COVID-19: Breathing Life into Increasing Ventilator Production is Constricted by Regulation

The COVID-19 Virus is a fast-changing emergency situation, with Taoiseach Leo Varadkar having warned that we are in “the calm before the storm”.  HSE Chief Executive Paul Reid has stated that this pandemic is going to put an unprecedented strain on the resources of the HSE, especially as the number of serious cases rise.  When that happens, access to ventilators, to help critically ill patients breathe, is a vital part of patient treatment.  A very significant percentage of the ventilators used in acute hospitals worldwide are produced in Ireland by manufacturers such as Medtronic and others.  The HSE has agreed the supply of another 900 ventilators to add to the 1,229 it already has, but even at that, there are concerns that more ventilators will be needed.

It is possible that like in the UK, our government may ask non-medical manufacturers to turn their attention to manufacturing medical devices for the HSE.  There are issues relating to the supply of the component materials necessary to manufacture the medical devices, however this logistical issue is not the only hurdle which needs to be cleared in order to enable mass-manufacturing.

Medical Device Regulation

There are a plethora of requirements which companies must comply with in order to put medical devices, such as ventilators, on the market.  If a company was to offer its services to help manufacture devices for the HSE, then they should be aware of the onerous obligations they will be subjected to under the regulations.

Manufacturers will be aware of ISO 9001, which is an international generic quality management standard for the production of all goods.  Medical devices have a further standard to comply with, ISO 13485, which is an expanded framework specifically adapted for medical device manufacturers to ensure that their products are fit for the market.

The Health Products Regulatory Authority (“HPRA”) regulates medical devices in Ireland.  The governing legislation is in a transition period with the Medical Devices Directive (in place since 1993) being replaced by the new Medical Device Regulations in May 2020.  These Regulations intend to further strengthen the standards required for medical devices thus increasing patient safety and ensuring medical devices are suitable for their intended purpose.

Under the regulatory framework, ventilators are categorised as “Class II” medical devices.  The classification system ranges from Class I to Class III, this system assigns a level of risk to the device and has implications on how much testing is required prior to being released to the market.  Class III devices undergo the most strenuous testing prior to release due to higher risk.  Ventilators must be approved by a notified body (designated by the HPRA) which in Ireland is the National Standards Authority of Ireland (“NSAI”) who carry out a conformity assessment for the product.  The notified body will issue a CE certificate which indicates conformity with the regulations.  The CE certificate will only be issued when the notified body is satisfied that the manufacturing process and the quality management systems comply with the regulations.  After the CE Certificate is issued the device may be put on the market.

Obligations on Manufacturers

Even after a product is on the market, the manufacturer is under an obligation to ensue the product is safe for use.  Manufacturers must undertake post-market analysis and if there are any serious incidents involving their product they must be swiftly reported to the HPRA.  The HPRA has the authority to attend premises in order to inspect products, manufacturing processes and testing arrangements.

It is clearly not a straightforward endeavour to produce medical devices due to the strict constrains of the regulations.  Emergency exemptions to the current framework could possibly be brought in if manufacturers were required to produce ventilators in order to help the HSE cope with COVID-19 cases.  These specific regulations are only part of the legal issues such companies would have to consider, other issues include employee safety standards for medical device manufacture, licensing, insurance and the impact on their ability to carry out existing customer contracts.

How we can help

BHSM’s Healthcare and Life Sciences Department offer practical legal and regulatory compliance advice to a variety of clients across the medical devices sector.

If you have any queries or concerns, or would like to discuss the above in further detail or generally in relation to COVID-19, please feel free to contact David Scott in the Healthcare & Life Sciences Department of BHSM on 01 440 8300 / dscott@bhsm.ie.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.