Blood-Borne Disease : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

FDA applied this principle in April 1992 when it issued a safety alert to hospitals, advising against the use of exposed hypodermic needles to connect two pieces of IV equipment, a practice known as "piggybacking." In one research study, this practice caused half of all the needlestick injuries at a university medical center.

The agency recommended that hospitals use devices with recessed needles, or no needles at all, to connect IV equipment. Such devices are among the more than 50 products with features designed to prevent needlestick injuries that have so far been cleared for marketing by FDA.

In addition to IV connectors, these devices include needle guards, sheathed syringes, needle-recapping products, blood-drawing devices, IV catheters, and needleless injection devices. Pilot studies conducted at 10 hospitals in New York state in 1990 and 1991 found that needlestick injuries declined in a range of from 75 to 94 percent in the hospitals using these preventive devices.

Preventive devices fall broadly into two categories: those providing "passive," or automatic, protection, and those with a safety mechanism that must be activated by the user. Several studies have found that devices providing passive protection are both more effective and more acceptable to health-care workers than those that require the user to activate the safety feature.

FDA Eyeing New Devices

While FDA is encouraging manufacturers to develop more devices designed to prevent needlesticks, the agency is also concerned that such products meet the same standards of patient safety and effectiveness as those already on the market.

"We need to ensure that in providing these safer devices we don't degrade quality of care for the patient," says Tim Ulatowski, associate director for general devices in CDRH's Office of Device Evaluation. "For example, a needleless IV connector is undoubtedly safer for the user, but it may also present an increased risk of infection to the patient."

For this reason, FDA can — and frequently does — order trials of new preventive devices in patient-care settings before clearing them for marketing.

Sharp devices designed with safety in mind may be significantly different in appearance from their traditional counterparts. According to Linda Chiarello of the New York state health department, some patients were taken aback when they saw a passive protective needle that was being used to give injections at a hospital participating in the state's pilot studies of safer sharp devices.

"This needle is about twice as long as a traditional needle because it has a protective housing that retracts as the needle is injected. Nurses, as well as patients, were intimidated by the sight of this needle because it was so much larger than an ordinary needle."

As both a regulatory and a public health agency, FDA has a strong interest in promoting the development of new technologies that protect both health-care workers and their patients from injury, says Arrowsmith-Lowe. Together with the Occupational Safety and Health Administration and CDC, FDA cosponsored a conference held in Washington, D.C., last August on preventing device-mediated blood-borne infections.

The purpose of the three-day meeting, which brought together scientists, government officials, device manufacturers, hospital administrators, and health-care workers, was to draw attention to the toll taken by needlestick injuries and encourage the adoption of safer sharps technology.

"There is a revolution in device design going on," says Arrowsmith-Lowe, "and I'm confident the result will be a significant reduction in the risk faced by clinicians — as well as by patients — of contracting blood-borne infections in the health-care setting." n

Preventing the spread of blood-borne infections among health-care workers and their patients means preventing exposure to infected blood or body fluids, coupled with strict sterilization and disinfection procedures for reusable devices.

Using precautions when caring for known infected individuals isn't enough, because people can carry HBV or HIV infection without being aware of it or showing symptoms.

Since 1987, therefore, the national Centers for Disease Control and Prevention, the federal agency responsible for monitoring and controlling infectious disease in the United States, has recommended the use of "universal precautions" to prevent the spread of HBV, HIV, and other blood- borne infections in health-care settings.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.