NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice

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1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice Review of Clinical Guideline (CG7) The use of pressure relieving devices (beds, mattresses and overlays) for the prevention of pressure ulcers in primary and secondary care Background information Guideline issue date: year review: year review: 2011 National Collaborating Centre: National Clinical Guidelines Centre Review recommendation The guideline should be amalgamated with the update of CG29 Pressure ulcers: the management of pressure ulcers in primary and secondary care, under a single scoping process. Factors influencing the decision Literature search 1. From initial intelligence gathering and a high-level randomised control trial (RCT) search clinical areas were identified to inform the development of clinical questions for focused searches. Through this stage of the process 33 studies were identified relevant to the guideline scope. The identified studies were related to the following clinical areas within the guideline: Risk assessment scales for predicting pressure ulcers development 1 of 29

2 Clinical effectiveness and cost effectiveness of high-tech pressure relieving mattresses and overlays for the prevention of pressure ulcers Support systems used with pressure relieving devices in the prevention of pressure ulcers 2. Three clinical questions were developed based on the clinical areas above, qualitative feedback from other NICE departments and the views expressed by the Guideline Development Group, for more focused literature searches. The clinical questions for the focused searches are as follow: Accuracy and clinical utility of various risk assessment scales in predicting the development of pressure ulcer compared to clinical judgement with holistic assessment, and the benefit of timely transfer. Clinical effectiveness and cost effectiveness of various high-tech pressure-relieving mattresses and overlays compared to low-tech high-specification foam mattresses and overlays for, including in the operating room setting. Clinical effectiveness of various advance support systems used with pressure-relieving beds, mattresses and overlays. 3. In total, 24 studies were identified through the focused searches. The review indicated that overall: The identified new evidence supports current recommendations that risk assessment scales should not be used as the sole risk assessment strategy to predict pressure ulcer development and to assist prevention plans. Timely transfer of patients identified as high risk to appropriate preventative interventions would improve outcomes. However, there is still a lack of evidence on the exact cut-off time for transfer. 2 of 29

3 The new identified evidence also supports current recommendations that high-tech alternating pressure devices should be provided for patients with elevated risk. However, there is still insufficient evidence on which individual high-tech devices or which individual alternating pressure devices are of most effective and cost effective. More RCTs are needed in order to provide sufficient evidence on the effectiveness and cost effectiveness of various advance support systems used with pressure-relieving beds, mattresses and overlays. 4. No evidence was identified which directly answered the research recommendations presented in the original guideline. 5. One ongoing Cochrane review (publication date unknown) was identified on pressure relieving devices specific for heel protection. Guideline Development Group and National Collaborating Centre perspective 6. A questionnaire was distributed to GDG members and the National Collaborating Centre to consult them on the need for an update of the guideline. Only two responses were received with respondents highlighting that since publication of the guideline, there is variation in practice mainly due to a lack of tissue viability nurse in the country. Other themes also include greater emphasis on skin and risk assessment, the NPSA incident report and zero tolerance approach to pressure ulcers, and the latest publication of the pressure ulcer prevention guideline from the European and US National Pressure Ulcer Advisory panel (EPUAP and NPUAP, 2010). The need to amalgamate existing guideline with CG29: The management of pressure ulcers in primary and secondary care was also emphasized. 3 of 29

4 7. No anecdotal efficacy or safety concerns were highlighted or any relevant ongoing research. 8. Feedback from the NCC also indicated that there is still insufficient evidence to warrant a formal update at this time. 9. Both questionnaire respondents agreed that there is insufficient variation in current practice supported by adequate evidence at this time to warrant an update of the current guideline, apart from the amalgamation of existing guideline with CG29. Implementation and post publication feedback 10. In total 18 enquiries were received from post-publication feedback, most of which were routine. Key themes emerging from postpublication feedback were: Request for more detailed recommendation on individual types of mattress The availability of CG29: The management of pressure ulcers in primary and secondary care. 11. The NICE implementation programme has not looked at any routinely collected data in order to determine the uptake of this particular clinical guideline. 12. Several were highlighted through qualitative input from the field team. In particular, an audit which showed variation in existing practice, and concerns were expressed about a lack of cost effectiveness evidence on numerous expensive new devices. In addition, the inclusion of pressure ulcers in Quality Standards was highlighted as a significant local issue due to the potential impact upon increased length of hospital stay and delayed discharge. Other programmes such as the High Impact Actions for Nursing and Midwifery were also mentioned, which aimed at developing evidence based actions on prevention in wound care that triangulated with NICE. 4 of 29

