Important Information about Sharps Safety

Legislation Background:

1991 - OSHA publishes Occupational Exposure to Bloodborne Pathogens standard
2000 - Congress passes the Needlestick Safety & Prevention Act
2001 - OSHA issues revision to Bloodborne Pathogens Standard

2001 OSHA Revisions:

• Requires health care employers to document in their exposure control plan that they have evaluated and implemented safety-engineered sharp devices and needleless systems in order to reduce employees' occupational exposure to HIV, hepatitis C and other bloodborne diseases.
• Requires that exposure control plans be reviewed and updated at least annually to reflect changes in sharps safety technology.
• Requires each health care facility to maintain a sharps injury log with detailed information on percutaneous injuries (including type and brand of device involved in exposure incident, department where exposure occurred and an explanation of how it occurred).
• Requires employers to solicit input from non-managerial health care workers when identifying, evaluating and selecting safety-engineered sharp devices, and to document this process in the exposure control plan.
• Expands the definition of "engineering controls" to include devices with engineered sharps injury protection.

1. Which health care facilities must comply with the regulations?

Any facility under federal OSHA regulations (i.e., hospitals, surgery centers, laboratories, and physician offices) where employees may be exposed to blood or other potentially infectious materials.

2. What if my state has its own OSHA plan?

State regulations must be "at least as effective/protective" as federal laws.

3. Doesn't the regulation primarily address needles and not knives?

The OSHA revised standard defines Engineering Controls as "controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace."

4. Under what circumstances may I choose not to employ a sharps safety device?

Only in the event the safety device comprises patient, staff or user safety or unduly interferes with the medical procedure; or if a device is not commercially available. Otherwise, where engineering controls are commercially available and feasible, they must be used.

5. What documentation is required if my site chooses not to employ sharps safety devices?

Regulations require that employers "document annually" the consideration and implementation of appropriate commercially available and effective safer medical devices. A site must specifically address the non-use of a sharps safety device in its Exposure Control Plan.

6. How is the use of standard sharps devices included in pre-packaged procedural packs interpreted by sharps safety regulations?

Employers must implement the use of "safety-engineered devices" or sharps with engineered sharps injury protection when performing medical procedures with sharps, regardless how they are packaged or supplied. If, during surgical procedures, physician specialists or other healthcare personnel are using medical instruments supplied in pre-packaged kits, those packages must include engineering controls appropriate for the specific procedures being performed.

7. What are the penalties for non compliance?

OSHA inspectors conduct on-site inspections to document compliance with federal regulations. A willful or repeated violation may result in a penalty of up to $70,000; there is a minimum penalty of $5,000 for willful violations.

8. Where can I find additional information?

www.osha.gov
www.cdc.gov/sharpssafety
www.cdc.gov/niosh
www.needlestick.org
www.sharpoint.com

Sources:

Revision to OSHA's Bloodborne Pathogens Standard
Technical Background and Summary, April 2001, http://www.osha.gov/needlesticks/needlefact.html

The Needlestick Safety and Prevention Act (HR 5178): What Does It Require?
Gina Pugliese, R.N., M.S. & Jane Perry, M.A.

OSHA Frequently Asked Questions, http://www.osha.gov/needlesticks/needlefaq.html

OSHA Standard Interpretations, 09/01/2004 correspondence; Limiting factors for implementing the use of engineering controls, i.e., safety scalpels, under the Bloodborne Pathogens standard.

OSHA Standard Interpretations, 02/20/2003 correspondence; Needlestick Safety and Prevention Act and the requirement to include safety-engineered sharps devices in pre-packaged surgical kits or trays.

Document should be used only as a guideline, not a measure of compliance with federal, state or local law or regulation.