Healthcare information technology designed to improve patient care might also be the cause of six deaths and hundreds of “adverse events,” a development that’s prompted the Food & Drug Administration to consider regulating the industry, according to a report by the Huffington Post Investigative Fund.
The website obtained advance testimony from newly-minted Center for Devices and Radiological Health chief Jeffrey Shuren, calling for a closer look at whether software programs should face similar regulatory hurdles as medical devices. Shuren is slated to testify before the Health Information Technology Policy Committee Feb. 25.
Shuren said the FDA has received 260 reports of HIT-related adverse events over two years, including 44 reported injuries and six deaths, according to the Huffington Post.
“Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist,” Shuren wrote in prepared testimony posted on the website.
The reported events fell into four different categories, according to Shuren’s remarks: Errors involving the confusion of one patient’s records with another’s, or the mistaken combination of two patients’ medical files; the loss of information or the corruption of data; medication and/or dosing errors; and software incompatibility issues.
Some of the examples Shuren is expected to cite include incidents in which a patient’s profile for drug allergies failed to display properly or in some cases were overwritten due to a database error. Another example he’s expected to cite is operating room management software “locking up” during surgical procedures.
“The FDA recognizes the tremendous importance of HIT and its potential to improve patient care,” Shuren wrote. “However, in light of safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety.”
That framework could take several forms, such as requiring HIT companies to list their software and submit Medical Device Reports to the federal watchdogs detailing each reported adverse event (as is required of medical device manufacturers), forcing companies to adhere to Quality Systems Regulations and even requiring HIT manufacturers to pass the regulatory hurdles medical device companies are required to clear, including pre-market review.
The FDA does not enforce regulatory requirements for EMRs or other forms of HIT, though they are considered medical devices under the federal Food, Drug and Cosmetic Act.