Implementing an in situ test to detect residual proteins on surgical instruments

University Hospitals Coventry and Warwickshire 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.  Prior to October 2017 we used 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 and Social Care (DHSC) 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) by July 2018 The letter set out how swabbing could be ineffective, open to error or misinterpretation and that the DHSC 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 had to implement in situ testing straight away in 2017 before the July 2018 deadline. This was the right thing to do to keep our patients safe, and ensure we were meeting all national recommendations.

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