Hospitals in the U.S. are the envy of much of the world. Billions of dollars are spent every year acquiring and upgrading technology in hospitals. These devices range from million dollar MRIs to thermometers costing a couple of dollars. And while the Food and Drug Administration (FDA) requires clinical tests for drugs before they are approved for general medical use, medical devices need no such testing.
If you have been in a hospital and had an IV, you may have experienced an Infusomat, which regulates the flow of fluids and drugs into the IV. A man in a VA hospital in Seattle died last year after the hospital used an infusomat that had been subject to a “Class 1” recall.
While the reason for the recall did not seem to be connected with the cause of his death, investigators were unable to determine why the device malfunctioned and killed him. Clearly, it was negligence, but who was responsible?
The man suffered from throat cancer and was receiving a morphine drip to control his pain. At some point during the night, the infusomat went into “free flow,” where the morphine pours uncontrolled into the man’s vein. He received 10 times the prescribed dose of the drug and died within minutes.
The device had been recalled by the manufacturer, and while “urgent recalls” have to be done in a “timely matter” they do not have to be done immediately. The manufacturer’s trainer told the hospital’s nurses they could use the device with care, until the correction arrived.
The FDA does not specifically indicate how quickly a recalled device must be pulled from use, and the recall on this infusomat involved a plastic clip that could break, but the device that killed this patient did not have a broken clip.
The partner of the man who died recalled that when the nurses set up his morphine drip, they had problems, and she remarked that their behavior “did not inspire confidence.” Sadly, there are many aspects of the regulation of medical devices, their approval and their recalls, that lead one to have that very thought.
Source: KUOW.ORG, “How A Recalled Medical Device Killed A Vet At Seattle’s VA Hospital,” John Ryan, Dec. 5, 2013