5 13. This feedback contributed towards the development of the clinical questions for the focused searches. Relationship to other NICE guidance 14. NICE guidance related to CG7 can be viewed in Appendix 1. In particular, this guideline is closely linked to the care pathway of CG29: The management of pressure ulcers in primary and secondary care, Summary of Feedback Review proposal put to consultees: The guideline should not be updated at this time. The guideline will be reviewed again according to current processes. 15. In total 20 stakeholders commented on the review proposal recommendation during the 2 week consultation period. 16. There was equal agreement and disagreement amongst stakeholders with the review proposal recommendation. Two stakeholders did not provide a comment. 17. Those stakeholders that disagreed with the review proposal commented that: There are regarding uptake and implementation of current recommendations, which currently outside the remit of the guideline. The guideline should be in line with the European and US National Pressure Ulcer Advisory panel (EPUAP and NPUAP, 2010) guideline on pressure ulcer prevention. However, from the review it was established that most recommendations from the EPUAP and 5 of 29

6 NPUAP (2010) guideline on pressure ulcer prevention are based on low or very low evidence (i.e. indirect evidence or expert opinions). The guideline should provide specific recommendation on which individual high-tech devices should be provided. However, from the review there is still insufficient good quality multiple head-to-head comparative trials on individual devices to provide specific recommendation on which individual high-tech devices should be recommended. The guideline should provide specific recommendations on pressure relieving devices for sitting and heel protection, and recommendation on SKIN bundles (a series of steps developed in the US that are implemented for at-risk patients: Surface selection, Keep turning patients, Incontinence management, and Nutrition). However, from the review there is still insufficient good quality trial on pressure relieving devices for sitting and heel protection, and the effectiveness of SKIN bundles. An ongoing Cochrane review was identified on heel protection and this should be incorporated and assessed at the next review. 18. During consultation, other areas of the guideline to consider for review in an update of the guideline were highlighted including: Exact timing for initiating preventative interventions after risk assessment. The effectiveness of Australian Medical Sheepskin in operating setting for pressure ulcer prevention. 19. Individual stakeholder comments can be viewed in Appendix 2. Anti-discrimination and equalities considerations 20. No evidence was identified to indicate that the guideline scope does not comply with anti-discrimination and equalities legislation. The original scope covers individuals of all ages who are at risk of developing pressure ulcers in primary and secondary care. 6 of 29

7 Conclusion 21. A review of the guideline indicated that no additional areas were identified which were not covered in the original guideline scope or would indicate a significant change in clinical practice. Also, no additional factors were identified which would invalidate or change the direction of current guideline recommendations. 22. Whilst the review for this guideline indicated no substantial need to update the gudleine, the previous decision by GE was that this should be incorporated into an update of CG29, this was supported by stakeholder comments. It is proposed that the guideline should be amalgamated with the update of CG29 Pressure ulcers: the management of pressure ulcers in primary and secondary care, with further consideration on exact timing for initiating preventative intervention and the effectiveness of Australian Medical Sheepskin in operating setting for pressure ulcer prevention. Relationship to quality standards 23. This guideline relates to a quality standard on pressure ulcers. Fergus Macbeth Centre Director Sarah Willett Associate Director Toni Tan Technical Adviser Centre for Clinical Practice June of 29

8 Appendix 1 The following NICE guidance is related to CG7: Guidance CG29: The management of pressure ulcers in primary and secondary care, CG74: Surgical site infection: prevention and treatment of surgical site infection, Review date May 2011 July of 29

9 Appendix 2 National Institute for Health and Clinical Excellence CG7 Pressure relieving devices Guideline Review Consultation Table 18 th April to 9 th May 2011 Agree All Wales Tissue Viability Nurse Forum Yes Arjohuntleigh No Our own published research (Buttery 2008; Phillips 2010) and that of others (Vanderwee 2007) has indicated an alarming lack of adoption of the current and previous best practice guidelines in the UK; this clearly continues to put patients at risk. It is apparent from these observations, our on-going client support and your own post-launch feedback, that there is still confusion regarding the existing recommendations and still significant gaps in practice. Nurses continually seek guidance as to which support surface mattress or overlay, active (alternating) or reactive (foam, low air loss) etc. and need, in our view, a definitive instruction to link assessment with intervention. on areas excluded We agree that, as it stands, the guideline is still relevant so maybe a full review is not required, but there are important areas which now need to be strengthened given the body of evidence which has plugged some of the gaps since the first literature review almost 10-years ago. If, true to its mission, NICE wish to have patient safety and cost-effectiveness at heart, then clinicians deserve to have areas reviewed and updated so that they can use the information to shape the future of preventative care. Thank you. Thank you for the references on local audit reports. However, recommendations for implementation are outside the remit of this guideline. From the review, there is still a lack of RCTs on multiple direct comparisons of different specific individual products/devices to warrant a formal update in this area. We believe the new literature you have reviewed, much of it arising from the highest Thank you for the references. The 9 of 29

