Introduction    

Needle is a class 2 medical device under the regulation of the FDA. Other sharps such as lancets are commonly used medical devices. These devices could be obtained at local community pharmacies behind-the-counter for limited quantities or by prescription. Currently, approximately 9 million Americans use needles at home to manage their diseases. This accounts for over 3 billion needles and other sharps that must be disposed outside healthcare settings per year.

Background

The current FDA guideline recommends a 2-step disposal process including disposing sharps into the sharps container and contacting local collection sites for disposal of the sharps containers. However, whether or not to follow this guideline is at the discretion of the patient. Even though the FDA has issued many warnings regarding the danger in improper disposal of needles and sharps, the results of these patient education efforts seem to be limited. News reports on blood-borne pathogen transmissions via improperly disposed needles continue to headline throughout the country.

Rule

The FDA should be given the authority to enforce penalties on improper needles and sharps disposal if all of the following are true:

1)    The current FDA guideline is not being followed

2)    The FDA has the authority to regulate needles and sharps

3)    Established penalties are not severe enough

4)    Improper disposal of needles and sharps has caused harm

Analysis

1)    According to the FDA consumer update on April 3, 2013, “many sharps used outside of a doctor’s office or hospitals are thrown in the household trash, and that’s hazardous.” This provides evidence that the current FDA disposal guideline is not being followed.

2)    A needle is a class 2 medical device under the regulation of the FDA. Other sharps such as lancets are class 1 medical devices under the regulation of the FDA. These devices do not need pre-market approval. However, they do need to be registered with the FDA.

3)    Currently, each state has its own penalties associated with improper disposal of needles and other sharps. For the state of New Jersey, the penalty is only up to $500, and for states like Wisconsin, there is no fully established penalty. The lack of penalty in many states contributes to patients disregarding the FDA guideline.

4)    In 2005, a 12 year old was arrested for allegedly pricking 19 students with an improperly disposed lancet. In 2012, a sanitation department worker was stuck by an improperly disposed needle as well.

Conclusion

As harm from improper disposal of needles and sharps continues, it becomes necessary for the FDA to step up. The FDA has full authority to regulate these devices, and since penalties determined by states vary and are often not severe enough, the FDA should start enforcing penalties on improper needles and sharps disposal.

For more information on this issue, contact the Kulkarni Law Firm.