Legal Regulations of Hygiene

Preventative hygiene measures against infection are standardized by laws, regulations, and technical rules that are based on the standards of modern medicine and science.

At first glance, the complex structure of these rules can be confusing, as both national and international rules and recommendations are simultaneously applicable. It goes without saying that all laws should be observed. The ethical obligation to keep patients out of harm’s way should be enough of a motivator. Every patient has to have faith in the dental team that it is taking every measure to protect his/her well-being. The dentist is also responsible for the safety of his staff by providing a working environment absent of all health hazards. Should however an accident occur, the injured party may make claims. Standardized criteria allow courts to hold doctors and dentists accountable for injuries resulting from negligence.

Legal Regulations in Switzerland

There are various laws that affect health care in Switzerland. The most important laws pertaining to infection control are the following:

The Epidemics Law regulates the identification, prevention, and combating of infectious diseases; defines the competencies of both the federal government and of the individual cantons; and coordinates the international cooperation to produce standards against infectious diseases.
In the Federal Law on Medicinal Products and Medical Devices (Medicine Law, HMG), the Swiss Federal Council defines the requirements of medicinal products and medical devices that are allowed in Switzerland. These requirements and the classification rules are laid out by Swissmedic, the Swiss authority on medicine and medical devices. The Swiss regulations conform largely to international standards.
All biocidal products and their active ingredients are subject to the Regulation on Biocidal Products. Biocidal products are those that use chemical or biological methods to combat so called pest organisms.
The Regulation on Disinfection and Disinfestation, subordinate to the Epidemics Law, requires the Federal Ministry of Health to register all disinfectants that are permitted to be used in Switzerland.
Similarly subordinate to the Epidemics Law are the Regulation on Public Vaccinations and the Regulation on Measures for Combating an Influenza Pandemic, which require that all people are offered the possibility of a gratuitous vaccination against polio, tuberculosis, and influenza.
The Regulation on the Reporting of Infectious Diseases lists forty-two infectious diseases that must be reported if they appear. This facilitates an early detection and allows the government to quickly enforce measures for containing the disease.

Legal Regulations in Terms of an Employment Contract

There are further laws that pertain to infection control measures employed in a dental office:

The Swiss Code of Obligations. The employer is obligated to protect the life, health, and personal integrity of all employees.
The Employment Law (ArG) Article 6 with the same content as in the Swiss Code of Obligations excerpt above.
The Regulation on the Prevention of Accidents (VUV) calls for protective measures, devices, and personal protective equipment (PPE) for all employees in accordance to safety-related and occupational health regulations. It highlights the employer’s duty to supply information, as well as the duty of the employee to “obey the directives of the employer in reference to occupational safety and to consider and regard the generally recognized rules of safety.“ (§ 11)

Laws or Compulsory Recommendations

A series of publications (of both standard literature, as well as publications of the Robert Koch Institute), deal primarily with other laws, for example the Medical Devices Directive.

These are mostly German laws that have no legal validity in Switzerland. Their content is, however, concordant with Swiss legislation. Furthermore, there are a number of international legal recommendations that have been published by medical and technical institutions. This includes the recommendations of the Robert Koch Institute and the DAHZ (German Committee for Hygiene in Dentistry) as well as other valid European standards such as DIN, EN, ISO, and CE. They have no legal authority but can serve as assessment criteria in the event of a lawsuit to assess the infringement of the duty to exercise diligence.

Hygiene on Trial

The employer or owner of the clinic is responsible for the lawful implementation of hygiene regulations. If an infection occurs, he will be legally held accountable. Employees can also be held liable but only if the employer can prove that they negligently or deliberately ignored instructions.