10 quality research methods, does indeed answer some of these questions, as do other papers not included in your summary (Finnegan 2008, Clark 2001); it is important that these are now incorporated into the guideline even as an addendum if a full review is not warranted. For example; the Nixon and Igelsias RCT (overlay vs. mattress replacement) gives very clear direction regarding cost-effectiveness and in these difficult economic times NICE would be failing in its mission not to share this with cash strapped healthcare providers. We petitioned to have it included in the first guideline and it was rejected on account of timing (published just before the guideline); we were assured that it would be included in the next scheduled update. It is unacceptable to consider this substantial RCT as not sufficient high quality data to warrant an updated to the guideline. on areas excluded references will be passed to the developers who are responsible for amalgamating this guideline with CG29: Pressure ulcer management. The Nixon and Igelsias RCT (PRESSURE trial) was included in the review (please check references of the review proposal), and the study does not contradict current recommendations Also, based on our published observations, it is clear that there is a complete disconnect between risk assessment and preventative interventions; this is supported by others such as Vanderwee (2007). Your search revealed conclusive evidence that it is probably not the type of risk assessment tool that matters, but rather the timing of the preventative care; surely this must be emphasised in any guideline of Thank you for the comments. The issue raised will be discussed during the amalgamation of this guideline with CG29: Pressure ulcer management. 10 of 29

11 merit Right now the guideline simply says risk assessment within 4-hours, yet makes little comment on the immediacy of intervention we audit, on average, the care of 30,000 patients per annum and consistently see a failure to provide preventative interventions before damage occurs. In our view this is probably the most important reason the NHS still sees around 50% of ulcers still acquired under supervised care! on areas excluded We agree that, as it stands, the guideline is still relevant so maybe a full review is not required, but there are important areas which now need to be strengthened given the body of evidence which has plugged some of the gaps since the first literature review almost 10-years ago. If, true to its mission, NICE wish to have patient safety and cost-effectiveness at heart, then clinicians deserve to have these two areas reviewed and updated (an addendum would suffice) so that they can use the information to shape the future of preventative care. References: Buttery J, Phillips L (2009). Pressure ulcer audit highlights important gaps in the delivery of preventative care in England and Wales of 29

12 2008. EWMA J. 9(3): on areas excluded Clark M. (2001). Models of pressure ulcer care: costs and outcomes. Br J Healthcare Man.7(10): Finnegan MJ, et al (2008). Comparing the effectiveness of a specialised alternating air pressure mattress replacement and an airfluidized integrated bed in the management of post-operative flap patients: a randomised controlled pilot study. J Tiss Viab 17(1): 2-9 Phillips L. Pressure ulcer audit: a paradigm shift. (2010) In: Cherry GW, Hughes MA (Eds). Second Oxford European Wound Healing Course Book. Positif Press, Oxford Ashford & St Peter's Hospitals NHS Foundation Trust Associazione Infermieristica per lo Studio delle Lesioni Yes Yes Vanderwee K et al (2007). Pressure ulcer prevalence in Europe: a pilot study. J Eval Clin Pract. 13(2): Area of pressure relieving devices for sitting (chairs, armchairs, wheelchairs ecc ) Thank you for your comments. These will be considered by the developers when this 12 of 29

13 Cutanee (AISLeC) Barnsley Hospital NHS Foundation Trust Agree Yes on areas excluded Review of heel protection devices for bed pressure care. BES Rehab Yes A) I would support the joining of CG7 and CG29 into one document. B) An area which needs more emphasis is the equally high, or often greater, importance of moisture, heat, and shear leading to pressure ulcers. C) In para synthetic sheepskins needs synthetic defining since there are now materials on the market made from wool which achieve higher densities than natural skins, and which operate as effectively as real skins, while there are also ineffective low density wool woven products. D) In the full guidelines there is the recommendation: One small trial of the standard hospital mattress with and without sheepskin overlays was guideline is amalgamated with the update on CG29. Thank you for your comments. These will be considered during scoping by the developers when this guideline is amalgamated with the update on CG29. A) Thank you. B) Thank you for your comments. These will be considered during scoping by the developers when this guideline is amalgamated with the update on CG29.C), D) and E) Thank for the additional references for the studies on Australian Medical Sheepskin. This issue will be discussed during the amalgamation of this guideline with CG29: Pressure ulcer management. 13 of 29

