Study Finds More Medical Device Deaths Than Reported
A recent study found a significant number of medical device adverse events resulted in patient deaths were miscategorized in the FDA’s Manufacture and User Facility Device Experience (MAUDE) database. Analysis of the database with a natural language processing algorithm uncovered that 23% of the reports in which a serious injury or death was reported were classified as either malfunction, injury or unclassified. Here, the experienced Maryland product liability attorneys at Peter Angelos Law further explain the study.
Misclassified Deaths in FDA Database
The study, published in the Journal of American Medical Association (JAMA), utilized a natural language processing algorithm to examine reports in the MAUDE database in which a serious injury or death was reported. The algorithm looked for at least one term in each report that suggested a patient death, such as “patient died” or “patient expired”, and all findings were followed by manual text review. The study included data over a 28-year window, looking at reports from December 31, 1991, to April 30, 2020.
The terms in the natural language processing algorithm identified 290,141 reports in which a serious injury or death was reported. Of these, 151,145 (52.1%) were classified as ‘death’, 47.9% were classified as ‘malfunction’, ‘injury’, ‘other’, or ‘unclassified’. This indicated that approximately 31,552 reports in the sample included deaths that were misclassified in other categories. Overall, the study found that 17% of the analyzed deaths caused by medical device malfunction were misclassified.
Medical Devices with Higher Rates of Misclassification
Some medical devices had higher rates of misclassification. Researchers found that 17.5%, or 217 out of 1,238, of patient deaths linked to the Sapien 3 transcatheter heart valves were misclassified. The study also found that 24.7%, or 97 out of 392, of patient deaths linked to the MitraClip transcatheter heart valve device was misclassified.
Improving Accuracy of Medical Device Safety Ratings
The report concluded that “many of the findings of this study suggest that many medical device adverse event reports in the FDA’s MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.” Due to the discrepancy in classifications, it is possible that defective products may stay on the market longer than they should, thus resulting in more deaths. Because of this, it is imperative that both the FDA as well as medical device manufacturers improve the clarity and consistency of the MAUDE database classification system.
Consult With an Experienced Maryland Product and Medical Device Liability Attorney
Patients entrust that medical devices are deemed safe by both physicians as well as the FDA. When reports of the number of deaths caused by a medical device are inaccurate, the safety ratings may be compromised, and unsafe products may be allowed to stay on the market much longer than they should. If a defective medical device has caused injury or death to you or someone you love, it is important to consult with an experienced attorney. While financial compensation cannot heal all wounds caused by medical device malfunction, it can help with the financial burden of increased medical bills. Consult with the team of experienced attorneys at Peter Angelos Law by calling 1-866-454-1837 or filling out the form below.