Infection prevention technologies assessed

New products designed to help prevent hospital-acquired infection are being tested in “showcase hospitals” across England in a project led by the NHS Purchasing and Supply Agency (NHS PASA), which could help facilitate adoption across the NHS. Part of the Department of Health’s Healthcareassociated Infections (HCAI) Technology Innovation Programme, the aim of the initiative is to gather evidence on the effectiveness of each product – along with the views of staff on how easy they are to use. The technologies – which have all been given “recommendation 1” status by the DH’s Rapid Review Panel (RRP1) – are now at various stages of evaluation. Reports have been published on a number of technologies – including: Enturia’s ChloraPrep skin antisepsis system, Bioquell’s hydrogen peroxide vapour (HPV) disinfection technology, 3M’s Clean-Trace Hygiene Monitoring device and Bard’s silver-coated Foley catheter. The most recent of these published reports was on ChloraPrep – a sterile, single patient use skin antisepsis system, which is recommended by the epic2 guidelines for cutaneous antisepsis when inserting venous catheters. The device contains a solution of 2% chlorhexidine gluconate and 70% isopropyl alcohol and is the only product of its kind to have marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for use on human skin prior to puncture or incision. Use of 2% chlorhexidine gluconate in 70% isopropyl alcohol is also recommended as part of the DH’s Saving Lives initiative. • For skin preparation prior to the insertion of a central venous catheter (High Impact Intervention No. 1). • For skin preparation prior to the insertion of a peripheral intravenous cannula (High Impact Intervention No. 2). • For skin preparation prior to the insertion of a renal dialysis catheter (High Impact Intervention No. 3). • In a swab for disinfecting the skin prior to venepuncture for taking blood for culture (Taking blood cultures – a summary of best practice). Awarded Rapid Review Panel (RRP) recommendation 1 in 2005, ChloraPrep was used in seven showcase hospitals for three to six months for cutaneous antisepsis prior to the insertion of a vascular access device, renal dialysis catheter care and for collecting blood cultures. Three types of applicator are available: • Sepp – which contains 0.67 ml of the solution and which is pinched before use until the inner ampoule breaks. • Frepp – which contains 1.5 ml of the solution and has two wings which are pinched together until the ampoule breaks. • Other products containing 1.5 mL, 3 mL, 10.5 mL and 26 mL of the solution (the 1.5 mL size was not included in this evaluation) which either have wings or (for the 26 mL a handle) which are squeezed to break the ampoule. Data on blood culture contamination rates were collected by the showcase hospitals’ microbiology laboratories using coagulase-negative Staphylococci as the marker for contamination. Overall, there was no discernible effect on blood culture contamination following the introduction of ChloraPrep, though some hospitals did see a reduction. The report pointed out, however, that the patient’s skin is only one of a number of potential sources of contamination, and the blood culture contamination rates could have been affected by other factors. It also highlighted the fact that a study undertaken by the National Blood Service, which measured bacteria present on donors’ arms pre and post disinfection, showed that ChloraPrep was 10 times more effective than a wipe impregnated with isopropyl alcohol and 0.5% chlorhexidine acetate in disinfecting donor arms. In the light of this study, it was not felt necessary to measure skin contamination as part of this evaluation. During the final stages, 50 staff at each showcase hospital (who had routinely used ChloraPrep) were selected to participate in structured interviews and focus groups regarding their experiences. The majority of staff questioned used the ChloraPrep range of products for peripheral venous cannulation and post insertion site care in place of the previously used wipes. A significant majority of those who responded found all the ChloraPrep products to be easy to use, were confident in their efficacy and would recommend the products to their NHS colleagues. The larger sized products were shown to be even easier to use than the smaller sized Sepp product. Over 90% of staff found the larger sized products easy to activate compared with 83% of staff who found Sepp easy to activate. The larger sizes were also more likely to be recommended to colleagues. For example, 88% of staff who responded said they would recommend Sepp to a colleague and would like to continue to use the product. For Frepp this was even higher – 93% would recommend the product and 92% would like to continue to use the device. Staff were asked to give ChloraPrep a score out of 10 for 31 different factors. Overall, staff opinions were favourable – although some concerns around cost were raised and there were a few adverse skin reactions (a known issue). However, the project demonstrated that ChloraPrep can be safely implemented in NHS hospitals and that its use was popular with staff. The report concluded by stating: “Failure to comply with epic2 and Saving Lives guidelines will be hard to justify, particularly where bacteraemias are found by Root Cause Analysis to be the result of inadequate cutaneous antisepsis. “However, these risks have to be balanced against the costs, and it is important to assess the level of risk associated with each type of procedure, and the degree of benefit which the use of ChloraPrep is likely to bring.” A template business case has now been produced which can be downloaded from the website (www.showcasehospitals.com). Another innovation evaluated was the Bioquell HPV service, which achieves biodecontamination within a room by depositing an even layer of  “micro condensation” of HPV over the surfaces. The report pointed out that the HPV system is not intended to replace standard cleaning, so all rooms and equipment at the showcase hospitals were cleaned in the usual way. Bed managers, ward staff and infection control teams identified rooms for disinfection, which was then performed by Bioquell engineers. Across the seven showcase hospitals, a total of 2,093 rooms with a total room volume of 113,345 m3 were disinfected using the HPV system. Around 60% of rooms were disinfected as they became vacant or as part of a hospital disinfection schedule. Other reasons why rooms were selected for disinfection included MRSA (around 15%), C. difficile (around 9%), diarrhoea and vomiting, hepatitis B and C, norovirus, Pseudomonas and