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).
Angela Cobbold 18th October 2012
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.
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.
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.
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.
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HTM series still recognised as acceptable standards but they have now been archived…..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.
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
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.
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”…….
Primary Care Trust Chief Executives (CE’s)
NHS Trust CE’s
Foundation Trust CE’s
Director of nursing
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).
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.
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.
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.
The Director of Infection Prevention & Control (DIPC)
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.
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 .
The Director of Infection Prevention & Control (DIPC) will have ultimate responsibility for the risk assessments & decontamination options driven forward.
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.
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…