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Choice Framework for local Policy andProcedures 01-01 Management and

decontamination of surgical

instruments (medical devices) used in

acute care. Part E:Alternatives to steam

for the sterilization of reusable medical

devices

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Choice Framework for local Policy andProcedures (CFPP) 01-01Management and decontamination ofsurgical instruments (medical devices) used inacute care

Part E: Alternatives to steam for the sterilizationof reusable medical devices

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CFPP 01-01 Part E Alternatives to steam for the sterilization of reusable medical devices

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Crown copyright 2013

Terms of use for this guidance can be found at http://www.nationalarchives.gov.uk/doc/open-government-licence/

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Preface

Introduction

The Choice Framework for local Policy and Procedures(CFPP) is an initiative being piloted by the Departmentof Health.

It forms a suite of evidence-based policy and guidance

documents on the management and decontamination ofreusable medical devices.

Purpose

The purpose of CFPP is to enable local choices to bemade regarding the management, use anddecontamination of reusable medical devices at controlledcosts using risk control.

CFPP is designed to reflect the need to continuouslyimprove outcomes in terms of:

patient safety;

clinical effectiveness; and

patient experience.

Essential Quality Requirements andBest Practice

The Health Act Code of Practice recommends thathealthcare organisations comply with guidanceestablishing Essential Quality Requirements anddemonstrate that a plan is in place for progression to BestPractice.

Essential Quality Requirements (EQR), for the purposesof this best practice guidance, is a term that encompassesall existing statutory and regulatory requirements. EQRsincorporate requirements of the current Medical Devices

Directive and Approved Codes of Practice as well asrelevant applicable Standards. They will help todemonstrate that an acute provider operates safely withrespect to its decontamination services.

Local policy should define how a provider achieves riskcontrol and what plan is in place to work towards BestPractice.

Best Practice is additional to EQR. Best Practice asdefined in this guidance covers non-mandatory policiesand procedures that aim to further minimise risks topatients; deliver better patient outcomes; promote andencourage innovation and choice; and achieve costefficiencies.

Best Practice should be considered when developing localpolicies and procedures based on the risk of surgicalprocedures and available evidence. Best Practice

encompasses guidance on the whole of thedecontamination cycle, including, for example, improvedinstrument management, where there is evidence thatthese procedures will contribute to improved clinicaloutcomes.

The CFPP suite is listed below.

Choice Framework for local Policy and Procedures01-01: Management and decontamination of surgicalinstruments (medical devices) used in acute care

Choice Framework for local Policy and Procedures

01-04: Decontamination of linen for health and socialcare

Choice Framework for local Policy and Procedures01-06: Decontamination of flexible endoscopes

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Andrew Thomas Royal College of Surgeons

Bill Keevil Southampton University

Brian KirkIHEEM Decontamination Technology Platform

David PerrettBarts & the London School of Medicine & Dentistry, Queen Mary University of London

Gavin Maxwell Royal Society of Medicine Patients Support GroupGeoff Sjogren Institute of Decontamination Sciences

Geoffrey L. Ridgway, OBE, MD Clinical Microbiologist

Graham Stanton NHS Wales Shared Services Partnership Facilities Services

Helen Baxter University of Edinburgh

Jackie Duggan Health Protection Agency

James Ironside University of Edinburgh

Jim GrayBirmingham Childrens Hospital NHS Foundation Trust

Jimmy Walker Health Protection Agency

Ken Toal Health Estates, Northern Ireland

Margaret Hollis Great Ormond Street Hospital

Mike Painter Public Health Physician

Mike Simmons Public Health Wales

Peter Brigham Newcastle upon Tyne Hospitals NHS Foundation Trust

Peter Hoffman Health Protection Agency

Robert Baxter University of Edinburgh

Robert Kingston IHEEM Decontamination Technology Platform

Sylvia Martin University College Hospital London

Terry DurackGreat Ormond Street Hospital

Tracy CoatesAssociation for Perioperative Practice

Acknowledgements

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ACDP-TSE RM [subgroup]:Advisory Committee onDangerous Pathogens Transmissible SpongiformEncephalopathies Risk Management [subgroup](formerly the TSE Working Group)

ACDST:Advisory Committee on DecontaminationScience and Technology

AE(D):Authorising Engineer (Decontamination)

AP(D):Authorised Person (Decontamination)

BCH: Birmingham Childrens Hospital

BS: British Standard

BSE: Bovine Spongiform Encephalopathy

CFPP: Choice Framework for local Policy andProcedures

CJD: Creutzfeldt-Jakob disease

CMO: Chief Medical Officer

CP(D): Competent Person (Decontamination)

