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FDA Alerts Hospitals to Begin Reporting Digital Information Hazards

March 12, 2010
Written by: , Filed in: Practice Management
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The FDA is taking a closer look at the safety of health information technology and, toward that end, put together a network of 350 US hospitals last month to report hazards, according to an article in The Huffington Post Investigative Fund by Fred Schulte and Emma Schwartz.

As well as citing several recent specific glitches in computerized hospital equipment, the agency is responding, in part, to six deaths in two years that were caused by equipment malfunctions that the FDA’s Jeffrey Shuren said, “may represent the tip of the iceberg.” In one incident, a radiology workstation slowed down, which delayed therapy sessions and forced techs to repeat X-rays. Information technology staff later determined that the software had a flaw which surfaced when too many characters were typed in. In another hospital, operating room software often froze without any indication of doing so and left surgery data incomplete.

The FDA is asking that hospitals particularly note problems with laboratory, pharmacy radiology and anesthesia systems, as well as the growing number of digital patient records that will be made possible through stimulus money. Hospital staff members can alert the FDA through its Medical Product Surveillance Network, or MedSun, and the information will be placed on the FDA Web site.

Upholding its right to regulate medical technology, the agency rarely does so in practice, allowing for voluntary reporting. Past information came through its former data recording system, but it was seen as sporadic and not representational of the industry as a whole, though it did find two years of evidence of 260 potentially harmful occurrences, 44 injuries and the six deaths.

“The fundamental problem we have here is we’re dealing with an industry that really isn’t used to a transparent reporting of problems,” said Paul Egerman, co-chair of a government health information technology panel, as quoted in the article. “The more data we get – I view that as a valuable thing,” he said. His panel will go public with their findings in April.

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