April 2, 2020

COVID-19 UK: Healthcare update and regulatory considerations

There has been an impressive response from non-medical device companies to the demand for medical equipment in the face of the current COVID-19 pandemic. Dyson has reportedly designed a new ventilator in 10 days; Mercedes Formula 1 team have been involved in creating a CPAP breathing aid in under a week; and UK manufacturers, such as Airbus, BAE Systems, Ford, Rolls-Royce and Siemens, have formed a consortium to deliver ventilators to the NHS during the crisis.

Medical device development is often a lengthy process and can take several years. Even then, things can and do go wrong, which can lead to complex product liability litigation against manufacturers. In a global health emergency however, time is a luxury that manufacturers, healthcare providers and patients just do not have. 

How then can manufacturers who want to play a vital role in the face of a global health crisis ensure their devices are safe, when the clock is ticking?

Regulatory considerations

The Medicines & Healthcare products Regulatory Agency (MHRA) have issued helpful guidance for manufacturers, including specifications for rapidly manufactured ventilators and CPAP systems. The guidance sets out the minimum clinically acceptable requirements for such devices. 

Notably, the MHRA accepts that full compliance with certain standards is unrealistic in the current time critical situation. However, compliance with the essential safety standards must be demonstrated for patient safety.

The MHRA do not anticipate that devices will be CE marked. Instead, MHRA approval will be through the “Exceptional use of non-CE marked medical devices” route. This allows the MHRA to authorise manufacturers to supply non-CE marked devices in the interest of the protection of health.

Importantly, after the pandemic, these devices will not be eligible for use in routine patient care, unless they have been CE marked. 

Insurance

Those stepping into the medical devices manufacturing arena for the first time should also ensure they have appropriate insurance in place. Whilst many manufacturers will already have product liability insurance cover, that coverage may not extend to medical devices used in a life or death situation. That is particularly so if the device falls outside the manufacturer's normal business.

Legal implications

Manufacturers must also be live to the legal implications of rapidly manufacturing medical devices. 

The Consumer Protection Act 1987 governs liability for "defective" products. A product is defective under the Act if its safety is not such as persons generally are entitled to expect. This test is an objective one. In determining what persons generally are entitled to expect, all circumstances will be taken into account, including the manner and purposes for which the product has been marketed and the time when the product was supplied. 

Ordinarily, one would expect the level of safety which the public is entitled to expect to increase over time. As time goes on generally safety standards will improve as manufacturers innovate and improve upon previous designs. However, during a time of national crisis it is to be hoped that the courts would interpret the Act so as to allow for a potential lowering of the expected standard. Otherwise the law could act as a deterrent to the benevolent manufacture of potential life-saving products.

Authors: Duncan Batchelor and Megan Lafferty