- OSHA Occupational Safety and Health Administration
- CDC Centers for Disease Control and Prevention
- CDC/NIOSH National Institute of Occupational Safety and Health
- FDA Food and Drug Administration - Medical devices
- FDA/CDRH Center for Devices and Radiological Health
The following federal agencies play a key role in reducing needlestick injuries. State agencies may have additional regulatory authority.
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 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, and a links to National Clinician's Consultation Center's Hotline. Some key web pages include
- HIV in the United States A fact sheet providing the latest data on HIV transmission and includes training materials such as slide presentations.
- Recommendations and guidelines for HIV/AIDS Management of occupational exposures to HIV and recommendations for post exposure prophylaxis.
- Healthcare settings and viral hepatitis Provides information specifically about hepatitis in healthcare settings and includes a link to various state requirements. This site also offers specific HBV instructions.
- HCV specific information for healthcare professionals
- MMWR Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease Although these guidelines are from 1998 they include an analysis of the risk for HCV transmission by a needlestick from a HCV positive patient and specific categories of workers who are at increased risk.
- Hepatitis C FAQs for health professionals includes a description of statistics for HCV and information about testing and diagnosis.
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:
- Resources for employers complying with OSHA's Bloodborne Pathogens Standard will be helpful for those just getting started.
- Preventing needlestick injuries in healthcare settings provides scientific information about the risk of needlestick injury and the transmission of bloodborne pathogens to healthcare workers. The document focuses on needlestick injuries as a key element in a broader effort to prevent all sharps-related injuries and associated bloodborne infections. The alert describes an approach for evaluating these devices.
- Engineering controls and personal protective equipment gives examples of new technologies for needlestick reduction.
- Selecting, evaluating, and using sharps disposal containers DHHS (NIOSH) Publication No. 97-111, January 1998. This document presents a comprehensive framework for selecting sharps disposal containers and evaluating their efficacy as part of an overall needlestick injury prevention plan
Additional information about ordering publications about needlestick injuries is available from NIOSH by callings call 800-35-NIOSH (1.800-356-4674).
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 Featuree||Recommendation|
|All||The user should be able to easily tell whether the sharps injury prevention feature is activated.|
|All||Once 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 shield||The shield should completely enclose the needle and prevent finger access when activated.|
|Retractable sharp||The sharp should be fully retracted within the housing of the device.|
|Fixed recessed needle||The housing should extend beyond, i.e., fully cover the sharp and prevent finger access.|
|Colored feature or component||The 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).|
Information on medical device safety alerts and reporting of problems with medical devices is available at the FDA web site: http://www.fda.gov/cdrh/. 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.