Education
expertise in sterilisation has stemmed from research and development into the effects of sterilisation on materials. Presenting as a member of the IDSc research committee, he considered the question: what are the safety concerns related to the repeated reprocessing of these single-use devices? He pointed out that there are pros and cons
of reprocessing implants versus using pre- sterile implants. However, on balance, pre-sterile implants may have a favourable risk/benefit ratio.
“Despite the effort we put into validating
sterilisation and cleaning processes, they’re never going to be a hundred percent effective – so there’s always a risk of contamination slipping through the net,” he commented, adding that: “Continuous sterilisation and disinfection can also put stress on materials – they may weaken or may not implant in the patient as effectively.” Jack commented that many people say, ‘how can we convince theatres that they should stop using these implants?’ He pointed to the planned changes to the Medical Device Regulations that states there is likely to be a need for traceability of the implants going into patients.
“I’m assuming, from the questions raised, that theatres aren’t necessarily keeping that information and they’re not recording the batch number and manufacturer of the screws that are going into the patient. If we don’t have full traceability, what kind of alerts and safety issues are slipping through the net, and what kinds of things might hospitals not be responding to?” he questioned. Jack presented some of the published
research and evidence around the effects of repeated reprocessing. The studies showed mixed results. However, there was some evidence to suggest that repeated exposure of plates and screws to sterilisations may have the potential to negatively affect their strength or corrosion potential. Stainless steel was more affected than titanium. “I would say that changing implants as a contamination/infection reduction method should certainly be considered. The evidence is somewhat mixed, although the material effects of repeated reprocessing seem to have some kind of impact on implants. It’s not entirely clear how much of a clinical impact this has. It is highly dependent on implant design – not all implants are created equal,” he commented. “It may be that individually packed screws
increase theatre costs and operation times, but we really need to see a much more detailed analysis to look at the whole life cycle, the reprocessing costs, and postoperative infection
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From an educational perspective, we now have the Technical Certificate which really underpins the knowledge that you need to be a decontamination practitioner. It gives people the theory and the reasons behind what they do, as well as providing them with mentors. Sharon Fox, IDSc Director of Finance.
rates,” he continued. Jack’s conclusion was that there is “a need for further research”. However, traceability is also an important issue, as highlighted by the case of the PIP breast implant scandal, in which the manufacturer changed from medical grade silicone to industrial grade silicone. The lack of traceability with the breast implants meant that it was extremely difficult to identify which patients had been affected. “A similar thing could theoretically happen in the implant sphere - we could end up with some contaminants within the materials,” he warned. Ultimately, there is a lack of robust data on patient outcomes and infection rates when comparing pre-sterile versus reprocessed implants. Improved traceability and post-market surveillance of implants is needed, which the UK is proposing to mandate through new Medical Device Regulations. Jack explained that the new regulations are expected to be much more stringent on traceability requirements. The proposal is for healthcare institutions to store the Unique Device Identification (UDI) numbers for all implantable devices. “Not only should the hospital be recording the
batch number of each implant, MHRA wants to move to a system where every patient that gets an implant gets an implant card – and this is for all implantable devices,” he concluded.
Looking forward As the UK’s lead professional body for medical device reprocessing, the IDSc continues to embrace the challenges that arise within the sector and to support decontamination professionals with education, to ensure high standards of patient safety. Sharon Fox, Director of Finance, at IDSc, commented: “Reflecting back on my own career, without education, development and support, I would not have had the opportunity to progress from a technician to a decontamination lead for one of the largest Trusts in the UK. I had some very good mentors, who were very insightful about the value of education. Sharing knowledge is so important, particularly as part of succession planning. If you don’t offer that
support and education, staff will move on to pastures new. Providing this development will keep staff motivated. Having been a member of the IDSc for around 20 years, I have found the support that it provides is absolutely vital. If I have a problem, for example, I know I can go to someone within the organisation, who has had a similar experience, and they will offer me support. From an educational perspective, we now have the Technical Certificate which really underpins the knowledge that you need to be a decontamination practitioner. It gives people the theory and the reasons behind what they do, as well as providing them with mentors.” She pointed out that IDSc’s annual
conference brings together experts in decontamination – covering operational and day-to-day technical issues. As the event is attended by influential decision-makers, they have the ability to take action forward and deliver real change. This makes the event a powerful forum in which to share real-world challenges, exchange ideas and drive forward solutions. The conference sessions delve into the practicalities and detailed knowledge that decontamination departments need for their everyday practice, but the IDSc is also focusing on innovation to help solve some of the key challenges faced on the frontline of decontamination. “We ensure the decision makers are part
of our committees, part of our conferences, and part of our branches, and come up with strategies for the best way forward,” Sharon continued. “It is all about collaboration.” The next educational event, hosted by the Midlands IDSc branch will be free of charge to members and non-members, and will take place in July. It will provide the underpinning knowledge needed within sterile services to support staff undertaking the Technical Certificate. For further details on the event, venue details and dates, please contact Midlands Branch Secretary, Agnieszka Strzalkowska Miltko, at: Agnieszka.
StrzalkowskaMiltko@uhb.nhs.uk For more details on the IDSc and annual conference, visit:
https://idsc-uk.co.uk
CSJ
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