Medical devices, whether implanted or used in testing or surgical procedures, usually work as they should. However, those involving adverse events that patients suffer must be reported to the Food and Drug Administration.
The FDA disclosed that some hospitals are guilty of reporting lapses that failed to expose serious device-related dangers to patients.
To be in compliance with federal rules, hospitals and other medical facilities must report injuries or deaths potentially caused by medical devices to both the product manufacturer and the FDA within 10 days of an occurrence. In 2016, the FDA disclosed violations that surfaced in its inspection reports. Federal regulators named 12 hospitals that were specifically associated with these violations, including large, well-known hospitals such as Massachusetts General in Boston, Cedars-Sinai Medical Center in Los Angeles and New York Presbyterian Hospital.
The duodenoscope matter
Through routine inspections, the FDA found that many hospitals report medical device-related injuries late or not at all. An example of failure to report is an incident that occurred at Huntington Memorial Hospital in Pasadena, CA. FDA inspectors discovered that a patient had died after sustaining a multidrug-resistant infection and cardiac arrest involving a duodenoscope procedure. The hospital failed to report the death to either the manufacturer or to the FDA. However, hospital testing showed this fatality was related to 14 other infections caused by contaminated duodenoscopes.
Indicative of a larger problem
Although the FDA singled out certain hospitals for criticism in its 2016 report, the agency believes under-reporting of serious medical device-related incidents is a problem at other hospitals and medical centers across the country.
The statute of limitations in cases related to injuries associated with flawed or contaminated medical devices is normally one year. If negligence contributed to such an injury, the patient is eligible for financial compensation to cover both current and ongoing medical expenses, loss of wages and other issues, such as pain and suffering.