A. Performance Criteria
Focus group studies (Appendix A) suggest that there are four major criteria for sharps disposal container safety performance: functionality, accessibility, visibility, and accommodation. More detailed descriptions of these criteria follow:
Sharps disposal containers should be of sufficient thickness or construction design to be durable, leak resistant, and puncture resistant under normal use and stresses imposed during storage, handling, installation, use, closure, and transport within the user facility before final disposal.* Durability and puncture resistance should remain unaffected by moderate variation in temperatures during storage and use.† Brackets and locking mechanisms used for installation should also be durable.
†Caution must be exercised when handling sharps disposal containers at extremes of temperature—such as those encountered by home health care providers when transporting sharps disposal containers in their cars. Sharps disposal containers are not typically designed for high- and low-temperature conditions.
Barrier material performance. Sharps disposal container material should be resistant to chemical or liquid permeation or degradation, punctures, tearing, abrasion, and laceration.
Closure mechanisms. Closure mechanisms should be designed to minimize exposure to contents and injury to the hand during engagement of the closure mechanism or during transport within the user facility before final disposal. Once activated, the final closure mechanism of a sharps disposal container should be resistant to manual opening.
Stability. Containers (including those designed to be kicked or wheeled) should be stable when placed on a horizontal surface and when used as described in the product labeling. Some manufacturers provide trays, holders, or enclosures to stabilize their containers in certain applications. The use of these items should also be detailed in the labeling.
Size and shape. Where workers handle sharp devices, a sufficient quantity of sharps disposal containers should be available in the appropriate size and shape. Sharps disposal containers should be of sufficient size to accommodate the largest sharp used at the workstation it serves. Containers should also be shaped to accommodate the particular type of sharp that requires disposal. At a minimum, one sharps disposal container should be provided at each worksite where sharps are predictably generated or located.
Sharps disposal containers should also be of sufficient size to accommodate the volume of sharps typically generated at the site between maintenance operations. Providing sharps disposal containers of sufficient size will minimize the possibility of overfilling the container, which would compromise its safe operation.
Mounting brackets. Mounting brackets for sharps disposal containers should be rugged and provide for ease of servicing and decontamination.
2. Accessibility criteria
Disposal opening or access mechanism. Sharps disposal containers should be designed to permit safe disposal of sharps. They should be simple and easy to operate. The disposal opening should prevent spills of the contents (objects or liquid) while in use in the intended upright position, during the closure and sealing process, and during transportation within the user facility before final disposal. The design should also minimize any catching or snagging of sharps during insertion into the sharps disposal container. The disposal opening should be identifiable and accessible by the user and should facilitate one-handed disposal.
Security may be a concern in some areas of facilities using sharps disposal containers. For in stance, to prevent children and others from putting their hands into the containers, the facility should consider selecting containers with guards that prevent hands or fingers from entering the containers. Where safety features are added to restrict child access, these features should not interfere with the worker's vision of the inlet opening. Injury to visitors may also be a problem.26 Sharps disposal container options that accommodate these concerns should be available within the facility.
Handles. For some designs, handles may facilitate safe handling of the sharps disposal container. If present, they should be sufficiently sturdy to avoid breaking when the sharps disposal container is in use or during transportation before final disposal. If handles are present, they should be placed so that the user's hands are not close to the disposal opening when the handles are used, and they should be positioned above the full-fill level.
General location and placement. Proper sharps disposal container location and placement should ensure that containers are readily visible and within easy horizontal reach of the user. Placement of containers should be in compliance with any existing State or local regulations or site-specific certification or accreditation licensing requirements. Where containers are fixed to walls or other permanent sites, the vertical height should allow the worker to view the opening or access of the container.
Sharps disposal containers should be placed with no furniture or other obstacles between the site of use and the container. Injuries may result if sharps disposal containers are located in awkward, unsafe locations. These unsafe locations may force workers to make unnecessary movements while holding a sharp and accessing the container. Placement of the sharps disposal container outside the patient room also increases the possibility of injury. Examples of inappropriate installation include placement in the corners of rooms; on the backs of room doors; under cabinets; on the insides of cabinet doors; under sinks; in areas where people might sit or lie beneath the container; near light switches, room environmental controls, or utility system access ways; near mail boxes; or where the container is subject to impact and dislodgement by pedestrian traffic, moving equipment, gurneys, wheelchairs, or swinging doors. Standard operating procedures and practices should be developed to allow the worker to dispose of the device as soon as possi ble after use—preferably without needing to put the device down and pick it up again.
