Consultation on Covid-19 PPE for Healthcare and Other Key Workers
This paper is intended to provide useful directions for new manufacturers of Covid-19 PPE for healthcare and for other key workers. The OPSS PPE Legislation Guidance for Businesses (PPE Regulations) includes guidelines for importers, but this category is not addressed in the current research paper. This is a research paper and it is advised you seek and consult the relevant legal and professional advice for manufacturing PPE equipment.
The Office for Product Safety & Standards (OPSS) has released in April 2020 guidance for Businesses in regards to the Personal Protection Equipment (PPE) Regulations and for new high-volume of Covid-19 PPE manufacturers.
While we have not found official guidance for small scale and home-made manufacturing of PPE, the OPSS guidance for high-volume PPE manufacturers says that this type of manufacturers can follow the same principles. We understand this applies in lack of other official guidance sources. Producers of PPE might commit an offence and can be penalised if the PPE is donated or sold without approval. New garments such as scrubs produced with the intention to help key workers during Covid-19 without conformity assessment from a Notified Body or in an organised Governmental/NHS purchase or donation, can be considered isolation and social distancing measures/tools but not PPE.
The PPE Regulations have been changed during 2020 Covid-19 outbreak to accelerate the availability of PPE for healthcare workers and for other front-line staff. All PPE must be designed and manufactured in accordance with the essential health and safety requirements. The British Standards Institution (BSI) has made available for free the relevant regulations for Covid-19 PPE manufacturing and testing during the pandemic. Cabinet Office and the Department of Health and Social Care have released the technical specifications for Covid-19 PPE. They include: examination gloves, growns and protective coveralls, surgical face masks, respirator masks, eye protection, aprons and body bags. The product-specific regulations mentioned in these specifications can be found on the BSI portal informed above. The Public Health England has released recommendations of PPE use for healthcare workers for the correct use of PPE by the NHS workers (check tables). We advise that the regulations, specifications and standards informed in this paragraph to be checked in parallel for Covid-19 PPE manufacture planning to be in conformity with essential health and safety requirements, as a minimum.
Following the updated PPE Regulation published by OPSS in April 2020, Covid-19 PPE can be produced without CE certificate on the duration of the pandemic and for healthcare sector only, and there are two routes for PPE approval, according to the OPSS guidance for new high-volume PPE manufacturers:
1) Covid-19 PPE purchased or donated to the Government/NHS for NHS workers use (not to be donated or sold on the wider market)
Where PPE necessary for protection in the context of the COVID-19 outbreak is being manufactured for healthcare workers and being purchased by the Government/ NHS bodies, it can be purchased without conformity assessment by a Notified Body. Such products may not be placed on the wider market. PPE in an organised purchase or dotation to the Government/NHS must be approved by the Market Surveillance Authority (Health and Safety Executive (HSE)), and manufacturers interested have to submit their offer on the cross-Government Decision Making Committee webform: https://www.gov.uk/coronavirus-support-from-business.
2) Covid-19 PPE donated or sold on the wider market for healthcare workers (not purchased or donated to the UK Government/NHS for NHS use)
A manufacturer must have contacted a Notified Body which can assess for Covid-19 PPE (list of UK Notified Bodies on p.7-9 of this OPPSS guidance) and begun conformity assessment procedures (simplified product testing) before PPE specifically, necessary for protection in context of COVID-19 outbreak can be placed on the market. Conformity assessment procedures must be completed as soon as possible.
Offer application for Covid-19 PPE purchased by or donated to Government/NHS
To enable the cross-Government Decision-Making Committee to assess the COVID-19 related PPE, manufacturers have to register interest on the webform at https://www.gov.uk/coronavirus-support- from-business and sent the Committee relevant documentation, including any test reports, that shows that the PPE has been designed and manufactured in line with a relevant European Standard, or a standard referenced in the WHO guidelines, or an alternative technical solution that delivers adequate safety. Applicants will be told where to send that documentation by the Government/NHS purchaser who replies once the interest is registered.
REFERENCES / HYPERLINKS USED IN THE PAPER
EU REGULATIONS FOR COMPLIANCE
Specific: https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/medical-devices-ppe/
COMMISSION RECOMMENDATION (EU) 2020/403
https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1584482018128&uri=CELEX:32020H0403
UK GOVERNMENT TECHNICAL SPECIFICATIONS/COMPLIANCE WITH EU REGULATIONS
PHE RECOMMENDATIONS OF PPE USE FOR HEALTHCARE WORKERS (TABLES)
https://www.gov.uk/government/publications/wuhan-novel-coronavirus-infection-prevention-and-control
GOVERNMENTAL GENERAL GUIDANCE
https://www.hse.gov.uk/news/face-mask-equivalence-aprons-gowns-eye-protection-coronavirus.htm
OPSS GUIDANCE FOR NEW HIGH-VOLUME PPE MANUFACTURERS
OPSS PRODUCT SAFETY LAW: COMPLIANCE ADVICE FOR MANUFACTURERS AND IMPORTERS
https://www.gov.uk/guidance/product-safety-law-compliance-advice-for-manufacturers-and-importers
Coronavirus (COVID-19): personal protective equipment (PPE) hub
https://www.gov.uk/government/collections/coronavirus-covid-19-personal-protective-equipment-ppe