DECONTAMINATION
the steriliser, layer at the top, and would produce locally high temperatures near the sensor at the top of the machine, while air would be found at the bottom layer. This meant that the top bottles reached sterilising temperature, the middle bottles got to around pasteurising temperature and the bottom bottles would have had an insignificant rise in temperature. Three bottles were taken from the machine for quality assurance testing, but it was likely that these were taken from the most accessible level – the top layer – so any issues were missed.
It was estimated that around 64 affected bottles were shipped to Devonport, and the hospital probably received all of the bottles from the lowest layer in the machine. All the bottles from the identified batch were retrieved, apart from eight – so it is reasonable to assume that all eight were used. The death toll from the batch was probably around 12. Contamination from the endotoxins would have resulted in 100% fatality.
However, the inquiry further looked at the autoclave records and found 70 occasions where there had been an inadequate cycle, ‘generally no rise in temperature’, or a
temperature below the necessary. Based on the available data, it is possible to estimate that there could have been as many as 3,500 contaminated bottles produced during the timeframe – however, as some records were missing, it is likely this is just the tip of the iceberg. Hoffman commented that it is likely that the incident resulted in “hundreds of deaths; possibly thousands”. When it comes to quality assurance,
it is important to monitor the process, as opposed to just focusing on the end product.
Today’s challenges “Sterilisation standards, today, are comfortingly excessive. I’m not suggesting they are inappropriate, but I am suggesting that steam sterilisation is not the problem with decontamination, at present,” Hoffman asserted.
He pointed out that there are key issues associated with the acquisition of new instruments that are impossible to sterilise, which remains a problem today. He also highlighted the need for manufacturers to produce satisfactory instructions for decontamination.
Wayne Spencer and Sulisti Holmes
Safety and the lives of our patients are paramount. I hope you don’t need surgery. But if you do, which one will you choose? The one that follows the guidance, that learns from previous incidents, that has gone through independent review by an independent expert
– an AE(D) – or one that doesn’t?” Sulisti Holmes, strategic lead for medical device safety for NHS Scotland.
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WWW.CLINICALSERVICESJOURNAL.COM
Hoffman recalled that, on a previous visit to a hospital, he found that staff were unaware that a brush was needed to clean the internal channels of an endoscope. Subsequent cleaning with a brush produced a large amount of ‘gunge’ suggesting the endoscope in question had never been properly reprocessed. There are now considerable amounts of guidance on decontamination, but endoscope decontamination is not nearly as secure as steam sterilisation, he observed. In addition, transoesophageal echocardiogram (TOE) probe decontamination is not performed well and there have been reported incidents involving patient-to-patient transmission of infection. A key factor is the design of the device. Parts of the TOE probe cannot be immersed – a factor that could be overcome by the manufacturers, he argued.
The technology for fully immersible devices exists with endoscopes, yet it is not incorporated into TOE probes, which poses the question of ‘why?’ Hoffman believes there is insufficient pressure being placed on manufacturers to engineer solutions to make these devices easier to reprocess. He highlighted the fact that there are other types of equipment that continue to
JUNE 2022
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