Bruce Campbell

IDEAL-D: a rational framework for evaluating and regulating the use of medical devices.

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal

Registers needed for new interventional procedures

1734 www.thelancet.com Vol 371 May 24, 2008 improve practice through advocacy-based evidence and analysis, to be set up in 2009. This platform of the many global-health participants in Europe would promote: European health values (eg, universality, access to good-quality care, equity, and solidarity) in the international arena and good governance; coherence of broad policy making and synergy of policies for health benefi ts (eg, as development, trade, environment, and agriculture), especially for the social and economic determinants of health; and European commitment to global-health equity, with a focus on the health of the poorest populations. The meeting welcomed the possibility that such a European Council on Global Health could become part of a larger alliance of similar councils from other regions of the world. The participants proposed that, during the constitution of such a council, dialogue with colleagues from the developing world would be ensured, along with continued dialogue with the Global Health Council, USA, and the Canadian Society for International Health (both of whom were at the meeting). Those at the meeting further suggested making use of European presidencies and that the initiative should aim to include global health in the agenda of the next EU presidencies. This suggestion implies a structured dialogue with the European Commission on global-health matters via the European Health Strategy and building relations with WHO, in particular its Brussels offi ce. There is also a need to keep abreast of the development of a European foreign policy and, in line with the Oslo Ministerial Declaration on Health in Foreign Policy, to ensure that health is considered as part of this agenda. The meeting also proposed that a taskforce be created to extend the proposals for the goals and objectives, governance, structure, membership, benefi ciaries, partnerships, location, fi nancing, and performance measures of a European Council on Global Health. This taskforce will meet in May, 2008 in Geneva on the occasion of the Geneva Health Forum. Revising and updating the European Foundation Centre’s globalhealth policy glossary could be a useful method of communication for the initiative. The initiative will set up a small secretariat to support the members and taskforce. The initial organisers were made responsible for pressing the initiative forward, along with fundraising. A strong plea was made to European institutions to continue their support on matters of global health, and assist as well as engage in the initiative.

How guidance on the use of interventional procedures is produced in different countries: An international survey

OBJECTIVES Technology assessment systems for interventional procedures (including surgical operations, minimally invasive procedures, and others) have lagged behind those for pharmaceutical treatments. Such systems have been introduced in some countries during the past decade amid debate about how they should be organized, but there is no collated information about where they exist or how they work. This study was designed to provide hitherto unavailable information about the existence, organization, methods, and outputs of systems aimed at influencing the use of interventional procedures in different countries. METHODS Data were gathered from a questionnaire survey of key informers associated with healthcare technology assessment (HTA) organizations in different countries. RESULTS Responses were received from key informers working for twenty-eight HTA organizations in twenty-five countries (response rate 83 percent). Information about a national system for assessing interventional procedures was obtained for fifteen countries. There was substantial variability in the type and funding of these organizations, the systems used for the selection of procedures, the types and sources of evidence used, the personnel involved in the appraisal of the evidence, the arrangements for consultation on the draft assessment, the format of assessment recommendations, the status of the guidance, and the use of guidance from other countries. CONCLUSION Guidance on interventional procedures is produced variably in different countries--and not at all in some. Greater international collaboration in the assessment of new interventional procedures could help to optimize the efficiency of existing systems as well as the quality of the assessments, by capitalizing on the outputs from scarce (international) resources and expertise.

New interventional procedures

Unlike drugs, are implemented despite paucity of evidence

How can we get high quality routine data to monitor the safety of devices and procedures

Following recent problems with some medical devices, Bruce Campbell, Andrew Stainthorpe, and Carole Longson suggest some pragmatic steps to improve safety data

Regulation and safe adoption of new medical devices and procedures

BACKGROUND Recent problems with medical devices have highlighted the need for improved surveillance. New procedures are largely unregulated. SOURCES OF DATA Information from regulators. Guidance produced by the National Institute for Health and Care Excellence Interventional Procedures and Medical Technologies Advisory Committees and the evidence used in their evaluations. AREAS OF AGREEMENT More and better evidence is required for new medical devices and procedures when they are introduced into practice. Routine collection of observational data on outcomes should be improved. AREAS OF CONTROVERSY How best to protect patients from harm while allowing rapid access to potentially beneficial interventions. GROWING POINTS Establishing systems for good data collection on the use of devices and procedures. AREAS TIMELY FOR DEVELOPING RESEARCH How to accrue more and better evidence about devices and procedures through clinical trials and various avenues of observational data collection.