14 on areas excluded inconclusive and of poor quality (Ewing et al 1964).Another trial conducted on 297 orthopaedic patients (McGowan et al 2000) found that pressure ulcer incidence was reduced in those assigned a sheepskin produced to Australian standards (relative risk for sheepskins relative to standard treatment was 0.28; 95 per cent CI, ).Although the results from this trial are promising, it should be replicated using a similar product on a large sample. It is not possible at this stage to say whether these Australian medical sheepskins are comparable to those available elsewhere in the world E) Please be aware that two further trials have been carried out, and are summarised in Mistiaen et al Med J Australia (2010) 193, , and include data from European and Australian studies. The weight of these studies does show the beneficial use of Australian Medical Sheepskin. The proceedings of 14 of 29

15 on areas excluded EPUAP September 2010 conference also has a paper by Call et al which shows the benefits of high density wool and natural sheepskins in handling water vapour, heat, and shear, as well as the pressure redistributing properties. This evidence should be considered for CG7 and CG29. British Association of Dermatologists British Healthcare Trades Association Yes No The review recommendation not to update the use of pressure relieving devices guideline is surprising in view of the recent publication of the European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel Guidelines 2009 ( These guidelines produced evidence based recommendations for the prevention and treatment of pressure ulcers for use by health professionals worldwide. This guidance is a result of collaboration with 903 individuals and 146 societies / organisations in 63 countries across 6 continents. One cornerstone premise None identified. It would seem sensible to combine this and the guideline on pressure ulcer management. There is currently no specific mention or guidance on the use of pressure relieving devices for specific anatomical sites, for example, heels. The EPUAP-NPUAP 2009 pressure ulcer prevention and treatment guidelines give advice and recommend devices for the management of heel pressure ulcers. The heel is the second most common location for pressure ulceration (after the sacrum), with one study showing the heel/ankle area accounting for None identified Thank you for your comments. Current review found that there is still a lack of robust evidence on heel pressure ulcer prevention to provide any specific recommendations. This issue will be considered again when the proposed Cochrane review on Pressure relieving devices for preventing heel 15 of 29

16 initiating the EPUAP-NPUAP 2009 guidelines was a recognition backed by evidence of an over reliance upon risk assessment tools (Waterlow, Braden etc) which has led to an over provision equipment to address the level of risk identified. This issue was addressed in the EPUAP-NPUAP 2009 guidance where pressure relieving devices are categorized by specific technology. An evidence based approach was adopted to recommend specific technologies to specific application either for prevention or treatment of pressure ulcers and the guidance takes account of technologies that were not available at the time of the CG7 publication. We believe the EPUAP-NPUAP 2009 guidelines should be considered and recognised in both the CG7 and CG29 Reviews on areas excluded 44% of ulcers in a rehabilitation unit (Schue M, 1998), and 47% on an orthopaedic unit (Wilson A, 2002). Other estimates indicate incidence of heel ulceration at 20% (David et al, 1983; Dealey, 1991), and their incidence has increased steadily over the past few decades (Collier, 2000). 38% of diabetic patients with heel ulcers lost their ipsilateral leg (Kerstein M, 2008). Section 3.1 of the EPUAP-NPUAP 2009 prevention guidelines notes that, "Ensure that the heels are free of the surface of the bed" and section 3.2 notes that, "Heel protection devices should elevate the heel completely (offload them) in such a way as to distribute the weight of the leg along the calf without putting pressure on the Achilles tendon..." The shape of the foot makes heel ulceration difficult to manage, and it has little fatty tissue to act as a cushion or protection. "Therefore tissue damage occurs rapidly due to reduced mobility, sensory impairment and sedation" (Wheeler 1997). The heel is worthy of specific consideration as it is distinct from pressure ulcers (Protocol) (McGinnis et al.) is published (no publication date yet) and during the amalgamation of this guideline with CG29.. Thank you for your comments regarding the EPUAP-NPUAP (2010) guideline on pressure ulcer prevention. However, current review has established that recommendations from the EPUAP-NPUAP (2010) guideline are mostly based on low or very low quality evidence (i.e. indirect evidence or expert opinions). 16 of 29