CQC: Care Quality Commission

DH: Department of Health

DIPC: Director of Infection Prevention and Control

EDIC: episcopic differential interference contrast

EDIC/EF: episcopic differential interference contrast/epifluorescence

EFSCAN: epifluorescent surface scanner

EN: European norm

FITC: fluorescein isothiocyanate

GOSH: Great Ormond Street Hospital

ISO: International Standards Organisation

MDD: Medical Devices DirectiveMDR: Medical Devices Regulations

MHRA: Medicines and Healthcare products RegulatoryAgency

NDS: National Decontamination Survey

NICE: National Institute for Health and ClinicalExcellence

NICE IPG 196 (2006): NICEs (2006) interventionalprocedure guidance 196 Patient safety and reduction

of risk of transmission of CreutzfeldtJakob disease(CJD) via interventional procedures

OPA/NAC: o-phthalaldehyde/N-acetyl-L-cysteine

PO: posterior ophthalmic

sCJD: sporadic Creutzfeldt-Jakob disease

SSD: sterile services department

TSEs: transmissible spongiform encephalopathies

UCHL: University College Hospital London

vCJD: variant Creutzfeldt-Jakob disease

Abbreviations

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Choice Framework for local Policy and Procedures(CFPP) 01-01 offers best practice guidance on the wholedecontamination cycle including the management anddecontamination of surgical instruments used in acutecare.

Part A covers the policy, management approach andchoices available in the formulation of a locallydeveloped, risk-controlled operational environment. Thetechnical concepts are based on European (EN),International (ISO) and British (BS) Standards usedalongside policy and broad guidance. In addition to theprevention of transmission of conventional pathogens,precautionary policies in respect of human prion diseasesincluding variant Creutzfeldt-Jakob disease (vCJD) areclearly stated. Advice is also given on surgical instrumentmanagement related to surgical care efficiencies andcontingency against perioperative non-availability of

instruments.Part B covers common elements that apply to all methodsof surgical instrument reprocessing such as:

test equipment and materials

design and pre-purchase considerations

validation and verification.

Part C covers standards and guidance on steamsterilization.

Part D covers standards and guidance on washer-

disinfectors.

Part E covers low temperature (non-steam) sterilizationprocesses (such as the use of vapourised hydrogenperoxide gas plasmas and ethylene oxide exposure).

CFPP 01-01 Part A supersedes Health TechnicalMemorandum 01-01 Part A (2006).

CFPP 01-01 Parts BE supersede Health TechnicalMemoranda 2010, 2030 and 2031, and Health BuildingNote 13 Supplement 1.

Executive summary

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Contents

PrefaceIntroductionPurposeEssential Quality Requirements and Best Practice

AcknowledgementsAbbreviations

Executive summary1 Introduction 12 Guidance for commissioners 23 Guidance for regulators 34 Role of non-steam sterilization techniques 45 Quality and safety standards for non-steam sterilization 56 Guidance on safety risk assessment 67 Surgical instrument and other device compatibility 7References 8

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1.1 Steam sterilization is well-defined and has beenused safely with the majority of medical devices formany years.

1.2 For some specialist instrumentation and devices,steam sterilization has a number of limitationsparticularly in regard to the reprocessing of medicaldevices that may be damaged by steam at hightemperatures.

1.3 Non-steam sterilization is becoming increasinglyrequired for the reprocessing of thermolabile newtechnology medical devices. In addition, some non-

steam sterilization technologies may provide moresignificant inactivation of prions; this is the subjectof current research.

1.4 Many alternatives to steam sterilization are availablefor use in sterile services departments (SSDs) andother environments.

1.5 Current sterilization technologies include ethyleneoxide, gaseous hydrogen peroxide and ozone.Future potential technologies include lowtemperature electronic gas plasmas.

1 Introduction

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2.1 Commissioners should ensure that local policies forinstrument management and decontamination arein place within provider institutions.

2.2 The use of specialist surgical instrumentation mayextend the range of surgical care available from aprovider or may advance the quality of care andimprove clinical outcomes.

2.3 In considering such service improvement,commissioners are advised to consult with their

providers on the availability and capability ofdecontamination services in respect of newinstrumentation and technologies and the ability toensure adequate and validated decontaminationand sterilization. More specifically: are viablecleaning and sterilization methods in place and,

where applicable, can validated sterilization beprovided?

2 Guidance for commissioners

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3.1 A quality framework based on a systems approachis not currently provided within the EuropeanNorms (ENs) or BSI standards for alternativesterilization methods. Accordingly, policy guidancefollows the broad outline of EN 14937, withsignificant adaptations to suit the technologies

under consideration.3.2 This guidance recommends that providers of non-

steam sterilization and decontamination servicesuse the CFPP risk assessment approach (see CFPP01-01 Part A), along with manufacturersrecommendations (both those of the instrumentmanufacturer and from the manufacturer of thesterilization system).

