Poor quality of new surgical instruments
Quality is everything, and something which must never be compromised. Since the formation of our Company over thirty years ago, we have strived to produce only the highest quality surgical instruments. We work hard to train our staff, and teach them that quality really does come as standard at Platts & Nisbett.
Unfortunately these values do not appear to be shared by some companies, who may be supplying surgical instruments which are of inferior quality. As the market has been flooded with poor quality instruments over the years, many hospitals are now seeing trays which contain instruments that are failing.
As many surgical instruments are Class 1 devices, these products can be self certified by the manufacturer (the person placing the device on the market). This means there is currently opportunity for any person selling these instruments to apply a CE Mark to the products, without taking serious responsibility for what it means. As Class 1 devices are deemed the lowest risk, it is not something which is audited by an external body on a regular basis. The fact that a Company is registered to a Quality Management System is a great start, however in reality all this means is that the Company is operating a system to ensure that a consistent quality of product is supplied. It does not ensure that the quality of the product is high. This can be quite misleading to potential customers. It is not currently mandatory for a lot number to be marked on to an instrument, although this is something we would definitely recommend. All Platts & Nisbett branded instruments are fully laser marked with our name, CE, part number and lot number. This ensures instruments can be traced back via manufacturing records, which show the material composition of all components used, and all staff who were involved in producing the instrument itself. We are passionate about the quality of our workmanship, so choose to operate a system which is over and above the legal minimum requirements. It is essential that patients are never put at unnecessary risk, which may happen if the equipment is not of the highest standard.
It pleases us greatly when we see NHS Trusts beginning to implement systems which ensure only the best quality instruments are accepted. Barts and the London NHS Trust have developed a Surgical Instruments Service after the clinical physics department found faults with a number of newly procured instruments. They now carry out comprehensive quality assurance checks on newly purchased instruments entering the Trust. Any faults are entered onto a database along with statistical data, to allow comparisons to be made between suppliers. They are urging other Trusts to follow their lead in implementing stringent quality assurance processes, to ensure newly purchased instruments are fit for purpose. This should urge all suppliers to improve their performance, which in turn will give better value for money and improve patient safety.
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