FDA’s new medical device guidance questioned

Mark A. DeSorbo

ROCKVILLE, MD—Single-use reuse: An oxymoron by any standard, but a reality now that the U.S. Food and Drug Administration (FDA) has issued its final guidance on salvaging medical devices from catheters to tracheal tubes.

The 43-page “Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals” means more business for third-party processors, higher costs and red tape for hospitals and a potential threat to the contamination control effort.

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Hank Rahe: “Single-use device performance is validated for what it says, single-use. “

“Single-use device performance is validated for what it says, single-use. There is probably little or no data to say otherwise,” says Hank Rahe, a member of the CleanRooms Editorial Advisory Board and director of Contain-Tech Inc. (Indianapolis).

Many industry agencies, however, stand ready to enforce the FDA's guidelines, while others, like the American Hospital Association (Washington, DC), attempt to approach the subject diplomatically.

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While reprocessing single-use devices is on the minds of many, some manufacturers make products that cannot be reprocessed once it is used. The SoloShot FX syringe from Becton, Dickinson and Co. (Franklin Lakes, NJ) is designed to prevent reuse. The plunger can only be pulled back once. Once the plunger is pushed in to inject the medication, it locks in place and cannot be pulled out again.

“We strongly endorse vigorous FDA oversight of reprocessing and we look forward to complying with the agency's new guidelines,” says Pamela Furman, executive director of the Association of Medical Device Reprocessors (Washington, DC).

In June, Dr. John Clough, testified on behalf of the American Hospital Association (Washington, DC) before the Health, Education, Labor and Pensions Committee of the U.S. Senate, citing FDA and Centers for Disease control reports that single-use reprocessing poses little or no risk to the public, but new FDA guidelines punish healthcare organizations.

“It represents responsible waste management and appropriate use of scarce healthcare resources,” says Clough, chairman of the health affairs committee at the Cleveland Clinic Foundation (Cleveland, Ohio). “In the absence of evidence that reprocessing and reuse of medical devices labeled as 'single use' are a threat to patient safety, regulating reprocessing by treating hospitals as manufacturers adds costs without adding the benefits of increased patient safety or improved outcomes.”

Under the final guidance, issued August 14, the FDA will regulate third-party processors and hospitals that reprocess single-use devices the same way the agency now regulates original equipment manufacturers.

This includes: pre-market notification and approval requirements; registration and listing of firms; submission of adverse event reports; manufacturing requirements; labeling requirements; medical device tracking and correcting or unsafe medical devices removed from the market.

Enforcement priorities for pre-market submission requirements will be based on an existing three-tier medical device classification system: Class I for low risk devices, Class II for moderate-risk devices and Class III for high-risk devices.

According to the FDA's “List of Single-Use Devices known to be reprocessed,” low-risk or Class I devices range from orthodontic brackets to general hospital items like blood lancets, mattress covers and disposable scissors. Class II or moderate-risk devices include angiographic needles, urological catheters and surgical gowns. High-risk or Class III devices include cardiovascular balloons and catheters, needle-destruction devices and endotracheal tube changers.

The FDA intends to actively enforce the pre-market submission requirements for third-party and hospital reprocessors in six months for Class III devices, in 12 months for Class II non-exempt devices, and in 18 months for Class I non-exempt devices. In the future, the FDA will examine on a case-by-case basis whether it needs to revoke exemptions from pre-market requirements for Class I- and II- exempt products based on the risk that may exist due to reprocessing.

FDA will enforce other existing requirements for third-party reprocessors, including registration, listing, medical device reporting, tracking, corrections and removals, manufacturing and labeling. The FDA, however, intends to phase enforcement of existing non pre-market requirements for hospital reprocessors within one year of the issuance of the guidance. The agency will use this time to educate hospitals about their regulatory obligations.

Single-use reuse, however, raises issues of functionality, performance and liability, says Rahe, a columnist for CleanRooms. “The original equipment manufacturer says 'use it once and throw it away.' If you reprocess it, where's the data? Does it work twice? Three times? How many times can you reprocess it?”

Other issues, Rahe says, are performance and sanitization or sterilization. “The original device was clean when it was manufactured, and when it's used, it is exposed to an unclean environment. Now, you need to clean and sterilize it. What's the guarantee that it will perform as designed.”

There are even circumstances in which devices are incorrectly classified as single-use. Minntech Corp. (Minneapolis, MN), a medical device manufacturer, produces dialyzers, blood filters used in dialysis that are often classified as single-use devices.

Although dialyzers can be discarded like a single-use device, they are reprocessed and used up to 15 times by the same patient, says Wayne Carlson, a reprocessing product manager in hemodialysis products at Minntech.

Carlson raises the question, “Is it really single-use or multiple-use?” While the FDA guidelines are aimed at a plethora of medical devices labeled as single-use, dialyzers, he says, are inappropriately classified.

There are indeed single-use dialyzers, but one that is reprocessed is not a single-use medical device, Carlson explains, adding multiple-used dialyzers “get thrown in” with the FDA's “known to be reprocessed” list.

“It's apples and oranges,” he says. “The reality is dialyzers have been reprocessed and reused since the late 1960s, and cross-contamination is not an issue, as long as the reprocessed dialyzers are used by the same patient and procedures and protocol are followed.”

Before coming to Minntech, Carlson worked on the clinical side of healthcare, directing a dialysis program at a hospital. “I routinely reused devices, and routinely followed protocols and procedures that verified that the device was safe for multiple use,” he adds.

In the contamination control world, the word “verified” means validation, a process that, Rahe says, should be mandatory to ensure the sterility of reprocessed single-use medical devices.

“If you are going to reuse single-use medical devices, you need validation,” he says. “You have to validate that it will function multiple times and that you have cleaned and sterilized it.”


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