3.3 Providers should seek to minimise risks to theoperator, patient and environment from the use ofthese technologies while promoting satisfactoryclinical service outcomes.

3.4 Ensuring effective sterilization is considered to be akey outcome. Validation, being defined asachieving an effective, reproducible sterilizationoutcome, needs to be conducted to ensure thatsterilization has been achieved.

3.5 The validation process should be carried out in

agreement to the users, manufacturers and AE(D)and be supported by an audit trail.

3.6 The operational responsibility for ensuring thatthese key objectives are addressed should be withthe Decontamination Lead and possibly theSurgical Instrument Manager, working to the localpolicies agreed by the risk assessment group.

3.7 Regulators should ensure that such policies are inplace and that operational protocols areappropriately employed. These structures should

assure that an adequate validation system is in placeand that auditable records exist.

3 Guidance for regulators

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4.1 Any non-steam sterilization technology should fitin with the broad approach to instrumentmanagement and decontamination given in CFPP01-01 Part B.

4.2 The installation of the technology needs to work inan environment well-integrated with the local SSDand surgical facilities. The flow of work and itemsfrom dirty to clean needs to have the samecharacteristics as for any other process elementwithin an SSD or external facility.

4.3 The risk of recontamination should be minimised.These considerations apply whether the

reprocessing is done locally or by an externaldecontamination provider.

4.4 The compatibility of any alternative sterilizationtechnology with the instruments for which it isintended is a key consideration. The advice of boththe technology and instrument manufacturersshould be sought when considering non-steamsterilization methods; it should be ensured that therequirements of both the technology and theinstrument manufacturers can be reconciled.

4 Role of non-steam sterilization techniques

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5.1 In current practice, policy and proceduresgoverning the use of non-steam sterilizationmethods rely on local risk analysis andmanufacturers advice and instruction. Thisapproach is compatible with the CFPP approach.However, a framework is offered within this

guidance in order to strengthen the backgroundand provide guidance in decision-making.

5.2 There is a lack of definition for test methods andprotocols together with associated validation acrossthis area. This makes assessment of sterile statusand assurance potentially more difficult comparedto steam sterilization. However, a quality assuranceprocess should be used with a plan on how thetechnology and sterilization process fits into theoverall quality assurance audit process. The reportsand processes generated should be transparent and

open for assessment and inspection.5.3 Safety when using non-steam sterilization methods

must take into account:

safety of the patient, in particular that no toxicresiduals remain or are formed on the device

following the process and that sterility is reliablyobtained;

safety of staff using the process present duringthis time, including physical, ergonomic andchemical considerations;

safety of the devices, to ensure that they are notdamaged by the process;

safety for the environment.

5.4 Workplace exposure limits are published by theHealth and Safety Executive (HSE) for some of thechemicals involved in non-steam sterilization (forexample ethylene oxide, ozone, hydrogen peroxide),and the use of sterilization systems must adhere tothese limits.

5.5 Care should be taken regarding instrument package

degassing after sterilization, where processchemicals may be retained in the processed devicepack and eluted afterwards. This should form partof any local risk assessment.

5 Quality and safety standards for non-steamsterilization

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6.1 Factors to be considered in local risk assessmentinclude but are not limited to the following:

a. consideration of environmental and workplaceexposure limits for the chemical agents used andany secondary products generated;

b. appropriate application of environmental andpersonal monitoring. This is selectively referredto for some sterilization agents. However, it isadvised that consideration should be givenwhenever toxic gases or vapours are employed.In some instances, equipment may containmonitoring devices. The assessment shouldinclude the possible use of non-machine-integrated monitors and alarms;

c. consideration to degassing associated hazardsand the environments used in processing and

storage;

d. containment and ventilation associated with thework environment;

e. constraint of splash and aerosol hazards fromliquid agents in use, including hydrogenperoxide;

f. the use of secondary containment combinedwith negative pressure exhaust ventilationshould be considered and may be an HSErequirement for some of the technologies.

6.2 Safety risk assessment should be applied to alldecontamination technologies, regardless of type orstatus.

6 Guidance on safety risk assessment

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7.1 It is the responsibility of reprocessable medicaldevice suppliers to inform users of compatibledecontamination processes. However, guidanceregarding specific incompatibilities of otherprocesses is not always provided.

7.2 Before any decontamination technology is used(whether steam or otherwise), it must bedetermined as compatible by consultation with thereprocessable device supplier.

7 Surgical instrument and other devicecompatibility

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EH40/2005 Workplace Exposure Limits (HSE Books,2011).

References
http://www.hse.gov.uk/pubns/priced/eh40.pdfhttp://www.hse.gov.uk/pubns/priced/eh40.pdf

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