17 on areas excluded other bony prominences and as such may be at increased risk from pressure induced tissue trauma. (Donnelly 2008). It is our view that the CG7 and CG29 guidance should take account of evidence supporting technologies that have been commonly adopted to address specific site ulceration such as Wedges and Heel Protectors to aid in the prevention and treatment of heel ulceration. Pressure ulcer prevalence and incidence and a modification of the Braden scale for a rehabilitation unit. Richard M. Schue MS, RN, and Diane K. Langemo PhD, RN. Journal of WOCN, January 1998 Prevention of heel pressure ulcers in an orthopaedic unit. Wilson A. Nursing Times.net, The size of the pressure ulcer problem in a teaching hospital. Dealey C. J Adv Nurs An investigation of current methods used in nursing for the care of patients with established pressure ulcers. David GG, Chapman RG, Chapman EZ. Nursing Practice Unit, Har Thank you for the references on heel protector. This issue will be considered again when the proposed Cochrane review on Pressure relieving devices for preventing heel pressure ulcers (Protocol) (McGinnis et al.) is published (no publication date yet) and during the amalgamation of this guideline with CG of 29

18 British Psychological Society Yes The Society does not disagree with your recommendation not to undertake an update at this time. on areas excluded Heel Ulcerations in the Diabetic Patient. Kerstein MD. Wounds Pressure relieving devices for preventing heel pressure ulcers (Protocol). Donnelly J, Kernohan GW, Witherow A. The Cochrane Collaboration 2008 Thank you. Cornwall & Isles of Scilly PCT Department of Health Frontier Therapeutics Ltd No N/A No As stated below, however there may not be any new evidence to support this. I wish to confirm that the Department of Health has no substantive comments to make regarding this consultation. Your review recommendation concludes that no additional factors were identified which would invalidate or change the direction of current guideline recommendations. This opinion appears to ignore more recent recommendations from the European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel 2009 ( This was I feel that consideration needs to be given to SKIN Bundles in the prevention of pressure ulceration and assessment, also the effect mobility has on the decision with regards to the equipment used, more on heel pressure ulcers and sitting out, also on cushions. There is currently no specific mention or guidance on the use of pressure relieving devices for other anatomical sites, for example, heels. The EPUAP-NPUAP 2009 pressure ulcer prevention recommendations specifically give advice for the management of heel pressure ulcers. Thank you for your comments. These will be considered during scoping by the developers when this guideline is amalgamated with the update on CG29. Thank you for your comments regarding the EPUAP-NPUAP (2010) guideline on pressure ulcer prevention. However, current review has established that recommendations from 18 of 29

19 developed through International collaboration to produce evidence based recommendations for the prevention and treatment of pressure ulcers that could be used by health professionals throughout the world. This guidance is a result of collaboration with 903 individuals and 146 societies / organisations in 63 countries across 6 continents. One cornerstone premise initiating the EPUAP-NPUAP 2009 guidelines was a recognition backed by evidence of an over reliance upon risk assessment tools (Waterlow, Braden etc) which has led to an over provision equipment to address the level of risk identified. This particular issue is partially addressed in CG7 by reminding professionals to consider the use of higher specification foam mattresses. The EPUAP-NPUAP 2009 guidance recommends the same but also recommends the use of non powered pressure redistribution support surfaces in recognition of technology which was not generally available in 2003 but has become widely used in the NHS and other countries since that time. An example of the most commonly used non powered pressure redistribution support surface in the NHS is the Repose air-filled overlay upon which more than 2 million NHS on areas excluded The heel is the second most common location for pressure ulceration (after the sacrum), with one study showing the heel/ankle area accounting for 44% of ulcers in a rehabilitation unit (Schue M, 1998), and 47% on an orthopaedic unit (Wilson A, 2002). Other estimates indicate incidence of heel ulceration at 20% (David et al, 1983; Dealey, 1991), and their incidence has increased steadily over the past few decades (Collier, 2000). 38% of diabetic patients with heel ulcers lost their ipsilateral leg (Kerstein M, 2008). Section 3.1 of the EPUAP-NPUAP 2009 prevention guidelines notes; "Ensure that the heels are free of the surface of the bed" and section 3.2 notes that, "Heel protection devices should elevate the heel completely (offload them) in such a way as to distribute the weight of the leg along the calf without putting pressure on the Achilles tendon..." The shape of the foot makes heel ulceration difficult to manage as it is poorly perfused and has little fatty tissue to act as a cushion or protection. "Therefore tissue damage the EPUAP-NPUAP (2010) guideline are mostly based on low or very low quality evidence (i.e. indirect evidence or expert opinions). Thank you for the data on NHS Supply Chain 2009, Frontier Therapeutics Data, and audit from NHS 19 of 29