Special situations may require innovative sharps disposal container placement and security approaches. Examples of these special situations include pediatric and geriatric wards and mental health or correctional facilities. If necessary, in areas with high patient or visitor traffic, sharps disposal containers should be mounted in a lockable fixture. In the emergency room, sharps disposal containers may need to be mounted on wheels to facilitate the movement of gurneys and monitoring equipment. In some situations, it may be appropriate to mount sharps disposal containers directly on gurneys to facilitate their use. Although some pediatric facilities mount sharps disposal containers high on walls to prevent access by children, such placement should not be so high that it impairs safe access by workers.
Installation height. Installation of a container at an appropriate height for the user may reduce sharps-related injuries. Sharps disposal containers should be placed within arm's reach and below eye level at their point of use. For certain types of permanently fixed, wall-mounted containers, an ergonomically acceptable range of installation height can be calculated (Appendix B). Standard anthropometric tables should be used to determine the normal range of human physical variation. Fixture heights are commonly designed to accommodate 95% of the adult population. The following criteria should be used to determine the optimal range for fixed installation height: (1) users should have a clear, unobstructed view of the container inlet opening, (2) the container should be located within arm's reach, and (3) the fixture height should be below the eye level of 95% of adult female workers. These requirements yield an optimal installation range of 56 to 52 inches at a standing workstation, and 42 to 38 inches for a seated workstation. The upper and lower ranges for the installation height are calculated by allowing for the reach behavior of workers. For a complete explanation of calculating optimal installation height, see Appendix B.
Other ergonomic alternatives include (1) using an extension arm on a fixed-height installation at a seated workstation to bring the sharps disposal container closer to the work surface, (2) providing height-adjustable chairs that allow the worker to view the entire top surface of a container at a seated workstation, and (3) using bracketing and mounting systems designed to allow user adjustment of the container (Appendix B).
3. Visibility criteria
To reduce the chance of percutaneous injury, sharps disposal containers should be visible and recognizable. Safe disposal of sharps requires clear vision of both the sharp device and the container. The disposal opening or access mechanism and current fill status should be visible to the user before sharps are placed in the container.
Sharps disposal containers should carry a hazard warning labeling. Such labels and device colors should imply danger. Either the device color or a warning label should be visible to the user to warn of a potential hazard before sharps are placed in the container. The current fill status of the container should be easily observable by the user before sharps are placed in the container. Sufficient illumination is needed at the container to determine whether any sharp object is protruding from the container or whether the container is grossly soiled at holding points or on opening mechanisms. Container fill status should be obvious under lighting conditions at the installation location. Safety features, security measures, and aesthetics should not distort recognition of the container, fill status, warning labels, or the disposal opening or access.
OSHA's bloodborne pathogens standard [29 CFR 1910.1030, section (g)(1)(I)(C)] contains very specific requirements about the labeling of containers for contaminated sharps: "These labels shall be fluorescent orange or orange-red or predominantly so, with lettering or symbols in a contrasting color." The standard also requires that the biohazard symbol and the word Biohazard be displayed; note, however, that "[R]ed bags or red containers may be substituted for labels" in section (g)(1)(I)(E).
4. Accommodation criteria
Sharps disposal container designs should be accommodating to the user, the facility, and the environment. Accommodation is a measurement of ease of storage and assembly, minimal worker training requirements, ease of operation, and flexibility in design. Container design should promote one-handed disposal. Design and product finish should minimize sharp surfaces or cross-infection hazards. Special aesthetic, operational, or safety features should not hide or impede free access to the device, the inlet, or the closure process. Users should be able to assemble containers easily, if required. Mounting systems should be safe, durable, stable, cleanable, and (where appropriate) lockable. Placement in and removal from mounting systems should be simple and uncomplicated and should not compromise safety and security. To ensure proper fit and functioning of the container mounting system, mounting systems should be used only for the sharps disposal containers for which they were designed. Modifying mounting systems to accommodate containers for which they were not designed is not a safe or effective practice.