Salmonella, refurbishments and deep cleans. The results showed that the HPV system proved popular with both staff and patients – 99% of staff said they would recommend it, while patients reported feeling reassured that rooms were disinfected. Although the evaluation was not designed to assess the effectiveness of Bioquell in reducing infection, one site also reported that there appeared to be a downward trend in C. difficile cases, and in one ward which had been disinfected, no further C. difficile cases occurred. In addition, feedback from the hospitals showed that the system did not cause undue disruption. Staff were asked to record details of any delays to patient movement and 83% indicated that the Bioquell process caused no delay to discharges or admissions. However, the report pointed out that, to ensure disruption is minimised, good communication between bed managers, facilities and estates departments and Bioquell engineers is crucial. The overall efficiency of the service was evaluated and staff were required to record details of the Bioquell response time. The report concluded that, in 56% of cases, disinfection commenced within one hour of the request being made, with a further 32% being started within three hours. They also recorded details of the time areas were out of use and found that, in 64% of cases, this was less than four hours. Effective management of the service is important to ensuring cost-effective deployment, the evaluation report pointed out. The cost-effectiveness of the service varied between hospitals and from week to week, which was influenced by the contractual arrangement with Bioquell and how staff utilised the service. Under the contract agreed, payment was unaffected by the proportion of idle time during which Bioquell staff were not actively engaged in disinfecting rooms. Therefore, the greater the number of rooms and/or the greater the room volume disinfected each week, the more cost-effective the service proved. For example, the highest number of rooms disinfected in a week was 27, at a cost of £138.58 per room. The lowest was one, at a cost of £3741.75. The highest room volume disinfected in a week was 1,538 m3 at a cost of £2.43 per cubic metre. The lowest was 44 m3 at a cost of £78.90 per cubic metre. The showcase hospitals were asked for their comments on these variations. The main issue was the difficulty in matching availability of rooms with the hours of work of Bioquell staff, with rooms becoming available late in the day when patients were discharged, when Bioquell staff were finishing for the day. High bed occupancy levels added to these difficulties. The report therefore advised that it is important for a hospital to consider how and when it wishes to use the Bioquell system. Every effort should be made to match the availability of the service with the times when it is most likely to be needed – for example, when rooms are likely to become vacant – and continuous planning and organisation is required in order to ensure cost-effective use of the service. It also stated that it is vital to engage with bed managers in order to identify which rooms would be suitable/available for disinfection using the Bioquell system. Trusts may wish to prioritise use of the system, for example, by reference to whether a patient with a nosocomial pathogen has been discharged from the room, or for widespread disinfection in the event of an outbreak. Weekend working may be helpful where bed pressures during the week may affect uptake. The report further advised that best value can be derived from the Bioquell system by placing items of equipment which have been identified as needing disinfection – such as electronic equipment, drip stands, commodes and wheelchairs, in rooms which need to be disinfected. Although this evaluation used the Bioquell managed HPV disinfection service (which included equipment, personnel and consumables), an alternative would be to choose the manufacturer’s equipment-only option, which would require the Trust to train or recruit staff to undertake the disinfection process, and to pay for the consumables; or to purchase equipment and deploy Bioquell’s service personnel. Typical costs for a managed service (two on-site Bioquell engineers, three HPV generators and consumables) are £15,000/month, while Bioquell equipment (suitable for up to 250 m3) can be purchased for £33,000. Based on the managed service, the report cited the following pricing guide: assuming a bed space equal to 30 m3, the manufacturer predicts that a two-man team using three HPV generators could disinfect about 25 “equivalent bed spaces” per week. This equates to a cost of about £130 per bed space for the Bioquell service. The average achieved in the showcase hospitals was around 23 bed spaces per week, at a cost of £152 per bed space. The highest achieved in any week was 51 equivalent bed spaces at a cost of £68 per bed space. The report concluded that it was not possible to make a direct connection between the use of Bioquell and cost savings, but pointed out that it is reasonable to suggest that there would be some effect on infection rates. There is also some limited evidence, particularly in relation to C. difficile, that HPV disinfection, through elimination of the spores, may lower subsequent incidence of disease. However, it also emphasised the value of patients, visitors and staff being reassured that rooms had been disinfected – a reaction that is likely to enhance a Trust’s reputation. The report offered valuable advice on implementing the service – including highlighting the need to ensure “buy-in” from key-personnel. “The system requires a multi-disciplinary approach, with the cooperation of nurses, bed managers, infection control teams, facilities and estates management and the manufacturer’s team,” the report stated, adding that it is essential to ensure that all those who could veto or disrupt the efficient use of the system have their concerns addressed before the system is introduced. Communication systems (e.g. telephones, email and pagers) are also essential, to ensure that Trust staff can stay in close contact with the engineers. Other issues that need to be addressed, to ensure smooth operation, relate to fire alarms. The project found that several hospitals had problems with fire detection systems being activated by the HPV process and Bioquell advised that hospitals isolate rooms from the fire alarm system during disinfection. However, this may not be acceptable, so PASA suggested that covering smoke detectors temporarily during treatment may be a more acceptable option. It added that fire officers should agree local policies to ensure that hospital safety concerns are met.

