August 2003 Bulletin

Be aware of existing federal regulations on safer sharps

Orthopaedic practices must comply with OSHA regulations

By Daniel H. Sung, JD

In November 2000, a federal needle-safety law was enacted to reduce the risk to health care workers from accidental needlesticks. The law directed the Occupational Safety and Health Administration (OSHA) to amend its existing regulations under the Bloodborne Pathogen Standard. On April 2001, a revised set OSHA regulations regarding needlesticks became effective and included three important new requirements.

Under the revised regulations, each covered employer still must maintain an exposure control plan that addresses how the worksite limits exposure to bloodborne pathogens. The exposure control plan must be reviewed annually and should contain detailed instructions on exposure determinations, engineering and work practice controls, post-exposure evaluation and follow-up and record-keeping.

Three new requirements

The new regulations include requirements that detail the engineering controls that must be used to reduce or eliminate health care worker exposure to any bloodborne pathogens. In particular, employers must now demonstrate that their exposure control plan includes a process to evaluate and implement safer sharps devices. Employers also must take into account innovations in medical procedures and technological developments that reduce the risk of exposure. OSHA states that newer, safer sharps devices can significantly reduce the risk of needlesticks and the chance of contracting deadly bloodborne diseases.

The second major change to the regulations requires employers to document the involvement of non-managerial health care workers in evaluating and choosing safer sharps devices. This requirement ensures that health care workers who actually use these devices have the opportunity to participate in purchasing decisions.

Finally, employers must show that they have established and maintained a sharps- injury log for recording injuries from contaminated sharps. This additional recordkeeping requirement ensures that employers and employees can accurately track all needlestick injuries. The log will assist in identifying problems areas or operations in the workplace.

OSHA's revised regulations apply to all worksites with employees who have occupational exposure to blood or other potentially infections materials, regardless of how many workers are employed. However, workplaces with 10 or fewer employees are exempt from OSHA requirements on record keeping and from recording and maintaining a sharps-injury log. All other applicable provisions of the Bloodborne Pathogens Standard still apply.

An estimated 600,000 to 800,000 needlestick injuries occur yearly in all health care settings. Needlestick injuries expose health care workers to serious and potentially fatal bloodborne pathogens such as Hepatitis B, Hepatitis C and HIV. A study by the Centers for Disease Control and Prevention estimates that 62 percent to 88 percent of needlestick injuries can be prevented by the use of safer sharps devices.

Enforcement of the revised regulations began in July 2001 and is ongoing. Therefore, it is important for orthopaedic practices to be aware of all the requirements and to make sure they are currently in compliance with all applicable provisions of the revised regulations.

OSHA has detailed evaluation, compliance and training materials available on its Web site. Visit for more information on this issue.

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