Warning! OSHA is zeroing in on regs for needlestick injury: How to comply

You’ll need a system to evaluate and purchase safer needle devices

(Editor’s note: This is the first of a two-part series on needlesticks and the emergency department. This month, we cover how to comply with needlestick prevention regulations. Next month, we’ll cover prevention of needlestick injuries and reporting requirements.)

Karen Daley, RN, MPH, was an ED nurse at Brigham and Women’s Hospital in Boston — until her career was cut short by a needlestick injury that resulted in her infection with HIV and hepatitis C. In 1998, Daley was drawing blood from an elderly patient with dementia. She turned to dispose of the butterfly needle in the sharps container and suddenly felt a stinging pain.

Daley was stuck on the finger by another needle that had become wedged in the container’s hinged opening. If a safer system had been in place, the injury would not have occurred, she contends.

"The injury did not have to happen, and would not have happened, if a safer system had been in place in my work setting," says Daley, now president of the Canton-based Massachusetts Nurses Association.

A 1999 compliance directive from the Washington, DC-based Occupational Safety and Health Administration (OSHA) aims to ensure that EDs and other hospital departments take specific steps to prevent tragic injuries like Daley’s. If your ED doesn’t have a system in place to evaluate and purchase safer needle devices, your hospital could be fined $7,000 for serious violations and $70,000 for willful violations.

Although the 1991 Bloodborne Pathogens Standard required hospitals to use safer needle devices, the regulations weren’t enforced because few products were available at that time. Currently, the FDA has approved more than 250 safer needle devices, and your ED is required to evaluate and purchase them, says Daley. "It is clear that using these devices offers the most effective protection against needlestick injuries," she says.

The Nov. 5, 1999, directive instructs inspectors to cite hospitals for failure to evaluate and purchase safer needle devices and reflects an expanded interpretation of the 1991 Bloodborne Pathogens Standard, Daley explains.

"Several major changes are articulated within this compliance document," she says. "It is based on the feedback OSHA received from more than 300 hospital employers in response to its request for information."

A new federal law amends the existing Bloodborne Pathogens Standard to require the use of safer devices to protect individuals from sharps injuries, Daley reports. It also requires that employers solicit the input of direct patient care employees who are potentially exposed to sharps injuries in the identification, evaluation, and selection of safer devices, she says.  

The OSHA directive requires you to do the following:

• Evaluate and purchase safer needle devices.

• Review your exposure control program annually, and update it if it is shown to be ineffective.

• Recognize hepatitis C as a unique pathogen, separate from hepatitis B (previously identified as non-A, non-B hepatitis), which you must routinely test for in all source patients and in follow-up lab testing of employees.

• Provide "interactive" education/training to employees regarding device use.

Here’s what you’ll need to do to comply with the OSHA directive:

Be on the lookout for better, safer products.

Continuously evaluate the latest devices, urges Daley. "That doesn’t mean only buying devices from manufacturers under contract, but also other devices which best meet staff needs," she says. You need to have a system for ongoing product evaluation, advises Daley. "It is not a one-shot deal," she says. "The reality is there are over 250 FDA-approved devices on the market."

Contact manufacturers to see what options are available for clinical evaluations, says Robyn Silverman, project officer for ECRI’s Health Devices Group, a nonprofit health services research agency in Plymouth Meeting, PA. "Bring in devices and have the staff use them clinically. Then report on their use by filling out evaluation forms," she advises. 

Use guides to select products for evaluation.

Because there are hundreds of devices available, refer to independent evaluations, such as ECRI’s Needlestick Prevention Device Selection Guide, to narrow down the number of devices you try, suggests Silverman. (See resources at end of article for ordering information.)

Have staff answer the following questions about new products, Silverman recommends:

— Is the device easy to use?

— Does the device minimize the risk of a needlestick injury during and after use and during and after disposal?

— Is the safety mechanism reliable?

— Is the device compatible with other devices used?

Consider issues specific to the ED when choosing devices, Silverman advises. When beginning to implement use of these devices, consider what types of sharps are commonly used in the ED and in what procedures most needlestick injuries occur, she says. For example, many EDs do a significant amount of blood drawing, so they would need safety devices designated for blood collection.

Provide "interactive" education.

The OSHA directive requires you to provide "interactive" education and training to employees, says Daley. "You’ll need to offer appropriate education, training, and support for converting systems in the ED," she explains. "That means you can’t simply send employees off to view another video."

