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Frequently Asked Questions about the Cal/OSHA Regulations in Section 5193

A memo from Michael W. Smith,
CEO of Biomedical Disposal, Inc.

To help our customers, we have summarized our thinking on some of the most frequently asked questions regarding the proposed new bloodborne pathogen regulations drafted by Cal/OSHA. While the regulations are still a work in progress, the answers below incorporate publicly available information, as well as our own conversations with people responsible for passing the law, and for drafting and approving the proposed regulations.

To highlight the key elements of our viewpoint:

  • Use of Biomedical Disposal Sharpx® needle destruction unit fulfills the expected requirements of Cal/OSHA s proposed new bloodborne pathogen regulations.
  • Early adoption of Sharpx® is encouraged, since rapid improvement in worker safety is rewarded through an exception to the most onerous provisions of the proposed regulations.

Where do needle destruction units appear in Section 5193?

NDUs are Engineering Controls, as defined in subsection (b), Definitions, since they remove the bloodborne pathogens hazard from the workplace. Subsection (b) states, “'Engineering Controls means controls (e.g., sharps disposal containers, needleless systems and sharps with engineered sharps injury protection) that isolate or remove the bloodborne pathogens hazard from the workplace.

Furthermore, use of Engineering Controls is mandated in subsection (d)(2), General Compliance: Engineering and work practice controls shall be used to eliminate or minimize employee exposure.”

But doesn’t the law mandate the use of safety needles?

This is a common misconception. Governor Wilson of California had indicated that he was unwilling to sign any legislation that did not allow alternatives to safety needles to be used. Based on our conversations with insiders, the phrase including, but not limited to was added to the bill at the behest of the governor. (See California Labor Code Section 144.7, subsection (b)(1), a revised definition of engineering controls that includes sharps prevention technology, including, but not limited to, needleless systems and needles with engineered sharps injury protection.)

Why do some people think that AB 1208 is a safety-needle bill?

This is an example of another common – and understandable – misconception caused by the drafting. Based on our conversations with people close to the regulatory process, we expect changes so that needle destruction units are treated like safety needles. The draft regulations, as currently written, do have an implied emphasis for implementation, unless the provider can show that certain exceptions apply. In laymens terms, the order is no needles, safety needles, and other devices. However, this does not apply under the following circumstances: (1) the device is not available in the market; (2) the device would endanger patient safety; (3) the employer can show that safety performance of existing systems is at least as effective; and (4) reliable safety information for the device is not available.

With so many “outs,” why should a health care provider do anything at all?

Currently, safety needles are not generally available, so the market availability exception will probably apply for the next few years. Many will be tempted to do nothing. However, this will become very costly to those health care providers who procrastinate, since the considerably more expensive safety needles will eventually become sufficiently available and the procrastinators will be forced to buy them at premiums to existing technology.

The best alternative is to take advantage of the safety performance exception, utilizing much more cost-effective patient-side needle destruction units and advanced training techniques. Sharpx® and NICSx® were designed to reduce costs overall and are therefore a good solution for the proactive health care provider, regardless of any regulatory pressures.

By the time the considerably more expensive safety needles become sufficiently available, safety needle manufacturers will be forced to show that safety needles are better than a much higher safety standard – a standard set using Sharpx® and NICSx® and a standard that Biomedical Disposal believes safety needle manufacturers will not be able to meet. In other words, proactive implementation will produce a cost advantage versus the competition.

But aren’t needle destruction units against the law?

The source of this misconception is probably found in subsection (d)(3)(B), Prohibited Practices. This subsection states, Shearing or breaking of contaminated needles and other contaminated sharps is prohibited. Some needle destruction units are, no doubt, prohibited. But the Sharpx® destroys needles by using electrical current; hence, it is fully in compliance with all laws and regulations. For more information, click here to access the proposed emergency standard to amend Section 5193.

For More Information:
California OSHA

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