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The Economic Impact of Reprocessing External Fixation Components
Daniel S. Horwitz, MD1; Kathryn L.S. Schabel, MD1; Thomas F. Higgins, MD1
1 Department of Orthopaedics, University of Utah, 590 Wakara Way, Salt Lake City, UT 84108. E-mail address for D.S. Horwitz: Dan.Horwitz@hsc.utah.edu. E-mail address for K.L.S. Schabel: Kathryn.Schabel@hsc.utah.edu. E-mail address for T.F. Higgins: Thomas.Higgins@hsc.utah.edu
View Disclosures and Other Information
Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
Investigation performed at the Department of Orthopaedics, University of Utah, Salt Lake City, Utah

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2007 Oct 01;89(10):2132-2136. doi: 10.2106/JBJS.F.01409
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Abstract

Background: The trend toward temporizing external fixation of complex fractures has resulted in increased expenditures for these devices. Increasing pressure to reduce health-care expenditures has led to exploration of reuse of equipment intended for single use. Devices must be tested and recertified prior to redeployment in hospital stock. We report the rate of manufacturer recertification and institutional cost savings associated with a reuse program approved by the United States Food and Drug Administration.

Methods: All Hoffmann-II external fixation components that had been removed at our institution during the study period were submitted to the manufacturer for visual inspection and mechanical testing. Pass rates for original components and previously recycled components were determined. With use of a conservative pass rate and the assumption of a maximum of three recertifications of each component, the total potential hospital savings on external fixation were calculated.

Results: The first pass rate was 76%. The second pass rate (i.e., the rate for components that had already been recertified once and had been sent for a second recertification) was 83%, but that rate was derived from a limited sample. On the basis of a conservative pass-rate estimate of 75%, the predicted average number of uses of a recyclable component was 2.7. The recertified components were sold back to our hospital at 50% of the original price. Because carbon-fiber bars and half-pins are not recycled, 85% of the charges expended on a new external fixation component are spent on portions of the system that are recyclable. The potential total savings on reusable components was found to be 32%, with a total savings of 27% for the whole external fixation system. No recertified components failed in clinical use over the course of the study.

Conclusions: With the expansion of cost-control efforts, the recycling of medical devices appears inevitable. Previous data have demonstrated the safety of reuse of external fixation devices, and this study confirms that finding. Our paper demonstrates the real cost savings associated with a manufacturer-based testing and recertification program. Issues of voluntary participation in reuse programs, component ownership, and the impact of savings on patient charges are yet to be worked out by individual institutions.

Level of Evidence: Economic and decision analysis, Level II. See Instructions to Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Thomas F Higgins, M.D.
    Posted on January 30, 2008
    Dr. Higgins et al. respond to Dr. Riley.
    University of Utah, Dept. of Orthopaedics, Salt Lake City, Utah

    We appreciate Dr. Riley’s feedback on our study(1). Her point is well taken--our paper(1) focused mostly on the economic impact, but environmental impact must be assessed as well.

    The trend toward single use devices may be largely driven by financial and industry concerns, but in many cases there is little reason not to salvage much of what is used in the operating room. As surgeons and citizens, we are obliged to consider our environmental impact and assess the true resource cost of that which we consume.

    As with many environmental concerns, establishing economic incentives may be the best way to insure improved environmental stewardship. Hopefully programs, such as the one examined in this study, may be a step toward demonstrating the viability of such incentives.

    Reference:

    1. Horwitz DS, Schabel KLS, Higgins TF. The economic impact of processing external fixation components. J Bone Joint Surg Am. 2007;89:2132-2136.

    Diane C. Riley, M.D.
    Posted on January 14, 2008
    Economic and Environmental Impact of Orthopaedic Surgery
    Mt. Ascutney Hospital, Windsor, VT

    To The Editor:

    Dr. Horwitz and his colleagues are to be commended for their study. The health care sector comprises 16% of our GDP. Twenty-five per cent of hospital waste comes from the operating room and much of that is red bag waste, i.e., waste that is ten times more expensive to dispose of. Because of our need for fixation devices, orthopaedics has large resource needs.

    It has struck me as inane that drill bits or used screws are discarded. Dr. Horwitz et al. recognized the benefits of a products "life-cycle assessment". They proposed that the manufacturer has a responsibility for disposing of the products they produce; and they created an opportunity for themselves as well as for the producer. By repurchasing a product from the manufacturer at a reduced cost they not only saved money, but diverted the product from their most expensive waste stream. Stryker, the company in question, avoided losing business to a third party reprocesser by recycling components – a process that uses less energy than virgin product production.

    None need to be told of the concern regarding the increasing costs of orthopaedic implants. This paper(1) shows that if we start asking questions of our manufacturing colleagues, we can create opportunities to decrease our implant costs through recycling programs. Although not mentioned in the paper(1), such programs can also lead to decreased waste costs. When we look at new products, we should ask manufacturers to reprocess or recycle old product, provide autoclavable containers, and to use recycled metals in their products.

