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Thursday, July 30 2015
Maryland Sharps Container Regulations
Who is Enforcing Sharps Container Regulations?
“Can someone help me better understand what motivates a reusable sharps container user to record the cycles left on a container?”
“What’s happening is that some containers are being used differently than the FDA approval requirements,” said George Weishoff, Owner, MED-FLEX, Inc., Hainesport, N.J. “At MED-FLEX we work with the manufacturer to purchase a container that will work for our customers and is in compliance, but some companies purchase a sharps container with detailed manufacturer instructions and then manage the containers in a way that better matches their company and customer operations. In at least one situation, a manufacturer designed and sold a sharps container claiming FDA approval, but then changed their mind about that approval. Users of the container, who spent a lot of money on purchasing the containers, are still using them as a sharps container.”
So, what are the requirements for sharps containers, what are different agencies enforcing, and why should a healthcare facility and waste management company follow manufacturer instructions?
The process starts when a manufacturer decides to consider producing a sharps container. “The container must meet customer needs and performance requirements, which have to be documented from the very first thought,” stated Meissen. She added, “Before a manufacturer can start molding plastic, a quality system is established. This system includes developing design parameters with a document control system, design verification and validation, and extensive testing.”
Sharps containers are regulated by the FDA as a Class II general hospital medical device through the authority of the Federal Food, Drug, and Cosmetic Act. The requirements are called the 510(k) process in reference to the applicable section of the act. A sharps container manufacturer must receive an order, in the form of a letter, from the FDA clearing the device for commercial distribution. This includes showing that the device is substantially equivalent to another device already legally marketed in the U.S. and is at least as safe and effective as that device.
A manufacturer must follow design controls during device development and provide the FDA with design control documentation. These design controls include several stages of planning. In general, planning refers to design and development activities and defines the responsibility for implementation of the plan. For example, the plan must show the relationship between different groups or activities that have input in the process such as the role of a company’s engineering and marketing teams. As the development process proceeds, the plan must be reviewed, updated, and re-approved by a designated company employee.
Procedures must be established to make sure the device is designed for its intended use. The FDA’s “Current Good Manufacturing Practices” regulations are part of the design quality control process. These requirements were added in the 1990s to comply with the Safe Medical Devices Act passed by the U.S. Congress to address device failure concerns.
Before the first container is produced, final specifications, inspections and testing criteria must show that the device’s design and final product match. “All of the participants in the container’s design look at the results to make sure that their activities and concerns have been fully considered – engineering, marketing, sales – everyone,” said Meissen.
Once the design is finalized, the manufacturer validates the design by producing a low volume of the container ensuring that the device conforms to its intended use. The container must be tested using actual or simulated use conditions and risk analysis.
While not part of the regulatory requirements, the FDA has published a detailed list of questions product evaluators (healthcare facilities or waste disposal companies) should ask when selecting a sharps container that manufacturers should consider in the design process. These include puncture resistance, safety features, opening and closing mechanisms, potential for spillage, ease of use, safe transport, autoclaving capability, handling procedures, container color and warning labels, overfill protection, container access, mounting systems, and cost effectiveness.
“At the end of the design stage, we must maintain a design history file that includes all required documentation,” Meissen stated. This file is not a place to dump documents, but, instead, includes an index and identifies the location of all applicable documents.
Once the container is ready for production, labeling, tracking, cleaning, and reporting requirements must be followed. The FDA’s labeling requirements include information provided through markings on the device (fill line, warning labels), manufacturer instructions, advertising, and other promotional material. Samples of these labels are submitted to the FDA through the approval process.
For reusable sharps containers, the FDA wants to see a tracking mechanism to allow users to determine the number of cycles a container can undergo before failure. 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. Instead, approvals make note of the tracking system provided to users and may state that the user can decide on whether to purchase that manufacturer’s cleaning equipment and tracking software.
“In my experience, no one from the FDA point of view is monitoring the cycles,” said Andrea Arredondo, President, Earth Compliance Solutions, Virginia Beach, Va. She explained that when she worked for a manufacturing company, “The FDA asked how we would track the containers, but seemed willing to accept any method. 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.”
