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Diabetes Disaster #68: FDA ALERT — Insulin Pen Sharing

Insulin Pens and Insulin Cartridges Must Not Be Shared. The U.S. Food and Drug Administration 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 due to the potential risk of transmitting blood-borne pathogens such as HIV and the hepatitis viruses….

Due to a growing number of reports about improper use of insulin pens, the U.S. Centers for Disease Control and Prevention has issued a reminder that the devices must never be used on more than one person, even with the use of a new needle.

Using insulin pens on more than one person puts people at risk for infection with blood-borne pathogens such as hepatitis viruses and HIV, which causes AIDS, the agency warns. Infection can occur even if an insulin pen’s needle is changed.

Insulin pens are injector devices that contain a reservoir for insulin or an insulin cartridge. They’re designed to enable patients to self-inject insulin and are intended for single-person use.

Reports of improper use of insulin pens in hospitals led the FDA in 2009 to issue an alert for health care professionals to remind them that insulin pens are for use on a single patient only. Despite the alert, there have been continuing reports of patients put at risk through inappropriate reuse and sharing of insulin pens, including an incident last year that required notification of more than 2,000 potentially exposed patients, the CDC said.

In the new clinical reminder, the CDC says:
  • Insulin pens containing multiple doses of insulin are meant for use on a single patient only, and should never be used for more than one person, even when the needle is changed.
  • Insulin pens should be clearly labeled with the patient’s name or other identifying information to ensure that the correct insulin pen is used only on the correct patient.
  • Hospitals and other facilities should review their policies and educate staff regarding safe use of insulin pens and similar devices.
  • If re-use of an insulin pen occurs, exposed patients should receive immediate notification and be offered appropriate follow-up, including blood-borne pathogen testing.

The recommendations apply to any setting where insulin pens are used, including health care facilities, assisted living or residential care facilities, health fairs, shelters, detention centers, senior centers, schools and camps, the CDC said.

Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically contain enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty. All insulin pens are approved only for single-patient use (one device for only one 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 contacted by the two hospitals and are being offered testing for hepatitis and HIV. 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 and professional organizations to address infection control issues related to insulin pens.

For more information on the alert: Reuse of insulin pen for multiple patients risks transmission of bloodborne disease or just go to: ISMP.org.

Courtesy ISMP

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