Needlestick Safety Law

Edition: February 2002 - Vol 10 Number 02
Article#: 1153
Author: Repertoire

Effective April 18, 2001, your customers were required to evaluate and use safety-engineered medical devices to eliminate or minimize occupational exposure to bloodborne pathogens. This was a result of the Needlestick Safety and Prevention Act. Are they in compliance today? Do they understand that the Occupational Safety and Health Administration can issue fines up to $7,000 per incident for violating the law? Are you helping them understand their requirements under the law?

Recently Repertoire spoke with Peter Allen, senior director, advanced protection technologies, Becton Dickinson, Franklin Lakes, NJ. Allen has been spending much of his time over the past few months talking with BD salespeople, distributor reps and end-user customers about the Needlestick Safety law. He shared with us some of what he's learned during that time.

In a nutshell, what does the Needlestick Safety and Prevention Act say?
Allen: Among other requirements, it says that in any situation where there exists potential contact with blood or other potentially infectious materials, everyone is required to evaluate using a safety-engineered device. This extends not only to hospitals, but to physicians' offices, nursing homes, surgery centers- any place where there is a risk for the employee.

How compliant have physicians' offices been?
Our feeling is that in the non-hospital market, awareness of the law is still fairly low. Compliance has not happened as swiftly in this market as it has in the acute care market. But that's not unexpected, given how large the market is and how many people have to be educated on the benefits of safety-engineered devices and the requirements under the federal law.

Assuming there is awareness of the Needlestick Safety Act, why would customers object to evaluating or buying safety-engineered devices?
Awareness is the number one concern, but some believe that the needlestick law does not apply to them. They believe that because they're in a very low-risk environment or because they've never had a needlestick, they're not required to make any changes. It's also common for primary care sites to believe that OSHA isn't active in their type of facility.

Is that true?
We've had reports that OSHA has inspected all types of facilities – nursing homes, physicians' offices, surgery centers, hospitals. And now [the Joint Commission on Accreditation of Healthcare Organizations] has said that effective April 1 [2002], they will use this law as one requirement for accreditation.

Any other objections to buying safety-engineered devices?
I can think of two recent examples of people who think they're in a very low-risk environment and hence don't need safety-engineered devices. We had a question from a fertility clinic who said that prospective patients are tested for bloodborne diseases before they enter the program. The reality is, pre-testing of patients is not sufficient to exempt them from the law. And the second example is a pediatrician who provides childhood immunizations. They tell us they're in a very low-risk environment because of the profile of their patient population. But in both examples, OSHA has told us that they're still covered by the law. Employers must try to reduce the exposure risk for their employees.

It's been said that some physician practices are putting a box or two of safety-engineered devices on their shelves to satisfy OSHA inspectors, but are in reality still using conventional devices. Will they be successful in avoiding fines?
No. It's our understanding that the OSHA inspectors will actually interview employees to find out if they're using safety-engineered devices.

What can distributor reps do to raise awareness of the Needlestick Safety law among their customers?
We've worked with a number of distributors to generate interest in safety-engineered devices. In terms of raising awareness among their customers, that's the No. 1 thing they can do. They should look at every sales call as an opportunity to be an expert resource for their customers.

And we have provided reps with a number of tools to help educate them, to help them become experts for their customers. Together with [the Health Industry Distributors Association], we sponsored the printing of about 30,000 brochures about the needlestick safety law. [It's called ''Safe Needles: It's the Law.''] And we're working with HIDA to produce a second piece on frequently asked questions, which again will be aimed at distributors.

We direct people to our website (, which contains a lot of educational materials and links to other sites and documents, to help people understand the law and come into compliance with it. In addition, by mid-February we will have a section where customers can ask questions and we will have them answered by industry and/or government experts.


The Occupational Safety and Health Administration published the Occupational Exposure to Bloodborne Pathogens standard in 1991 because of a significant health risk associated with exposure to viruses and other microorganisms that cause bloodborne diseases. Of primary concern are the human immunodeficiency virus (HIV) and the hepatitis B and hepatitis C viruses.

Since then, many different medical devices have been developed to reduce the risk of needlesticks and other sharps injuries. These devices replace sharps with non-needle devices or incorporate safety features designed to reduce injury. Despite these advances in technology, needlesticks and other sharps injuries continue to be of concern due to the high frequency of their occurrence and the severity of the health effects.

The Centers for Disease Control and Prevention estimate that health care workers sustain nearly 600,000 percutaneous injuries annually involving contaminated sharps. In response to both the continued concern over such exposures and the technological developments which can increase employee protection, Congress passed the Needlestick Safety and Prevention Act, directing OSHA to revise the bloodborne pathogens standard to establish in greater detail requirements that employers identify and make use of effective and safer medical devices. That revision was published on Jan. 18, 2001, and became effective April 18, 2001.

Exposure Control Plan
The revision includes new requirements regarding the employer's Exposure Control Plan, including an annual review and update to reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens. The employer must:
--Take into account innovations in medical procedure and technological developments that reduce the risk of exposure (e.g., newly available medical devices designed to reduce needlesticks); and
--Document consideration and use of appropriate, commercially available, and effective safer devices (e.g., describe the devices identified as candidates for use, the method(s) used to evaluate those devices, and justification for the eventual selection).
No one medical device is considered appropriate or effective for all circumstances. Employers must select devices that, based on reasonable judgment:
--Will not jeopardize patient or employee safety or be medically inadvisable; and
--Will make an exposure incident involving a contaminated sharp less likely to occur.

Source: OSHA (

For more information on OSHA's compliance directive, visit: