Published 11/1/2013
Stuart B. Goodman, MD, PhD; William M. Mihalko, MD, PhD; William J. Robb III, MD; Kevin J. Bozic, MD, MBA; Michael J. Goldberg, MD

Issues Surrounding Adverse Event Reporting

Changing landscape affects clinical practice and research

The reporting of adverse events during the practice of medicine has received increasing attention by government agencies, insurance companies, industry, state and hospital credentialing committees, medical societies, and patient advocacy groups. Previously, the clinical results of various nonsurgical or surgical treatments for a specific disease or medical condition focused on the patient’s level of pain and other predefined functional variables, often tabulated in an outcome score. Less emphasis was placed on adverse events and complications that occurred during the delivery of a particular treatment.

Recently, especially with the introduction of new medical technologies, implants, and biologic treatments, increased importance has been placed on obtaining a satisfactory outcome while avoiding or minimizing complications. This article outlines some of the issues associated with reporting adverse events in the clinical and research arenas.

In the clinical setting
During orthopaedic residency, the reporting of adverse events is a critical feature of “Complication Rounds,” but this program is not limited to universities or residency programs. Many private and public hospitals and clinics have adopted this process as a means of continued quality assurance and improvement.

Complication Rounds focus on discussions of all adverse outcomes, critical reviews of the literature on the subject, and the development of strategies to mitigate the complication. However, new, unanswered questions pertaining to this reporting have arisen, including the following:

  • What constitutes a complication or adverse event?
  • What time frame should be included (eg, in hospital, 30 days, 90 days)?
  • How was the decision for subsequent treatment made?
  • What was the outcome of the subsequent treatment rendered?

For example, if a patient’s displaced open comminuted midshaft femur fracture is treated surgically by débridement and intramedullary fixation without any complications during hospitalization, the case would not be reported during Complication Rounds. However, if the patient returns 3 months later with a delayed union and bone grafting is recommended, should this be reported as an adverse event associated with treatment or a known potential outcome of a highly comminuted open fracture?

In many respects, the traditional Complication Rounds or Morbidity & Mortality (M&M) Conference are no longer able to capture the scope of orthopaedic practice and where missteps might occur. The episode of illness is no longer limited to the hospital stay; the venues for intervention are both inpatient and outpatient, and many orthopaedists provide both musculoskeletal medical and surgical care. As such, quality indicators become more numerous and include the following:

  • failures and delays in diagnosis
  • malunion from closed fracture treatment, including cast saw injuries
  • intraoperative and postoperative complications ranging from neurovascular to wound infections
  • complications of regional anesthesia

Because a number of orthopaedic complications (spine pseudarthrosis, failed hardware, late joint infections) may present long after the surgery, it is reasonable to expand the traditional M&M time parameters of 30 days to as long as 3 years postoperative.

Assigning a severity score to all reported complications may mitigate any arguments about whether or not it is a true complication. The best-studied classification system (Dindo’s) must be modified from its general surgery origins and nomenclature to accurately capture the severity of orthopaedic complications and the magnitude of subsequent functional impairment. Table 1 reflects such a modification and is used at Seattle Children’s Orthopaedics.

Lastly, the goal of reporting and analyzing adverse events is not to itemize them, but to identify correctable problems that occur during the care of patients and, in doing so, identify processes that will reduce the risk of recurrence. Actionable metrics are an essential requirement, as are metrics that report the total number of cases, provider variation, and trends.

In the research setting
The reporting of adverse events is also highly relevant to the reporting of clinical trials. With the introduction of new medical devices, drugs, and biologics, the reporting of adverse events is integral to providing safe, effective treatments. This process is dependent, in part, on careful scrutiny of appropriate preclinical and clinical studies by the U.S. Food and Drug Administration (FDA) and review panels. However, reporting of all adverse events ultimately depends on the investigators and their teams carrying out the clinical trial.

