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The facts & fiction regarding CFPP 01-01: Management and Decontamination of Surgical Instruments used in Acute Care. Margaret Hollis Trevor Garcia Angela Cobbold 18 th October 2012. Decontamination of Reusable Invasive Medical Devices (RIMD).

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The facts & fiction regarding CFPP 01-01: Management and Decontamination of Surgical Instruments used in Acute Care

Margaret Hollis

Trevor Garcia

Angela Cobbold 18th October 2012

decontamination of reusable invasive medical devices rimd
Decontamination of Reusable Invasive Medical Devices (RIMD)

Effective & efficient decontamination of RIMD endeavours to eliminate inadvertent infectious agents & human prions disease transmission

There are several pertinent Regulatory UK, EU & ISO standards to adhere to, DH emphasis is to empower departments to be more proactive in there own local decision-making processes

Thus, improving patient experience in line with health policy direction & support

The following session aims to address some of the questions many Nursing & Allied Health Professionals may want answered in relation to Part A of this series.

choice framework for local policy procedures cfpp 01 01 2012 england only
Choice Framework for local Policy & Procedures(CfPP) 01-01 (2012) (England only)

This newly released series of DH documents relates to decontamination of surgical instruments (RIMD) acute care

Series of five documents offering best practice (BP) & Essential Quality Requirements (EQR) guidance on management, use & decontamination of RIMD

One of the main objectives - encourage & support local decision-making in relation to commissioning, regulation, management & decontamination of RIMD

It is designed to support continuous improvements in efficiency, essential quality, clinical effectiveness, patient safety & experience.

essential quality requirements eqr best practice bp
Essential Quality Requirements (EQR) & Best Practice (BP)

EQR -is a term that encompasses all existing statutory & regulatory requirements :

Current Medical Device Directives (MDD)

Approved Codes of Practice

Relevant applicable Standards

They will help to demonstrate that an acute care service provider operates safely with respect to management & decontamination of RIMD

EQR should also include a local risk assessment for surgical instrument management & the provision of instruments that are safe & reliable to use.

essential quality requirements eqr best practice bp1
Essential Quality requirements (EQR) & Best Practice (BP)

BP-’ is additional to the EQR & covers non-mandatory policies & procedures

Aims to further minimise risks to patients; deliver better patient outcomes; promote choice / encourage innovation / achieve cost efficiencies

BP - considered when developing local policies & procedures i.e. based on surgical procedural risk & available evidence

Gives guidance on the decontamination cycle, including, improved instrument management & contributions towards improved clinical outcomes’

The CfPP definition differs from the Health Act ….confusing.

how does this guidance document differ from health technical memorandum htm
How does this guidance document differ from Health Technical Memorandum (HTM)?

HTM series (2030/2031/2010)

Some common sections

HTM series still recognised as acceptable standards but they have now been archived…..

CfPP 01-01 series should still be used in conjunction with UK / EU and ISO standards for relevant sections.

what does the cfpp 01 01 series relate too
What does the CFPP 01-01series relate too?

There are five documents in total:

Part A; local policy & management approach, & choices available in support of local policy development.

Part B; common elements of reprocessing i.e. test equipment & materials, design & pre-purchasing, validation & verification.

Part C; steam sterilization standards & guidance.

Part D; washer-disinfectors standards & guidance

Part E; low temperature (non-steam) sterilization standards & guidance

where is cfpp 01 01 available from
Where is CfPP 01-01 available from?

The five guidance documents are readily available in full text and free to NHS employees via ‘’ (some universities)

However - printing each of these documents, there is around 100 pages each series!

Separate sections for Scotland/Wales/NI & UK.

northern ireland scotland wales
Northern Ireland, Scotland & Wales

Northern Ireland has issued statement suggesting that BP is the other standard to work at…

Wales and Scotland – still using HTM 2030 / 2031 / 2010 (not yet archived) but are being updated

Also suggested they do not necessarily want “Choice”…….

who is the target audience of cfpp
Who is the target audience of CfPP?

