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Published 6/1/2011
Jennie McKee

Using the FDA’s MedWatch program

Orthopaedic surgeons—unlike medical device manufacturers and facilities such as hospitals and surgical centers—are not legally required to report adverse events associated with medical devices to the U.S. Food and Drug Administration (FDA). And yet, reporting these problems through the FDA’s MedWatch program is something all orthopaedists can do to help improve patient safety, according to the authors of “Reporting and Notification of Adverse Events in Orthopaedics”.

The authors—including William M. Mihalko, MD, PhD—state that orthopaedic surgeons must understand the importance of reporting adverse events involving devices and pharmaceuticals to the FDA.

“The identified trend of failures or complications of a certain device can raise red flags through the MedWatch program, which can properly alert surgeons to issues with these particular devices,” they wrote.

What is MedWatch?
The MedWatch program was created in 1993 to help physicians and end users alert the FDA to adverse events related to pharmaceuticals and medical devices or equipment approved under the 510(k) or Premarket Approval pathways. Since its inception, the program has received more than 40,000 reports of adverse events.

The FDA keeps the patient’s identity confidential, but may share the physician’s identity with the device manufacturer, unless the physician requests otherwise. Reporting of adverse events is allowed under the Health Insurance Portability and Accountability Act.

MedWatch not only allows consumers and medical professionals to report adverse events, but also issues alerts to healthcare professionals about possible device-related issues.

“The MedWatch Web site allows any orthopaedic surgeon to learn about adverse events and report such an event for a pharmaceutical or medical device,” wrote the authors. “The MedWatch homepage has more than 1 million visitors each month and can be directly accessed by a smartphone or the Internet.”

In addition, the MedWatch e-list, which has more than 130,000 subscribers, notifies healthcare professionals when the FDA identifies a new safety issue and announces it to the public.

Reporting via MedWatch
Orthopaedists can voluntarily report adverse events by downloading form 3500 from the MedWatch Web site, filling it out, and submitting it to the FDA.

“Sections D, Suspect Product(s), and E, Suspect Medical Device, are most relevant to orthopaedic surgeons,” noted the authors. “The more complete the information the surgeon can provide, the better.”

Information that should be provided includes the name and type of device or tissue product, as well as the name of the distributor or manufacturer, the lot number, and any distinct identification code available. Orthopaedists may work with their office staff members to obtain this information from hospital records.

According to the authors, orthopaedic surgeons have a responsibility to report adverse events, especially because they are now using biologic devices such as bone morphogenetic proteins and combination products that have the possibility of more severe systemic reactions as well as higher levels of morbidity or even mortality.

“Feedback provided to surgeons and manufacturers aids in defining appropriate populations and diagnoses for product use,” they wrote. “Nuances of product behavior in vivo may not be fully described through preapproval studies, but they may come to light in the postmarket environment.

“Adverse event reports,” they added, “are one means of capturing data on suboptimal events and refining applications to the most appropriate patients and diagnoses to obtain the best possible outcomes.”

The authors concluded by noting that “each of us needs to refrain from thinking that such events are scarce and not sufficiently significant to report to the FDA. Such an attitude may allow a faulty device to remain on the market much longer than would have been the case if the reports were properly filed and problems identified early.”

Jennie McKee is a staff writer for AAOS Now. She can be reached at mckee@aaos.org

Orthopaedists can use form FDA 3500 to report medical device-related adverse events to the FDA. (PDF)

Defining “adverse events”
As Dr. Mihalko and his fellow authors note, the FDA defines adverse events for devices as any of the following:

  • a mix-up of the device or its labeling with that of another article (eg, the wrong-size implant label placed on or in an implant container)
  • an adverse reaction, side effect, injury, occurrence of toxicity, or sensitivity reaction not addressed in the product labeling or in excess of expectations (eg, severe swelling or local reaction from a bioabsorbable suture anchor)
  • any significant chemical, physical, or other deterioration or change in the device, or failure to meet specifications in the labeling (eg, fracture of a total hip implant trunnion or stem at any time)

“The FDA also requires that adverse events for biologic products (human cell, tissues, and cellular and tissue-based products, or HCT/P) be reported when there is any adverse reaction involving a communicable disease related to a distributed product,” wrote the authors.

“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,” they wrote.

In addition, any serious reaction involving a communicable disease must be reported when it is fatal, life-threatening, results in permanent impairment of a body function or structure, or requires medical or surgical intervention, including hospitalization.

JAAOS article has immediate impact
“I knew nothing about MedWatch prior to reading the JAAOS article,” said Samer S. Hasan, MD, PhD, an orthopaedist specializing in treating shoulder and elbow conditions at the Cincinnati Sports Medicine and Orthopaedic Center.

“It couldn’t have been timed any better,” he remembered, noting that shortly after reading the article, he had occasion to use the program.

“I had no experience reporting adverse events to the FDA and really had no idea where to turn,” he said. “In fact, I had put it on the back burner. Then, I happened to come across the article.”

Although Dr. Hasan initially had some concerns about navigating a government Web site, he was pleasantly surprised at how easy it was to use. He encourages other orthopaedists to become familiar with MedWatch and to use this resource for reporting adverse events.

“It’s important for orthopaedists to provide information that, together with other reports, might bring to light potential implant-related problems,” he said.

“I think the principal barrier to reporting is just not knowing how to report,” he continued. “If more surgeons knew about the Web site—and understood that the process only takes a few minutes and reporting is confidential—more surgeons would participate.”

Additional Links:

Information about MedWatch—as well as a link to the reporting form

Subscribe to MedWatch Safety Alerts (and receive them via e-mail or text message)

Information on reporting adverse events from the AAOS Biomedical Engineering Committee