Biopatch (Ethicon) is composed of a sterile polyurethane foam dressing impregnated with CHG, an antiseptic used in the sterilisation of insertion sites before catheter insertion.
Biopatch is applied to the insertion site before, and in addition to, applying a standard sterile transparent semipermeable IV dressing. The patch is designed to continuously release CHG onto the insertion site for 7 days.
Unlike antiseptic skin preparation before catheter insertion, which is aimed at reducing colony counts of bacteria on the skin surface, Biopatch is designed to provide continuous protection from re-colonisation. It does this by slowly releasing CHG with the aim of reducing the risk of CRBSIs. Biopatch also provides full coverage of the insertion site and can absorb and draw fluids away from it.
NICE has published a guideline on preventing and controlling healthcare-associated infections and a quality standard on infection control and prevention, both of which refer to vascular access devices. NICE medical technologies guidance recommends the 3M Tegaderm CHG IV securement dressing instead of standard IV dressings to reduce rates of CRBSIs.
Reducing rates of infection and bacterial colonisation in relation to venous and arterial catheters is essential before and during catheter insertion and maintenance of catheter insertion sites. Both the NICE guidance and the Department of Health-commissioned epic3 guideline on reducing healthcare-associated infections recommend that hands should be cleaned before accessing or dressing a vascular access device, using an alcohol hand rub or washing with liquid soap and water. Also, the insertion site should be cleaned using 2% CHG in 70% alcohol and allowed to dry before inserting the catheter. After catheter insertion, a sterile transparent semipermeable membrane dressing should be used to cover the insertion site. This should be changed every 7 days, or sooner if moisture collects under the dressing or there are signs of infection. The same skin decontamination process should be used whenever the dressing is changed. NICE also advices maintenance of the catheter itself by cleaning it with 2% CHG in 70% alcohol before accessing the system and also flushing and locking the catheter lumens with sterile 0.9% sodium chloride injections. It is recommended that peripheral vascular insertion sites are inspected at least once every shift, with visual phlebitis scores recorded. Central venous catheters should be inspected daily. The epic3 guideline also advocates the use of CHG patches at insertion sites.
NICE is aware of the following CE-marked devices that appear to fulfil a similar function as Biopatch:
3M Tegaderm CHG IV Dressing (3M Healthcare)
Algidex Ag IV Patch (deRoyal).
Biopatch is intended for use by people who would normally apply and change patients' dressings at CVC insertion sites; typically these would be vascular access specialist nurses. Minimal additional training would be needed.
The device is used for venous and arterial catheters or cannulas, and so it will most likely be used in secondary care settings but could also be used in community and home settings.
Biopatch would primarily be used in patients in whom a central venous catheter was being placed, to reduce the risk of catheter colonisation, CRBSIs and exit site infections.
The cost of Biopatch is £4.44 per patch (Johnson & Johnson). On average, 2 patches are used per central venous catheter, with an overall cost of £8.88 (Ye et al. 2011).
The cost of a standard catheter dressing (defined as non-antimicrobial transparent film dressing) is £1.34. On average 3 dressings are used per patient, with an overall cost of £4.02 (Thokala et al. 2016).
The practical impact of implementing Biopatch would be minimal, consisting of a short training session for those using the device. The company provides training at no extra cost.
Using Biopatch would represent an additional cost compared with standard catheter dressings, which might be offset if it reduced the risk of CRBSIs and so avoided the associated costs. A recent UK-based study used an estimated cost for CRBSI of £9,900 in its cost-effectiveness model (Thokala et al. 2016).
One US-based cost-benefit analyses of Biopatch estimated savings of at least $237 per patient (Crawford et al. 2004). The analysis predicted between 329 and 3,906 fewer CRBSI-related mortalities in critically ill patients each year when using Biopatch, depending on the assumed rates of infection, catheter usage and attributable mortality. Another analysis, Ye et al. 2011, reported results from a hypothetical 400-bed hospital with 60 ICU and 240 non‑ICU beds. They estimated net annual savings of $895,818 using Biopatch compared with standard treatment because incidences of infection fell from 59 to 24 (60%).