sharps disposal container design meets all the dis- Second, containers must be accessible to workers . The following criteria should be used to deter-. To reduce the risk of this occurring, all sharps must be used and disposed of safely in Follow normal first aid measures for a contamination incident. sharps disposal container design meets all the disposal containment needs for all health care settings or following criteria should be used to determine the.
This may be as simple as numbering the containers. Some manufacturers offer bar coding or radio frequency identification systems. Note that this tracking is not the formal tracking regulations where FDA will notify certain device manufacturers defibrillators, heart valves that they must implement a life-cycle tracking system for their device. The regulations are tricky.
The FDA insists that a manufacturer provide a means of tracking along with instructions, but the regulations do not require the manufacturer or the user to actually track the containers.
When the FDA inspector came to our facility during an annual audit, we were asked about tracking, but mostly, the auditor wanted to know how the containers were being cleaned.
Both the manufacturer and the user must file a report with the FDA. The manufacturer is required to investigate the cause of the injury. If the user is operating the wrong cleaning equipment such as using chemicals for cleaning that the manufacturer did not test for or the wrong temperature, we have no way of knowing.
According to a regulatory expert at the U. The definition of routine is not in the regulations and we do not enforce FDA requirements. However, potential liability can force a healthcare facility or disposal company to use the tracking system. For example, if a nurse gets stuck with a needle protruding from a container and sues for damages, an attorney may look at whether the container was used more times than the manufacturer specified. In its guidance to regional administrators, OSHA recommends the use of a fully-automated system for opening, emptying, and cleaning reusable containers.
Operating equipment designed by the container manufacturer may ensure compliance, but is not required. For those healthcare facilities and waste company partners using a sharps container that is not FDA approved, a federal DOT inspection, will land them in hot water. The DOT also will check for a protocol or other documentation to make sure that a container is leak-proof and puncture-resistant. OSHA requires reporting when an injury happens.
The DOT requires reporting if a sharp has punctured the container even if no personal injury occurred. While there is a gap in enforcement regarding tracking and cleaning, FDA does level the playing field for manufacturers. Publicly-available enforcement actions of sharps containers have included three FDA warning letters to manufacturers for failure to comply with the k requirements and obtain an approval letter before marketing their container.
These warning letters are detailed on company failures. In a letter, the FDA informed a company that the quality system regulations were not followed. Design changes were made and control procedures were not followed, documentation was incomplete, procedures did not ensure that manufacturer instructions were placed in the customer shipments, and procedures were not followed to ensure that the design matched production. A second warning letter in identified that a healthcare facility had contracted with a manufacturer to design a sharps insert system for their containers and did not follow Current Good Manufacturing Practices, including failure to designate a management representative to monitor the design process or to create a complaint evaluation process, lack of procedures for conducting quality audits or for implementing corrective and preventive actions, failure to perform evaluation tests when the contract manufacturer delivered the product, and failure to document changes to the design.
This warning letter was the result of an FDA finding of a number of needle stick injuries that the facility failed to investigate. The third warning letter in also showed a failure to comply with good manufacturing practices, including lack of written quality procedures, failure to obtain approval for material-failure reporting procedures, no established auditing procedures, inaccurate container labels, and failure to maintain complaint files or to document the design process.
In this situation, the company was a distributor with a contract arrangement with a manufacturer for a container that the distributor designed. Needle stick injuries continue to plague healthcare providers. However, published enforcement actions have not included material failure investigations for sharps containers.
Both the DOT and OSHA have found problems with container lids, mostly from failure to follow manufacturer procedures for closing the containers.
Leaks have occurred from overfilling and from wheels not properly attached or using carts not designed for the containers. With these inconsistent enforcement actions, a manufacturer may question whether to spend the money to seek FDA approval for a reusable sharps container. Disposal companies may wonder about spending funds on tracking systems. Which employees must be trained? Should part-time and temporary employees be trained?
Who has the responsibility for training workers employed by agencies which provide personnel e. What are the qualifications that a person must possess in order to conduct employee training regarding bloodborne pathogens?
Who is Enforcing Sharps Container Regulations?
Where could information be obtained for conducting training on the Bloodborne Pathogens Standard? Who are some examples of persons who could conduct training on the bloodborne standard? Definitions What is an Exposure Control Plan? The exposure control plan is the employer's written program that outlines the protective measures an employer will take to eliminate or minimize employee exposure to blood and OPIM.
The exposure control plan must contain at a minimum: What does OSHA mean by the term "regulated waste"? The Bloodborne Pathogens Standard uses the term, "regulated waste," to refer to the following categories of waste: It is the employer's responsibility to determine the existence of regulated waste.
This determination should not based on actual volume of blood, but rather on the potential to release blood, e. If an OSHA inspector determines that sufficient evidence of regulated waste exists, either through observation, e. OSHA has provided some additional guidance for the determination of regulated waste. OSHA stated that bandages which are not saturated to the point of releasing blood or OPIM if compressed would not be considered as regulated waste.
Similarly, discarded feminine hygiene products do not normally meet the criteria for regulated waste as defined by the standard. Beyond these guidelines, it is the employer's responsibility to determine the existence of regulated waste. Management of Sharps How should sharps containers be handled?
Healthcare Environmental Resource Center (HERC)
Each sharps container must either be labeled with the universal biohazard symbol and the word "biohazard" or be color-coded red. Sharps containers must be maintained upright throughout use, replaced routinely, and not be allowed to overfill. Also, the containers must be: Closed immediately prior to removal or replacement to prevent spillage or protrusion of contents during handling, storage, transport, or shipping; Placed in a secondary container if leakage is possible.
The second container must be: Closable; Constructed to contain all contents and prevent leakage during handling, storage, transport, or shipping; and Labeled or color-coded according to the standard. Reusable containers must not be opened, emptied, or cleaned manually or in any other manner that would expose employees to the risk of percutaneous injury. Upon closure, duct tape may be used to secure the lid of a sharps container, as long as the tape does not serve as the lid itself.
Where should sharps containers be located? Sharps containers must be easily accessible to employees and located as close as feasible to the immediate area where sharps are used e. In areas, such as correctional facilities and psychiatric units, there may be difficulty placing sharps containers in the immediate use area. If a mobile cart is used in these areas, an alternative would be to lock the sharps container in the cart.
What type of container should be purchased to dispose of sharps? Sharps containers are made from a variety of products from cardboard to plastic. As long as they meet the definition of a sharps container i. How do I dispose of regulated waste? Disposal of all regulated waste must be in accordance with applicable state regulations. In addition to state rules for disposing of regulated waste, there are basic OSHA requirements that protect workers.
The OSHA rules state that regulated waste must be placed in containers which are: Closable; Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; Labeled or color-coded in accordance with the standard; and Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping. If outside contamination of the regulated waste container occurs, it must be placed in a second container meeting the above standards.
OSHA has no specific requirement for hospitals or other healthcare facilities to treat e. Communication of Hazard to Employees When are labels required? In addition, contaminated equipment which is to be serviced or shipped must have a readily observable label attached which contains the biohazard symbol and the word "biohazard" along with a statement relating which portions of the equipment remain contaminated What are the required colors for the labels?
The background must be fluorescent orange or orange-red or predominantly so, with symbols and lettering in a contrasting color. The label must be either an integral part of the container or affixed as close as feasible to the container by a string, wire, adhesive, or other method to prevent its loss or unintentional removal.