Fig. 1 The AAOS Device Recall Dashboard offers members up-to-date information regarding safety concerns related to medical devices and recent recall activity.

AAOS Now

Published 9/13/2022
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Jonathan Dubin, MD, FAAOS; Jason L. Dragoo, MD, FAAOS; Julie Balch Samora, MD, PhD, MPH, FAAOS, FAOA

AAOS Reinforces Its Focus on Patient Safety, Launches New Device Recall Dashboard

When a medical device fails to function as originally intended, it can jeopardize patient safety. One important role of the U.S. FDA is to continue monitoring devices after approval to mitigate the detrimental effects of unforeseen problems. Orthopaedics constitutes the single largest specialty of medical devices and accounts for approximately 20 percent of all recalls issued by the FDA. It is important for orthopaedic surgeons to be familiar with the medical device recall process and understand what role they can play in improving patient safety.

AAOS leadership and the Committee on Devices, Biologics, and Technology have teamed up with the Patient Safety Committee to publish a quarterly Device Recall Dashboard (Fig. 1). The dashboard went live on Sept. 1. The goal of the dashboard is to provide orthopaedic surgeons with critical recall information that will ensure high-quality patient care and protect the health and well-being of their patients.

A medical device recall is when a “manufacturer takes a correction or removal action to address a problem.” Although the FDA can require a company to recall a device, most recalls are voluntary. A recall is not equivalent to a ban, which proscribes all current and future sales of a device. Rather, during a recall, a manufacturer can take several actions to correct a violative product, such as repairing the device, relabeling, monitoring patients, and more, depending on the issue.

The FDA classifies recalls into three tiers according to perceived risk. A Class 1 recall is the highest risk and is defined as “a situation where there is a reasonable chance … [of] serious health problems or death.” A Class 2 recall involves moderate risk and is reserved for situations where a device “may cause temporary or reversible health problems.” Class 3 is the lowest risk, and the issue is not expected to cause any health problem or injury.

In 2011, the U.S. Government Accountability Office reported that 83 percent of recalls were Class 2, whereas only 4 percent were Class 1. These numbers, however, may belie the overall patient impact. The now infamous DePuy ASR (articular surface replacement) metal-on-metal hip implant was deemed Class 2, whereas a Class 1 recall was issued for the Stryker ShapeMatch Cutting Guide indicated for the Triathlon Total Knee System. With more than one million metal-on-metal hip arthroplasties performed worldwide, and countless dollars spent on investigations and treatments from the unforeseen complications, it is likely that the metal-on-metal recall had a more profound impact on patients even though it was deemed a “moderate risk.”

It is incumbent upon surgeons to discuss any clinically relevant recalls with patients who received a flawed device once the surgeons are aware of the defect. However, surgeons can go further by reporting concerns they see in their practices regarding medical devices. Unlike manufacturers and hospitals, physicians are not mandatory reporters, but they can voluntarily go to www.Medwatch.com and file an adverse event report with the FDA. These reports are collected along with those from industry and hospitals in the Manufacturer and User Facility Device Experience (MAUDE) database. The database assists in the detection of errors and ultimately recalls. It can also be a useful tool for investigators. Somerson et al. successfully used the database to investigate modes of shoulder arthroplasty failure and found that adverse events reported in MAUDE differed significantly from events in the published literature.

Even so, MAUDE’s ability to capture device safety concerns is limited by its passive design, with reports often being “incomplete, inaccurate, untimely, unverified, or biased data,” per the FDA’s own disclaimer. Furthermore, without baseline data, one cannot determine incidence or prevalence. In the future, developing high-quality, centralized registries, as well as integrating unique device identifiers into computerized medical records will immensely strengthen post-approval device monitoring and improve patient safety.

When problematic devices are detected, it is imperative that physicians be made aware. A recall can only work if the physicians who care for the complications are aware. By providing an up-to-date, readily accessible Device Recall Dashboard, AAOS hopes to support the membership in handling device recalls. The dashboard, which is available at www.aaos.org/device-recall-dashboard, is user-friendly and searchable by specialty and provides direct links to the FDA website regarding recalled devices.

Jonathan Dubin, MD, FAAOS, is an associate professor at the University of Missouri–Kansas City and vice chair of the Department of Orthopaedics and director of orthopaedic trauma at University Health Hospital. He is also a member of the AAOS Committee on Devices, Biologics, and Technology.

Jason L. Dragoo, MD, FAAOS, is a professor of orthopaedics, vice chair of academic affairs, and the Endowed Chair of Regenerative Medicine at the University of Colorado; head team physician for the Denver Nuggets; and an associate team physician for the Denver Broncos. Dr. Dragoo is the current chair of the AAOS Devices, Biologics, and Technology Committee and is a past president of the Biologics Association.

Julie Balch Samora, MD, PhD, MPH, FAAOS, FAOA, is a pediatric hand surgeon at Nationwide Children’s Hospital in Columbus, Ohio, where she serves as medical director of quality for the hospital. She is also the deputy editor of AAOS Now.

References

  1. U.S. FDA: What Is a Medical Device Recall? Available at https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall. Accessed July 26, 2022.
  2. U.S. FDA: Recalls Background and Definitions. Available at: https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions. Accessed July 26, 2022.
  3. U.S. Government Accountability Office: Medical Devices: FDA Should Enhance Its Oversight of Recalls. Available at: https://www.gao.gov/products/gao-11-468. Accessed July 26, 2022.
  4. U.S. FDA: Recalls, Corrections and Removals (Devices). Available at: https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices. Accessed July 26, 2022.
  5. Somerson JS, Hsu JE, Neradilek MB, Matsen FA III: Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016. J Shoulder Elbow Surg 2018;27(11):1978-1986.
  6. U.S. FDA: MAUDE—Manufacturer and User Facility Device Experience. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/textsearch.cfm. Accessed July 26, 2022.