Device makers face no requirements for safety

Mandate applies to employers, not manufacturers

Why do manufacturers sell devices that employers can't legally use?

That was a question that arose when Novartis Vaccines shipped pre-filled flu vaccine syringes with a fixed, conventional needle. After all, the syringes have no other use than injection into patients, and there are acceptable alternatives. The U.S. Occupational Safety and Health Administration requires employers to use safety-engineered sharps, as mandated by the Needlestick Safety and Prevention Act of 2000, unless the activity poses no risk of bloodborne pathogen exposure (as in a pharmacy) or there is a medical necessity to use a conventional device.

"It's the employers' responsibility to make sure these devices are purchased with engineered sharps protection," says Robert Harrison, MD, MPH, professor of occupational medicine at the University of California San Francisco. "The only exception is where these engineered sharps devices are not available on the market or cannot be used because of patient safety."

"The OSHA standard put the responsibility on the employer. The employers can only get so far in tackling this issue own their own," says Angela K. Laramie, MPH, epidemiologist with the Sharps Injury Surveillance Project in the Massachusetts Department of Public Health in Boston.

Yet employers can't expect any assistance from the Food and Drug Administration. When the FDA approves medical devices for "safety and efficacy," it considers those issues only as they relate to patients, not workers. (A spokesperson for the FDA could not be reached for comment.)

In 2000, the advocacy group Public Citizen and the Service Employees International Union (SEIU) petitioned the FDA to ban certain "unsafe devices," including glass capillary tubes. The FDA, National Institute for Occupational Safety and Health, and U.S. Occupational Safety and Health Administration had issued a joint alert in 1999 cautioning against using the glass capillary tubes because of the risk of breaking.

In 2005, the FDA rejected the petition, noting the lack of data on specific devices that cause needlesticks. "In the absence of such information about specific devices, FDA was unable to conclude that any particular device presented a 'substantial deception or an unreasonable and substantial risk of illness or injury.'" Instead, the FDA focused on the need for education about safety devices.

The Sharps Injury Surveillance Project in the Massachusetts Department of Public Health is collecting information on sharps injuries by brand and type of device, but that information has not yet been analyzed. In the meantime, Harrison and others have called for greater FDA involvement in ensuring the safety of sharps devices for workers.

Other agencies could help guide employers and manufacturers by providing voluntary design standards, Harrison says. "This would be a benchmark that purchasers could use," he says. "The consumer has to have a way to evaluate those devices."

Buyer be wary - and demand safety

Currently, manufacturers have been influenced by customer demand. While some employers seek the cheapest device, the market clearly has created new innovation and a focus on safety. In 2003, BD of Franklin Lakes, NJ, discontinued sales of some conventional devices, citing U.S. progress in converting from conventional to safety products.

The TDICT (Training for Development of Innovative Control Technologies) Project in San Francisco developed user-based criteria checklists for device evaluation and selection, and those device-specific documents became de facto benchmarks that many manufacturers used in designing new products, says director June M. Fisher, MD.

Fisher and other sharps safety experts have hesitated calling for manufacturing criteria for devices because they don't want to stifle innovation into new and better designs. However, user-based criteria should be established to act as broad benchmarks for the industry, she says.

The FDA published criteria in a 1992 that said sharps safety devices should: provide a barrier between the hands and needles after use; allow or require the worker's hands to remain behind the needle at all times; be an integral part of the device, and not an accessory; and be in effect before disassembly, if any, and remain in effect after disposal. The safety alert also said the device should be simple and easy to use and require little training.

The FDA should move beyond just making recommendations, says Fisher. "I would like to see FDA look not only at patient safety, but at worker and community safety," she says. "And that should be in their mission."