(This is the third installment of a short series of articles focused on surgical instrument quality, repair, and refurbishment from the perspective of a UK instrument manufacturer and repair professional [Daniel Coole] and a US sterile processing consultant [Hank Balch]).
Daniel Coole: New instruments are manufactured from stainless steel and may appear to be robust, shiny and fit for purpose, but please beware that after manufacture the instruments can be quite vulnerable in relation to the surface. Surgical instruments are manufactured from stainless steel which contains elements such as Iron, Chromium and Carbon. The Chromium in the stainless steel facilitates a unique phenomenon known as passivation. Passivation is the reaction of Chromium reaction with oxygen, which forms a very thin layer of Chromium Oxide on the surface of the stainless steel (can be as little as 30 microns). Passivation actually occurs naturally on stainless steel and if the instruments weren’t immediately going to be used, reprocessed and soiled then the manufacturer wouldn’t really have to intervene. However, because of the use of the devices, the manufacturer will perform the passivation artificially using an acid of some description. This artificially creates the reaction and forms a passive layer on the instruments.
Manufacturers can test that the passive laser is present, but instruments are like newborn babies and need to be handled with care initially while the passive layer builds up. When instruments are new, the instrument passive layer can easily become stained/marked through high pH chemistries or insufficient drying, particularly in and around the site of laser marking. If you imagine that the instrument has been finished and we are burning into the surface of the instrument and releasing free iron which has potential to become iron oxide (rust) and we passivate the surface of this laser marking. Some manufacturers may sometimes recommend something like 3 reprocessing cycles of the new instruments to gently break them in to their new environment.
To protect new instruments I would start by ensuring that they are ideally not mixed with older instruments. Hospitals sometimes will have stocks of what they perceive to be basic instruments that can be accepted as lower quality i.e. rampleys sponge holders, spencer wells, towel clips; I would argue that this is where you should be spending a bit more money as these instruments are generally ignored the longest. If we invest in these tray basics, it won’t come back and bite us, as otherwise there is the risk of corrosion cross contamination when you put them on the tray with your brand new instruments.
Additionally, it is important to ensure the basket we are using to reprocess the set is big enough; we sometimes see huge sets crammed into a small 480 x 250 basket, where there is no way the instruments can all be washed efficiently without shadowing. Use decent instrument pins/stringing systems to organise the trays and create SOPs to help with tray organisation.
Silicone fittings can be costly for customising trays, but arguably that investment means that the instruments may never need to be replaced again. Whatever the choice, instruments should be in an open position, allowing good flow throughout the washer from top and bottom. Consider the basket types that are used and the size of the mesh. I saw a great presentation last year from Professor Andrew Smith (Glasgow). He has carried out a study of protein residue on Neuro trays. Think of the complexity across those trays and potential pitfalls for cleanliness. Professor Smith described the research, the findings and the big reveal on what was the culprit instrument that help the most protein…the research showed this was a simple flat malleable brain spatula and it was being laid flat when washed, so it was just presumably pooling on the surface; we need to let gravity do its thing where possible.
When the instruments then go into use, we must ensure they are lubricated correctly. Mechanical working parts need lubricant or it is possible the parts will bind, corrode and eventually crack. Instruments should ideally be lubricated during inspection, using an approved CE marked lubricant. Any instrument with a working part, hinge should be lubricated and worked through.
Hank: Daniel covered many of the important points to consider when bringing the bundles of surgical instrument joy home to your department, but I want to address the training side of new instrumentation.
As CS/SPD technicians, we can easily be overwhelmed by the sheer volume of different instruments that come through our assembly tables. And when you are a new technician, or an experienced technician being introduced to a new type of surgical instrument, there are certain things that are critical to know for safe, consistent, and sustainable instrument reprocessing.
1) What is the name of this instrument? Even though this may seem simplistic, there is much more that goes into knowing an instrument name than just reading a packaging slip. Technicians should know the official manufacturer name of the device, in addition to any nicknames or slang that may be used to describe it. Finally, they must learn what the instrument will be called within the hospital tracking system documentation (count sheets, recipes, etc).
2) How does this instrument work? Even though instrument technicians are not the ultimate users of these devices, it is still important that they know how the device will be used for a number of reasons. Understanding which end of the device is the “working end” or distal tip will assist with more thorough inspect. Learning the different areas the instrument is bent or torqued during a procedure can give technicians critical insight when inspecting the device for potential damage, as well as determining when the instrument has reached the end of life.
3) Are any parts of the instrument removable? Knowing whether a new device has multiple pieces is imperative for ensuring devices come through our reprocessing workflow appropriately disassembled, cleaned, and sterilized. Many mistakes are made by technicians who simply did not know a particular device could be and needed to be disassembled.
4) What are the key inspection points for cleanliness and/or damage? Every instrument will have certain areas that are more likely to retain bioburden or become damaged during use. When new instruments or new technicians are introduced into the CS/SPD workflow, these key inspection points should be highlighted and described in detail. If possible, showing similar devices with existing damage can be helpful to train technicians what to look for in these new devices.
5) Are there any necessary functional tests required for this device? In addition to inspecting for cleanliness, education around new instruments should include when and how to test the functionality of the device. This could include things like laparoscopic insulation testing, scissor sharpness tests, hinge openings, smooth actions, etc. Because some of these functional tests may not come intuitively just by looking at a new device, manufacturer instructions should be reviewed as a part of this onboarding process.