The MedTech Europe blog

Having been involved with the medical devices industry for many years, I’ve seen how the industry has evolved using innovative solutions and has constantly embraced technological developments. Recently however I had a friend on the receiving end of this technology and I hope you find his ‘patient case report’ below of interest – do note he also works in the medtech industry hence his knowledge on this subject:

“Firstly I’m thinking of starting an organisation named OHIHA. No, it’s not an expression from a cowboy western movie but ‘Oh How I Hate Acronyms’, mainly because I can never remember them! This is about patient safety and healthcare technology and with my advancing years the ‘old trusted ticker’ [heart] has been coming under a bit of strain recently and a number of investigations were recommended by my GP (General Practitioner), including an angiogram. Upon arrival at the angiography department I was provided with a ‘bar coded’ patient wristband (not another acronym; UPI – Unique Patient Identification?), at which point I started to think about ‘patient safety’. Half an hour before the procedure all the ‘risks’ were clearly explained; stroke, heart attack, excessive bleeding… Suddenly there was a power failure and the emergency generators started immediately, but only for lighting and other essential equipment, not the refrigerators containing drugs? This wasn’t mentioned as one of the ‘risks’. One nurse very kindly asked the patients if they had any spare money for the electricity meter, as the power failure might have been caused by funding cutbacks. Twenty minutes later the electricity supply was restored (without further patient funding) and everything was ready. I was surrounded with many bar coded medical devices, bar coded drugs, bar coded contrast media and I had my UPI. Patient safety (my wellbeing) was at the forefront of my thoughts again but then I discovered to my surprise (even horror) that another ‘risk’ had been completely overlooked, there were no bar code scanners in the department and none of the staff knew anything about bar coding. Fortunately the patient wristband had ‘back-up’ human readable information on it and I was ‘identified, verified and authenticated’ and the procedure went ahead (with no clinical complications I’m pleased to say).

Lying in ‘recovery’ I could see animated patterns, in my peripheral vision (a side effect of the contrast media), which reminded me about bar codes again. Suddenly, alarm bells started to ring. No, they weren’t in my head but there was a fire in another wing of the hospital, which had to be evacuated. During the next two hours I continued to see and think about ‘twinkly patterns’; most were ‘linear’ with a gradual change to ‘data matrix’, but after drinking lots of fluid (tea and water) the patterns gradually disappeared, which left me with the following thoughts; industry provides bar codes on medical devices and pharmaceuticals, regulators are regulating them (FDA, EU Commission…), working groups are working on them (GHTF…), standards organisations are standardising them (ISO, GS1…), trade associations are supporting them (Eucomed ETF(1)…), some countries are even localising them (but that’s another story and another major concern) and hospitals are printing them on patient wristbands but, when will all hospitals be properly funded and equipped to be able to use them effectively?

I then thought of how many other patients are faced with the same situation (and potential risks), not just in the UK but worldwide and I related this experience to Mark Neuenschwander(2), a world leading authority on bar coding and evangelist for patient safety. He said that it reminded him of a chapter from the children’s classic The Owl at Home entitled “Tear-Water Tea”. Owl decides to make tear-water tea. So he puts a teapot on his lap and thinks of very sad things. The resulting tears start to fill the pot. He thinks of books that will never be read, pencils that are too short to use and left over mashed potatoes that will never be eaten. Mark then wondered about bar codes that will never be scanned and added, “that would have filled Owl’s pot to overflowing”. Rather poignant as I was having to drink lots of fluids, including tea, to clear the ‘twinkly patterns’ but in reality we need to use them.”

There are so many benefits to UDI (Unique Device Identification) using bar codes containing GTINs (Global Trade Item Numbers) based on Global Standards (GS1); not just patient safety but supply chain efficiency, product traceability, EHR (Electronic Healthcare Records), anti-counterfeiting, reimbursement, cross border trading, authentication, eCommerce, etc.

Now, with a new European Directive ‘patient rights on cross border healthcare’, does this strengthen the need for EU wide standardisation for UDI using Global Standards (not local standards)? Just consider the following from the Directive; The Commission shall adopt measures to facilitate the correct identification of medicinal products or medical devices. Is this another step towards EU (European Union) wide standardised UDI? In today’s healthcare environment, Patient Safety has to be at the forefront of everyone’s thoughts and bar coding [UDI] is a technology that is proven and will help with this global initiative, as long as global standards are used.

I just hope that bar coding doesn’t remain in everyone’s peripheral vision but comes sharply into focus.

– Mike Kreuzer
Chairman of the Eucomed Taskforce on E-Business and Supply Chain Management (ETF)

(1) Eucomed ETF Task Force was established in June 2000 and in recent years has focused on the increasing needs, developments, policy and implementation of UDI. Read more

(2) On December 7th 2010 the Institute of Safe Medication Practitioners (ISMP) presented Mark Neuenschwander with their 10th Lifetime Achievement Award for his extraordinary contributions to medication safety.

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