t
OPERATING THEATRES
Implementing atest to detect residual proteins
Robbie Cormie, decontamination lead at University Hospitals Coventry & Warwick NHSTrust,explainswhy – and how – his departmenthasadoptedan insitu test fordetectingproteinsonsurgicalinstruments.
University Hospitals Coventry & Warwick NHS Trust Sterile Services Department (SSD) employs 55 staff and currently reprocesses around 13,000 trays of surgical instruments per month. The types of instruments we decontaminate vary in complexity and are from a full range of surgical specialties, including cardiology, neurology, othopaedics, trauma, ENT and ophthalmology. To process our surgical instruments, we operate five Getinge 88 Turbo and one Medisafe Niagara washer-disinfectors, five Getinge H-66 Series sterilisers and a STERRAD 100NX gas plasma steriliser. Like all accredited SSD departments we fully comply with HTM 01-01 and we are ISO 13485 (2016) accredited. Washers are checked daily, weekly, quarterly and annually as required by the HTM 01-01 and until October 2017, we were using a standard swabbing technique to test our surgical instruments for residual protein after cleaning. In 2017, we received a letter from the
Department of Health (DoH) which stated that the HTM 01-01 regulations on testing for residual proteins on surgical instruments were changing and all SSDs had to move to in situ testing for protein on surgical instruments likely to be in contact with tissue potentially harbouring prions that could cause infections such as Variant Creutzfeldt-Jakob disease (vCJD).
The DoH letter made it clear that swabbing could be ineffective, open to error or misinterpretation and that the DoH now required a quantitative process to check for proteins. We looked and listened to all the advice and arguments which were (and still are) underway with regards to contaminant scanning. As a high-risk Trust, we decided we
From Left to right Subash Lekishmanan Nadar (team leader), Kathleen Clarke (team leader) and Robbie Cormie (decontamination lead & general manager) with the ProReveal in situ protein detection system.
had to implement in situ testing straight away. From a quality/regulatory compliance point of view, our belief was that it would be easier to comply rather than thinking up excuses as to why we had chosen not to.
Assessing the technology
When deciding which in situ testing technology to implement at Coventry & Warwick NHS Trust, I drew on previous experiences of the
The DoH letter made it clear that swabbing could be ineffective, open toerror or misinterpretation and that the DoH now required a quantitative process to check for proteins.
JUNE 2018
technology I had seen or used. I first came across in situ testing in 2012, when I used a Synoptics Health ProReveal system at Southport and Ormskirk Hospital NHS Trust, where I worked previously. At this Trust we had constant failures in the cleaning of one specific orthopaedic instrument. Whilst following the manufacturers’ reprocessing instructions to the letter, we would still have residual protein contamination within this item. We used the ProReveal for in situ testing to measure the levels of the contamination on this surgical instrument after its first, second and third reprocessing until the contamination was gone. It took between three and four wash processes to achieve this and it was only possible to understand what level of cleaning this instrument required using in situ testing. My second experience with in situ testing was in January 2017 when our SSD at the Coventry & Warwick NHS Trust chose to change from an alkaline detergent to a neutral one to ensure our department was compliant with most instrument manufacturers’ reprocessing instructions.
Our detergent manufacturer used a
ProReveal for in situ testing to set up and validate the new detergent on all our machines as they said it was the most accurate method of checking for residual protein for this application. Having had positive experiences using the ProReveal for in situ testing, we purchased our machine in September 2017 and after delivery and training went live with it in October 2017.
Implementing in situtesting
Implementing in situ testing has not changed the way we reprocess instruments, just the way we test them. This has involved writing a Standard Operating Procedure (SOP) and putting in place a regime of daily instrument testing. Using the ProReveal our SSD now tests a minimum of 50 instruments per month per washer-disinfector and we test one instrument from each washer disinfector per day (Monday to Friday) and one instrument from our handwashing sink too as a comparison to see how manual cleaning compares with an automated validated process.
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