Position Statement

Training for New Technologies

This Position Statement was developed as an educational tool based on the opinion of the authors. It is not a product of a systematic review. Readers are encouraged to consider the information presented and reach their own conclusions.

As technological advances occur in orthopaedics, it is essential that surgeons have appropriate training prior to using medical devices, biologics, drugs, and combination products. Training should comprise of both didactic and practical training techniques including indications for use and specified surgical approaches. The American Academy of Orthopaedic Surgeons (AAOS) remains committed to providing education regarding new technologies to enable enhanced, safe patient care¹.

The American Academy of Orthopaedic Surgeons (AAOS) believes that surgeons must be adequately trained and assessed before performing new, complex procedures. Fellows should be apprised of manufacturer’s specific conditions of approval from the Food and Drug Administration (FDA), which may require extensive surgeon education and training. The orthopaedist should thoroughly examine his/her own training, skills, and experience to determine the level of training necessary to perform such new procedures in a competent, safe manner. The AAOS recommends that Fellows trained in a new technology be assessed by a surgeon already trained and qualified in that procedure. Additionally, surgeons should work with hospital administration to ensure that all necessary equipment and appropriately trained staff are available for procedures.

Credentialing

Manufacturers have initiated requirements for education on the use of their technology that approximates a credentialing activity. The AAOS believes that education should be provided by multiple sources and not solely by the manufacturer of a particular product. Educational needs will vary according to a surgeon’s existing skills and the capability of the sponsor of the educational course.²

Certification

Manufacturers use direct to consumer advertising to market pharmaceuticals, devices, and surgical techniques. Company web sites provide lists of surgeons that have received training for use of specific medical devices and surgical procedures. These advertising lists are essentially marketing tools and should not be confused with board certification.³ Certification by the American Board of Orthopaedic Surgery (ABOS) or the American Osteopathic Board of Orthopaedic Surgery (AOBOS) is a rigorous examination that assesses cognitive knowledge, practice performance, life-long learning, and professional standing.

Privileges

It is essential that hospital medical staff develop criteria for the delineation of clinical privileges for the use of new technologies. The criteria should apply to all individuals who are permitted by law to provide patient care services independently. These criteria should serve as an objective framework from which to evaluate a practitioner’s competence and should be clearly specified in the hospital’s medical staff bylaws. At a minimum, these criteria should address licensure, training in both didactic and practical elements, experience (including the volume of particular clinical experience critical for that privilege), and current competence.⁴

Assessment

For any new procedure with the use of a medical device, biologic, drug, or combination product, assessment of safety and efficacy should occur after an initial period. In addition, Fellows should participate in post-marketing surveillance on new technologies. Manufacturers should adhere to agreed-upon FDA post-marketing studies and report findings in an ethically responsible manner.

References:

1. AAOS Position Statement on Commitment to Excellence: Maintaining Skills and Knowledge Through Lifelong Learning
2. AAOS Position Statement on Credentialing in the Use of Specialized Instrumentation in Orthopaedics
3. AAOS Position Statement on Pharmaceutical and Device Company Direct to Consumer Advertising
4. AAOS Position Statement on Delineation of Clinical Privileges in Orthopaedic Surgery

© December 2004 American Academy of Orthopaedic Surgeons

This material may not be modified without the express written permission of the American Academy of Orthopaedic Surgeons®.

Position Statement 1164

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