Draft:Needlestick Safety and Prevention Act
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| Long title | An Act to require the Occupational Safety and Health Administration to revise the bloodborne pathogens standard to reduce needlestick and other sharps injuries. |
|---|---|
| Acronyms (colloquial) | NSPA |
| Enacted by | the 106th United States Congress |
| Effective | November 6, 2000 |
| Citations | |
| Public law | Pub. L. 106–430 (text) (PDF) |
| Statutes at Large | 114 Stat. 1901 |
| Legislative history | |
| |
The Needlestick Safety and Prevention Act (NSPA) is a United States federal law that required updates to the OSHA Bloodborne Pathogens Standard to address injuries from contaminated needles and other sharps in healthcare settings. Enacted on November 6, 2000, the law directed OSHA to revise 29 CFR 1910.1030 to reflect advances in safety technology, require annual documentation of safer device evaluation and implementation, involve non-managerial workers in device selection, and maintain a sharps injury log.[1][2]
Background
[edit]Percutaneous injuries from contaminated sharps can transmit HIV, Hepatitis B, and Hepatitis C to healthcare workers. OSHA first issued its Bloodborne Pathogens Standard in 1991. By 2000, Congress found that an estimated 380,000 percutaneous injuries occurred annually among U.S. hospital workers, and 600,000–800,000 across all healthcare settings, with newer safety-engineered devices capable of preventing 62–88% of injuries depending on device and procedure.[1] In the late 1990s, several U.S. states—beginning with California in 1998—adopted needle safety requirements, creating momentum for federal action.[3][4]
Legislative history
[edit]The Act was introduced in the U.S. House of Representatives as H.R. 5178 by Rep. Cass Ballenger (R–NC) on September 14, 2000. It passed the House by voice vote on October 3, 2000, passed the Senate by unanimous consent on October 26, 2000, and was signed by President Bill Clinton on November 6, 2000, becoming Pub. L. 106–430 (text) (PDF) (114 Stat. 1901).[5][1]
Provisions
[edit]The law required OSHA to revise the Bloodborne Pathogens Standard within six months and specified several substantive changes that took effect 90 days after publication:[1][2]
- Broadened definitions of engineering controls to explicitly include safer medical devices, such as needleless systems and sharps with engineered sharps injury protections (SESIPs). It added definitions of those terms at 29 CFR 1910.1030(b).[1]
- Exposure Control Plan updates: employers must annually document consideration and implementation of appropriate, commercially available safer devices and reflect technology changes that reduce exposure.[1]
- Employee involvement: employers must solicit input from non-managerial employees responsible for direct patient care when identifying, evaluating, and selecting engineering and work-practice controls, and document that process.[1]
- Sharps injury log: employers required to keep OSHA injury and illness records must maintain a confidential log recording at minimum the type and brand of device, department/work area, and how the incident occurred.[1]
OSHA published the revisions on January 18, 2001; they became enforceable on April 18, 2001.[2]
Implementation
[edit]OSHA issued compliance materials and clarified that state OSHA plans must adopt standards at least as effective as the federal standard, including the new sharps-injury log and worker-input requirements.[6] OSHA also published technical background documents summarizing the definitional and recordkeeping changes.[7]
Effects and impact
[edit]Early evaluations and subsequent surveillance suggest mixed but substantial effects:
- In nonsurgical settings, sharps injuries declined by about 31.6% in the five years following enactment, while injuries in surgical settings increased 6.5%—reflecting different device mixes and practices in operating rooms.[8]
- National and state surveillance (e.g., EPINet and Massachusetts reports) show ongoing injuries despite adoption of safety-engineered devices, underscoring the need for training and safer practices.[9][10]
- On the 20th anniversary of the NSPA, NIOSH noted progress alongside persistent risks and highlighted modern engineering controls and reporting.[11]
A contemporaneous GAO analysis estimated that hospital adoption of safety-engineered needles could prevent about 69,000 needlestick injuries annually and that device costs would total $70–$352 million per year, offset in part by avoided post-exposure evaluation and treatment costs.[12]
Related developments
[edit]Prior to the NSPA, several U.S. states (led by California in 1998) required inclusion of safety-engineered sharps in bloodborne pathogen standards.[13] OSHA later issued technical corrections to the Bloodborne Pathogens Standard, leaving the NSPA-driven provisions intact.[14]
In popular culture and public discourse
[edit]The 2011 feature film Puncture dramatizes efforts to promote safety-engineered syringes in U.S. hospitals. The film was co-written by attorney Paul Danziger and portrays his former law partner Michael David Weiss, a Houston trial lawyer, as central figures in litigation challenging group purchasing organizations (GPOs) and medical supply companies that critics said impeded adoption of safer devices.[15][16]
Although the film takes dramatic license, it reflects Weiss and Danziger’s real-life lawsuit on behalf of a safety syringe inventor, which sought to expose exclusive contracting and alleged kickbacks in the hospital purchasing system.[17][18] While the litigation was ultimately settled and the Act itself advanced separately through Congress, commentators have noted that the publicity generated by such cases and subsequent media depictions helped draw attention to the risks of needlestick injuries and to the market barriers facing safety devices.[19]
Scholars and policy analysts note that while the Needlestick Safety and Prevention Act advanced independently through Congress, popular accounts such as Puncture have contributed to a public perception that litigation by Weiss and Danziger played a direct role in its passage.[20]
See also
[edit]- Bloodborne pathogens
- Occupational Safety and Health Administration
- Safety syringe
- Sharps waste
- Michael David Weiss
References
[edit]- ^ a b c d e f g h "Public Law 106–430: Needlestick Safety and Prevention Act". GovInfo. U.S. Government Publishing Office. November 6, 2000. Retrieved September 14, 2025.
