Needleless devices stick it to infections
Denver — Two medical products — a needleless injection device and a skin adhesive that replaces stitches — are part of a growing trend to reduce the contamination risk associated with needle use, according to the companies that developed the products.
Concern over needle stick injuries to healthcare professionals and others who come in contact with used needles has accelerated since the advent of the AIDS virus and spread of other blood-borne infectious diseases. The industry`s goal is to eliminate the use of needles, says Joe Barefoot, vice president of quality assurance and regulatory affairs for Closure Medical Corp. (Raleigh, NC), makers of the skin adhesive Dermabond.
Genesis Medical Technologies Inc. (Denver), developer of the needleless jet injector, wants to provide “a product to the world that avoids the needle stick nightmare of transmitting communicable diseases, and
makes needleless injection inexpensive and user friendly,” according to President Robert Jones.
The Genesis jet injector replaces traditional hypodermic needles and syringes for injecting medications and vaccines into subcutaneous or intramuscular tissue. It features a delivery device and a small plastic disposable vial that holds and delivers the medication. Held against a patient`s skin, the injector forces a fine stream of liquid medicine through a microscopic hole in the end of the vial. The fluid passes out of the vial at a high rate of speed and pierces the skin in a fraction of a second, almost painlessly, Jones says.
With no needle to invade body tissues, the jet injector reduces patient and healthcare workers` risk of needle stick injuries. It also eliminates the possibility of accidental contamination — and temptation for re-use, particularly in third world countries — because the vial self-destructs after one use. The delivery device, however, works for up to 200 inoculations.
In addition, the injector`s simple operation will allow patients, especially the elderly and children, to safely administer their own medications, Jones says. The device is particularly suitable for routine insulin injections, allergy shots and mass vaccinations.
In fact, the Ministry of Public Health in Havana, Cuba, is conducting a 6,000-person inoculation field test of the needleless jet injector for its national vaccination program. Results of the test will be used to make improvements on the injector prototype, which has not yet been marketed in the U.S.
But the Dermabond skin adhesive product, approved for use by the FDA last summer, is now being marketed to hospitals, emergency rooms, operating rooms and clinics by Ethicon Inc. (Somerville, NJ), a Johnson & Johnson company. It is the only liquid topical skin adhesive the FDA has approved.
The adhesive replaces sutures, staples or skin strips to close wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations.
After cleaning the wound, a physician holds the edges of the wound together and applies the sterile adhesive in several thin layers on top of the wound. It dries in less than one minute and reaches full strength within two and a half minutes. Healing typically occurs in five to 10 days, after which the adhesive sloughs off.
Dermabond, which uses the chemical compound octyl cyanoacrylate, was developed primarily as a better method for wound closure, but needle stick injury concerns also played a role in its development, Barefoot says.
Although it is difficult to quantify needle stick injuries, the Centers for Disease Control and Prevention reported a 1 percent to 15 percent rate of needle stick injuries in surgical procedures, according to Barefoot. Those rates are mostly related to physicians putting the suture needle into their own hand. There is also a reported 6 percent to 8 percent rate of infection associated with the use of sutures and staples, Barefoot says.
“Most of that infection resulted from contamination entering the wound prior to treatment. But we know that when you make a hole, you are creating another route for bacterial ingress. With Dermabond, you are not making those punctures in the skin, so you are reducing the number of routes for contamination to move below the skin and cause an infection,” he says.