2.1 SecurAcath (Interrad Medical) is a single-use device to secure percutaneous catheters in position on the skin. It is intended for use in adults and children who need a central venous catheter (CVC), a long, thin, flexible tube that is inserted into a vein through the skin. It is positioned so that the distal tip lies in a large central vein, usually the superior vena cava, right atrium or inferior vena cava.
2.2 CVCs are inserted using various access sites, including veins in the arm, chest, neck or groin; the choice in individual patients depends on a variety of factors such as anticipated duration of access needed (dwell time), reason for insertion and the quality and patency of venous sites available. There are 4 types of CVCs (Dougherty et al. 2015):
Peripherally inserted central catheters (PICCs): CVCs inserted into a peripheral vein in the arm, rather than in the neck or chest. PICCs may be used for short-term access (7 to 10 days), but are more typically used in people needing intravenous access for several weeks or months. They are used in inpatient and outpatient settings.
Non-tunnelled CVCs (referred to in this guidance as 'CVCs'): Short-term CVCs placed into a large vein near the neck, chest, or groin. Non-tunnelled CVCs are indicated for short-term access (usually 7 to 10 days) when peripheral access is impractical or in acute, urgent situations. Non-tunnelled CVCs need securing at the site of insertion.
Tunnelled CVCs (also called Hickman lines): CVCs that are passed under the skin (tunnelled) from an insertion site near the neck or chest to a separate exit site, which helps to prevent infection and provides stability. Tunnelled CVCs are indicated for long-term access (more than 30 days). These long-term CVCs need securement for the first 2 to 4 weeks until tissue granulation around the 'cuff' of the tunnel, but after this, do not need additional securing.
Implanted ports: CVCs placed completely under the skin, which are used for long-term therapies. Implanted ports have few complications, have minimal risk of infection and do not need securing.
2.3 SecurAcath has 2 parts, a base and cover. The base is made up of 2 foldable metal legs and 2 securement feet. The feet are placed under the skin at the catheter insertion site, and unfolded to make a subcutaneous anchor. The cover attaches to the catheter shaft and holds it in place when it is clipped onto the base. The device stays in place as long as the catheter is needed and can be lifted off the skin to allow cleaning of the insertion site.
2.4 SecurAcath is a class IIB device first CE marked in 2012. It is available in 6 different sizes (3 F to 8 F). The SecurAcath device is size-specific and the choice of device should be matched to the size of the catheter. The current size range for SecurAcath is not suitable for use with most renal dialysis catheters (a specific type of long-term tunnelled CVC). However, larger sizes (up to 12 F) are planned to be available in late 2017, which may be suitable for use with these type of CVCs.
2.5 The list price of SecurAcath stated in the company's submission is £16.00 excluding VAT. During development of the guidance, the company updated the UK list price of SecurAcath to £20.00.
2.6 The claimed benefits of SecurAcath in the case for adoption presented by the company are:
no interruptions or delays in therapy because of improved catheter securement
fewer repeat procedures by improving vessel preservation and reducing reinsertions
fewer catheter complications (dislodgements, migration, thrombosis and infection)
a decrease in catheter replacement costs
a reduction in overall treatment costs because of fewer delays and complications.
2.7 Current options for catheter securement include adhesive devices (such as StatLock and Grip-Lok), steri-strips, tape and sutures (stitches).
2.8 NICE has not produced guidance on securing catheters for central venous access. The NICE guideline on healthcare-associated infections recommends that the skin at and around the catheter insertion site is cleaned with chlorhexidine gluconate in 70% alcohol and allowed to air dry during dressing changes. The insertion site should be covered by a sterile transparent semipermeable membrane dressing which should be changed every 7 days or sooner if the dressing is no longer intact or moisture collects under it.
2.9 British Committee for Standards in Haematology on the insertion and management of central venous access devices in adults (Bishop et al. 2007) recommend using securing devices such as StatLock rather than sutures, and discourage the suturing of catheters to the skin. Several NHS trusts have produced local guidance on using catheter securement devices including SecurAcath.
2.10 The US Infusion Nursing Society's Infusion Standards of Practice (2016) refers to engineered stabilisation devices such as SecurAcath and StatLock. It suggests that these types of devices should be considered for securing catheters. It also says that engineered stabilisation devices promote consistent practice among clinicians, reduce catheter movement that can lead to complications, reduce the number of interruptions needed for infusion therapy, and may lower costs of care. The document suggests that tape or sutures should be avoided because they are not as effective as engineered stabilisation devices, based on good quality evidence from randomised controlled trials. The document also states that users should be aware of the risk of medical adhesive-related skin injury with the use of adhesive-based engineered stabilisation devices.