PAUL EDWARDS – VICE PRESIDENT MEDICAL GASES, AIR LIQUIDE HEALTHCARE MEDICAL GASES
Assessing the quality of on site medical air
A number of standards include system design guidance to help acute care facilities achieve a reliable supply of medical air, but they do not look at how to measure and ensure product quality. However, healthcare facilities producing medical air must now conduct a quality risk assessment and where necessary, continuously monitor quality.
In North America and Europe, most acute care facilities produce medical air on site. It’s a simple process and much cheaper than using commercially produced high-pressure cylinders. Canadian Standards Association (CSA), National Fire Protection Association (NFPA), International Organization for Standardization (ISO) and Health Technical Memoranda (HTM) standards all offer system design guidance to achieve supply reliability, and in north America the prevailing CSA and NFPA standards prescribe a baseline product quality equivalent to the United States Pharmacopeia (USP) specification for medical air. However, it is the last point that the
standards do not address. They prescribe quality but remain silent on how to measure and ensure product quality. With the objective of filling this gap, since launching the aerALin quality control service in 2014, Air Liquide Healthcare has routinely notified the CSA of measured quality incidents. As a result, in the 2017 edition of Canada’s medical gas pipeline systems standard Z7396.1, there is a new requirement for healthcare facilities producing medical air; they must now conduct a quality risk assessment and where deemed in the best interests of patient safety, employ continuous quality monitoring with the means to prevent off- spec product from entering the pipeline. So how does one go about assessing
product quality risk? The most common approach starts with three questions: l What can go wrong? l What is the likelihood that something will go wrong?
l What is the severity or impact, should something go wrong?
Answering the first question can be as simple as looking outdoors. On site medical air quality is linked to outdoor air quality. Smoke from a forest fire, a vehicle exhaust, a power generator or industry near and far may influence the air
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On site medical air quality is linked to outdoor air quality.
drawn in by medical air compressors. While standard medical air filtration does a reasonable job of blocking fine particles, it does little to filter chemical impurities. Therefore, the answer to the first question is, a whole host of things that are outside the control of the producer. So, what is the likelihood that product quality will drift out of bounds? Through a quality control service, the authors have amassed over 60 million data points that show:
l quality breaches occur without warning, day and night
l most breaches last less than 10 minutes, while some persist for days
l the most common breach is CO2 > 500 ppm
l root causes range from production methodology to variable outdoor air quality
l quality breaches have occurred at every site they monitor, rural and urban.
Paul Edwards
Paul Edwards, vice president medical gases, Air Liquide Healthcare, has been actively involved in the medical gas industry since 1991. He is a long standing member of the CSA Z251.20 technical sub-committee responsible for medical gas standards and is an active member and strong supporter of CHES. Paul is recognised as a pioneer in quality
control for gaseous drugs produced on site. He has championed the cause through lectures across Canada, the US and Europe, and has been published in the Canadian Healthcare Facilities Guide and the 2016 IFHE Digest.
IFHE DIGEST 2018
©Jean-Paul Bounine/Fotolia
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