One recent example in which the study design and reporting of adverse events of the original clinical trials were allegedly biased involves the use of recombinant human bone morphogenetic protein (rhBMP-2) in spinal fusion. A published paper suggested that the adverse events associated with rhBMP-2 treatment may have been underreported by 10 to 50 times the original estimates cited in the industry-sponsored studies that were published in peer-reviewed publications.

As a result, systematic reviews and meta-analyses under the auspices of the Yale University Open Data Access Project were conducted. Their findings, as well as accompanying editorials, delve into this subject further.

The clinician’s responsibility
The reporting of complications and adverse events associated with implants, biologics, and drugs is the clinician’s responsibility and can be accomplished through various mechanisms. The Safe Medical Devices Act of 1990 enacted by Congress requires that medical device user facilities (hospitals, ambulatory surgical centers, and nursing homes) report device-related deaths and serious injuries to the FDA and manufacturers.

In 1993, the FDA started the MedWatch program for end users to report adverse events concerning pharmaceuticals and medical devices. The program emphasizes the importance of reporting adverse events from consumers and medical professionals and alerts healthcare professionals of possible device-related issues. The FDA also uses Internet technology-based tools to inform physicians of adverse events along with other safety information.

Orthopaedic surgeons can learn about and report an adverse event for a pharmaceutical or medical device on the MedWatch website (www.fda.gov/medwatch). In addition, end-users can sign up for the MedWatch e-list, which notifies healthcare professionals via emails, text messages, and smart phone notifications whenever the FDA identifies a new safety issue and announces it to the public. The immediate nature of these adverse event alerts may lead to the avoidance of potential harm to any other patients. Any physician can subscribe to the safety alerts on the website at www.fda.gov/MedicalDevices/Safety/default.htm

A recent survey conducted by the AAOS Biomedical Engineering and Biologic Implants Committees revealed that, on average, only 10 percent of AAOS fellows knew how to utilize the FDA MedWatch program. In addition, more than 60 percent of fellows had witnessed an adverse event involving either a medical device or pharmaceutical in the previous 6 months. This undoubtedly means that adverse events in general are being underreported.

In summary, to ensure optimal patient care, we as orthopaedic surgeons must continually assess our patients’ clinical outcomes and carefully document and mitigate complications and other adverse events. Future articles in AAOS Now will explore these issues in more detail.

Stuart B. Goodman, MD, PhD, chairs the AAOS Biological Implants Committee; William M. Mihalko, MD, PhD, chairs the AAOS Biomedical Engineering Committee; William J. Robb III, MD, chairs the AAOS Patient Safety Committee; Kevin J. Bozic, MD, MBA, chairs the AAOS Council on Research and Quality; and Michael J. Goldberg, MD, is a member of the AAOS Committee on Evidence-Based Quality and Value.

Disclosure information: Dr. Goodman—Accelalox, Biomimedica, Tibion, StemCor, Baxter, Association of Bone and Joint Surgeons, Dr. Mihalko—Aesculap/B.Braun, Medtronic, Saunders/Mosby-Elsevier, Springer, American Orthopaedic Association, ASTM International. Dr. Robb—Innomed, Abbott, Baxter, Johnson & Johnson, Stryker, Orthopaedic Research and Education Foundation (OREF). Dr. Bozic—American Association of Hip and Knee Surgeons, American Joint Replacement Registry, American Orthopaedic Association, California Joint Replacement Registry Project, California Orthopaedic Association, AAOS Now, OREF. Dr. Goldberg—BioMarin Pharmaceutical.

Bottom Line

  • Reporting adverse events in both the clinical and research settings is a physician’s responsibility and is becoming more important as quality measures are implemented.
  • Using a modified severity score may help differentiate adverse events from true complications.
  • A recent survey found that, although 60 percent of responding orthopaedists had witnessed an adverse event in the previous 6 months, only 10 percent knew how to report it using the FDA MedWatch program.
  • Adverse events are probably being underreported, and orthopaedic surgeons must assess clinical outcomes and carefully document and mitigate complications and other adverse events.


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