Protective clothing in pharamcy and medicine

The new PPE regulation and its relevance to the handling of CMR drugs and potentially infectious materials

For 20 years, users of certified personal protective equipment (PPE) have been able to rely on their products meeting basic health and safety requirements. The PPE Directive 89/686/EEC, in force since 1989, created the conditions for a uniform level of design and testing throughout Europe, which has contributed significantly to the reliability of individual protective measures.

However, over the years, vagueness in the wording and changes in the requirements for market and product surveillance have made it necessary to revise the directive. With the last transition period, the PPE Directive will therefore expire in April 2019. Two years earlier, the new PPE Regulation (EU) 2016/425 came into force as its successor. More detailed, more precise and more binding than its predecessor, it now regulates the design, provision and free movement of PPE within the European Union.

The following article shows the significance of the new provisions for personal protective equipment when handling CMR drugs and infectious materials.

Authors of the article: Michael Klein and Tobias Mürdel, D-Elmshorn

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Protective clothing in pharmacy: The new PPE regulation