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Regulated Medical Waste Management

Course Number: 498

Contaminated Sharps

The primary route of occupational exposure to blood and OPIM is accidental percutaneous injury, i.e., needlestick and other sharp injury. As many as one-third of all sharps injuries occur during the disposal process. Factors most often sited include (1) inadequate sharps disposal container design, (2) inappropriate sharps disposal container placement (3) inappropriate sharps disposal handling practices by HCP, and (4) overfilled sharps disposal containers.18

Sharps disposal containers are regulated as class II medical devices by the FDA19,20 Class II medical devices are those devices for which general regulatory controls alone cannot assure safety and effectiveness. These devices are subject to special labeling requirements, mandatory performance standards, pre-marketing FDA notification, and post-marketing surveillance, i.e., the practice of monitoring the safety of medical devices after it has been released on the market.

OSHA mandates that sharps disposal containers be puncture resistant, the sides and the bottom be leak-proof, and they be closable (i.e., they have a lip, flap, door, or other means of closing the container).4,17 The containers must be labeled with the universal biohazard symbol and the word “BIOHAZARD,” and/or color-coded red. The label must be fluorescent orange or orange-red, with the symbol and lettering in a contrasting color (Figures 7 and 8).4,17

ce498 fig07 universal biohazard label

Figure 7.

The universal biohazard label must be fluorescent orange or orange-red, with lettering and symbol in a contrasting color.

ce498 fig08 fda cleared container

Figure 8.

FDA-cleared sharps disposal containers, available in a variety of sizes, must be appropriately labeled or color-coded red.

NIOSH recommends the placement of a container of sufficient size, i.e., one that accommodates both the volume generated and the largest sharp used, at each workstation.18 It must also be readily accessible, i.e., without obstacles between the user and the container.18 Horizontally, they must be located within easy arm’s reach and the vertical height must be below eye level, i.e., the user must have a clear, unobstructed view of the container’s opening (Figure 9).18

ce498 fig09 container installation

Figure 9.

Ergonomic installation height for a wall mounted sharps disposal container.

Sharps containers must be kept upright throughout use to keep the sharps and any liquid from spilling out.4 The fill status of the container must also be obvious under prevailing lighting conditions.18 The container’s opening must be identifiable and easily accessible by the user and must facilitate one-handed disposal of sharps.18 Contaminated broken glass (e.g., broken local anesthetic cartridges) must be placed into the container by mechanical means.4,17

Contaminated disposable needles must never be sheared or broken. If bending or removing a needle from the syringe is necessary, it must be accomplished with the use of a mechanical device or a one-handed technique. Recapping must be accomplished by the one-handed “scoop technique,” i.e., using the needle itself to pick up the cap and then pushing the cap against a hard surface to ensure a tight fit over the needle.4,17

Sharps containers must be closed before removal from the workstation to prevent spillage or protrusion of contents during transportation within the user facility before final disposal. If there is a chance of leakage, the container must be placed in a secondary container. The secondary container must also be closable, constructed to contain all contents, and labeled with the universal biohazard symbol or color-coded red as noted above for the primary container.4