· 3 min read
NSF’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.
NSF’s Senior Director of Health Sciences James Pink is now supporting both medical device manufacturers and industries not usually involved in medical devices (such as automotive, aerospace, defense and consumer electronics) to rapidly scale up the manufacture of life-sustaining oxygen ventilators.
As part of a government industry liaison initiative, Pink has been on-site at various locations across the UK. His support includes advice on product safety, regulatory compliance and the quality systems requirements necessary for the emergency use authorization to place rapidly manufactured ventilators into the National Health Service.
“I am providing project teams with real-time guidance relating to design verification and validation, operations and product quality assurance requirements as well as risk-based decision making. COVID-19 has also created a new dimension in ‘clinical benefit over risk’ as the demand for components greatly exceeds supply,” said Pink. “This makes it harder to achieve the necessary level of safety as hard choices on material provenance, safety and reliability become the forefront of our concerns.”
Pink is also helping technical and operations teams understand the Medicines and Healthcare products Regulatory Agency (MHRA) specifications and essential ventilator performance requirements with respect to performance, function, safety and user requirements. “These requirements include rules around the delivery of the necessary breathing volume and pressures, and the ability to deliver ‘clean’ oxygen through the patient breathing circuit and in a way that is safe, effective and able to be manufactured reliably at scale,” said Pink.
As well as advising industry on product development and scale-up operations, Pink is also helping to ensure that manufacturers tasked by the government cabinet office are capable of meeting the stringent conformity assessment criteria defined by the MHRA such as technical documentation reviews, type tests, service evaluations and quality systems assessments necessary to place a life-sustaining critical care medical device into service for COVID-19 initiated acute respiratory distress syndrome.
NSF Executive Director of Health Sciences Robyn Meurant has also been instrumental in the global life-saving effort by establishing crucial connections between UK ventilator manufacturers and the World Health Organization department associated with local production of needed health products. The devices offer resource-limited countries the real possibility of manufacturing their own ventilators as an alternative to expensive, highly engineered solutions.
Meanwhile, Laboratory Director Simon Warburton from NSF’s water testing lab in Wales has helped by identifying safe alternative suppliers for the various pipes and fittings used for oxygen ventilators through his extensive knowledge of the pipe and fittings supply chain.
“This is the fastest-moving new product introduction process I have experienced in 25 years of safety critical design and manufacture,” says Pink. “I am being entrusted by government advisory bodies, regulators and industry to help identify and prioritize the critical path for manufacturers to achieve ‘emergency use authorization’ and meet the stringent but proportionate tests, trials and quality system requirements necessary to expedite safe and effective devices in such an unforgivably short timescale.”
“NSF has unique expertise that is invaluable in the battle against COVID-19 and the pervasive human health risks because of our deep regulatory and industry experience,” says Pink.
“There are so many people in our organization that advise on emergency use authorization, safety of essential products and infrastructure, vaccine and test kit clinical studies and have the essential auditing, testing and consulting expertise to help navigate complex supply chains and product safety decisions, be it in food, water or health care products.
Find out more
More from the BBC on ventilators and the UK’s battle to save lives