AAOS Bulletin - December, 2005

Orthopaedic devices and consensus standards

By Jack E. Lemons, PhD

With the increasing number of orthopaedic devices on the market today, orthopaedic surgeons and their patients are frequently faced with tough decisions. They need some assurance that the device shape, dimension, material and design properties, packaging, cleanliness and sterility are appropriate for the intended clinical application, even when the device is FDA-approved. Consensus standards provide that assurance.

What are consensus standards?

Consensus standards for orthopaedic device systems are based on mutual agreements reached by all stakeholders, including users (medical professionals and hospitals), developers/producers (manufacturers) and general interest groups (academia, regulators and patient-oriented participants). Consensus standards serve as fundamental reference documentation for product quality by outlining appropriate standards to ensure compliance with the physical, mechanical, chemical, electrical and biological properties of devices.

The American Society for Testing and Materials’ (ASTM) Committee F04 on Medical Devices develops orthopaedic device standards for the United States as well as for international considerations. The ASTM F04 committee meets twice a year to ensure appropriate process and balanced consensus development. Voting on proposed standards is monitored by stakeholders to obtain even, unbiased representation. The consensus process requires that all negative votes be resolved or categorized as “nonpersuasive” by the overall F04 membership.

The ASTM F04 committee is comprised of about 600 professionals and is subdivided into medical specialty divisions for administrative purposes. ASTM publishes standards annually; the current volume (13.01) includes more than 100 published medical and surgical device standards. Each specialty division has several new standards in progress, as drafts under review at the task force or current ballot level. Standards are reviewed and revised or reaffirmed on a five-year cycle.

Value to orthopaedics

The fundamental value of consensus standards for surgical implants was recognized in 1962 when the ASTM F04 committee was established, primarily by orthopaedic surgeons. From the outset, support from the AAOS Biomedical Engineering Committee has been instrumental to the development and evolution of standards for devices. Anticipating the need for standards for new biological and combination products, the AAOS Biological Implants committee has also become involved with the ASTM. AAOS participation in the Orthopaedic Device Forum has also contributed to the development and application of relevant orthopaedic standards.

Consensus standards are recognized within the regulatory approval process for medical products not only by the U.S. Food and Drug Administration but also by the regulatory bodies of many other nations. This acceptance helps to ensure quality and reduce costs while increasing the competitiveness of U.S.-based products. The long-term success of implant-related surgical treatment outcomes is due, in part, to the standardization process.

Global standards

The various U.S.-based standards organizations actively participate in the global harmonization of medical device standards. For example, representatives of the U.S. Technical Advisory Group participate in the International Standards Organization (ISO) process and annual international meetings. The ISO works to ensure the safety, consistency and effectiveness of medical device products on a worldwide basis.

As international markets continue to increase, technical and scientific interactions will also expand. Recently, the ASTM broadened its reach and membership to become ASTM International, with the goal of promoting the acceptance of consensus standards worldwide.

The future of orthopaedic surgical products is changing rapidly as new devices are developed from synthetic biomaterials, cell signaling proteins, active biologicals and combination products. In each category, specification standards for basic chemistry and biochemistry, tissue processing requirements, and structural and biocompatibility test methods are being developed to ensure consistency, quality and safety. These standards and related clinical trials combine to ensure the safety and effectiveness of these new products.

Device standards in orthopaedics are directly associated with the consistency of the device system properties and how these relate to clinical outcomes. It is critical that all device components comply with established requirements and that applicable and consistent material and design properties relate directly to biocompatibility to ensure the safety and efficacy of the device. The role of orthopaedic surgeons is fundamental to this process at all levels and the ASTM welcomes the participation of orthopaedic clinicians and researchers in the standards development process.

Jack E. Lemons, PhD, serves as a consultant to the AAOS Biomedical Engineering Committee.

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