- ^ a b c "Bloodborne Pathogens; Needlestick Prevention (Final rule)". Federal Register. OSHA. January 18, 2001. Retrieved September 14, 2025.
- ^ "AB 1208 (1998), California sharps safety amendments". leginfo.ca.gov. California Office of Legislative Counsel. Retrieved September 14, 2025.
- ^ "Needle Safety Laws Now on Books in 16 States". Infection Control Today. October 1, 2000. Retrieved September 14, 2025.
- ^ "H.R.5178 — Needlestick Safety and Prevention Act (106th Congress)". Congress.gov. Library of Congress. November 6, 2000. Retrieved September 14, 2025.
- ^ "Quick Reference to OSHA's Bloodborne Pathogens Standard". OSHA.gov. OSHA. Retrieved September 14, 2025.
- ^ "OSHA Bloodborne Pathogens and Needlestick Prevention". OSHA.gov. OSHA. Retrieved September 14, 2025.
- ^ Makary, Martin A. (2011). "Increase in Sharps Injuries in Surgical Settings Versus Nonsurgical Settings After Passage of National Needlestick Legislation". Journal of the American College of Surgeons. 212 (6): 922–927. doi:10.1016/j.jamcollsurg.2009.12.018. PMID 20347743. Retrieved September 14, 2025.
- ^ "2019 EPINet Summary: Needlestick & Sharps Injury Report" (PDF). International Safety Center. 2020. Retrieved September 14, 2025.
- ^ "Sharps Injuries among Hospital Workers in Massachusetts, 2019". Massachusetts Department of Public Health. January 2021. Retrieved September 14, 2025.
- ^ "Every Needlestick is One Too Many: 20 Years After the Needlestick Safety and Prevention Act". NIOSH Science Blog. CDC. November 4, 2020. Retrieved September 14, 2025.
- ^ "Occupational Safety: Selected Cost and Benefit Implications of Needlestick Prevention Devices for Hospitals". U.S. Government Accountability Office. November 17, 2000. Retrieved September 14, 2025.
- ^ "California sharps safety requirements (1998)". Relias Media. December 1998. Retrieved September 14, 2025.
- ^ "Bloodborne Pathogens Standard; Corrections and Technical Amendment". Federal Register. April 3, 2012. Retrieved September 14, 2025.
- ^ "Review: Puncture". RogerEbert.com. October 5, 2011. Retrieved September 14, 2025.
- ^ "Puncture credits". Box Office Mojo. Retrieved September 14, 2025.
- ^ "The Horrific Truth Behind the Movie Puncture: Inadequate Needle Safety in the U.S." LegalNews.TV. September 15, 2018. Retrieved September 14, 2025.
- ^ "The Retractable Syringe, Mike Weiss, and the Story Behind Puncture". Blurred Bylines. July 15, 2021. Retrieved September 14, 2025.
- ^ Danziger, Paul (October 21, 2011). "Cut Kickbacks to Hospital Group Purchasing Organizations, Not Medicare and Medicaid". Roll Call. Retrieved September 14, 2025.
- ^ Makary, Martin A. (May 2006). "Needlestick Injuries in the United States". BMJ. 332 (7530): 1230–1231. doi:10.1128/JVI.00049-06. PMC 1472145. PMID 16699003.