USA’s First Coast News has been writing about the hazard and consequences of so-called dirty surgical instruments, bringing into focus one more item for the list of things that can compromise a surgical procedure. Their story relates to a case of Pseudomonas Aeruginosa found in the arthroscopic shavers at a Texas Hospital, which affected seven patients and resulted in numerous reoperations and “debilitating and lifelong repercussions.
The article raises two issues. Firstly it questions the process, practices and people capability in departments responsible for the activity, then it goes on to examine whether certain types of instrument, especially those containing fine cannulations (like shaver blades) and other intricate parts (like shaver handles) are really “sterilisable”.
Is EU ahead of the game?
The issue is not new and indeed many companies are thriving on the switch to single-use items. It’s probably a bigger issue in EU where the amount of cash slewing around in healthcare has been historically lower and so use of expensive consumable iterations of previously re-usable devices has not taken off to the extent it has in US. However, in the EU, notably UK, the local sterile services departments are being superceded by regional supercentres in a move which brings efficiency to the process (well, cost “saving” really… “efficiency” is a sore point if you’re an orthopaedic surgeon and your instruments haven’t made the fifty mile return journey in time for the case) and ought to provide reassurance that things are being done properly. Instruments placed on the market have to comply with strict directives requiring validation activities to prove that recommended decontamination activities will decontaminate and that sterilisation activities will sterilise. The pre-existing tools being used on a daily basis may not of course have undergone this rigour. What’s clear though is that far from being the elephant in the room the First Coast News item says it is, in Europe this has been high profile for many years. Go back a decade and you would see a mini autoclave, a so-called “little Sister” in a corner of the operating suite and a cidex fume cupboard for chemical sterilisation, neither of which are now allowed for routine decontamination because neither of which actually decontaminate.
Back to USA, FDA has permitted reprocessing of certain “single-use” items, items such as shaver blades sold by manufacturers as “single-use” for strategic commercial reasons and presumably because they are difficult to clean and sterilise. While that might sound illogical, the guidance relates more to industrial reprocessing for re-sale rather than hospital DIY reprocessisng.
Use until it becomes “too bloody”
In fact the list of items that can be reprocessed is short and does not include finely cannulated devices, especially in view of the horror stories of the past few years, like the one in which a Las Vegas urologist used plastic endocavity needle guides to perform prostate biopsies until they became “too bloody”. His licence was suspended by the way.
UK’s MHRA has its own, slightly more black and white view of reprocessing of single-use items, which can be found here, but to save you the click says don’t do it.
A few more snippets from the First Coast item
The First Coast News item then claims the problem isn’t isolated with “other investigations in hospitals across the country revealing that use of other dirty surgical instruments, such as endoscopes used for colonoscopies, has led to infection outbreaks.”
It suggests that unlike the Operating Room which is staffed by qualified people, the “basement” containing a few hourly paid workers using old toothbrushes to scrub the muck off intricate tools is an unhealthy contrast.
“These workers can be a forgotten and neglected part of the team involved in a surgical procedure.”
“The faster the instruments make it into the operating rooms, the more patients are moving through the surgical suites. But what may seem like a push for efficiency can backfire, with disastrous consequences.”
“Risk management clinical engineer Jahan Azizi at the University of Michigan ran a video camera through 350 suction instruments and found that all of them contained some kind of debris after they had been sterilized according to protocol. His results were presented to the Food and Drug Administration at meetings this past year.”
According to a statement the FDA gave NBC News, “Hospitals are reminded to carefully clean and sterilize reusable medical devices. A patient’s risk of acquiring an infection from a reprocessed medical device is very low.” But requirements for reprocessing medical devices largely consist of such reminders.
US medtech industry body Advamed has commented; “The medical technology industry is committed to providing patients with safe and effective medical devices and diagnostics. Reprocessing of reusable medical devices is done in accordance with strict FDA requirements to ensure their safe and effective use.”
The full article can be found here.
Source: First Coast News