Preceding the Procedure: Medical Devices and Shared Decision Making
Year: 2013
Type: preprint
Abstract: This article teases out the ethical issues underlying the choice of a medical device for surgical procedures, using the example of total joint arthroplasty to illustrate the interactions between surgeons and their patients. We highlight shortcomings in the current regulatory process that result in a thin evidence base on which to anchor these technical decisions, and we note the potential for decisions to be influenced by the surgeon’s personal beliefs and possible conflicts of interest. We suggest that the informed consent process could be enriched with a greater focus on shared decision making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values. Table 1 highlights the most salient aspects of the conversations that we suggest occur between surgeons and their patients. We focus our discussion around the example of total joint replacement, but these issues are generalizable to decisions about non-orthopedic devices such as cardiac pacemakers, stents, and implantable defibrillators, as well as innovative, technically complex, and potentially risky nonsurgical therapies such as biologic agents for rheumatic conditions.
Source: SSRN Electronic Journal
Authors: Julian J.Z. Polaris, Jeffrey N. Katz, Elena Losina, Thomas S. Thornhill, John Wright, Lisa Soleymani Lehmann
Institutions: Brigham and Women's Hospital, Harvard University
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W3124787513