain the medical device, whereby the principles of quality assurance must be observed.
Since reprocessing is considered an act of maintenance, the principles of quality assurance must also be applied to these activities.
Art. 19: Reprocessing
1. Any healthcare professional who uses a medical device intended for multiple use several times shall ensure that it is checked for functionality and reprocessed correctly before each reuse.
2. Reprocessing means any maintenance measure necessary to prepare a used or new medical device for its intended use, in particular activities such as cleaning, disinfection and sterilization.
3. The process and validation data for sterilization must be recorded.
4. anyone who reprocesses medical devices for third parties must demonstrate that they have passed a conformity assessment procedure in accordance with Annex 3 for the reprocessing and sterilization of medical devices..
Specialist knowledge is a prerequisite for the reprocessing of medical devices in order to be able to assess the functionality of the product and the correct reprocessing measures. Manufacturers are obliged to provide information on reprocessing (in accordance with SN EN ISO 17664) together with the medical device, which must be taken into account.
During the sterilization process, at least the sterilization temperature, saturated steam pressure and sterilization time must be recorded. Data on the validation of the sterilization process must also be recorded; the validation dossier must be retained.
Art. 20: Maintenance
1. Anyone who uses medical devices as a qualified person shall ensure that maintenance and the associated inspection are carried out in accordance with the regulations.
2. maintenance must be carried out in accordance with the principles of quality assurance, must be planned and organized appropriately within the company and is based in particular on
a) according to the instructions of the person who first placed the product on the market;
b) the risk inherent in the product and its use.
3. the results of maintenance and the associated inspections, defects and malfunctions identified and measures taken must be recorded for:
(a) active medical devices;
Anyone who deviates from the manufacturer's specifications when maintaining medical devices must analyze and evaluate the new risks that may arise as a result and assess the acceptability of the residual risks. The risk assessment must be documented. Maintenance measures must be recorded for active medical devices (e.g. sterilizers, washer-disinfectors/thermal disinfectors).
Art. 20a: Modification
Anyone who modifies medical devices or has them modified or reprocesses them or has them reprocessed in such a way that they no longer serve the intended purpose or provide the intended performance must meet the requirements for placing them on the market for the first time. The reprocessing of devices intended by the manufacturer for single use falls under Article 20a. It will hardly be possible for small structures to meet the requirements for first placing on the market.
To the full text of the law
Cantonal laws and ordinances
These requirements may vary from canton to canton.
Recommendations, directives & guidelines
Swiss Agency for Therapeutic Products Swissmedic:
Guideline “Good practice for the reprocessing of medical devices in medical and dental practices and for other users of small steam sterilizers”
to the complete guideline, publisher: Swissmedic (PDF)
KlGAP implementation working group:
Requirements for a quality assurance system (QSS) for the reprocessing of sterile medical devices
to the complete guideline (PDF)
Practice hygiene dentists:
Quality guidelines for dentistry