20 patients have been supported since the CG7 report was published. More than 400,000 NHS patients are supported on a Repose Mattress today and everyday in the UK. (Data; NHS Supply Chain 2009 and Frontier Therapeutics Data on File 2010) Such products do usually provide for substantial cost savings, A Pressure Ulcer Prevalence audit in 2006 in NHS Fife demonstrated, There has been a definite shift away from the use of dynamic systems. Due to the increased availability of Repose mattresses, patients are being upgraded more quickly... A reduction in Pressure Ulcer Prevalence of 2% over the 5 years was witnessed. the Trust was spending in excess of 300,000 in 2001 on dynamic equipment. The budget for all pressure relieving equipment is now 62,000 (a saving of over 225,000 pa (>79%)). Wilson A, 2006 on areas excluded occurs rapidly due to reduced mobility, sensory impairment and sedation" (Wheeler 1997). The heel is worthy of specific consideration as it is distinct from other bony prominences and as such may be at increased risk from pressure induced tissue trauma. (Donnelly 2008) The design and shape of a high specification foam mattress (as a minimum provision) does not fall within these criteria, and as such we believe that due to the specific requirements for heel protection there is merit for a separate category listing. The Repose Foot Protector for example has become the most widely prescribed heel off-loading device within the NHS with more than 30,000 NHS patients receiving a Repose foot protector in 2010 with an equivalent number of NHS patients estimated to have received foam shaped devices with similar properties. They are designed to offload pressure from the heels, and are indicated for the prevention of pressure ulceration in patients at all levels of risk, including very high risk, Fife. These will be considered during scoping by the developers when this guideline is amalgamated with the update on CG29. Thank you for the comments on heel protectors. This issue will be considered again when the proposed Cochrane review on Pressure relieving devices for preventing heel pressure ulcers (Protocol) (McGinnis et al.) is published (no publication date yet) and during the amalgamation of this guideline with CG of 29

21 on areas excluded and treatment of existing ulcers at all Grades. Evidence in support of the Repose Foot Protector includes a series of case studies for example Using the heel protector led to a significant reduction in the incidence of heel pressure ulceration from more than 6% to 0%. A significant reduction in cost (70%) was also identified. Evans J, 2009 There was a significant improvement in the skin condition of the heels and comfort (p<0.0001) from study entry to exit. Bale S, et al 2001 "None of the patients using the Repose foot protector developed a heel ulcer in the unit, resulting in a fall in clinical incidence from 17% to 0% MacFarlane A, et al 2006 Pressure ulcer prevalence and incidence and a modification of the Braden scale for a rehabilitation unit. Richard M. Schue MS, RN, and Diane K. Langemo PhD, RN. Journal of WOCN, January 1998 Prevention of heel pressure ulcers in an orthopaedic unit. Wilson A. Nursing Times.net, of 29

22 Hill-Rom Ltd. NO The terminology used should follow that used in the 2009 EPUAP NPUAP Pressure Ulcer Guidelines which talk about pressure redistributing support surfaces rather than pressure relieving and the importance of pressure redistribution, immersion and envelopment. on areas excluded The size of the pressure ulcer problem in a teaching hospital. Dealey C. J Adv Nurs An investigation of current methods used in nursing for the care of patients with established pressure ulcers. David GG, Chapman RG, Chapman EZ. Nursing Practice Unit, Har Heel Ulcerations in the Diabetic Patient. Kerstein MD. Wounds Pressure relieving devices for preventing heel pressure ulcers (Protocol). Donnelly J, Kernohan GW, Witherow A. The Cochrane Collaboration 2008 Thank you for your comments. The issue on terminology will be addressed when this guideline is incorporated into CG29: Pressure ulcer management. With reference to p.11 of 24, Health economic evaluation (two studies). Theaker, C, M. Kuper and N. Soni, Pressure ulcer prevention in intensive care study refers to the Duo mattress manufactured by Hill-Rom. This product is no longer available and has been superseded by Thank you for your information on Theaker et al. s study, the study will be removed. 22 of 29

