The Food and Drug Administration (FDA) has launched a new Web site that will benefit current and potential users of hearing aids.
FDA regulates hearing aids, which it defines as sound-amplifying devices designed to aid people who have impaired hearing.
"People who already use a hearing aid know that selecting the right one is not a simple process," says Eric Mann, M.D., Ph.D., deputy director of FDA's Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices. "There are many issues...
Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically hold 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). They are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection.
Why has FDA issued this alert?
FDA knows of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens was used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.
Who has been affected by these incidents?
Patients who have been 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's not known if the virus was spread as a result of insulin pen sharing.
FDA, the Centers for Disease Control and Prevention, and professional organizations are working to address infection control issues related to insulin pens.