Improved surveillance of surgical instruments reprocessing following the variant Creutzfeldt-Jakob disease crisis in England: findings from a three-year survey.

BACKGROUND

Sensitive, direct protein-detection methods are now recommended for the inspection of reprocessed reusable surgical instruments in England to reduce the risk of prion transmission.

AIM

To implement an established, highly sensitive method to quantify proteinaceous residues on reprocessed instruments in a Sterile Services Department (SSD) and evaluate its potential impact on service provision.

METHODS

We introduced highly sensitive epifluorescence (EDIC/EF) microscopy in a large SSD. Over three years, we periodically tested two models of washer disinfector using stainless-steel tokens spiked with mouse brain homogenate or Browne test soil for comparison. We also obtained data and feedback from staff who had been using EDIC/EF to examine almost 3000 reprocessed instruments.

FINDINGS

All reprocessed test surfaces harboured residual contamination (up to 258.4 ng from 1-μg spikes). Proximity between surfaces affected decontamination efficacy and allowed cross-contamination. Up to 50 ng de novo proteinaceous contamination was deposited on control surfaces after a single automated washer disinfector (AWD) cycle. The test soil behaved differently than real tissue contamination. SSD staff observed proteinaceous residues on most reprocessed instruments using EDIC/EF, which can detect far smaller amounts than the currently accepted national threshold of 5 μg per side.

CONCLUSIONS

Implementing recent national guidelines to address the prions concern proved an eye-opener. Microscopic levels of proteins remain on many reprocessed instruments. The impact most of these residues, potentially including prions, may have on subsequent patients after sterilization remains debatable. Improving surveillance capability in SSDs can support decision making and raise the standards of surgical instruments reprocessing.