Decontamination


These devices have two lumens/channels, which can present significant challenges to the decontamination process. After the 2009 incident, there were no further incidents for several years – until the hospital changed the make and model of the phacoemulsification system and hand pieces in 2015. A surgeon detected a particle. “This happened on and off at three hospitals for five years. Due to the diligence of the surgeon, they managed to retrieve a particle,” Sulisti Holmes explained. Although there were no obvious adverse impacts on the patient, in this incident, it raised concerns – the presence of a non-infectious particle has the potential to cause toxic anterior segment syndrome (an inflammatory reaction). “After I received the incident report, we


started an investigation and contacted the manufacturer. A representative came to the meeting. We asked the representative: why has this problem suddenly appeared after changing to your system? “He told us, ‘We sell this system worldwide


and have only received a small number of a complaints. You did not clean them properly; your staff did not follow the instructions for use.’ Have you experienced similar feedback – that you have not followed instructions for use – despite knowing that you are not to blame? How did it make you feel? Worried? Confused? Angry? Ready to call Jackie Chan?” she asked the audience. The manufacturers’ instructions stated: ‘After


cleaning, inspect the instrument to ensure all debris has been removed.’ “How? We are talking about 2-3 mm diameter


of lumen and a tiny particle. It is impossible to see with the human eye and a borescope is not in the IFU. We didn’t want to be accused of not following the IFU again. So, the manufacturer told us to send the device and particle for examination and testing, and we did,” Sulisti Holmes explained. A few weeks later, they received a report


which once again blamed ‘inadequate cleaning’. During the investigation, the IFUs were


changed several times: “First, we were told to use automatic cleaning machines to flush the inside channel. We did that. Particles still followed. Second, we were told to flush the phacoemulsification system and the hand pieces before surgery. But particles were still found. “Third, we were told to switch from automatic


washer disinfection processing to manual cleaning. It was the most laborious manual cleaning I have ever seen,” she exclaimed. Everything that came into in contact with the handles were single use – single bowls, single use brush and sterile water for irrigation – yet still particles were identified.


56 www.clinicalservicesjournal.com I August 2025


“We tried everything! At the time, we felt like giving up – but we remembered the patient, like my mum; the 75-year-old who lost their sight. So, we changed our approach,” Sulisti Holmes continued.


An independent laboratory was asked


to examine the device – it was cut open to examine the internal geometry, to identify any degradation of the internal components, and to look for any potential entrapment of material inside the lumen. They found nothing and the investigation continued even further. This time, they carried out an analysis of the


particles using an electron microscope and infrared spectroscopy, and through a process of elimination, discovered that the material from particle ‘x’ was an acrylic polymer, originating from a single use consumable attached to the hand pieces before surgery. There was a further discovery of particle ‘y’. Using the same technique, this was linked to a wrench used to tighten a needle before connecting to the hand pieces. They Googled the wrench and the model of the hand pieces and found that the FDA and Swiss Medic had issued a safety alert about the wrench and identified a risk of plastic particulate, as far back as 2010. “That was five years before we detected the first particle,” said Sulisti Holmes. “Did the manufacturer know all along about the wrench issue? If that was the case, why didn’t they tell us?” commented Sulisti Holmes. She went on to share that she also had to


undergo cataract surgery and was naturally apprehensive in the lead up to the surgery. “I did not have an infection or complication, and I can see the world clearly, now; it looks more interesting – the colours of the flowers are bright and beautiful,” she enthused. “So, what have we learned? There are


three things to remember: first, don’t jump to


conclusions too quickly. Decontamination is not always the root cause of the incident. Secondly, don’t give up when you carry out an investigation until it is fully concluded – just like a Jackie Chan movie, you fall, you get up, you fall, you get up. And thirdly, don’t forget to report an incident because, one day, it could be you or your loved one who is on the operating table. Just like me, you will be glad that someone reported an incident beforehand and, in doing so, made the world a safer place,” she concluded.


Challenges in theatres and their impact on sterile services During the event, the audience were invited to take part in some live surveys, using Mentimeter. One of the questions asked included: ‘how good is communication between sterile services departments and theatres?’ The majority said that ‘links exist but information is sporadic’ (30), a significant number said that links between the departments are great (23), and a sizeable proportion reported that communication was poor (29). Clearly, there is wide variation across healthcare organisations and room for improvement. Of particular concern, however, was the fact that the majority (70) reported that theatre staff are not aware of the importance of instrument set storage – only 10 said that they were.


Claire Jones-Manning and Becky Peach,


from the University Hospitals of Leicester NHS Trust, looked at some of the challenges and opportunities to drive efficiency and improved inter-department teamworking. Claire Jones-Manning is a Decontamination Lead and Deputy Head of Operations for Intensive care, Theatres, Pain and Sleep (ITAPS). She began her NHS journey in 1993, qualifying as an Operating Department Practitioner (ODP). For 26 years,


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