A study, published in Anaesthesia, has looked at aerosol boxes (used to protect healthcare workers) and exposure to airborne particles.
Prof Derek Hill, Professor of Medical Imaging, UCL, and an expert in medicine and medical device regulation, said:
“This paper illustrates the risks of introducing innovative but largely untested medical equipment into the healthcare frontline during the COVID-19 pandemic.
“The COVID-19 pandemic has resulted in a dramatic increase in demand for many types of medical equipment from personal protective equipment (PPE) to mechanical ventilators. These technologies are normally carefully regulated, with the manufacturer required to design and make the equipment in a very controlled way, and with rigorous testing undertaken (often according to an agreed international standard) prior to marketing. This regulated equipment can only be legally sold in normal times after being approved by the relevant regulator (e.g. CE marked in Europe or cleared by the FDA in the USA). Developing medical equipment in this way, however, takes many months or years. During the COVID-19 pandemic many national regulators have allowed new or modified designs of medical equipment to be rushed into the market, using a process called a derogation from the medical device or PPE regulations in Europe, and an emergency use authorization in the US. In other settings, hospitals and authorities have turned a blind eye to the introduction of non-approved medical equipment because of the need for solutions. These are pragmatic approaches but will inevitably have resulted in some equipment being used on patients or by staff that does more harm than good.
“The authors of this paper undertake a small-scale evaluation of some innovative equipment designed to protect staff from tiny infected droplets, for example generated when putting a COVID-19 patient on a ventilator. Their study suggests this novel equipment can in fact do more harm than good, and illustrates the risk of rushing medical equipment to the frontline during public health emergencies. Rigorous regulation of medical equipment remains key to ensuring safety of patients and staff.”
‘Measurement of airborne particle exposure during simulated tracheal intubation using various proposed aerosol containment devices during the COVID-19 pandemic’ by J. P. Simpson et al. was published in Anaesthesia at 23:01 UK time on Thursday 9 July 2020.
All our previous output on this subject can be seen at this weblink:
Prof Hill: no conflict of interest