    New developments in Orthopaedics are exciting, but it seems that we are moving away from designing reusable items and moving towards more single use items. None of us wishes to compromise our results with substandard equipment but does that mean each implant or product needs to be used only once? It is my hope that articles such as this can help us understand the economic and environmental impact of surgery and how to make it a more sustainable field.

    The author did not receive any outside funding or grants in support of her research for or preparation of this work. Neither she nor a member of her immediate family received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the author, or a member of her immediate family, is affiliated or associated.

    Reference:

    1. Horwitz DS, Schabel KLS, Higgins TF. The economic impact of reprocessing external fixation components. J Bone Joint Surg Am. 2007;89:2132-2136.

    Thomas F Higgins, M.D.
    Posted on January 10, 2008
    Dr. Higgins replies to Mr. Vukelich
    University of Utah, Department of Orthopaedics, Salt Lake City, Utah

    We appreciate Mr. Vulkelich’s interest in our research. We welcome his feedback on behalf the Association of Medical Device Reprocessors, a trade organization he directs to promote third party re-processing. He reports, however, that there are “errors and false assumptions” in the article, and we are happy to respond to these claims below.

    Mr. Vulkelich asserts that single use devices may be re-used, a point which is the very basis of our article. Next he asserts that third party reprocessing is regulated by the FDA, a point also stated in our article. Finally, he states that original equipment manufacturers only inspect and test a sample of the reprocessed product, while third party re-processors test 100 percent and mark each device for the number of cycles it has undergone. A thorough reading of the materials and methods section of our paper reveals that each piece of equipment was inspected and tested, and etched with a marking for each time it was re-processed (1).

    We were also referred to the AMDR website. Here they further claim that our report that carbon fiber components were not being re-certified is incorrect, pointing out FDA clearance was obtained as of December, 2007. Our article was published in October, 2007, at which time our statement was accurate.

    Our paper was meant to provide an economic analysis of potential cost savings associated with external fixation reprocessing by the original manufacturer. This was not done at the behest of industry, but rather as an academic search for answers and possible savings.

    Further claims are made as to the stellar safety record of third party reprocessors. If Mr. Vukelich wishes to study and publish the cost savings and safety of third party reprocessing of external fixation components, we believe this would be a valuable addition to the literature.

    Reference:

    1. Horwitz DS, Schabel KLS, Higgins TF. The economic impact of reprocessing external fixation components. J Bone Joint Surg Am. 2007;89:2133.

    Daniel J Vukelich
    Posted on December 17, 2007
    Reprocessing External Fixation Components
    Association of Medical Device Reprocessors

    To The Editor:

    I read with interest the article, The Economic Impact of Reprocessing External Fixation Components(1). As Executive Director of the Association of Medical Device Reprocessors (AMDR), the trade association that represents third-party reprocessors of medical devices, I was pleased to see the article confirm what our industry has demonstrated for many years-- that reprocessed external fixation devices are safe and effective. However, AMDR discovered errors and false assumptions about the third-party reprocessing industry in the article. A summary of our concerns is listed below:

    The authors highlight an example of an original equipment manufacturer (OEM) reprocessing its own "single use" devices, confirming once again that "single use" doesn't always mean just that. Indeed, the reprocessing of devices labeled for "single use" has been standard practice in U.S. hospitals for years. Reprocessing emerged when hospitals noted that OEM's had begun to change the labels on devices from "reusable" to "single use," without making significant design, performance, or material changes to the devices. It became clear that this practice was often motivated by economic objectives rather than patient safety concerns.

    Third party reprocessing of “single use” devices (SUDs) is fully regulated by the Food and Drug Administration (FDA). Reprocessed devices marketed in the U.S. are as safe and as effective as original equipment. AMDR’s members serve all of the top ten heart hospitals and all of the top ten orthopedic hospitals in the nation, as ranked by U.S. News & World Report. Overall, we serve 17 of the nation’s 18 “Honor Roll” hospitals.

    The nation’s third-party reprocessors have accomplished all this while maintaining a stellar safety record. Unlike OEMs who may test or inspect only a sampling of the devices they produce, AMDR’s members test or inspect 100 percent of the devices they reprocess. AMDR’s members are also committed to complete device traceability. Each reprocessed device is marked or otherwise designated so that users know it is reprocessed, and our tracing mechanisms track how many times each device has been reprocessed.

    The reprocessing industry has safely reprocessed over 50 million devices and prevented over 10,000 tons of medical waste from entering our landfills. No other segment of the medical device industry is helping hospitals reduce waste and costs like the third-party reprocessors.

    A more detailed response by AMDR to this article is available at www.amdr.org.

    The authors did not receive any outside funding or grants in support of their research for or preparation of this work. One or more of the authors, or a member of his or her immediate family, received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Association of Medical Device Reprocessors - AMDR). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

    Reference:

    1. Horwitz DS, Schabel KLS, Higgins TF. The economic impact of reprocessing external fixation components. J Bone Joint Surg Am. 2007;89:2132-2136.

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