The personal protective equipment (PPE) purchased at the national level during the COVID-19 crisis for use in the healthcare sector only partly met the required standards of quality. These findings are from research conducted by RIVM, which included testing of various personal protective equipment between March and October 2020. In particular, the quality of respiratory protection devices (FFP2 and KN95 respirator masks) and surgical face masks (type IIR) was insufficient.

Only 22% of the FFP2 and KN95 masks and 14% of the Type IIR masks were fully compliant with PPE requirements. For example, respirator masks were not always properly fitted; without a good seal on the face, they provided insufficient protection against virus particles. In addition, the isolation gowns and gloves tested by RIVM were not always waterproof. Moreover, product quality sometimes varied significantly within the same batch, even though the products were the same according to the description on the packages.

No full assessment procedure

RIVM tested and assessed the products at the request of the Ministry of Health, Welfare and Sport (VWS). This happened between March and October 2020. Due to the severe shortages, there was no time for a full assessment procedure during that period. Working with various parties, an abbreviated assessment procedure was therefore set up which approximated the prevailing standards as closely as possible. The procedure has undergone further development along the way.

Quality assessments as advisory input for LCH

The quality assessments were provided as advisory reports to the Ministry of Health, Welfare and Sport, and later to the National Consortium for Medical Devices (LCH). Due to the shortages, LCH purchased these medical products centrally for the Netherlands. LCH decisions on purchase and distribution of the products were based in part on the advisory reports from RIVM. LCH determined which products were assessed by RIVM. In total, RIVM assessed approximately 2,500 batches provided by LCH.