Medical devices and shared decision-making: Daisy chains of decades of device approval without rigorous assessment

The journal Arthritis Care & Research has accepted for future publication – and posted online (for subscribers) – an unedited paper, “Preceding the Procedure:  Medical Devices and Shared Decision-Making.”  The paper builds on a hypothetical example of a man in his 50s with hip arthritis who is facing a decision about total hip replacement.  Excerpts:

“(The surgeon – Dr. Jones) reviews the procedure with him and confirms that he understands his options. Then (the patient – Mr.Thomas) signs the surgical consent form. This discussion appears to include all the elements of informed consent, but several ethical questions linger beneath the surface. Dr. Jones discussed the risks and benefits of total hip replacement in some detail to help Mr. Thomas decide whether or not to have surgery, but should Mr. Thomas also have participated in the decision about the specific implant to be used?…
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. …

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.”

Daisy chains of decades of device approval without rigorous assessment

This is an important discussion. The authors describe the FDA’s  510(k) expedited review process for medical devices which allows “these devices (to) be approved for sale without formal testing in clinical trials as long as they confer low or moderate risk to patients and are structurally similar to a previously approved device. However, the previously approved device could also have been approved under 510(k), leading to daisy chains of approved devices going back for decades, most of which have not undergone rigorous premarket assessment in human subjects.”

It describes surgeons reporting “that that they typically face few institutional constraints on their choice of implants, so many are able to decide for themselves when they wish to begin using newer models.”

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And it provides background for consideration of conflicts of interest:  “The choice of implant is complicated further by the possibility for conflicts of interest stemming from the consulting fees that some orthopedists receive from device manufacturers. In 2007, the five largest manufacturers made payments to approximately 4% of the 25,000 registered orthopedic surgeons in the United States. These payments typically involve surgeons in high volume practices and academic settings. Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

The authors point out that this is not merely an issue in orthopedics:  “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 non-surgical therapies like biologic agents for rheumatic conditions.”

Note:  One of the authors, Dr. Jeffrey Katz, has been one of our story reviewers on HealthNewsReview.org.

Addendum on October 23, 2012:  In a somewhat related note, the BMJ has begun a series, announcing “A joint undercover investigation by the BMJ and the Daily Telegraph has exposed flaws in the EU system used to grant market access for devices such as replacement hips, cardiac defibrillators, and breast implants.”