Decontamination
Why IFUs are important to reduce SSI
Stuart White and Emile Jubeli highlight the importance of Instructions for Use (IFUs) to ensure the effective decontamination of instruments, including those used in robot-assisted surgery.
In the UK, Public Health England (PHE) conducted a national survey in 2017 involving 95 NHS Trusts and 13 surgical specialties. In total, 1,807 SSI cases were documented with reoperations reported in 36.2% of all identified cases, and an associated delayed discharge rate of 34.1%.1
Additionally, 383 medical negligence
claims related to SSI have been identified in data collected by the NHS Resolution between April 2012 and March 2017, which are estimated to cost £35.2 million.2 In 2012, a sudden increase in surgical
site infection rates was reported among patients undergoing ‘clean’ surgery in England. Consequently, an investigation was triggered, where the increased incidence was attributed to improper reprocessing practices. The investigation highlighted inadequate maintenance of autoclave components and poor practices by staff, compounded by lapses in inspection of surgical sets. The investigation outcome was a series of recommendations from operator training, supervision, and staffing at the sterilisation units, in conjunction with formal inspection and reporting of by theatre staff.3 More publications have reported incidents
where contaminated surgical instruments have been identified as the cause for transmission of SSI-causing pathogens.4-6
For example, data
collected from 40 hospitals in Canada between 2011 and 2020 reported 4,751 infections related to surgical instruments and surgical procedures.7
Another Canadian study revealed that infections related to instruments and surgical procedures represented more than 35% of all healthcare- associated infections (HCAIs) recorded.8 ECRI is a global, independent authority on healthcare technology and safety.9
Every
year, ECRI publishes a list of the ‘Top 10 Health Technology Hazards’. Risks related to reusable devices reprocessing are repeatedly cited and, in the 2020 list of hazards, ‘device cleaning, disinfection, and sterilisation’ were in the top five.10
The ECRI associated this risk to a “lack of
access to current manufacturer instructions for use (IFU) and reprocessing technologies; lack of necessary supplies; communication breakdowns between Sterile Processing Department staff and the departments they support; and a lack of universal training and certification requirements”. Most reusable surgical instruments become contaminated during surgical procedures and, depending on the type and site of the surgery, microbial loads can reach high-level values of contamination. The complex design of some reusable surgical instruments is one factor that may negatively affect proper reprocessing, due to areas that are difficult or impossible to brush during cleaning (Figure 1). Cleaning is considered the most important step of reprocessing and, if not adequate, may contribute to biofilm formation and could lead to serious consequences for the patient.11
Reprocessing Adequate reprocessing practices are essential to reduce the incidence of reusable instrument- associated SSIs on patients undergoing surgery. The Compliance and Enforcement Group (COEN), a European working group, has created an ‘IFU Working Group’ to address the number of non-conformities related to reprocessing IFU of reusable medical devices. At present, several reusable medical devices are marketed without a validated IFU. Reprocessing allows the safe reuse of instruments through following validated IFUs. Any deviations from the IFU can lead to the survival of microorganisms and, therefore, increased risk of infection. Just in the first 9 months of 2023 there were 500 recorded incidents related to decontamination and 47 recorded incidents of reusable medical devices with residue following decontamination.12 The reprocessing IFU contains information on
Figure 1. Example of complex design (robotic surgical instrument).
the appropriate processes to allow safe reuse. These processes involve sequential steps which begin in the vicinity of the use of the medical device and continue in the sterile service department. Generally, the reprocessing IFU includes a combination of the following steps: point of use, initial manual cleaning, cleaning, disinfection, and sterilisation. Point-of-use processing is conducted in the location where the device has been clinically employed and is closely followed by initial manual cleaning at the sterile service department. These steps facilitate subsequent cleaning steps by preventing drying of soil and contaminants in and on the device. Cleaning can be done manually and/or can be automated through the use of washer disinfectors or ultrasonic machines. Cleaning is performed to physically remove contaminants and prevent accumulation for contaminants. Where devices need to be disinfected or sterilised, cleaning is critical to the success of subsequent steps. Disinfection and sterilisation are intended to
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