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FDA Issues Injectable Pen Warning

Mar 20, 2009 | Parker Waichman LLP
Injectable Insulin Pen

U.S FDA Issued an Alert to Health Care Professional Reminding them that Single-Patient Insulin Pens should not be used to administer medication

The U.S. Food and Drug Administration (FDA) just issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients because of the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses.

The FDA explained that insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge.  Insulin pens typically contain sufficient insulin for one patient to self-administer several doses of insulin before the reservoir or cartridge is empty.  The FDA stressed that all insulin pens are approved only for single-patient use; in other words, just one device per patient.

The FDA is aware of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens were used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.  “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.”

Patients Exposed to Shared Insulin Pens are being Contracted by Two Hospitals

Patients exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV, said the FDA. Some of the potentially exposed patients have reportedly tested positive for the hepatitis c virus, although it is not known if the virus was spread as a result of insulin pen sharing.  The FDA is working with the Centers for Disease Control and Prevention (CDC) and professional organizations to address infection control issues related to insulin pens.

Meanwhile, Army officials confirmed in earlier, separate reports revealed that that 16 patients have tested positive for hepatitis b (HBV) and hepatitis c (HBC).  The Associated Press (AP) reported that the Army said the patients were likely exposed to the dangerous blood-borne illnesses because of improper injection practices.

The 16 patients at the William Beaumont Army Medical Center were just some of the over 2,000 diabetics who might have been exposed HBV and HBC and other blood borne illnesses, said the AP.  It seems that multiple patients were administered injections from the same insulin pen, it noted.  Smart Brief said that, according to the El Paso Times, the insulin pens were injected into multiples patients from August 2007 until the end of January.  Journal Now said the program “systematically” injected multiple patients from the same pen; Lieutenant Colonel Sandy LaFon said that it remains unclear if the HBV and HBC infections originated from the shoddy injections or if there were previously undiagnosed infections.

Earlier this year, the CDC announced that, based on its decade-long review, over 60,000 patients have been placed at risk for potentially deadly, blood-borne infectious diseases.  According to the CDC, over the past 10 years, tens of thousands of American patients have been asked to undergo HBV and HCV testing because proper infection control practices were not followed.

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