Orthopedics Today—New York City—August 1, 2010
New technologies are constantly being introduced into the orthopedic marketplace with the promise of improved patient outcomes, but often with limited information regarding the comparative effectiveness vis-à-vis the gold standard technology. Hospitals, health systems, and surgeons are therefore faced with the need to evaluate the relative merits of these new technologies, and balancing the potential benefits to patients with the certainty of increased costs and potentially adverse clinical consequences associated with their use.
How do you evaluate the clinical efficacy, safety, risks and benefits of new technology in orthopaedics? What sources of information do you use in these evaluations?
Louis A. Shapiro
President and CEO Hospital for Special Surgery New York, N.Y.
Louis A. Shapiro: We require all medical staff who would like to introduce a new device or biologic to complete a new product request form. This form requires the requesting individual to disclose any business or other relationship that he or an immediate family member may have with the company involved with the product he or she would like to use, ie, a disclosure of potential conflict of interest, as well as key information about the use of the product, including the reason for the request.
The service chief reviews the submitted form and is required to make a recommendation for approval or not with respect to its clinical use, before it is submitted to the business director, operating room materials management. If there is an issue from a clinical or cost perspective, the surgeon-in-chief is consulted.
We also have a biomaterials team that is available to evaluate new technology and can be enlisted to provide feedback. We also review outcome information in peer-reviewed publications and from our own clinical research. As a general rule, although the new technology has already been approved by the FDA, we do not accept industry reports or a manufacturers’ own research alone as proof of safety and efficacy. Instead, those reports or research are analyzed in conjunction with the other information discussed above to determine whether the product may be used at our hospital.
We also have a Bone and Biologics Committee that is responsible for the clinical approval of any new biological implant. This committee has representation from the medical staff, legal affairs, and operating room materials management. All biologic products are requested through the use of the product request form referred to above providing key information about the use of the product and disclosure of any potential conflicts of interest. The approval process includes a review of available literature and a live presentation by a scientist from the company. As related to biologics, we do not accept industry reports or manufacturers’ own research, but the data supporting the reports is requested and analyzed independently by the committee.
Read the full story at orthosupersite.com.