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

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

Prions, Proteins, Sterile service departments, Surgical instruments, Surveillance
0195-6701
15-25
Hervé, R.C.
9baddc65-93cf-4a18-9388-088d60572b06
Hedges, J.
e7dcb103-5259-44bc-9f15-bf856a2a1d03
Keevil, C.W.
cb7de0a7-ce33-4cfa-af52-07f99e5650eb
Hervé, R.C.
9baddc65-93cf-4a18-9388-088d60572b06
Hedges, J.
e7dcb103-5259-44bc-9f15-bf856a2a1d03
Keevil, C.W.
cb7de0a7-ce33-4cfa-af52-07f99e5650eb

Hervé, R.C., Hedges, J. and Keevil, C.W. (2021) Improved surveillance of surgical instruments reprocessing following the variant Creutzfeldt-Jakob disease crisis in England: findings from a three-year survey. Journal of Hospital Infection, 110, 15-25. (doi:10.1016/j.jhin.2021.01.005).

Record type: Article

Abstract

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.

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More information

Accepted/In Press date: 12 January 2021
e-pub ahead of print date: 19 January 2021
Published date: April 2021
Additional Information: Copyright © 2021. Published by Elsevier Ltd.
Keywords: Prions, Proteins, Sterile service departments, Surgical instruments, Surveillance

Identifiers

Local EPrints ID: 446755
URI: http://eprints.soton.ac.uk/id/eprint/446755
ISSN: 0195-6701
PURE UUID: ded390ac-f6b3-4321-b47b-970569c48af8
ORCID for R.C. Hervé: ORCID iD orcid.org/0000-0001-8838-6515
ORCID for C.W. Keevil: ORCID iD orcid.org/0000-0003-1917-7706

Catalogue record

Date deposited: 19 Feb 2021 17:33
Last modified: 26 Nov 2021 02:47

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Contributors

Author: R.C. Hervé ORCID iD
Author: J. Hedges
Author: C.W. Keevil ORCID iD

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