Personal protective equipment (PPE)
There is a shortage of personal protective equipment within the healthcare sector during the COVID-19 pandemic. Various initiatives have been taken to meet the unusually high demand. It is important that all personal protective equipment is safe.
Personal protective equipment requires CE marking. This means that products in the European market shall meet common standards.
Personal protective equipment as protection against COVID-19 for healthcare and social care workers
The employer is always obligated to protect their employees against work environment risks.
- The employer’s risk assessment determines which protective measures should be taken.
- The risk assessment shall be done in cooperation with employees and safety representatives.
- The choice of protective measures must be adapted to the current general knowledge and which duties that need to be executed. The employer may therefore need to make new risk assessments if the general knowledge changes or if new duties are added.
- In situations where there is no complete or reliable knowledge available, the Swedish Work Environment Authority recommends applying the precautionary principle.
There are currently recommendations from the Public Health Agency of Sweden, the European Centre for Disease Prevention and Control (ECDC), and the World Health Organization (WHO) on which personal protective equipment protects against COVID-19. An employer who chooses to use other personal protective equipment than what is recommended by these organisations must be able to show the grounds of that assessment.
In the Swedish Work Environment Authority’s provisions on risks of infection (AFS 2018:4), it is required that personal protective equipment is used if the employee risks exposure to bodily fluids. The provisions include a list of examples of personal protective equipment. The fact that surgical masks, for example, are not included in the list shall not be interpreted as if these are not necessary. The choice of protective equipment depends, among other things, on how the virus may be transmitted, the consequences for the employee if infected by the virus, the work elements performed, and for how long the employee is risking exposure to the virus. The provisions also include the absolute requirement that respiratory protective equipment shall be used for work elements that carry a risk of serious airborne infection.
Manufacturers and suppliers
The required performance and capacity for various types of respiratory protection equipment is determined by applicable European standards. The European Commission has now issued a recommendation that enables manufacturers to use other, equivalent standards. At the same time, the Swedish Institute for Standards, SIS, is providing free access to additional standards. This will make it easier for manufacturers to quickly offer safe protective equipment on the Swedish market.
Read more on the SIS website:
FAQ on personal protective equipment (PPE)
What is Personal Protective Equipment and what is a Medical Device?
The Swedish Work Environment Authority is the market surveillance authority for personal protective equipment and the Swedish Medical Products Agency is the market surveillance authority for medical devices. Sometimes, it may be difficult to determine whether it is a medical device or personal protective equipment and some products may be approved as both personal protective equipment and a medical device. Examples of such products are disposable gloves, plastic aprons, face shields and disposable overalls. Products that are medical devices, but not personal protective equipment, are for example the mouthguards used in healthcare to protect a patient and not the user. For questions on medical devices, please contact the Swedish Medical Products Agency.
Last updated 2020-04-16