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US FDA Alerts Healthcare Professionals Not To Share Insulin Pens & Cartridges

The US 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.

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 zinvolving 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, 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.

(Ref : Chronicle Pharmabiz dated March 21, 2009)

New Study Reconfirms Long-Term Strength Of Biodesign Hernia Graft

A five-year study confirms the long-term strength and durability of the Biodesign Hernia Graft, Cook Medical, a world leader in advanced tissue repair, announced.

The study, the largest published series with the longest follow-up time for a biologic mesh used in hernia repair, demonstrated that the Biodesign Hernia Graft possesses the clinically important strength of non-absorbable mesh, while providing the benefit of decreased infection complications of absorbable mesh.

"Biodesign's long-term strength and ability to communicate with the body by signalling surrounding tissue to remodel are very important benefits for patients," said Mark Bleyer, president of Cook Biotech. "The body uses the Biodesign graft as a lattice to guide tissue regeneration and heal itself with a repair that endures, as shown in the study."

Morris E Franklin of the Texas Endosurgery Institute, San Antonio, Texas, performed the study investigating the placement of biologic grafts to repair infected or potentially contaminated abdominal wall defects. Placement of the Biodesign Hernia Graft for incisional, umbilical, inguinal, femoral and parastomal hernias in potentially or grossly contaminated fields was thoroughly examined.

"The use of the Biodesign Hernia Graft in contaminated or potentially contaminated fields is a safe and feasible alternative to hernia repair with a minimal recurrence rate and satisfactory results in long-term follow-up," said Franklin.

From May 2000 to October 2006, 133 procedures were performed on 116 patients. The study results were published in Surgical Endoscopy, Volume 22, No 9, September 2008.

Manufactured in the Cook Biotech facility in West Lafayette, Indiana, Biodesign is a breakthrough technology that provides signals and support for the body to restore itself. It incorporates the best attributes of a biologic graft-complete remodelling and resistance to infection-yet it's easy to use, widely available and moderately priced.

Cook Medical was one of the first companies to help popularize interventional medicine, pioneering many of the devices now commonly used worldwide to perform minimally invasive medical procedures.

(Ref : Chronicle Pharmabiz dated March 24, 2009)

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