Education should include an in-person demonstration, a hands-on practice session, question-and-answer sessions, and review of policies, says Daley. "It does take time to adapt," she notes.

Encourage staff to be fully comfortable with the new device before actually using it on a patient, recommends Vicki Cadwell, RN, MS, CEN, CCRN, MICN, the ED educator at St. Jude Medical Center in Fullerton, CA.

"I suggest that they look at it, play with it, and get to know it before using it for the first time," she says. "I ask them to look at safety features very closely."

It’s also important that vendor representatives are available to do "train the trainer" sessions for key staff members in your ED, Daley says. "These individuals will act as an ongoing resource for staff as they develop comfort levels with new products," she notes.

A "train the trainer" model with key individuals designated on each unit also promotes ongoing communication, says Daley. Designate senior employees to serve as a resource for less experienced staff as devices are trialed or newly adopted, says Daley. "Your employees will tell you if the devices meet their needs. Listen to them," she advises.

Vendor representatives can provide extra training to designated staff on all shifts who can then serve as "experts," says Cadwell.

Having experts available around the clock to assist staff with the new device will reduce anxiety, she says. "They can be the ED manager, educator, charge nurses, or staff nurses who have demonstrated a positive attitude toward the change to the new device, as well as being able to both use it and teach its use," Cadwell says. "By having peers as experts, staff are more likely to ask questions because they are more approachable." 


For more information about the compliance directive, contact:

Vicki Cadwell, RN, MS, CEN, CCRN, MICN, Educator, Emergency Department, St. Jude Medical Center, 101 E. Valencia Mesa, Fullerton, CA 92835. Telephone: (714) 992-3979. E-mail: vcadwell@sjf.stjoe.org.

Karen Daley, RN, MPH, Massachusetts Nurses Association, 340 Turnpike St., Canton, MA 02021. Telephone: (781) 821-4625, ext. 780. Fax: (781) 821-4445. E-mail: kdmna@email.msn.com.

Robyn Silverman, Project Officer, Health Devices Group, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298. Telephone: (610) 825-6000, ext. 5209. Fax: (610) 834-1275. E-mail: rsilverman@ecri.org.

Single copies of the Occupational Safety and Health Administration (OSHA) Compliance Directive, Enforcement Proceedings for Occupational Exposure to Bloodborne Pathogens, are available at no charge. Go to www.osha-slc.gov/OshDoc/Directive_pdf/. Click on CPL 2.2-44D. Or contact: OSHA, Publications Office, Room N3101, 200 Constitution Ave. NW, Washington, DC 20210. Telephone: (202) 693-1888. Fax: (202) 693-2498.

Free single copies of a publication titled NIOSH Guidelines for Selecting, Evaluating, and Using Sharps Disposal Containers (Pub. 97-111) can be ordered by contacting: NIOSH Publications, 4676 Columbia Parkway, Mailstop C13, Cincinnati, OH 45226. Telephone: (800) 35NIOSH. Fax: (800) 513-533-8573. Web: www.cdc.gov./niosh.

You can find the latest update on needlestick legislation from the American Nursing Association’s Web site (www.nursingworld.org). Click on "Needlestick.org" first, and then go to "Legislation."

The Emergency Nurses Association (ENA) has a position statement titled Bloodborne Infectious Diseases. Single copies of position statements are available at no charge. All ENA position statements can be accessed from the ENA web site: www.ena.org. Click on "Programs and Meetings" first, and then "Position Statements." Or to obtain copies, contact: Emergency Nurses Association, 915 Lee St., Des Plaines, IL 60016. Telephone: (800) 243-8362 or (847) 460-4000. Fax: (847) 460-4001.

ECRI has evaluated 49 needlestick prevention devices, including blood collection needles and tube holders, blood collection needle sets, disposable syringes, needleless IV connectors, IV catheters, drug vial adapters, and hemodialysis needle sets. All of these devices are included in a report titled Health Devices Needlestick Prevention Device Selection Guide: An ECRI Resource for Complying with Safer Needle Regulations. The report includes a cost analysis, health care worker evaluation form, and information on the OSHA compliance directive. The cost is $295, plus $10.25 shipping. To order a copy, contact: Brian Duffin, Membership Services, ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462. Telephone: (610) 825-6000, ext. 5414. Fax: (610) 834-1275. E-mail: BDuffin@ECRI.org.