Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
BMC Medical Ethics 11 (1):14- (2010)
Background: Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.Methods/DesignOur study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.Ethics - beneficence, non-maleficence, autonomy, justice.Economics - scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.DiscussionThe significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Sue Ross, Magali Robert, Marie-Andrée Harvey, Scott Farrell, Jane Schulz, David Wilkie, Danny Lovatsis, Annette Epp, Bill Easton, Barry McMillan, Joyce Schachter, Chander Gupta & Charles Weijer, Ethical Issues Associated With the Introduction of New Surgical Devices, or Just Because We Can, Doesn't Mean We Should.
P. Lehoux, M. Hivon, B. Williams-Jones, F. A. Miller & D. R. Urbach (2012). How Do Medical Device Manufacturers' Websites Frame the Value of Health Innovation? An Empirical Ethics Analysis of Five Canadian Innovations. Medicine, Health Care and Philosophy 15 (1):61-77.
Leigh Turner (2012). News Media Reports of Patient Deaths Following 'Medical Tourism' for Cosmetic Surgery and Bariatric Surgery. Developing World Bioethics 12 (1):21-34.
Wendy Rogers, Christopher Degeling & Cynthia Townley (2014). Equity Under the Knife: Justice and Evidence in Surgery. Bioethics 28 (3):119-126.
Franklin G. Miller (2004). Sham Surgery: An Ethical Analysis. Science and Engineering Ethics 10 (1):41-48.
Jochen Schaefer (1980). The Case Against Coronary Artery Surgery. Theoretical Medicine and Bioethics 1 (2):155-176.
Linda Farber Post (2007). Handbook for Health Care Ethics Committees. Johns Hopkins University Press.
Gavin H. Mooney & Alistair McGuire (eds.) (1988). Medical Ethics and Economics in Health Care. Oxford University Press.
Kali Penney, Jeremy Snyder, Valorie A. Crooks & Rory Johnston (2011). Risk Communication and Informed Consent in the Medical Tourism Industry: A Thematic Content Analysis of Canadian Broker Websites. [REVIEW] BMC Medical Ethics 12 (1):17-.
Barbara Ott & Robert Olson (2011). Ethical Issues of Medical Missions: The Clinicians' View. [REVIEW] HEC Forum 23 (2):105-113.
Alan G. Johnson (2006). Making Sense of Medical Ethics: A Hands-on Guide. Distributed in the U.S.A. By Oxford University Press.
John Mark Freeman (1987). Tough Decisions: A Casebook in Medical Ethics. Oxford University Press.
Added to index2010-08-24
Total downloads5 ( #226,052 of 1,100,932 )
Recent downloads (6 months)1 ( #290,065 of 1,100,932 )
How can I increase my downloads?