23 Innovation Rehab Leeds Teaching Hospitals NHS Trust No No the Duo 2 and therefore this reference/study is no longer valid and should be removed. I feel that that not enough evidence has been taken on the comparison in use of static air preasure overlay mattresses and devices. We represent a very large company in the USA in this area of product expertise for over 50 years and they have some very positive outcomes in connection with static pressure ulcer relief devices in use with standard hospital mattresses and sometimes in connection with devices to prevent heel ulcers. I do think we should look at this type of device again for use in prevention and healing of ulcer related symtems on patients. This method would also prove a very cost effective working treatment for the NHS. CG 7 should be reviewed and combined with CG 29, these 2 documents cannot be considered in isolation and there are gaps in CG29 because of this. Issues pertinent to both documents: There is no mention of referral to a Tissue Viability Service in either documents, this presence and use of this expert resource is essential to the successful implementation of the guidelines and the quality of patient care. There is no standardised reliable reporting system for pressure ulcers - without a TV service many on areas excluded See comments Thank you for you comments. In the review, a Cochrane review (McInnes et al.) of RCTs was identified and concluded that the relative merits of high-tech static low pressure and alternating pressure mattresses and overlays for prevention were unclear. Therefore, there is still a lack of robust RCTs to warrant a formal update in this particular area. Thank you for your comments. We agree to amalgamate this guideline with CG29: Pressure ulcer management. Service delivery and service configuration are outside the scope and remit of the guideline. Thank you for your 23 of 29

24 Royal College of Nursing No pressure ulcers are not identified. There has been a revision of guidance on pressure ulcer prevention from EPUAP and NPAUP which the UK needs to adopt to keep us in line with the rest of Europe and the US. The change of definitions of staging or grading of a pressure ulcer needs to reflect the new international guidance There needs to be additional guidance on when pressure ulcers are avoidable/ unavoidable. There needs to be guidance on when pressure ulcers are to be considered a safeguarding issue. We consider that this would be best incorporated into CG29 Pressure ulcers: the management of pressure ulcers in primary and secondary care since the use of pressure relieving devices is an inherent aspect of management. on areas excluded The whole issue about infection prevention, appropriate cleaning and decontamination should be included. Concern has been raised in the media, CQC about inadequate cleansing and increased risk of MRSA and CDiff especially. It would be valuable if recommendations could include not only appropriate decontamination but also audits. We also feel that consideration needs to be given to SKIN Bundles in the prevention of pressure ulceration and assessment, also the effect mobility has on the decision with regards to the equipment used, more No identified but consideration would be useful to include reference to weight limits. Bariatric patients are increasing and are at risk of equality. comments regarding the EPUAP-NPUAP (2010) guideline on pressure ulcer prevention. However, current review has established that recommendations from the EPUAP-NPUAP (2010) guideline are mostly based on low or very low quality evidence (i.e. indirect evidence or expert opinions). Thank you for your comments. We agree to amalgamate this guideline with CG29: Pressure ulcer management. Issues on cleansing, dressing and interventions for infection will be assessed during the scoping of the update of CG29: Pressure ulcer management. SKIN Bundles and prevention of heel pressure ulcers maybe 24 of 29

25 Royal College of Physicians Royal Liverpool & Broadgreen University Hospitals NHS Trust N/A (YES) As the Bri. Asso. Derma said Yes The Royal College of Physicians wishes to endorse the response submitted by the British Association of Dermatologists to the above review proposal consultation No This would be best incorporated into CG29 Pressure ulcers: the management of pressure ulcers in primary and secondary care since the use of pressure relieving devices is an inherent aspect of management. on areas excluded on heel pressure ulcers and sitting out, also on cushions. The whole issue about infection prevention, appropriate cleaning and decontamination should be included. Concern has been raised in the media, CQC about inadequate cleansing and increased risk of MRSA and CDiff especially. It would be valuable if recommendations could included not only appropriate decontamination but also audits. No identified but consideration would be useful to included reference to weight limits. Bariatric patients are increasing and are at risk of equality. considered by the developers when this guideline is amalgamated with the update on CG29.. Thank you. Thank you for your comments. We agree to amalgamate this guideline with CG29: Pressure ulcer management. Issues on cleansing, dressing and interventions for infection will be assessed during the scoping of the update of CG29: Pressure ulcer management. UK Clinical Pharmacy N/A We do not have any comments on the consultation. Thank you. 25 of 29

