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Key Agencies

The following federal agencies play a key role in reducing needlestick injuries. State agencies may have additional regulatory authority.

OSHA Occupational Safety and Health Administration

OSHA is the primary regulatory agency regarding needlestick prevention and recordkeeping. See: OSHA Program – “OSHA Regulatory Requirements” To find a local OSHA office, go to: http://www.osha.gov/html/RAmap.html or call the toll-free number: 1-800-321-OSHA TTY 1-877-889-5627

CDC Centers for Disease Control and Prevention

CDC develops national guidelines for the prevention and treatment of bloodborne pathogen diseases. In addition to the CDC Workbook on Sharps Prevention Injury, their website has post-exposure recommendations regarding HIV, HBV and HCV as well as other pathogens. Some key web pages include

CDC/NIOSH National Institute of Occupational Safety and Health

The NIOSH web page has well-researched documents related to bloodborne pathogens and needlestick prevention: “Bloodborne infectious diseases: HIV/AIDS, Hepatitis B, Hepatitis C“. Major, useful publications follow:

Additional information about ordering publications about needlestick injuries is available from NIOSH by callings call 800-35-NIOSH (1.800-356-4674).

FDA Food and Drug Administration

Medical devices with sharps injury prevention features

FDA issued a document, “Guidance for Industry and FDA Staff- Medical Devices with Sharps Injury Prevention Features.” on Aug. 9, 2005 (Download FDA Guidance – medical devices with sharps injury features)

A medical device with a “sharps injury prevention feature” is a device designed with a component or attachment that protects the user from a sharps injury. Although intended for manufacturers, these recommendations address important performance characteristics as listed below.

Type of FeatureeRecommendation
AllThe user should be able to easily tell whether the sharps injury prevention feature is activated.
AllOnce activated, the sharps injury prevention feature cannot be deactivated and should remain protective through disposal.
Active (i.e., feature requires activation by the user)It should be possible to activate the feature with a single- handed technique, allowing the user’s hands to remain behind the exposed sharp.
Needle shieldThe shield should completely enclose the needle and prevent finger access when activated.
Retractable sharpThe sharp should be fully retracted within the housing of the device.
Fixed recessed needleThe housing should extend beyond, i.e., fully cover the sharp and prevent finger access.
Colored feature or componentThe use of color should achieve a specific purpose, (e.g., differentiate device models or sizes) and conform with user conventions, (e.g., orange hubs and needle covers for insulin syringes).

FDA/CDRH Center for Devices and Radiological Health

Contact FDA regarding medical devices at CDRH by phone at 1-800-638-2041 or 301-796-7100, or visit their web site at:
http://www.fda.gov/MedicalDevices/default.htm.