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 In US, as estimated 5.6 million healthcare workers routinely handle medical sharps, and data from the US CDC suggests that 600,000 to 800,000 needlesticks and other injuries occur each year in the US. This has driven the adoption of government regulations.

 In 1998, Assemblywoman Carl Migden introduced Assembly Bill (AB) 1208 (Statutes of 1998, Chapter 999) requiring that the current California Bloodborne Pathogens Standard include a provision that needleless systems and safety-enhanced needle devices be used in all healthcare settings. California thus became the first state in the U.S. to implement a primary prevention program aimed at protecting healthecare workers from exposure to lethal and disabling bloodborne pathogens. Since then, over 20 states had passed similar legislation.

 As the spread of bloodborne disease caused by needlestick had become a major concern specifically for the safety of the healthcare workers, the Needlestick Safety and Prevention Act (NSPA) was signed into law on November 6, 2000 by President Clinton. The legislation directs the Federal Occupational Safety and Health Administration (OSHA) to ensure more widespread use of safer medical devices to prevent dangerous sharps injuries. It mandated OSHA to revise its bloodborne pathogens standard to include specific additional definitions and requirements.

 The Needlestick Safety and Prevention Act (NSPA) is not enforceable on its own, but rather the Occupational Safety and Health Act of 1970, which requires compliance with OSHA standards. Under the standard, as revised by the NSPA, employers are required to evaluate, select, and use engineering controls devices (e.g., sharps with engineered sharps injury protections or needleless systems) to eliminate or minimize exposure to contaminated sharps. In healthcare settings this requirement is easily interpreted to mean that 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. Additionally, the law requires that healthcare workers responsible for direct patient care participate in the evaluation of the safety-engineered devices. The healthcare facilities are also required to periodically update and review their Exposure Control Plans to reflect changes in technology, such as safety-engineered devices, and maintain a log of accidental needlestick occurrences.

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