26 Association Wound Care Alliance UK Yes The reference to patient arms when on a Nimbus 3 (page 9) doesn t seem relevant 3 aspects of care we think should be considered further are 1. use of overlays which then affect the overall height of the bed and cause concern in relation to reducing the effectiveness of side rails. 2. Nothing is mentioned regarding appropriate/ effective use of a profiling bed frame given that thought most Trusts were going to be using profiling fames by there is no mention of the use of cushions or specialist seating on areas excluded Thank you for the comments. These will be considered during scoping by the developers when this guideline is amalgamated with the update on CG29. These organisations were approached but did not respond: 3M Health Care Limited Abbott Laboratories Limited Aintree University Hospitals NHS Foundation Trust Alder Hey Children's NHS Foundation Trust All Wales Senior Nurses Advisory Group (Mental Health) Association of British Health-Care Industries BMJ British Association for Parenteral & Enteral Nutrition (BAPEN) British Dietetic Association 26 of 29

27 British Geriatrics Society British Medical Association (BMA) British National Formulary (BNF) BUPA Calderdale and Huddersfield NHS Foundation Trust Cambridge University Hospitals NHS Foundation Trust (Addenbrookes) Cardiff University Care Quality Commission (CQC) Chartered Society of Physiotherapy (CSP) Cochrane Wounds Group College of Occupational Therapists Community District Nurses Association Community Practitioners and Health Visitors Association Connecting for Health ConvaTec Craegmoor Department for Communities and Local Government Department of Health Advisory Committee on Antimicrobial Resistance and Healthcare Associated Infection (ARHAI) Department of Health, Social Services & Public Safety, Northern Ireland (DHSSPSNI) Elective Orthopaedic Centre, The European Pressure Ulcer Advisory Panel Faculty of Public Health First Technicare Ltd Great Western Hospitals NHS Foundation Trust Hampshire Partnership NHS Foundation Trust Healthcare Improvement Scotland Healthcare Quality Improvement Partnership Help the Hospices Humber NHS Foundation Trust James Paget University Hospitals NHS Foundation Trust Kaymed Lancashire Care NHS Foundation Trust Medical Support Systems Limited Medicines and Healthcare Products Regulatory Agency (MHRA) Midlands Centre for Spinal Injuries Ministry of Defence (MoD) National Council for Disabled People, Black, Minority and Ethnic Community (Equalities) National Patient Safety Agency (NPSA) 27 of 29

28 National Treatment Agency for Substance Misuse Newcastle Upon Tyne Hospitals NHS Foundation Trust NHS Clinical Knowledge Summaries Service (SCHIN) NHS Direct NHS Plus NHS Sheffield NHS Western Cheshire Nightingale Care Beds Ltd Norfolk Community Health and Care NHS Trust Northumbria Acute Trust Outer North East London Community Services Pegasus Limited PERIGON Healthcare Ltd Public Health Wales Relatives and Residents Association Rotherham NHS Foundation Trust Royal College of Anaesthetists Royal College of General Practitioners Royal College of General Practitioners Wales Royal College of Midwives Royal College of Obstetricians and Gynaecologists Royal College of Paediatrics and Child Health Royal College of Pathologists Royal College of Psychiatrists Royal College of Radiologists Royal College of Surgeons of England Royal Pharmaceutical Society of Great Britain Sanctuary Care Scottish Intercollegiate Guidelines Network (SIGN) Sheffield Teaching Hospitals NHS Foundation Trust Skin Care Campaign Smith & Nephew Healthcare Social Care Institute for Excellence (SCIE) Society of Chiropodists & Podiatrists Solent Healthcare Southend University Hospitals NHS Trust Southern Alliance of Tissue Viability Nurses Spenco Healthcare International Limited 28 of 29

29 Spinal Injuries Association Stockport NHS Foundation Trust Sue Ryder Care Talley Group Ltd The Royal Society of Medicine Tissue Viability Nurses Association Tissue Viability Society (UK) TOAST (The Obesity Awareness and Solutions Trust) Tomorrow Options Trafford NHS Provider Services UK Pain Society United Lincolnshire Hospitals NHS Trust Welsh Assembly Government Welsh Scientific Advisory Committee (WSAC) Welsh Wound Network West Essex Community Health Services Westmeria Healthcare Ltd Whipps Cross University Hospital NHS Trust York Teaching Hospital NHS Foundation Trust Your Turn 29 of 29