Containers should be designed so that they are simple to use. Manufacturers of sharps disposal containers should provide recommended user training information, which could include the following:
1. Assembly instructions
2. Safety considerations
3. Maintenance criteria for reusable containers
4. Optimum storage conditions
5. Warranty information
6. Decontamination recommendations (for re-usable containers and their holders)
7. Container retirement considerations (for re-usable containers and their holders)
8. Bilingual or multilingual material, where needed
9. Sharps disposal container disposal considerations
10. Information for periodic in-service retraining, if required
B. Existing Standards
Existing Federal standards for sharps disposal containers are outlined here. Published sources for other standards are listed in Appendix E.
Sharps disposal containers are regulated as class II medical devices by the Food and Drug Administration [21 CFR 860.3].* OSHA's bloodborne pathogens standard establishes minimum design performance elements for sharps disposal containers [29 CFR 1910.1030(d)(4)(iii)(A)]. The standard requires that contaminated sharps "be discarded immediately or as soon as feasible in containers that are:
(i) Closable;
(ii) Puncture resistant;
(iii) Leakproof on sides and bottom; and
(iv) Labeled or color-coded in accordance with paragraph (g)(1)(i) of the
standard."
Paragraph (g)(1)(i)(A) of the standard requires that warning labels "be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport, or ship blood or other potentially infectious materials. . . ."
Paragraph (d)(4)(iii)(A)(2) further states that "during use, containers for contaminated sharps shall be:
(i) Easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found (e.g., laundries);
(ii) Maintained upright throughout use; and
(iii) Replaced routinely and not be allowed to overfill."
When containers of contaminated sharps are being moved from the area of use, paragraph (d)(4)(iii)(A)(3) requires that they be:
"(i) Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping;
(ii) Placed in a secondary container if leakage is possible. The second container shall be:
(A) Closable;
(B) Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping. . . ."
Finally, the standard states in paragraph (d)(4)(iii)(A)(4) that "[R]eusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury."
Since most sharps disposal containers are designed to be autoclavable, steam ports and air spaces between nestable parts are located on the upper portion of containers. Steam ports allow steam to penetrate to the contents of the container during sterilization procedures. These openings may allow fluid leakage or needle-tip protrusion to occur if the container is placed on its side or overturned. The OSHA standard addresses this concern by further requiring that during handling, storage, and shipment, containers be maintained upright throughout their use, routinely replaced, and not overfilled [29 CFR 1910.1030 (d) (4)(iii)(A)(2)].
C. Recommended Strategy for Selecting and Using Sharps Disposal Containers
The following strategy for selecting and using sharps disposal containers should be implemented as part of an overall NSI prevention plan.
Selection of a container or combination of containers should be based on a site-specific hazard analysis. Components of a site-specific hazard analysis should include the following:
An individual or a group should be assigned the responsibility for regular monitoring and maintenance of sharps disposal containers. The designee(s) should frequently and routinely monitor fill levels of containers and be responsible for changing containers before they are overfilled.
Each time a reusable sharps disposal container is returned to service after reprocessing, the user facility should confirm that it meets its original performance elements. In addition, reusable sharps disposal containers should be rendered free of infectious organisms and infectious material each time they are reprocessed and before they are returned to service.
A flow chart describing a decision logic for selecting a sharps disposal container is presented in Appendix C (Figure 2).
This decision logic can be used alone or in conjunction with the performance evaluation questionnaire in Appendix D. Based on the four performance criteria, the questionnaire is designed to assign appropriate criteria and priorities to each step and can be used to frame the selection process. The questionnaire should assist product evaluation committees, facility management, and individual HCWs with proactive sharps disposal container selection and evaluation. Although it is not possible to provide precise guidelines for evaluating questionnaire scores, the lower the score, the better the sharps disposal container (i.e., the highest score would be 44 points and the lowest would be 220 points). A priority or value must be assigned to a criterion on a case-by-case basis. It may be useful to compare the model of sharps disposal container currently in use with the replacement models under consideration by using the questionnaire scoring system.
Before a new sharps disposal container is introduced, worker training should be conducted to address the proper use of sharps disposal containers. All workers who might come into contact with sharps should be included in this training (e.g., maintenance and laundry service staff). Where appropriate, multilingual educational materials should be developed.
For optimal protective value, the sharps disposal container must be readily available, of sufficient size and capacity, replaced when full, and used by workers. No single container type meets the disposal containment needs for an entire facility. The diversity of health care settings and procedures makes selecting a single container impossible.