2.1 The 3M Tegaderm CHG IV securement dressing (Tegaderm CHG) is a sterile transparent semipermeable polyurethane adhesive dressing with an integrated gel pad containing a 2% concentration by weight of chlorhexidine gluconate (CHG).
2.2 Tegaderm CHG is used to secure percutaneous devices and to cover and protect central venous and arterial catheter insertion sites. It aims to provide an effective barrier against external contamination. The dressing and the integrated gel pad are transparent to allow observation of the catheter insertion site. The integrated gel pad is designed to reduce skin and catheter colonisation in order to suppress regrowth of microorganisms commonly related to catheter‑related bloodstream infections (CRBSI). The dressing is available in 4 different sizes but the most commonly‑used size, accounting for 85% of sales, measures 8.5 cm×11.5 cm.
2.3 Tegaderm CHG was CE‑marked as a class III device in April 2009 to cover and protect catheter sites and to secure devices to the skin. There was a modification to the dressing design in 2011 to include a breathable film.
2.4 The cost of Tegaderm CHG stated in the company's submission was £6.21. This cost was based on the list price of the Tegaderm CHG 1657R (8.5 cm×11.5 cm) dressing; the cost includes VAT.
2.5 The claimed benefits of Tegaderm CHG presented by the company are:
A 60% reduction in the incidence of CRBSI in adult critical care patients with intravascular catheters.
Reduced risk of mortality due to catheter‑related infections.
Reduced incidence of skin and catheter colonisation during treatment with central venous catheters or arterial catheters.
Reduced length of stay in critical care or high dependency units.
Reduced costs for diagnosis of CRBSI.
Reduced material and staff costs for treatment of catheter‑related infection.
2.6 NICE's guideline on infection provides guidance on using dressings in adults and children with vascular access devices (central venous catheters or peripherally‑inserted central catheters) in primary and community care settings. The guideline recommends that the skin at the central venous catheter insertion site, and the surrounding skin during dressing changes, should be decontaminated with CHG in 70% alcohol and allowed to air dry. If the company's recommendations prohibit the use of alcohol with their catheters, an aqueous solution of CHG should be considered. The guideline further recommends using a sterile, transparent semipermeable membrane dressing to cover the vascular access device insertion site, and changing the dressing every 7 days or sooner if it is no longer intact or if moisture collects under it. A sterile gauze dressing, covered with a sterile transparent semipermeable dressing, should be considered only if the patient has profuse perspiration, or if the vascular access device insertion site is bleeding or oozing. The guideline states that systemic antimicrobial prophylaxis should not be used routinely to prevent catheter colonisation or CRBSI, either before insertion or during the use of a central venous catheter. It makes no specific recommendations about using CHG‑impregnated dressings, although the full guideline notes that they may be cost effective compared with sterile transparent semipermeable membrane dressings based on limited evidence from 1 study, Crawford et al. (2004).
2.7 The Department of Health commissioned the epic3 guideline on preventing healthcare‑associated infections in NHS hospitals in England. The guideline recommends using a sterile transparent semipermeable dressing to cover the intravascular insertion point as best practice in both adults and children. The guideline recommends, based on high‑quality evidence, a single application of 2% CHG in 70% isopropyl alcohol (or povidone‑iodine alcohol for patients with sensitivity to CHG) to clean the central catheter insertion site during dressing changes, and allowing it to air dry. The guideline also recommends, based largely on randomised controlled trial evidence, that hospitals consider using a CHG‑impregnated sponge dressing in adults with a central venous catheter, as a strategy to reduce CRBSI.
2.8 NICE carried out a 2‑year surveillance review of its infection guideline in September 2014 and decided not to update it. It noted that further research is needed to establish the efficacy of CHG dressings applied to CHG‑prepared skin to prevent CRBSI in patients with venous access devices.
2.9 Care bundles are a structured way of improving the processes of care and patient outcomes. They consist of a set of simple to implement evidence‑based practices, that when performed collectively and reliably, have been proven to improve patient outcomes. Central venous catheter care is an example of a care bundle produced by the Department of Health in 2010.