Hygiene monitoring system

Other products reviewed by the showcase hospitals include the 3M Clean-Trace clinical hygiene monitoring system – designed to help assess standards of hygiene. The 3M Clean-Trace system detects adenosine triphosphate (ATP), which is present in all animal, vegetable, bacteria, yeast and mould cells. The presence of ATP indicates that contamination still remains from any one of these sources post-cleaning. Measuring the level of ATP provides a real-time indication of surface cleanliness, demonstrating the presence of organic contamination that can both harbour and provide a nutrient base for pathogenic bacteria to proliferate. High levels of organic residues can also provide a protective barrier against the action of cleaning detergents. When ATP comes in contact with the combined luciferin/luciferase reagent contained in one of the tests, a reaction takes place which emits light in direct proportion to the amount of ATP present. Within seconds, the 3M luminometer measures the amount of light generated, indicating the level of contamination. The level of light is measured and presented as a number or Relative Light Unit (RLU). The greater the level of contamination and ATP the greater the amount of light produced and the greater the RLU number generated on the instrument. Awarded Rapid Review Panel (RRP) recommendation 1 in 2007, the system was evaluated at the showcase hospitals on four wards. Swab readings were taken at 20 different points in each ward seven days a week – a total of over 53,000 readings. According to the report, reductions in biocontamination levels were observed and the project successfully demonstrated that the system was not only popular with staff, patients and visitors, but also led to improvements in hygiene awareness. However, the report added that swabbing routines at the levels used in the evaluation were time-consuming and, in some cases, this had a negative impact on enthusiasm to use the product. As there are no standards for acceptable levels of ATP-measured biocontamination in hospital settings, the Clean-Trace Clinical ATP system is best used for comparing levels of contamination in different areas and/or over time. The device was introduced in four ward areas in each hospital – an intensive therapy unit (ITU), a surgical ward, a medical assessment ward and a ward associated with care of older people. The report concluded that there was strong evidence that RLU levels reduced over the time of the study. All seven hospitals experienced an overall decline in the level of contamination over the six-month evaluation period from an average of 568 to 194 RLUs. Cleaning managers were impressed with the results and the improvements in their cleaning protocol. At one hospital it was also noted that the system introduced a good spirit of competition among staff to ensure their wards were the cleanest. There appeared to be no perception among staff that their performance was being unreasonably judged; neither did there appear to be a reaction from others that wards were being swabbed because they might be especially hazardous or dirty. The Clean-Trace Clinical ATP system influenced a variety of indirect improvements on wards, including promoting better communication between staff regarding infection control, changes in cleaning practices and ward layout. It was also used as a training tool to demonstrate effective cleaning regimes. However, a number of points arose which will need to be borne in mind by any Trust considering making use of system. Swabbing 20 test points seven days a week presented many challenges, and several hospitals experienced significant numbers of missed days, particularly at weekends and when key staff were on leave. It was possible for “momentum to be lost” and for swabbing to become “hit and miss”. One hospital commented that “the novelty was wearing off”, but another found that training administration and support staff to do some of the swabbing helped to achieve continuity of results. The report suggested that there are a range of possible uses for the system, including: • Monitoring of decontamination where it is particularly important that cleaning is carried out effectively, for example after the discharge of patients with infections. • Comparison of levels of contamination to show which areas are most likely to be heavily contaminated, and therefore may require more frequent cleaning, or particular attention to the removal of biocontaminant. • To compare post-cleaning levels of contamination across different parts of a hospital. • Training – showing the effect of cleaning on a “before and after” basis, and showing whether further cleaning has an effect on levels of contamination. • Indication of the effectiveness of different cleaning products or methods – using “before and after” testing. The report pointed out that swabbing at different times in the cleaning cycle leads to wide variations in data readings, due to the soiling that occurs between cleaning, and suggested that hospitals implementing the technology may wish to consider less intensive swabbing regimes centred on cleaning cycles. The report also offered practical advice on considerations prior to implementation. Trusts should make a realistic plan to allow for sufficient training of staff and raise awareness of the new technology as well as the reasons for its introduction. The implementation plan should set out what using the product is expected to achieve and specify in detail what points will be swabbed, how frequently and by whom. Trusts also need to be clear on what action is to be taken in the light of results indicating a high level of contamination and devise a plan on how results on performance are reported back to relevant staff.