Published 3/1/2007
John S. Kirkpatrick, MD

MedWatch: Your link to adverse event reporting

Adverse event reporting—particularly through the FDA’s MedWatch system—is a critical part of the orthopaedic surgeon’s role in ensuring the public health

Orthopaedic surgeons use devices and tissue-related products for a growing number of indications. The reliability and safety of the tissue-related products and devices we use are key to protecting both individual patient safety and general public health.

For this reason, the U.S. Food and Drug Administration (FDA) follows a rigorous protocol to ensure that devices are appropriately evaluated before they are approved for marketing and made available for our use. The agency also has many methods to follow the safety and effectiveness of these devices after they have received marketing approval. An essential component of this monitoring process is Adverse Event Reporting through the MedWatch program.

What is an adverse event?
According to the FDA, adverse events for devices include the following:

  • A mix-up of the device or its labeling with another article
  • An adverse reaction, side effect, injury, toxicity, or sensitivity reaction not addressed in the product labeling or in excess of expectations
  • Any significant chemical, physical, or other deterioration or change in the device, or failure to meet specifications in the labeling

The FDA requires that adverse reactions for biologic products (Human Cell, Tissues, and Cellular and Tissue-Based Products or HCT/P) be reported if there is any adverse reaction involving a communicable disease related to a distributed product. In addition, any serious reactions involving a communicable disease must be reported if it is a) fatal, b) life-threatening, c) results in permanent impairment of a body function or structure, or d) requires medical or surgical intervention, including hospitalization. An adverse reaction is defined as an unintended response to any HCT/P for which there is a reasonable probability that the HCT/P caused the response.

Reporting responsibility
Manufacturers must notify the FDA of adverse reactions within 15 days of receiving information on such an occurrence. Manufacturers must use the MedWatch form FDA 3500A to report adverse reactions. Physicians, who are part of the voluntary system of reporting, must use the MedWatch form FDA 3500. Physicians must also promptly report any adverse reactions directly to the HCT/P tissue establishment that manufactured the HCT/P.

Manufacturers are required to submit adverse event reports to the FDA annually. These reports comprise approximately 90 percent of the adverse event reports received by the FDA. User facilities such as hospitals and surgical centers are legally required to report suspected medical device-related deaths to both the manufacturer and the FDA. User facilities are also required to report “serious injuries” related to the device to the manufacturer. If they are unable to identify the manufacturer, they must report the injury to the FDA.

Surgeons are a key component of this reporting because their patients may be involved and their expertise can help to document the relationship between the adverse event and the device. Surgeons are involved in the mandatory process by ensuring that the manufacturer and the surgeon’s facility have the necessary information to complete their mandatory reporting. Adverse event reporting is permitted under the Health Insurance Portability and Accountability Act.

Surgeons are also encouraged to participate in voluntary reporting mechanisms through the FDA MedWatch Web site (www.fda.gov/medwatch) by downloading and completing the voluntary reporting form (3500). Sections D (suspect products/biologicals) and E (suspect medical devices) are most relevant to orthopaedic surgeons. The more complete the information you can provide, the better. Include the name and type of device or tissue product, the name of the distributor or manufacturer, the lot number, and any distinct identification code available. Refer to “How to Report Problems with Products Regulated by FDA” (www.fda.gov/opacom/.html) for complete information and answers to frequently asked questions about adverse event reporting.

The importance of reporting
Adverse event reporting has numerous benefits. Feedback provided to surgeons and manufacturers aids in defining appropriate populations and diagnoses for product use. Nuances of product behavior in vivo may not be fully described through preapproval studies but may come to light in the postmarket environment. Adverse event reports are one means of capturing data on suboptimal applications and refining applications to the most appropriate patients and diagnoses for the best possible outcomes.

But adverse event reporting also presents several challenges. Adverse events are widely thought to be underreported, as seen in literature reports related to adverse events that do not correlate with FDA adverse event databases. Frequently, reports are submitted with inadequate information on the use of the device and its contribution to an adverse event. Inadequate documentation, the lack of unique device identifiers, design modifications, and even industry mergers or acquisitions may make it difficult to identify the specific device involved in the adverse event. Physician-directed or “off label” use—in which the adverse event may be related more to the unapproved indication rather than the device itself—is another complicating factor. Nonetheless, these events should also be reported to the FDA and the manufacturer.

Adverse event reporting is a critical part of the orthopaedic surgeon’s role in ensuring the public health. We should not only cooperate with manufacturers and hospitals, which must file mandatory reports, we should also voluntarily and actively report adverse events among our own patients. Only in this way can we help ensure the safety and availability of the devices we use in caring for our patients.

John S. Kirkpatrick, MD is the chair of the AAOS Biomedical Engineering Committee. He may be contacted at john.kirkpatrick@jax.ufl.edu