Ensuring safe PPE and supporting new manufacturers
PPE has long-established standards and test guidelines, and in some cases CE marking. If the equipment is to protect other people, not just the wearer, then is must comply with the medical devices directive which has more stringent requirements. During the COVID-19 pandemic new manufacturers of PPE were established and existing companies turned their manufacturing capabilities to PPE. In addition, schools, universities and other organisations with 3D printers produced head bands for the face shields.
NPL worked with new suppliers to fast-track prototypes, test them and then improve the design. This ensured that the new, better-designed products got through the testing process first time and received certification. NPL also provided testing guidance to other manufacturers and hospitals, and liaised regularly with Notified Bodies (NB), which were extremely busy with PPE testing.
During the COVID-19 crisis there were issues around false certification and misleading information about PPE, as well as production from companies with limited experience. NPL helped the NHS to assess PPE and make informed decisions on accepting or rejecting donated equipment.
NPL also created ‘test heads’ for testing new face shield designs, both our own and for other organisations. These rigs tested against critical aspects of the ISO 14683 standard and BS EN 149, and helped new manufacturers to test their products prior to formal testing and CE marking by NBs. They also provided additional data on how well items performed, rather than just a simple pass/fail, to help manufacturers to develop better PPE. Face mask ear bands were 3D printed by NPL, with wearer comfort being the priority.
NPL North of England provided consultancy to companies, often SMEs, to help them understand the standards. They also worked with the PPE Make team at BEIS to share information and maximise production of safe equipment.
We are also involved in the determining whether PPE could be effectively cleaned and re-used and specifying the cleaning process and protocols. This involved looking at changes in material properties, and hence performance, during and after cleaning, particularly due to chemical effects.