Disposition of Comments on CFPP 01-01 Part A

Disposition of comments on ‘CFPP 01-01 Part A’ GS - VOB

Consultee / Paragraph number / Comment / Suggested amendment /
IDSc / General
Comment (1) / Several concerns in relation to professional bodies that will need to imbed this guidance/policy, especially as they have not all been represented during the review of this document etc.
Can I suggest that a Purpose Statement is included within CFPP 01 01 (A) that includes and similar to the IDSc Purpose Statement below (General Comment 2) that includes competencies and qualifications (or link to where this is held centrally by the professional body) for:
1. IDSc (General Comment 2 below)
2. AED (IHEEM)
3. AfPP
4. IPS
We can no longer expect standards to improve without insisting that decontamination personnel (along with AED, AfPP, IPS) are competent and qualified to undertake the technical aspects of decontamination throughout healthcare organisations. / Please include Purpose Statements from the Professional Bodies, with a link to where the competencies and qualifications frameworks are held. /
IDSc / General Comment (2) / Institute of Decontamination Sciences (IDSc) Purpose Statement (to be introduced into CFPP 01 01 Part A): / Introduction to IDSc:
The Institute of Decontamination Sciences (IDSc) is the United kingdom’s largest professional body for the decontamination of re-usable invasive medical devices.
It aims:
§  To set the standards for professional practice within decontamination scientific services in line with current legislation, regulations and other published technical standards and guidance
§  To maintain a learned body, implement and sustain training program’s for its members, and those aspiring to membership, with the objective of achieving and maintaining high professional standards within the decontamination scientific professions
§  To determine academic attainments of those practicing or desiring to practice in the professions of applying Decontamination Sciences and Strategic Management thereof and to work with academic accreditation bodies to control and monitor these requirements
§  To provide, through regional branches, a forum for members to consider and discuss matters relating to the provision and improvement of decontamination sciences, and the career development and interests of such personnel /
/ Continued:
§  To promote and encourage research and development in all matters relating to decontamination sciences
§  To establish and monitor the high professional standards expected of decontamination scientific services personnel though registration, and to actively encourage the maintenance of such standards
§  To make available all the relevant International Standards through the use of a BSi Standards Collection, to ensure these standards are made available during Notified Body, CQC or NHSLA audits.
IDSc members’ work in all areas of medical device decontamination, within the NHS and Independent Healthcare Sector providing services to Acute and Primary Care functions including Endoscopy and Dental Services.
Our members include: Decontamination services personnel at all levels, endoscopy staff, microbiologists, infection prevention and control personnel, theatre staff, engineers, corporate members and members from the NHS, Commercial Service Providers and Independent Healthcare Sector throughout the United Kingdom.
The IDSc has proposed a professional structure for staff working in decontamination. A supporting educational programme has been developed in conjunction with Anglia Ruskin University, from which the course/qualifications relevant to each role have been approved. /
/ Continued:
The competencies and qualification framework that has been developed through the Modernising Scientific Career Framework is maintained on the IDSc Official Website at: http://www.idsc-uk.co.uk/ /
IDSc / General Comment / Letters have been sent to both the Chief Medical Officer (CMO) and Chief Scientific Officer (CSO) to request an extension to the response deadline, as the IDSc (AfPP, IPS AED (IHEEM)) were only given a very short time frame to comment on this document. The IDSc (who had not been involved in the vast majority of the detail) received notification of the consultation on the 23rd January 2012 and the deadline for comments is the 10th February 2012. There is a great deal of technical information to be reviewed, understood and commented on. A couple of weeks is an inadequate timescale to allow the relevant technical experts to consider their response. / Suggest further consultation if response time not extended by the CMO/CSO /
IDSc / General Comment / Availability of Annex for review – there were a lot of references to work that had been undertaken by pilots however not available which negated the points they were supporting / Provide the Annex? /
IDSc / General Comments / There is a lot of duplication of information / Delete duplication /
IDSc / General Comments / What timescales are being placed on achieving EQR? If some services achieve EQR and others don’t patients will receive a different service standard – is this acceptable? / Offer clarification on by when this needs to be achieved /
IDSc / General Comments / There is little reference to operating loading relating to Washer disinfectors and the number of instruments it is safe to load into a single DIN basket to ensure effective cleaning / Define the number of instruments that is deemed to represent a sample load – it is suggested that HTM suggested 20 instruments per DIN??? Please confirm. /
IDSc / General
Comments / There are many references to the AED providing advice on all standards within decontamination. / As decontamination now covers the whole of healthcare organizations from Ward to Board, please ensure the reference states: The AED will provide advice on all decontamination equipment standards and not the whole decontamination management process, this is the role of the Decontamination Lead /
IDSc / General comments / No reference is made to an effective cooling period for trays post sterilization / Can there be a defined period for trays of a certain weight? Design? Or size? C /
IDSc / Page 4 - 1.3 / Reusable Instrument Lifecycle, most SSDs return instruments (Loan) to lender further to sterilization cycle / Return to lender inserted @ Sterilization point /
IDSc / Bullet Point 3
Page 5 / Pilot Studies: / The scientific research evidence in support of the pilot studies needs to be made available as this document appears to be based upon personal opinion. We cannot allow guidance based upon a few trials to drive forward guidance for the whole of the English healthcare system. Also, are the pilots seen as the most compliant and up to date sites as there are many sites that are more state of the art than a port a cabin, can I suggest that the reference to the sites is removed as many organisations will be aware that their sites are much more compliant to building regulations. /
IDSc / Section 1.6
Page 6 / NICE Guidance failures - National concern
The National Decontamination Survey highlights the failures within NICE Guidance compliance.
