It’s a medical device – isn’t it?
Jun 29 2016 Comments 0
Since 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 have to be fitted with a number of features, must be temperature mapped and have annual, traceable UKAS standard calibration. They are also, 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 and is certified to Directive 93/42/EEC.
ISO 13485 is, like ISO 9001, a statement of quality and even more importantly traceability, a bit like GMP 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 it’s quality and safety. 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 incident demonstrated, sometimes medical device standards were too easy to obtain. This loophole has now been firmly shut, but there is an even bigger area for confusion. Sometimes ISO certification is ‘borrowed’ from another product a company manufactures, so doesn’t cover the manufacture of the product, but some other aspect like inspection.
This means it is vital that ISO certification is checked thoroughly before purchasing. Under BSQR, SHOT and MHRA regulations all incidents, no matter how small, have to be reported. This means that detailed forms not only have to be completed by the blood establishment itself, but by the manufacturer of the product. If the ISO covers the manufacture of the product, the manufacturer will easily be able to give all the answers to this comprehensive questioning. If, however, the ISO refers to something other than complete manufacture, then this information will be harder or even impossible to find.
There is ambiguity as to whether blood banks etc. have to be medical devices as they only store products that are used inside a patient. But, if blood, platelets or plasma is not stored at correct temperatures in a safe environment the quality may suffer making it unsafe for use. To mitigate against this, it makes sense to only use blood fridges, platelet incubators and plasma freezers which are manufactured to medical device standard and have ISO 13485 certification. For extra peace of mind the ISO certificate should be checked thoroughly because it will show what the ISO 13485 accreditation was awarded for. If it shows manufacture, then you can be confident medical device standards apply to the whole of the fridge or freezer. Most manufacturers, like Labcold, expect this inspection and have them to hand.
The 2012 SHOT report showed blood transfusion safety in the UK is the best in the world. This is testimony to the hard work of the professionals who ensure the blood supply is as safe as possible. Despite the ambiguity with what is a medical device and what isn’t, it also makes sense to only procure blood banks, plasma freezers, platelet incubators and agitators that are certified medical devices and thoroughly check that the ISO refers to the manufacture. This simple step will help ensure that the all the hard work that makes blood transfusion so safe in the UK is fully supported by the blood product storage cold chain.
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