VP23 Assessing The Effectiveness Of A Medical Device With Limited Evidence

Abstract

IntroductionSecurAcath (Interrad Medical), a catheter securement device designed for central venous catheters, was assessed by the National Institute for Health and Care Excellence (NICE) in 2017 resulting in Medical Technology Guidance 34 (MTG34). Due to the limited number and quality of published evidence, novel methods were used to deliver a report that allowed a recommendation on adoption to be made.MethodsKiTEC, an external assessment centre for NICE, independently evaluated the manufacturers submission of clinical and economic evidence. The submission was characterised by a lack of strong clinical evidence, comprising just one randomized clinical trial (RCT) and a small number of non-comparative observational studies, some of which were available as conference abstracts or poster presentations. KiTEC ran a meta-analysis of these studies along with data on the comparators, securement with sutures and securement with StatLock (Bard Access Systems). Due to the lack of comparative studies, KiTEC pooled data on five outcomes (migration, dislodgement, catheter-related infection, CRBSI, unplanned removals/reinsertions) and calculated relative risks for each. KiTEC revised the manufacturer's cost model, changing a number of parameters and assumptions. The decision to recommend SecurAcath for use in the National Health Service (NHS) was also supported by qualitative evidence from expert clinicians who had used the SecurAcath in practice.ResultsKiTEC's meta-analysis showed non-inferiority for SecurAcath over the comparators. The limited information in the studies made it impossible to ascertain study heterogeneity in the meta-analysis. KiTEC's economic analyses showed that SecurAcath could be cost saving in some scenarios, but not for short indwell times (≤5 days). However, clinical expert opinion was overwhelmingly positive and this qualitative evidence was viewed alongside the less conclusive clinical and cost-effectiveness evidence. SecurAcath was recommended to be used in the NHS, with annual savings estimated to be a minimum of GBP 4.2m.ConclusionsIn cases where there is a lack of published evidence, unpublished material and expert clinical opinion can be used to bolster the case for the adoption of medical devices.