Published 5/1/2013
John S. Kirkpatrick, MD, MS

Setting the Standard for Orthopaedic Surgery

ASTM Committee F-04 and AAOS celebrate 50 years of success

Every day, in operating rooms around the world, orthopaedic surgeons implant devices that restore mobility to their patients. Most do so without a worry about the biomechanics, biocompatibility, materials, and quality controls in manufacturing, processing, and delivering those implants.

But not that long ago—within the living memory of some surgeons who are still practicing today—implantable devices such as screws and wires came from the local hardware store. The surgeon would purchase several sizes, have them sterilized, and use whatever fit to stabilize fractures or in reconstructive bone procedures.

How did orthopaedic surgery move from homemade hardware to readily available, sophisticated implants and instruments? The bedrock of implant availability in contemporary times is standards.

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development of international standards to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. Its technical committee on medical and surgical materials and devices (F-04) celebrated 50 years of teamwork among orthopaedic surgeons, engineers, industry, and regulatory bodies last November. The contributions of many AAOS members were key to the success of the committee.

A short history
In the 1940s, surgical implants were beginning to have a profound impact on improving the care of fracture patients. Unfortunately, the wide variation of sizes and materials led to inconsistency in quality and safety. An effort to look at corrosion and physical properties of fracture implants was organized in 1941 by the American College of Surgeons (ACS), but unfortunately this work was not completed due to lack of funding.

In the 1950s, cooperative ventures among the ACS, the American Medical Association (AMA), and the AAOS were undertaken. Joseph S. Barr, MD, recognized that surgeons had limited education and training in materials science and, to some degree, biomechanics. Although educating surgeons in these areas could help lessen the problems from the inconsistencies in implants, he knew that standardization of implants would also be needed.

Dr. Barr called for the cooperative development of a group of surgeons and manufacturers to deal with all aspects of surgical implants. He learned about the ASTM and thought it might be ideally suited to standardizing surgical implants. He was also instrumental in forming the AAOS Committee on Bioengineering to address the education and training of surgeons and to work toward standards development in the field.

The first exploratory meeting was held at ASTM headquarters in Philadelphia in 1962 and resulted in the creation of ASTM Committee F-04. Approximately 20 surgeons, dentists, and engineers attended, representing the AAOS, the American Orthopaedic Association, the ACS, the American Dental Association, the U.S. Food and Drug Administration, the military (Army, Navy, and Air Force), implant manufacturers, universities, and other interested parties, including three other ASTM committees (A-1 on Steel, D-20 on Plastics, and E-7 on Nondestructive Testing). Herbert Lissner, an engineer, served as chair; surgeon Carl Martz, MD, as vice chair; and Patrick G. Laing, MD, as membership secretary. The membership was equally divided between manufacturers and “users” such as surgeons and general interest members.

The role of orthopaedists
Orthopaedic surgeons have remained active throughout F-04’s history, both in leadership and on committees. Their consistent participation and expertise have been critical to the Committee’s success.

AAOS has also been instrumental in the success of ASTM in general and continues to hold its Biomedical Engineering (BME) Committee meetings during F-04 committee weeks. This organizational support further encourages and provides for the participation of individual surgeon leaders in F-04 activities.

For example, orthopaedic surgeon leadership has been instrumental in the development of subcommittees in resources (materials), osteosynthesis (fracture fixation), joint replacement–related standards, spinal implants, and international standard efforts. Orthopaedists have helped enlist physician support for other subcommittees relevant to all fields of medicine.

Any attempt to describe the contributions of all orthopaedic surgeons would be likely to leave some important contributors out, so this article will focus on those who have received the Joseph S. Barr Award and those who served in leadership roles, including as committee chairs.

The Joseph S. Barr Award has been presented “for outstanding contributions as a physician” since 1977. Recipients, most of them AAOS members, are listed in Table 1.

A key component of the committee’s leadership is the user vice-chair. Surgeons in this role have included R.B. Elliott, MD (1979–1984); William C. Allen, MD (1984–1988); Ivan A. Gradisar Jr, MD (1988–1990); Harry B. Skinner, MD, PhD (1990–1992 and 1993–1996); Arnold T. Berman, MD (1992–1993); Joshua J. Jacobs, MD (1996–2000); John S. Kirkpatrick, MD (2000–2003); Michael J. Yaszemski, MD, PhD (2004–2012); and William M. Mihalko, MD, PhD (2012–present).

Five of the 10 chairmen of F-04 are orthopaedic surgeons and active AAOS volunteers. They are as follows:

  • Victor Frankel, MD (1974–1979). Dr. Frankel also was the first chair of the FDA Orthopaedic Advisory Panel.
  • Patrick G. Laing, MD (1979–1988), who wrote an excellent history for F04’s 30-year anniversary.
  • Michael B. Mayor, MD (1988–1994), who led the effort, with Bob Games (producer vice-chair, 1994–1996), to comply with federal mandates that required FDA to use performance standards in its regulatory function.
  • Joshua J. Jacobs, MD (2000–2003), whose term was marked by the first attempts to develop standards activity within the field of tissue engineering.
  • John S. Kirkpatrick, MD (2004–2007).

Surgeons continue to be active in F-04. Many members of the AAOS BME Committee participate in standards development and other committee activities. Dr. Mihalko, current BME Committee chair, leads the surgeon representation in joint replacement standards. Menachem M. Meller, MD, PhD, has also been participating in arthroplasty issues. Kent J. Lowry, MD, has been active in arthroplasty packaging and labelling. Paul A. Anderson, MD, and S. Raymond Golish, MD, PhD, are involved in the spinal implants standards work. Gregory A. Brown, MD, PhD, works on developing clinical trials standards. Jean Coumans, MD, has been a recent liaison from the neurosurgical community. Kenneth Urish, MD, PhD, the resident member of the BME Committee, has been attending some standards meetings and shows promise for the future.

John S. Kirkpatrick, MD, MS, is professor and chair of the department of orthopaedic surgery at the University of Florida College of Medicine in Jacksonville, Fla. He can be reached at John.kirkpatrick@jax.ufl.edu