The pilot site trials will need to be further extended throughout the UK, with funding and DH support as shown on the GOSH site. Guidance cannot be based upon a couple of trial sites without scientific research support. / NICE Guidance 196 has not been followed throughout the UK for a number of reasons, e.g. research into the impact of such changes in decontamination, funding, DH support.
NICE Guidance was supported by two CMO letters to NHS CEO's: PL/CMO/2007 and PL/CMO/2008. These letters detailed that although NICE Guidance 196 had been introduced into the NHS in 2006, it had been demonstrated that the guidance had not been fully put into practice, due to some of the recommendations being difficult to implement.
The CQC also requested that all NHS Trusts complied to NICE Guidance, although the majority of NHS Trusts claim to comply to this request, it has been clearly shown within this document (Gateway 9325) that no healthcare establishment completely follows NICE CJD guidance.
Using evidence from unscientific studies in a few sites may not improve the whole healthcare market in relation to decontamination management principles. It may help for the DH to attend all high-risk sites to aid the management to compliance with NICE Guidance, as was case at GOSH, it may also help if the DH funded the introduction of instrument tracking where needed as with the GOSH site.
It was made apparent during the 2008 National Decontamination Survey (Gateway 9325) that a major problem within decontamination and NICE Guidance was the clear lack of training across some high risk sites. This makes it very clear that training and qualifications are essential within decontamination (see General Comment 2 above: IDSc Purpose Statement) /
IDSc / Section 1.7
(Bullet Point 2)
Page 6 / Separate pool of instruments for Children born since 01/01/97. This has never been achieved, how are the instruments kept apart from other instruments used upon adults, an audit review of this process would see this fail / This allows reusable instruments to be used upon all high risk surgery upon children, utilizing the theory that these children have not been exposed to vCJD, what if the theory is that some of these patients may be 'silently' carrying vCJD and the streamed reusable instruments in theory transmitting vCJD. What if the sets get mixed up, what if the instruments are accidently processed with adult instruments? /
IDSc / Section 1.7
(Bullet Point 3)
Page 6 / Dropped instruments: the process of sterilizers in theatres was removed at huge expense to the benefit of patient safety / Remove this bullet point /
IDSc / Section 1.7
(Bullet Point 4)
Page 6 / Moist environment: it has been proven that some gels and foams are affecting washer-disinfectors, what gels or foams should be used / Provide the scientific research evidence in support of the gel or foam to use, if you spray the top of the instrument, how do you spray underneath? /
IDSc / Section 1.7
(Bullet Point 5)
Page 6 / Ensuring maximum protein removal / Please provide the system that allows this to happen with scientific research proving maximum protein removal - also set the 'clean definition' for instrument cleaning, is the level 1 mg, 10 mg - this needs to be developed and managed, as some sites may never achieve the level of cleanliness set, Ninhydrin is still being used, this does not detect to the level required, as stated within a DH study (2008), otherwise you will never remove the risk of vCJD transmissions, also if the instruments after cleaning, packing and placed in a sterilizer, may never sterilize the instrument if they have heavily coated in protein and possible vCJD /
IDSc / Section 1.11
Page 7 / Concerned that the review group have been convinced that contingency (use of sterilizers within theatre) against non-availability of instruments is safe practice, this is not safe practice. / Remove /
IDSc / Section 2.4
(Bullet Point 4)
Page 8 / Can you please provide the evidence of abandonment of surgery. Where is the evidence that this is a risk. The DH were advised that this could become an issue with the commercial centralization of SSDs, if there are pockets of issues throughout the UK, this should be managed locally and not pushed through all healthcare organizations. / I am afraid that this is totally unacceptable, the risk to too high, Evidence required for the reason to reduce decontamination standards, placing patients at risk /
IDSc / Section 2.5
Page 8 / If there is no risk benefit provided, then these pilot studies cannot be followed as they need further wider research / Remove /
IDSc / Page 9 - 2.10 / Seems to suggest that processing single use items is expectable / Suggest rewording the statement “the management of single use and management and decontamination processes for reusable surgical instruments” /
IDSc / Page 9 - 2.1/2.6 / Definitions of Essential Quality Requirements (EQR) & Best Practice (BP) unclear / Define which is the ‘gold’ standard, to ensure services providers continue to evolve & not an ‘do minimum’ approach /
IDSc / Page 9 - 2.16 / Local review of instrument sets / Need for this to be communicated independently to Clinical area e.g. Theatres, Clinics etc. /
IDSc / Page9 - 2.16 / Prion inactivation technologies reference – would be useful to have guidance on how to make the choice ie define which strain of TSE these must have been tested on and what the results should be to confirm they are effective / Provide a checklist? Or review methodology for determining how to make the choice, what criteria to use? Although, follow the reference to ACDP below /
IDSc / Section 2.16
(Bullet Point 1)
Page 9 / This will need AfPP approval, as this, although essential will need to free up all theatre nurse specialties to approve changes to instrument trays as already managed through change proposal forms utilised within CE accreditation. / Seek the advice of AfPP. Remove single room option as this will be very difficult to manage and reduces the need for safe practice. Is the single room option to allow the re-introduction of sterilizers in theatre, dangerous practice, remove /
IDSc / Section 2.16
(Bullet Point 2)
Page 10 / Novel prion inactivation technologies: please follow the advice from ACDP / Reference: The IDSc meeting with the Advisory Committee on Dangerous Pathogens: TSE Risk Management Subgroup: Section of minutes from the TSE risk Management subgroup – the members of this group expressed caution against the use of untested or untried detergents due to concern about potential toxicity and selective pressure to provoke change in agent/phenotype. As we must follow ACDP advice – remove this bullet point as the DH must be in line with ACDP advice /