Needlestick Safety and Prevention Act
Edition: March 2002 - Vol 10 Number 03
The following is a comprehensive look at the burning questions concerning the needle safety initiative. It comes from a number of different resources including OSHA's web site, the Health Industry Distributors Association, and the manufacturing community. It is intended to be a complete Q and A that sales reps can learn from as well as share directly with their customers. We hope it helps!
1. What is the Needlestick Safety and Prevention Act?
The Needlestick Safety and Prevention Act sets forth in greater detail requirements for employers to identify, evaluate, and implement safety-engineered medical devices. The Act mandates the maintenance of a sharps injury log and the involvement of non-managerial employees in evaluating safety devices. Under the law, medical practices should already be using safety devices, those where the safety feature is integral to the device. If you have not already purchased and made available safety medical devices, you must do so immediately. The law requires ALL employers to use safety-engineered devices, regardless of the size of the practice, the added expense of such products, or the type of facility.
2. How does the revision affect states that operate their own federally-approved occupational safety and health programs?
States with state OSHA programs were required to adopt the revised standard by Oct. 18, 2001. States may choose to implement their own, more stringent standards independently of the Needlestick Act.
3. Does the ''Needlestick Act'' apply to me?
The Act applies to all employers who have employees with reasonably anticipated occupational exposure to blood or other potentially infectious materials (OPIM). This includes:
Home Care/ Home Infusion
As long as there is an employee in the practice who has the potential of incurring an exposure to blood or OPIM, even if they are not the one using the device, the practice must be in full compliance with the Act.
4. What if a safety-engineered option is not available for the medical device that I use?
If there is no safety-engineered device available for a certain procedure, you are not required to use anything new. However, employers must implement work practice controls and, if exposure risks remain, must provide protective gear. Employers also must inquire as to the availability of safety devices each year, and document that fact in the Exposure Control Plan. If a safer device is available, but back ordered or delayed, this must be documented in the Exposure Control Plan. You must implement the device(s) as soon as it becomes available, and then document that fact.
5. We have tried safety-engineered devices, and we don't believe they are safer than what we use today. Do we still need to convert to safety products?
This judgment is likely to be challenged since OSHA has already collected data from across the country demonstrating that safety-engineered devices do effectively reduce needlesticks. Deciding not to use safety devices needs to be based on clinical justifications that are clearly documented in the Exposure Control Plan. In the absence of such clinical evidence, employers are expected to adopt available safety devices.
6. We feel safety-engineered devices cost too much. Is it acceptable if we delay conversion until the price comes down?
No. Before passing the Needlestick Act, OSHA conducted an industry-wide cost/benefit analysis and concluded that the use of safety medical devices was beneficial due to the reduction in the expenses associated with testing and treating injured healthcare workers. For example, it can cost upwards of $500,000 to $1,000,000 to treat a worker who contracts hepatitis C or HIV.
7. Is the use of a needle destroyer/pulverizer considered an acceptable alternative to using safety-engineered devices?
No. Needle destroyers / pulverizers as well as sharps collectors facilitate the safe disposal of used needles, but they do not provide any protection from the risk of a needlestick during product use, which is when most needlesticks occur.
8. We have placed a box of safety product on the shelf to use for select, high-risk situations. Does this make us compliant with the new safety legislation?
No. The legislation requires employees to use safety devices in all cases where safer medical devices are available.
9. What if we have never had anyone on our staff experience a needlestick injury, must we still convert to safety devices?
Yes. OSHA standards are intended to prevent occupational injuries and illnesses.
10. Does OSHA have a list of available safer medical devices?
No. OSHA does not approve or endorse any product. It is your responsibility as an employer to determine which engineering controls are appropriate for specific hazards, based on what is appropriate to the specific medical procedures being conducted, what is feasible, and what is commercially available.
11. What fines will OSHA issue if a healthcare facility is deemed out of compliance?
Each citation can lead to a fine of up to $7,000. Blatant violations can lead to fines as high as $70,000. Failure to use a safety product, like a safety hypodermic needle and syringe, can lead to multiple citations. The citations could include:
Failure to document evaluation and use of the safety product in the Exposure Control Plan.
Failure to include involvement of exposed employees in the evaluation and selection of safety products.
Failure to implement safety products.
Since the law was passed, OSHA officials have inspected all types of healthcare facilities, and have issued citations and fines to those not in compliance. This has included physician practices, surgery centers, nursing homes, and hospitals.
12. Does the safety legislation still apply when the physician is both the employer and employee?
The BBP standard applies to all workplaces, regardless of size, as not only the practicing physicians are at risk of needlesticks, but also those employees working with them and downstream.
13. Do I have to keep a sharps injury log? Does it have to be confidential?
If your practice has 10 or more employees, you must establish and maintain a sharps injury log for recording injuries from contaminated sharps. The Sharps Log must detail the injury, the type and brand of device involved in the injury (if known), the department or work area where the exposure occurred, and an explanation of how the incident occurred. The log must protect the confidentiality of the injured employee.
14. What information do I need to include in my written Exposure Control Plan? How often to I need to update it?
In addition to what is already required by the 1991 standard, the revised standard requires the documentation of annual consideration and implementation of appropriate engineering controls, and solicitation of non-managerial workers in evaluating devices. The plan must be reviewed and updated every year.
15. What is the position of key healthcare professional organizations on this safety legislation?
The American Medical Association supports the updated Bloodborne Pathogen Standard and the need to prevent needlestick injuries.
As of April 1, 2002, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) will require full compliance with the new Bloodborne Pathogen Standard, including the use of safety devices, in order to receive accreditation.
16. Where can I get information about what is expected of me?
Employers should read the OSHA Bloodborne Pathogens Standard and the Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, which can be obtained at http://www.osha.gov or by phone at 1-800-321-OSHA. The National Institute for Occupational Safety and Health (NIOSH) and the Centers for Disease Control and Prevention (CDC) also have documents related to the prevention of occupational exposure to blood and OPIM.