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  • It’s a medical device – isn’t it?

It’s a medical device – isn’t it?

Jun 13 2018 Read 1448 Times

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, regular maintenance and have annual UKAS calibration. They are also, under EU rulings, classed as ‘borderline medical devices’. This means any new blood refrigerator; plasma freezer or platelet incubator or agitator should come from a manufacturer that holds ISO 13485 so their products are designed and manufactured in compliance with EU Directive 93/42/EC (class IIa).

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. It also means that there is a process in place to ensure that quality is maintained at all times through robust processes and testing. An important consideration when that piece of equipment is storing expensive and essential ­­blood products required for life saving treatments.

However, this is not as simple as it might seem. For example, as the PIP incident demonstrated, medical device accreditation was sometimes too easy to obtain. This loophole has now been firmly shut, but there remains an even bigger area for confusion. Sometimes ISO certification is ‘borrowed’ from another process the company has, so doesn’t cover the manufacture of the product itself. For example, you can gain ISO 13485 for some other aspect of production like inspection or for another product altogether. For example, Labcold could claim that we are medical device manufacturers and imply all our products hold that standard of accreditation. Obviously we wouldn’t, we respect our customers so make sure they know that it is our blood product storage range of Blood banks, plasma freezers, platelet incubators and agitators that are manufactured to ISO13485 standards.

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 all certification to hand so can provide these certificates quickly and easily.

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 designed and manufactured in line with ISO 13485 medical device quality management systems and thoroughly check that the ISO refers to the manufacture. This simple step will help ensure that the all the hard work you do which makes blood transfusion so safe in the UK is fully supported by the blood product storage cold chain.

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