BMTA Newsletter BMTA Newsletter - Spring 2020 | Page 16 COVID-19 BUSINESS REACTIONS HSE has recently contributed to fresh guidance aimed at new manufacturers of personal protective equipment (PPE). Written in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), the document sets out requirements for the high-volume manufacture and supply of PPE and medical devices to the UK by those companies new to manufacturing PPE who are joining in on the national effort to protect health and care workers from Covid-19. Normally, such products must meet requirements set out in legislation and hold a valid CE mark before being placed on the market or put into service. While there have been adjustments to the process, the priorities of safety and ensuring protective equipment actually protects have not changed. Given the unprecedented global demand for PPE, healthcare supply chains and government agencies are working in close cooperation to ensure that the most appropriate PPE and medical devices ensuring adequate protection are made swiftly available to those who need it most during the Covid-19 threat. The European Commission has also issued a recommendation to speed-up the uptake of new products. In response, HSE has established a specialist PPE Unit made up of regulatory inspectors, policy makers and scientists. It has been evaluating materials and specifications against relevant PPE requirements, to rapidly provide agreement that new and novel sources of supply have been properly assessed and can be deployed to frontline workers without unnecessary delay. We are working closely with the Department for Health and Social Care, as well as Public Health England, the NHS and other Government departments, to provide our expertise in managing workplace risk and our knowledge of PPE material science and regulations to help the Government’s aims to ensure there is a continued supply to where PPE is needed. We are supporting a number of pharmaceutical companies with continued and additional calibration of key test equipment. Several have written to us for assurance that we will be able to continue to provide these services for the foreseeable future. GTMA have been in touch as they have a group of companies working together for supply of CPAP devices. Trescal have been asked to help test flow rates and oxygen levels for these devices. Some existing customers in automotive and aerospace industries are diversifying to new developments to support ventilator manufacturer and are asking for calibration of alternative or new test equipment. We have also had a number of new customers approach us as some smaller calibration companies have temporarily closed or have key staff unable to work. Trescal are not without our own challenges, but with a large number of labs and duplicate capabilities strategically placed across the UK, supported by our own logistics network we are continuing to provide calibration services to the UK market. Engineers are working shifts in line with some customer patterns, to minimise the number of staff in close proximity. Staff that can work at home are doing so and we have extended our IT capabilities to cope with additional demand. Plus with have additional cleaning practices in place, additional risk assessments and safe working practices and restrictions on travel, customer visits and visitors in general. Markes International are specialists in sampling and analysis of vapour phase organic compounds emitted from products and materials. As manufacturers of products used against COVID- 19 this is a challenging time for testing facilities stepping up to support manufacturers to create safe products. As an analytical instrument manufacturer, one area we may be able to help is on the specifics of sampling and analysis of chemical contaminants in breathing pathways emitted from respiratory medical devices i.e. ‘Chemical Characterisation’ as discussed in ISO 10993 series and specifically ISO 18562. These standards are intended to be used as a product conformity test, to identify any chemicals of concern, such as potential carcinogens, irritants and sensitising compounds. We would like to offer any support we can to help you with your mission to manufacture and/or test these vital products. With that in mind we are happy to offer: Advice on how to implement relevant standard methods /regulations i.e. ISO 18562 Prioritised support services and on-line training for those using Markes Instruments to carry out testing for devices used in the fight against COVID-19 Connect manufacturers with local test facilities Help general material emission test labs with Markes instruments adapt to the relevant medical device test methods.