BLOOD MANAGEMENT
‘It’s got an ISO hasn’t it?’ – Why it is important to check ISO certification before procurement
Michelle Rogers from Labcold discusses why the correct ISO certification is important for the safety of the blood product cold chain.
S
ince the introduction of the UK Blood Safety and Quality Regulations, the
correct storage of red blood cells and other blood products, such as plasma and platelets, has been heavily regulated. This is why all refrigerators, freezers and incubators that store blood products like red cells, plasma and platelets now have to be fitted with a number of features, such as dual refrigeration and alarm systems. They are also now, under EU rulings, classed as ‘borderline medical devices’. This means any new blood refrigerator, plasma freezer or platelet incubator should come from a manufacturer that holds ISO 13485.
ISO 13485 is, like ISO 9001, a statement of quality and – even more importantly – traceability, a bit like GMP (Good Manufacturing Practice) is for pharmaceuticals. It means that the manufacturer of the equipment can trace every component back to source in the finished product and be able to attest to its quality and safety. This is an important consideration when that piece of equipment is storing expensive blood products required for life-saving treatments.
However, this is not as simple as it might seem. For example, as the PIP breast implant incident demonstrated, sometimes medical device standards were too easy to obtain. This loophole has now been firmly shut by the EU, but there is an even bigger area for confusion: sometimes ISO certification is ‘borrowed’ from another product a company manufactures, or
doesn’t cover the manufacture of the product, but some other aspect of the product.
This means it is vital that ISO certification is checked thoroughly, especially when storing blood products, because under BSQR and MHRA regulations, all incidents have to be reported. This means that detailed forms not only have to be completed by the blood establishment, but by the manufacturer of the product. If the ISO covers the manufacture of the product, the manufacturer will be able to give the MHRA answers to this comprehensive questioning so it can ascertain what caused the problem and, if possible, put in place procedures to mitigate against re-occurrence.
If, however, the ISO refers to something other than complete manufacture, then the answer will be harder to find.
There is a lot of confusion as to whether blood banks etc have to be medical devices, as they only store products that are used inside a patient. However, it does follow that if the blood or plasma is not stored at correct temperatures, in a safe environment, the quality may suffer, making it unsafe for use. So, it makes sense to only buy cabinets with ISO 13485 certification.
If you purchase one that is ISO 13485 certified for manufacture, then you know it is compliant with all the blood regulations and that every component part is fully traceable. For extra peace of mind, it is worth checking the ISO
certificate thoroughly. Most manufacturers expect this and have them to hand. Then you can see that it is current, covers the product in question and concerns the manufacture of said product, not just some aspect of it like final inspection.
The 2012 SHOT (Serious Hazards of Transfusion) report showed blood transfusion safety in the UK is the best in the world. This is testimony to the professionals dedicated to ensuring the blood supply is as safe as possible and has also resulted in cost savings, as everything from blood fridges to tracking systems have been developed and improved to resolve and prevent issues.
It therefore makes sense, despite the ambiguity over what is a medical device and what isn’t, to only procure blood banks, plasma freezers, platelet incubators and agitators that are certified medical devices and to thoroughly check that the ISO refers to the manufacture. This simple step will help ensure that all the hard work that has made blood transfusion so safe in the UK is fully supported by the blood product cold chain.
Michelle Rogers FOR MORE INFORMATION
E:
marketing@labcold.com W:
www.labcold.com
national health executive Sep/Oct 14 | 67
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