Thousands of patients at two military hospitals are being notified that they may have been exposed to blood-borne pathogens that could cause diseases like hepatitis and HIV, as a result of sharing insulin pens and insulin cartridges which are only meant for single-patient use.
Although insulin pens may contain enough insulin for several rounds of injection by self-administration, the FDA has issued a health alert warning against the sharing of the devices, as they are only approved for use with one patient per device.
Even if the needles are changed between patients, it is not safe to share the insulin pens or insulin cartridges. Blood-borne pathogens, such as HIV and the hepatitis viruses, may contaminate the reservoir after the injection, before the needle is changed. This may expose the second user to a risk of serious and potentially life-threatening infection.
In a Medwatch alert and press release issued March 19, 2009, the FDA indicated that they have become aware of at least two hospitals in the United States who were using the cartridge of insulin pens to administer insulin to more than one patient.
Between August 2007 and January 2009, at least 2,114 patients at the William Beaumont Army Medical Center in El Paso, Texas may have been exposed to a risk of hepatitis, HIV or other disease transmitted through the blood.
A subsequent review of procedures at all Army medical centers found that 15 patients at Bayne-Jones Army Community Hospital at Fort Polk, Louisiana, may have also been potentially affected.
“Insulin pens are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection,” said Amy Egan, M.D., deputy director of safety at the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research. “Insulin pens are not designed, and are not safe, for one pen to be used by more than one patient, even if needles are changed between patients due to the risk of transmitting blood-borne pathogens.”
The patients exposed to shared insulin pens at the two hospitals are being contacted and offered free testing for hepatitis and HIV. An unspecified number of the exposed patients have reported positive for hepatitis C virus, but the FDA indicates that it is not known whether the virus was spread from the hospital sharing insulin pens.
The FDA indicated that they are working with the Centers for Disease Control and Prevention (CDC), as well as professional societies and healthcare organizations to make sure that both patients and doctors are properly educated about the safe use of insulin pens.
Last month, over 8,000 patients who received a colonoscopy at VA clinics in Tennessee and Georgia between April 23, 2003 and December 1, 2009 were notified that they may have been exposed to a risk of infection due to a valve in the equipment which may not have been connected properly and tubing attached to the colonoscope that may not have been changed properly between patients.