The typical engineering control is a medical device. Since 1976, the U.S. Department of Health and Human Services has regulated the marketing of medical devices through its Food and Drug Administration. The FDA has detailed requirements that must be fulfilled prior to the first commercial sale, and has extensive authority over how the product can be sold and what claims can be made about its performance. For example, in order to advertise that a product "reduces the risk of needlestick injury" the seller must demonstrate that to be the case to the satisfaction of the FDA.

Medical devices are grouped into 3 categories. A Class I device is a simple, non-critical item such as a tongue depressor. The typical safety device is either a Class II or Class III device. In order to market a Class II device, the seller must demonstrate that the device is "substantially equivalent" to a device the FDA has already allowed to be marketed. A safety syringe needle is an example of a Class II device. In order to market a Class III device, the seller must complete an exhaustive scientific review process which includes clinical trials. Clinical trials are performed in real world settings by actual healthcare workers. A new technology, such as a needle destruction unit, is an example of a Class III device.

Recent Trends

Recently there has been an increase in regulatory activity regarding this issue. In September 1998, California enacted a law that required the use of sharps prevention technology in engineering and work practice controls. Also, various other states have passed or are considering resolutions or laws regarding bloodborne pathogen safety in the workplace.

Typically, enactment of new regulations involves the passage of a law stating the general principles, and the promulgation (i.e., writing) of the corresponding regulations. Usually the promulgation of the regulations entails public hearings, with the relevant government agency having an obligation to respond in writing to public comments. In every instance, the regulations must correspond to the law.

Of the states that have passed legislation or resolutions, only California has completed the regulatory cycle. A law encouraging the use of sharps injury prevention technology was signed by then Governor Wilson in September 1998. The regulation writing and public hearing process was completed by June 1999. As part of this process, the Occupational Health and Safety Standards Board (Cal/OSHA) issued a "Final Statement of Reasons" giving its legally binding interpretation of the regulations. Cal/OSHA noted that "Under [the Methods of Compliance] subsection, technology such as needle-destruction devices are authorized and encouraged provided they do not violate other, more specific provisions." (Final Statement of Reasons, Section 5193, Bloodborne Pathogens, page 10, emphasis added).

At the federal level, OSHA has announced its intention to revisit this issue in light of advancements that have been made since 1991. Revisions in enforcement were issued in November 1999, reflecting improvements in medical device technology and post-exposure treatments, and emphasized that "OSHA does not advocate the use of one particular medical device over another". Work on a new bloodborne pathogen standard will probably begin in 2000. The U.S. Congress has weighed in on this issue. In the FY 2000 OSHA budget, Congress "urges OSHA to ensure that the use of all FDA-approved devices which reduce the risk of needlestick injury is allowed, whether or not such safety feature is integrated into the needle or other sharp medical object". Also, both houses have introduced additional legislation that would address this issue.

Observation