BMTA Newsletter BMTA Newsletter - Spring 2020 | Page 16

bmta.co.uk
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.