The tricky part is that while the FDA does not enforce tracking by users, the agency requires that a manufacturer maintain a relationship with users for purposes of reporting container material failure, i.e. when a medical device may have caused or contributed to a serious injury or death such as a needle stick from a sharp puncturing a container’s sidewall. Both the manufacturer and the user must file a report with the FDA. The manufacturer is required to investigate the cause of the injury.
“The first question we would want to ask is how many cycles has the container undergone,” said Meissen. She added, “The manufacturer is held liable if someone is harmed, but if the container was used for too many cycles, the fault is not ours. Yet, we have no control over the user’s management system. 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.”
The regulations are more complicated when reviewing the requirements of other federal agencies. According to a regulatory expert at the U.S. Occupational Safety and Health Administration (OSHA), “Our regulations require that a sharps container be leak-proof on the sides and bottom, puncture-resistant, not be overfilled, and be replaced routinely. The definition of routine is not in the regulations and we do not enforce FDA requirements. A healthcare facility subject to OSHA’s regulations must have an exposure control plan that should include sharps and sharps container management.”
This means that healthcare facilities can follow manufacturer instructions such as container tracking and cleaning systems as part of an exposure control plan, but OSHA does not require that they do. 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.
“We check our containers regularly to make sure that they are not cracked and that the lids fit,” said Weishoff. He added, “We really haven’t had a problem because the sharps containers we buy last for years, and I’m not going to deliver a container to a customer that isn’t right.”
Other OSHA regulations that apply include a provision that reusable containers cannot be opened, emptied, or cleaned manually. The definition of manual is controversial because the definition refers to preventing “employees from exposure to the risk of percutaneous injury,” but does not specify whether a cheap screw driver or an expensive electronic opening system is required. 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.
Rick Racksnis, Director of Field Operations, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation (DOT) said, “An offerer [(healthcare facility)] is responsible for the packaging and must follow the packaging requirements, including labeling, marking, puncture-resistance, shipping papers, and other specifications.” He added, “The DOT requires that a sharps container be FDA approved and our investigators are going to look for that approval, but will not check the tracking system because that’s not in our regulations.”
Like OSHA’s requirements, the results from the U.S. DOT’s regulations are mixed. 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. However, for reusable sharps containers, following a manufacturer’s tracking instructions may serve the purpose of the DOT’s container integrity regulations, but other evidence of compliance may also be acceptable.
A significant difference between the OSHA and DOT requirements are the reporting regulations. 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 510(k) requirements and obtain an approval letter before marketing their container. These warning letters are detailed on company failures. In a 2006 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 2008 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 2008 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.
Most of OSHA’s enforcement actions have been for failure to develop and comply with exposure control plans and failure to update these plans and test them for effectiveness. Needle stick injuries continue to plague healthcare providers. However, published enforcement actions have not included material failure investigations for sharps containers.
The DOT’s actions were mostly for failure to use a sharps container and disposing of sharps directly into plastic red bags or cardboard boxes. 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. But, there may be other reasons to invest.
“We use the tracking system with a bar code provided by the manufacturer because it helps us understand our business,” said Steven Groenke, Chief Executive Officer, Curtis Bay Medical Waste Services, Baltimore, Md. He explained, “A sharps container in a patient’s room may be exchanged every 60 days, but in an operating room a container is pulled daily. We use a standard operating procedure to manage these containers and incorporate a logistical deployment process that includes the bar code. Our company owns and operates medical waste facilities from the New England states to Georgia, we need to ensure compliance with a consistent process.”
Groenke emphasized the relationship of his company to his customers. He said, “From an economic standpoint, the use of a reusable container saves money because of reduced weight from fewer containers.” For a single-use container, the container becomes part of the disposal weight, but with a reusable some of this weight is saved. “In addition,” said Groenke, “customers are looking at zero waste opportunities, they want sustainability, and tracking helps them to reach that goal.”
So it seems that the FDA regulates the quality of sharps containers by requiring manufacturers to produce a well-made product and advise users on how to maintain that quality through tracking, cleaning, and other management instructions. The agency fails to fully implement its regulations by not requiring users to follow the instructions or purchase compatible cleaning equipment and tracking tools. This leaves manufacturers with questions about compliance and responsibility. Other agencies have overlapping regulations for sharps containers, but do not fill in the gaps left by the FDA. Ultimately, users will follow manufacturer instructions and buy compatible cleaning equipment when they make good business sense, reduce potential liability, and support their environmental policies.