HTA RR/07/06 September 2007 Mobile Computed Tomography Scanner for Head and Neck Imaging

Transcription

1 HA HTA Brief offers prompt assessment to new or undecided technologies that may be of value or concern to the HA. It serves as a quick reference to inform care providers and practitioners of the safety, efficacy, opinion and/or state of technology diffusion in other parts of the world. We caution readers to interpret our report in light of the literature search and evidence presented, and on the role of HTA to provide information to aid decision-making on a system level rather than for individual patients. Besides technical efficiency, the suitability of a technology in public health services also depends on its cost-effectiveness, health and economic impacts on the society, resources available to the service provider and competing needs of other patients. By making technical efficiency explicit, one is in a better position to evaluate the other considerations. HTA RR/07/06 September 2007 Mobile Computed Tomography Scanner for Head and Neck Imaging Prepared by TSANG, Kwai-fan Ice; CHEUNG, Tsz-fung Ian; LIU, Hing-wing Background / Introduction Computed tomography (CT) scanning is a valuable diagnostic tool. Besides generating high-quality images of internal body structures, it enables threedimensional reconstruction of images such that their display need not be restricted to the conventional axial view. CT technology contributes remarkably to diagnostic accuracy and management strategy. A timely CT scan can be life-saving. However, conventional high-resolution flat-bed CT scanners are huge, weighing up to 4,000 kg and require a high-voltage power supply to run the massive cooling system, and hence, are installed in climate-controlled and lead-shielded radiology suites. To bring CT technology into emergency settings and operating theatres, mobile CT scanners were introduced in the 80s, for example, the TomoScan M (designed by Analogic and sold by Philips Medical Systems.) The first-generation mobile CT scanners were, however, limited by image quality, speed, size (still too large to be moved easily to patient bedside) and had too many wires and cables. Lately, NeuroLogica launched CereTom, a compact and lightweight scanner equipped with wheels, runs on wall outlets in combination with batteries, and a translating gantry for selecting the scan plane, which makes it suitable for use at the bedside. The model received pre-market approval from FDA in July Page 1 of 5

2 The system generates up to 8 slices per revolution. Its 25cm field of view limits usage primarily to head and neck imaging. ii) What changes (and resources) are required, other than a mobile CT scanner, to run an efficient mobile CT service? Mobile CT scanners have been used in a number of settings, in particular, intra-operatively to facilitate imageguided surgery, and in the ICU to avoid transporting critically ill patients to and from the fixed CT suite. 2 iii) Will the benefit generated, in terms of patient outcome, justify the opportunity cost required to run a mobile CT service? Review Questions While there is little concern over the safety and technical feasibility of approved mobile CT scanners, questions facing healthcare providers are: i) What is the added value, in terms of patient outcome, of having a mobile CT scanner in an acute hospital already equipped with a fixed CT scanner? 1 PMA (K051765) was granted on the basis that Use of the NL3000 CereTom does not result in any new potential safety risks. The equipment performs as well in its intended use as devices currently on the market. 2 Gunnarsson T, Theodorsson A, Karlsson P, Fridriksson S, Boström S, Persliden J, et al. Mobile computerized tomography scanning in the neurosurgery intensive care unit: increase in patient safety and reduction of staff workload. J Neurosurg Sep;93(3): Page 2 of 5

3 Literature Search HTA Agencies A. Agence d évaluation des technologies et des modes d intervention en santé (AETMIS) The Québec government agency responsible for health services and technology assessment, and reports to Québec's Minister of Health and Social services. Web-site: B. Agency for Healthcare Research and Quality (AHRQ) A Public Health Service agency in the Department of Health and Human Services (HHS) and reports to the US HHS Secretary. Web-site: C. Australian Safety and Efficacy Register of New Interventional Procedures Surgical (ASERNIP-S). Website: D. Blue Cross and Blue Shield Association s Technology Evaluation Center. Website: E. Canadian Agency for Drugs and Technologies in Health (CADTH) An independent, not-for-profit agency funded by Canadian federal, provincial, and territorial governments. Website: F. Catalan Agency for Health Technology Assessment (CAHTA) / Agència d'avaluació de Tecnologia i Recerca Mèdiques de Catalunya (AATRM) A public non-profit company reporting to the Catalan Health Service. Web-site: G. Committee for Evaluation and Diffusion of Innovative Technologies (CEDIT) A hospital-based agency for the assessment of medical technology and responsible for formulating advice for the Director General of the Assistance Publique-Hôpitaux de Paris (AP-HP). Website: H. Hayes, Inc. An independent health technology assessment organization. Website: I. Health Canada A federal department in Canada. Website: J. Health Services/Technology Assessment Text National Library of Medicine A free, web-based resource of full-text documents. Website: K. International Network of Agencies for Health Technology Assessment (INAHTA) The Network stretches from North and Latin America to Europe, Australia, and Page 3 of 5

4 New Zealand. Website: L. Medical Services Advisory Committee (MSAC) To advise the Minister for Health and Ageing in Australia. Website: M. National Centre for Biotechnology Information (NCBI). Website: N. National Coordinating Centre for Health Technology Assessment (NCCHTA) Developed the NHS HTA programme under contract from the Department of Health s Research and Development Division. Website: O. National Horizon Scanning Centre Provides advance notice of significant new and emerging health technologies to the Department of Health, England. Website: P. National Institute for Health and Clinical Excellence (NICE) An independent organization. Website: Q. Ontario Health Technology Advisory Committee (OHTAC) Provides advice to the health care system, including the Ministry of Health and Long-Term Care. Website: R. Swedish Council on Technology Assessment in Health Care An independent public authority. Website: S. Trip Database. Website: Other Databases T. Cochrane Collaboration An international not-for-profit organization. Website: U. German Cochrane Centre A centre of the Cochrane Collaboration. Website: V. MEDLINE (1996 to August Week ) W. EMBASE (1996 to 2007 Week 34) Page 4 of 5

5 Evidence-base Recommendation FDA granted 510k premarket approval to CereTom mobile CT scanner on the bases that it is substantially equivalent to previously cleared predicate devices. 3 To answer the review questions raised, we scanned HTA agency web-sites, the Cochrane databases, MEDLINE and EMBASE for evidence on the safety and efficacy of mobile CT scanning for head and neck and its impact on patient outcome. While we found a number of papers on successful application of mobile CT in operating theatre and ICU, none of them reported impact of the technology on patient outcome. In summary, no published study satisfying the search criteria could be identified. Given the information available, the best conclusion one can draw is (i) CereTom mobile CT scanner is FDA approved, indicating its safety and performance are substantially equivalent to predicate devices previously cleared by FDA; (ii) Evidence on the relative safety and benefit of mobile CT scanning, as compare to fixed CT scanning, in terms of patient outcome, is currently lacking. There is insufficient evidence to support widespread adoption of mobile CT technology in the existing radiology services. The decision to install a mobile CT scanner in addition to a fixed one is primarily a cost-benefit consideration in service planning, subject to other factors pertinent to a particular healthcare setting. The following considerations may be relevant in assisting such a decision making: (i) Application of CereTom mobile CT scanner is primarily confined to head and neck imaging. (ii) While it is more convenient and safe to scan critically ill patients at the bedside, the margin of benefit that can be gained is uncertain due to lack of evidence. (iii) Given budgetary constraint, it is necessary to consider the opportunity cost in running a mobile CT service, which includes direct fixed cost (e.g. machine cost, maintenance cost), direct variable cost (e.g. staff salaries, consumables), and indirect cost (facility modifications such as lifts, bed design and spacing.) 3 FDA PMA (K051765): Page 5 of 5