Technical and safety practices - Case Study
Safety is absolutely paramount in the medical industry, with lives literally at stake if something were to go wrong. Regrettably, this was more than reinforced recently following the tragic news of a death of a newborn at a hospital in Sydney, Australia, after it was mistakenly administered nitrous oxide (N2O) instead of oxygen (O2) in July this year.
A tragic occurrence of similar circumstance was literally the reason behind UK-based Bedfont Scientific’s establishment in 1976, with Chairman Trevor Smith emphasising, “It is crucial to have the correct technical and safety practices in place. To put it bluntly, it is a matter of life and death.” After a patient at a London hospital was administered N2O instead of O2, Bedfont invented the TM3 Gas differentiator – a simple device which could differentiate the two gases and ensure there were no cross-connections.
This range has developed over the years and now Bedfont’s entire Medi-gas Check range safeguards patients and staff in accordance with the strictest legislation. Smith continued to stress, “Safety practices in the medical gas sector are the reason Bedfont exist; we strive to have the one-stop-shop for all medical pipeline testing needs so that all safety and technical procedures concerning the verification and validation of piped medical gas can be undertaken safely and efficiently with our trusted products.”
With this philosophy in mind, the UK-based business has released two devices that specifically cater for the medical market with safety practices for patients and health professions at the heart of their design – the G200 and G210 gas detectors. The G200 leak detection device acts as a personal portable alarm, providing the user with time weighted exposure to N2O, whilst the G210 accurately measures N2O as well as O2, carbon dioxide (CO2) and carbon monoxide (CO), verifying gas quality and impurities.
As Smith explains, “The Medi-gas Check range not only verifies the quantity of gas and makes sure there are no leakages, it also validates the quantity of gas, making sure the right gas and concentration is administered to the patient.”
But what is driving developments for safety practices for Bedfont now? “Most recently, we have discovered that it is sometimes difficult to monitor medical gas leakage, particularly in the neonatal sector,” said Smith. “Whilst we cannot prevent the leakage, by monitoring the anaesthetic gas it can notify you about a leak so that you may resolve the issue; perhaps by using scavenging systems whilst providing a time weighted average of exposure.”
Citing ‘safety in our products’ as one of its core company values, quick test valve and connector manufacturer FasTest, Inc. is currently developing electronic sensing capabilities in its medical connectors, having most recently launched ‘Connection Verification’ – a programme in which a FasTest connector is able to send a confirmation signal to the control system that a secure connection has been made. The controller can then initiate a leak test more quickly, resulting in a faster cycle time as well as eliminating one source of a ‘false signal’ if there is a system problem. Since its foundation in 1985, FasTest has developed an entire range of medical and general purpose leak connections dedicated to making reliable, leak-free and easy to use connections to common threaded, luer style and medical tubing.
Currently, the US-based business is developing solutions to accommodate new ISO 80369 type connectors. When asked how important it is to have the correct technical and safety practices in place in the medical sector, Thomas Braun, Vice-President of Product & Business Development at the company, exclaimed, “As a general statement, very!”
However, he went on to say, “The two most common impediments that we see are a lack of knowledge of ‘best practices’ and a fundamental misunderstanding of the ‘cost of quality,’ meaning that medical device manufacturers will often balk at the perceived ‘high’ cost of a precision test connector but fail to take into account the true cost of a failure – this oversight is multiplied many times over if the ‘failure’ of a device would result in harm to a patient.”
“As such, the main drivers for FasTest are the consistent drive towards higher quality and consistency from the manufacturer, which in turn drives increased testing, and the trend towards outsourcing of speciality tools and devices versus in-house ‘jerry rigging’ – of poor quality – to companies with expertise in producing highly reliable tools for specific applications such as FasTest.”
Another company that credits its success to “the safety provided by our products” is Ceodeux Meditec, the dedicated medical gas equipment manufacturing business unit of Rotarex SA. The unit’s Medical Division Product Manager Adrien Zoda underlined, “Safety and reliable performance are the primary considerations for medical gas applications. People’s lives are at stake. The product must perform consistently to administer O2 at the correct pressure and flow under any condition – and be so easy to use, that even untrained personnel can use it correctly. So Ceodeux Meditec strives to create designs that are ‘aesthetic’ and ‘human’ as much as they are functional.”
Ceodeux Meditec puts this tried and tested design process down to ‘attention to detail’ and the incorporation of the ‘unmatched’ manufacturing quality infrastructure from parent company Rotarex. Most recently, the company has released an intelligent valve integrated with pressure regulator (VIPR) called The Life+, employing digital technology for safer and easier usage, as well as an automatic, digital switchover board called the e-AlpiSwitch. With digital capabilities and strict testing procedures currently governing the company’s core manufacturing processes, Zoda described, “Manufacturing quality processes certified according to ISO 13485:2003 Medical Device standards are implemented across all valves and regulators as a matter of course. Every product that leaves the factory must pass a 12-point performance test to confirm the product performs perfectly, so caregivers can focus on saving patient lives with confidence that their gas equipment will do its job as if it were a matter of life and death.”
The Belgium-based corporation highlighted several critical elements driving trends in safety and technical practices, including patient and caregiver safety, reliable and continuous performance, productivity, value-added technology, and global breadth and responsiveness.
Responding to these trends, Ceodeux Meditec has “consciously widened the breadth of its range, beyond its historical focus on cylinder valves,” so it can now provide complete medical gas supply systems for hospital applications. Zoda continued to explain, “As the big global gas producers become increasingly global through acquisition, they increasingly need a supplier who can match their footprint and provide proven product solutions across their entire global network in all standards. This complexity is a drain on productivity and a risk for safety. Ceodeux Meditec recognises this trend and has actively been working to expand its product breadth and range of available standards to become a onestop- shop.”
So with lives hanging in the balance, how will future developments affect safety and technical practices? Zoda believes the answer lies in standardisation. “The medical sector remains very fragmented with each country continuing to enforce its own standard,” he stated.
“Manufacturers must deal with greater complexity and it takes more time and resources to adapt new technology to each market – often requiring certification or validation by authorities in every local jurisdiction. So we believe the medical sector will benefit from harmonisation, removing an important barrier to innovation and lowering costs.”
But on broader scale, Smith brought it back to basics and concluded, “Technical and safety practices can be improved if anywhere that uses piped medical gases implemented more regular and thorough checking of the gas they are working with – whether it be checking their exposure to the gas or that the right gas is being used for the right purpose.”