Effect of procedure volume on outcomes after iliac artery angioplasty and stenting.

Service reorganization to concentrate complex vascular services in hospitals with high caseload volume aims to reduce mortality and complication rates. The present study assessed the relationship between caseload volume and outcome for iliac artery angioplasty and stenting in England using a routinely available national data set (Hospital Episode Statistics, HES).

International collaboration in the use of registries for new devices and procedures.

The evaluation of new medical devices and interventional procedures (including surgical operations and transluminal interventions) is more challenging than the evaluation of new drugs. Fewer regulatory demands mean that the evidence base for devices is typically much more limited than for pharmaceuticals. There are no legal frameworks for regulation of procedures, although some countries have systems for producing guidance on their use1. The fact that some devices require novel procedures for their use, and that some novel procedures may be done using a variety of different devices whose design may be evolving, complicates the issue still further. Postmarketing surveillance of devices is variable and may fail to provide timely and reliable information about the incidence of serious adverse events2. Diffusion of procedures in the absence of good evidence increases the risk of poor outcomes for patients, and may have damaging effects on health services by disturbing established care pathways, altering use of resources and adding unexpected requirements for training3. Gathering good observational data would enhance the typically poor evidence base related to devices and procedures, and allow better planning of their use4. This is a well recognized need but has been achieved only in limited areas and on a limited scale5,6. International collaboration in collection and collation of data would be the ideal, to accrue information about real-world use in the shortest possible time. For international initiatives to be successful, there needs to be a shared view about which devices and procedures to prioritize for the allocation of resources. Registers need to be well conceived, with an agreed common purpose and compatible data items. This demands close links between clinicians in the countries involved (typically through their professional organizations) and significant infrastructure for support. Regulators such as the Medicines and Healthcare products Regulatory Agency in the UK and the Food and Drugs Administration (FDA) in the USA, and guidance-producing organizations such as the National Institute for Health and Clinical Excellence have considerable interest in the organization and success of registers. Some surgical specialties have already established registers that cross national boundaries, such as the European Cardiac Surgical Registry7. In the USA, the FDA recently held an exploratory meeting of those supervising joint replacement registers in several countries and is developing the capacity to collate data from these (MDEpiNet mission and strategic goals). The European network for health technology assessment (EUnetHTA) has developed the EVIDENT database (http://www. eunethta.eu), which aims to support collaboration between health technology assessment agencies and reduce duplication of work on additional evidence generation, while the Agency for Healthcare, Research and Quality in the USA is developing a ‘Registry of Patient Registers’8. Postmarket surveillance data from manufacturers could also be a valuable resource. Manufacturers hold unique information about all the devices they have sold and they often span national boundaries. For manufacturers’ data to be sufficiently useful and reliable for use in national assessments, their registers would need to be overseen by independent health professionals, scientists and others free from conflicts of interest, with all data on all patients available. Clinicians play a fundamental role in all stages of register development. Their engagement is vital to achieve comprehensive and valid submission of data9. Features of any register that help secure this engagement include a small data set, a ‘user friendly’ web-based data entry system that allows easy data submission, and easy retrieval of their own data for local audit and review of practice. Some registers (for example for joint replacements) are likely to continue in perpetuity. However, for any register there should be a clear plan about how long data submission will continue, in order to fulfil the specific purpose for which it was established. The burden of data submission and long-term followup may be reduced, and the likelihood of capturing certain outcomes may be enhanced, by linking registry data with other healthcare databases and national statistics systems. Such linkages may complicate data governance and international collaborations, but these issues will

Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes

BackgroundSeveral authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures.MethodsA literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index – Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed.ResultsFrom 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes.ConclusionsThe four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.

NICE medical technologies guidance: aims for clinical practice

NICE (the National Institute for Health and Care Excellence) produces a range of advice and guidance on medical practice and technologies. NICE was established in 1999, and in 2009 set up its Medical Technologies Evaluation Programme. This assesses new devices in terms of whether their use would offer benefits to the patient and NHS at a lower cost compared with current practice, or increased benefits for equal cost. NICE evaluates single products only, as multiple product assessments are time-consuming and mean that manufacturers have to wait longer for NICE to produce guidance on adoption of their technologies. Research into devices and diagnostics is often sparse and of low quality as there is little regulation requiring good research in this area. As a result, products are often not accepted for evaluation, because the evidence base supporting their claimed benefits is so poor.