Selection, evaluation and use of sharps box (Serialization 5)

B. Existing standards
Federal standards for existing sharps boxes are listed below. Attached Table E lists other standards for published resources.

The sharps box is regulated by the U.S. Food and Drug Administration as a Class II medical device [21 CFR 860.3]. The Occupational Safety and Health Administration's blood-type pathogen standards establish a minimum design performance element for the sharps box [29 CFR 1910. 1030] (d)(4)(iii)(A)〗. This standard requires that contaminated sharp objects be immediately discarded or placed in a feasible container with the following standards:

 (i) Closed
 (ii) Stab resistance
 (iii) Edge and bottom crack prevention
 (iv) Label or color the standard paragraph (g)(1)(i)

The standard paragraph (g)(1)(i) requires warning labels to be affixed to containers containing controlled waste, blood and other potentially infectious materials stored in refrigerators and cold storage, and other containers used for storage, transportation or shipping. Transport blood or other potentially infectious materials on containers.

The paragraph (d)(4)(iii)(2) emphasizes more that during use, the container for contaminated sharp objects should be:

 (i) Easy to get and place it in the place closest to the sharp weapon being used
 (ii) Always keep it upright during use
 (iii) Replaced frequently and not allowed to overfill

When the containers containing contaminated sharp objects are being moved from the place of use, paragraph (d)(4)(iii)(A)(3) requires them:
 (i) Immediately close and give priority to transfer and replacement to prevent the contents from overflowing or protruding from the container during handling, storage, transportation or shipping
 (ii) If there is a possibility of leakage, put it in a second container. This second container should:
  (A) Airtight
  (B) Can contain all contents and prevent leakage during handling, storage, transportation or shipping

Ultimately, the criterion in paragraph (d)(4)(iii)(A)(4) is that “non-disposable containers cannot be opened, emptied and cleaned manually or in any other way that may expose the user to skin damage. ."

Because most sharps boxes are pressure-resistant and heat-resistant, the air port and space in the sleeve are located in the upper part of the container. The air port allows steam to pass through the contents of the container during the sterilization process. However, such opening may cause liquid leakage or protruding needle tips when the container is placed on its side or upside down. The standards of the General Administration of Occupational Safety and Health Administration clarify this problem and further require that in the process of handling, storage, and shipping, the container should be kept upright during its use, replaced regularly and not overfilled. 〖29 CFR 1910.1030 (d)-(4)(iii)(A)(2)〗.

C Recommended strategy for selecting and using the sharp box
The following strategies for selecting and using sharps boxes should be implemented as part of the overall needle stick prevention plan.

The selection of a container or set of containers should be based on a specific risk analysis. The components of a particular risk analysis are as follows:
 Evaluate workplace risks (biological, physical, chemical and radiological risk control needs)
 Evaluate the model and size of the weapon to be processed
 Evaluate the volume of sharps to be processed after each use
 Evaluate the frequency of emptying the sharps box and the frequency of maintenance of the bracket
 Comply with federal, state and local regulations
 Safety requirements
 Container transfer and transportation requirements
 Clinical and procedural changes and changes
 Changes and changes in laboratory equipment
 Environmental constraints and constraints on waste disposal
 Budget considerations
 Continuous evaluation of medical device technology including the continuous development of equipment design and obstacle materials

An individual or a team should assign the responsibility for daily inspection and maintenance of sharps boxes. The designee should check the container capacity frequently and regularly and is responsible for replacing the container before it becomes overfilled.

Every time a non-disposable sharps box is reused after reprocessing, the user should confirm whether it can achieve the original performance. In addition, the non-disposable sharps box must not come into contact with susceptible organisms and materials before each reprocessing and reuse.

The flowchart in Appendix C illustrates a decision logic for selecting a sharps box.

This decision logic can be used alone or in conjunction with the effectiveness evaluation form in Appendix D. Based on the four performance criteria, this table selects the appropriate criteria and priorities for each step and can be used to build a framework for the selection process. This questionnaire can assist in product evaluation, and equipment management agencies and healthcare personnel can therefore be more proactive in the selection and evaluation of sharps boxes. Although it is impossible to provide a rigorous reference for evaluating questionnaire scores, the lower the score, the better the sharps box (minimum score 44, maximum score 220). Priorities and values ​​must be assigned item by item. It may be useful to compare the sharps box molds in use with the replacement sharps box molds being considered by using a questionnaire scoring system.

Before a new type of sharps box is promoted and used, staff should be trained in the correct use of sharps boxes. This training should include all staff who may have contact with sharps (for example, maintenance and laundry workers). If appropriate, multilingual training materials should be developed.

In order to optimize protection, when the sharps box is full or used by staff, there should be a spare sharps box of sufficient size and efficiency. A single type of container cannot meet the processing and storage requirements of the entire equipment. Because of the diversity of healthcare environments and processes, it is impossible to choose a single container.

A sharps box that is functional, accessible, visible, easy to use, and safe for patients and visitors to manipulate, will reduce the risk of accidents involving skin sharps. In order to optimize protection, a spare sharps box with sufficient size and efficiency is required. The use of sharps boxes should be part of the institutional process
 Support the monitoring of sharp weapon damage
 Reduce unnecessary weapons
 Education and training to promote the rational use of sharps boxes and safety equipment by staff
 Immunize healthcare workers to the risk of exposure to hepatitis B
 Promote compliance with standard preventive measures

There is no product that may meet all the performance standards mentioned in this document. However, in order to develop and popularize products that meet these standards, manufacturers and end users should design and improve sharps boxes together.