Primary Care Trust Chief Executives (CE’s)

NHS Trust CE’s

Foundation Trust CE’s

Medical Directors

Director of nursing

General Practitioners’

Decontamination Leads/Managers.

who are the cfpp guideline developers
Who are the CfPP guideline developers?

The authors’ are DH, Estates & Facilities, with contributors from experts within the UK, Wales, NI, including:

Health Protection Agency

Various Universities & NHS trusts experts

Members from the Institute of Decontamination Sciences (IDSc)

Association of Perioperative Practice (AfPP).

what is the purpose of the guideline
What is the purpose of the guideline?

Best practice guidance on management & decontamination of RIMD used in acute care

Precautionary policy on human prion disease transmission

Advice on surgical instrument management in relation to surgical care efficiencies

Contingency against perioperative non-availability of instruments.

the guideline provides a summary of its recommendations incorporating
The guideline provides a summary of its recommendations incorporating…

Health & Social Care Act 2008 & 2012

NICE guidelines (IPG 196) (2006)

Moist environment for surgical instruments

Inactivation of Human Prions disease transmission/detection

Instrument segregation (vCJD)

Single instruments & instrument tray tracking & tracing

Dropped instruments or compromised sterility of instruments during operative procedures

Loan sets & Repairs

Staff training & education / Staffing roles.

what examples of local choice does the document refer too
What examples of local choice does the document refer too?

Maintaining instruments in a moist environment following use & prior to reprocessing

Instrument sets & single instrument track & trace technology

Neurosurgey instrument sets & colour coding identification

Instruments used in paediatric high-risk surgery for patients born after 1 January 1997

Development of protein detection & quantification techniques

Maximisation of protein removal during washer-disinfection

Formation of local risk assessment group.

local risk assessment group membership includes
Local risk assessment group membership includes:

The Director of Infection Prevention & Control (DIPC)

Decontamination lead

Infection prevention & control lead

Clinical device user (e.g. incorporating the surgical instrument coordinator within their role)

Sterile services manager

Authorised Engineer (Decontamination)

Estates & facilities

Others as co-opted at the discretion of the DIPC.

what do the current surveys pilot studies findings refer to
What do the current surveys & pilot studies findings refer to?

Separate instrument pooling for patients born after 1997

Avoiding instrument migration between instrument sets

Instrument sets/single instrument track & trace technology via GS1 coding, Matrix Marking

Enhanced quality management & auditing systems

Improvements in protein removal when instruments are moist, & effective detection technology

Fewer yet larger instrument sets to improve tracking & traceability

Assessment of compliance with decontamination quality systems

Broader training & professional development

Clearer definition of staff roles & responsibilities .

who has ultimate responsibilities for decontamination risk assessment
Who has ultimate responsibilities for decontamination risk assessment ?

The Director of Infection Prevention & Control (DIPC) will have ultimate responsibility for the risk assessments & decontamination options driven forward.

main cfpp 01 01 part a recommendations
Main CfPP 01-01 (part A) recommendations

Decontamination policy must be developed & led by the Decontamination Lead to ensure EQR & BP

Improved instrument set integrity

Ensure a separate pool of instruments (& neuroendoscopes) are available for ‘high risk’ procedures on patients born since 1 Jan 1997

Ensure contingency for dropped / unavailable instruments

Ensure instruments are kept within a moist environment between use & decontamination

Maximum efficiency in protein removal during reprocessing

Audit system in place for surgical instrument management & to cover the quality, condition/suitability of RIMD

Undertake a full assessment of the volume & types of surgical service provided & turn around time.

to conclude
To conclude…

The DH aim is to give back ownership to decontamination departments, in-line with local, EU & ISO regulatory standards, offering guidance & support

Part A, focuses on the formulation of local policy, choices & the drivers behind effective decontamination processes

Part A, utilises current EBP, sharing lessons learned from contemporary studies to ensure EQR & BP are at the forefront of patient safety care…