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SURGICAL INSTRUMENTS
How clean are your single use instruments?
Harry Gray, owner of Avondale Surgical UK, discusses the single use instrument market and discovers that there’s no substitute for quality over quantity.
The main reason for the sudden demand for single use instruments was the reports of a potential risk of spreading creutzfeldt-jakob disease (CJD) from patient to patient through using the same set of surgical instruments that may be carrying residual protein and the virtually impossible to destroy rogue prion. The Government declared that all surgical instruments used on tonsillectomies should be destroyed and replaced with single use disposable sets. It was from this course of action that many other single use procedure packs started to be introduced over the following years.
As a result of this I was approached by one of the instrument manufacturers to work with them promoting single use instruments. Through sheer luck, one of my customers was asked if he knew of anyone that could supply disposable surgical instruments. The company in question had a long history of supplying various medical goods. At the time of our first meeting they had never even sold one pair of scissors. By the time they were up and running we had designed literature and a range of products that lifted them way above what was available in the market. This approach made them one of the leaders in single use supply. Eventually other suppliers raised their standards and things became more competitive, right up to the point of price cutting. Whereas before you could present the products to the buying teams and know that many would tell you that they were a better quality than the ones they bought as reusable, it started to tail off and price became the major purchasing factor over quality.
The main production area for the instrument manufacturers is the town of Sialkot in Pakistan. It is here that extremely high quality instruments are produced and supplied to companies all over the world and marketed under well know brand names. It is also here that single use instruments are produced. Both types of instruments are produced by people that have had their skills handed down between many generations and both types of instruments need many specialised processes to turn a piece of steel in to an instrument. Now that the prices are
SEPTEMBER 2017
but there is one unique product that we show each year at Arab Health, the ProReveal Residual Protein Detection System. As it needs instruments for the presentation I started to use sealed sterile procedure packs obtained from UK kit packers and was met with alarming results.
Highlighting problems
The most consistent problem highlighted by the ProReveal system is unidentified manufacturing debris and protein on ready to use sterile instruments.
dominating the sales market the high quality reusable instrument manufacturers are able to absorb any decreases in profits and still produce beautiful items which the lower end of the single use markets cannot. The manufacturer I worked with accepted the fact that I would say to potential customers that there is no excuse for poor quality single use and he kept to it.
My company deals mainly in the Middle East offering a variety of medical products,
The most consistent problem highlighted by the ProReveal is unidentified manufacturing debris and protein on ready to use sterile instruments. Just because they look clean does not mean they are. Manufacturing debris can come from various sources starting with the initial cleaning of the instruments after manufacturing due to poor quality cleaning chemicals, not enough time left in the ultrasonic cleaner, ultrasonic cleaner not functioning fully, and too many instruments stacked in the basket to allow the chemical to reach all parts. It can also come from handling washed products without gloves, using non approved oil to make the instrument function smoothly, or trying to wipe the instrument clean with a soiled cloth. If you check the screen of your mobile phone you will see smears that are difficult to remove. These smears are amino acids from your face and the same happens when instruments are handled without gloves, except you cannot see it on the instruments. The same applies to reusable instruments and it is only in the last few years when the ProReveal became available that some central sterile services departments (CSSDs) started to accept this method of checking the quality of their reprocessing on a more regular basis. As a result they have been able to identify what action needs to be taken to eliminate any identified problems. With so many specialised processes an instrument has to go through before being considered perfect, there are ways of trying to lower production costs by cutting short some of them. Rushed milling and grinding on an instrument will show up on close inspection. I use a small microscope to examine instruments and have found on a number of occasions very poor machining on
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