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Margaret Hollis Trevor Garcia Angela Cobbold 18 th October 2012

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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Margaret Hollis Trevor Garcia Angela Cobbold 18 th October 2012

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  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. Where is CfPP 01-01 available from? The five guidance documents are readily available in full text and free to NHS employees via ‘spaceforhealth.com’ (some universities) However - printing each of these documents, there is around 100 pages each series! Separate sections for Scotland/Wales/NI & UK.

  9. 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”…….

  10. 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.

  11. 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).

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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 .

  17. 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.

  18. 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.

  19. 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…

  20. The reason for change…

  21. Any questions???????

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