The current Corona pandemic has led to a strong increase in demand in all sections of society for respiratory masks. Supplies of this form of protective equipment to healthcare professionals have now ground to a halt, placing in doubt the safety of the affected workers, and their work ability, in the coming weeks. In the space of a few days, the Institute for Occupational Safety and Health of the German Social Accident Insurance (IFA) and DEKRA Testing and Certification GmbH have developed a rapid test for these products. This test can be used to determine whether respiratory masks currently being manufactured in fast-track processes in many places, and still awaiting approval, can be used for the duration of the acute threat to health in order to protect personnel in the health services.
Respiratory masks are a form of personal protective equipment (PPE). They are subject to strict quality and performance requirements and, where they are intended for the European market, must be tested and certified by independent bodies. Only then may the manufacturer apply the CE mark to them and offer them for sale in Europe.
On 13 March 2020, the European Commission permitted the Member States to purchase respiratory masks for supply to skilled medical personnel even where the masks concerned do not bear the CE mark. This exemption from the normal rules is to be in place for the duration of the current Sars-CoV-2 pandemic, and is also conditional upon the respiratory masks assuring an appropriate level of safety and health. The test method developed by the IFA and DEKRA is intended to verify swiftly that this level is assured.
"The purpose of the test specification is for more respiratory masks to be made available as quickly as possible, and for the time required for testing of these products to be reduced to just a few days, i.e. to a fraction of the time required for the usual complex tests," says Dr Peter Paszkiewicz, head of the IFA's test and certification body. Absolute assurance of the necessary protective action would thereby be sacrificed in the interests of time savings.
Paszkiewicz: "We must emphasise that protective equipment intended for use during pandemics and tested against this specification does not constitute normal personal protective equipment in the sense of the European PPE Directive. It is intended as a last resort for health services personnel of systemic importance, and should be used only when approved respiratory masks, including those approved in countries outside Europe, are no longer available."
The IFA and DEKRA are offering the test with immediate effect. Other interested test bodies may contact the ZLS (the central body of the German regional authorities with responsibility for safety technology).
Paszkiewicz: "We are already planning additional test capacity of our own at the institute. At the same time, we are hoping to receive wide support from other competent bodies."