Volunteers who have sacrificed time and money to make the NHS free PPE now have to pay more than £4,000 to prove it is up to standard, due to new regulations.
Hack the Pandemic is a group of creatives who have set up a pop-up PPE (personal protective equipment) factory, at Emersons Green Village Hall near Bristol.
They volunteered their services in response to a lack of protective equipment for staff on the coronavirus frontline, and have since made about 10,000 pieces of PPE including face shields and clips.
Staff at hospitals, care homes, pharmacies and GP surgeries in the Bristol and Bath area are among those to benefit from their donations, but new regulations to control the quality of PPE have come into force this week.
It means any volunteer groups who want to continue supplying to NHS staff will have to submit their designs to the government-approved standards bodies, to gain the correct accreditation and stamp of quality approval.
This process will take a minimum of two weeks and will cost more than £4,600 including VAT, according to Hack the Pandemic co-founder Edward Clyne.
'Red tape'
Speaking in an emotional video posted on Facebook today (May 14), he said: "Multiple [volunteer] groups across the UK ceased to exist due to this new regulation.
"We have an obligation to get this certification done and get these things out on the frontlines no matter what obstacles we face.
"We are going to battle through it, push the red tape out the way, go through it if we have to and make this work."
The Bristol group relies solely on donations from supporters to fund their operation, and they have raised more than £17,000 so far on their JustGiving page.
Mr Clyne said in the video: "It's very frustrating. I'm so sorry that the money you've donated has to go to a bureaucratic process, as opposed to directly spent on PPE.
"Unfortunately, bureaucracy costs lives. We are now unable to provide our PPE to NHS frontline workers or any National Health Service staff full stop.
"It's painful to know that if we get certified, at least 9,000 units are not going to be making it to the frontlines because the money has to go elsewhere."
He said the factory will continue making PPE for other key workers, however, and hopes to resume operations for the NHS once accreditation has been gained in a couple of weeks.
Although he said the restrictions were "massively upsetting", he said he understood the need for quality control and that not all PPE donations were of a high quality.
He added: "We will be pushing ahead and paying that money for the certification, as we need to get it to those NHS staff."
A document detailing the specification for PPE, published by the Office for Product Safety & Standards, is available on the government's website.
It states: "To limit infection from COVID-19, PPE must be effective in guarding against specific risks, for example from contact with anything the virus is on or from infected breath, coughs or sneezes.

"It is your legal responsibility to ensure that any PPE you supply is effective in guarding against the risks it is designed for."
Mr Clyne, who set up the group with Paul Haines, said he was confident the PPE being produced at Emersons Green was of high quality and that the restrictions were "blocking PPE from reaching our medical heroes".
The group is seeking accreditation from one of the government-specified standards bodies, the BSI Group, which has been approached for comment.