10 Common Myths About Medical Device Reprocessing

"Reprocessed devices are less safe than new ones."

Safety is a fair concern. Any device used in patient care must meet strict expectations. But FDA-regulated reprocessed single-use devices are required to meet the same applicable FDA requirements as original equipment manufacturers before they can be marketed and used again.

The FDA states clearly that third-party reprocessors are subject to the same types of regulatory requirements that apply to original equipment manufacturers.¹

"Reprocessing compromises device performance."

A reprocessed device is not returned simply because it looks clean. It must be demonstrated, through validation and testing, to continue to meet applicable performance and safety requirements. The FDA expects reprocessors to demonstrate that the device can be adequately cleaned, that its physical characteristics will not be adversely affected, and that it will continue to meet regulatory requirements.²

That is exactly why functional testing is a non-negotiable part of the reprocessing workflow. Devices that cannot meet quality, performance, or safety standards do not make it back to clinical use. It is also worth noting that findings can vary by device type, reprocessing method, and regulatory clearance status. Not every device is eligible, and that distinction matters.

"Sterilization isn't as thorough as OEM manufacturing."

Reprocessing is not simply wiping down a device. The process includes validated cleaning and disinfection or sterilization methods specifically designed to reduce infection risk before reuse.

"Reprocessed devices aren't FDA regulated."

This is one of the easiest myths to disprove. Third-party and hospital reprocessors of single-use devices are subject to the same regulatory requirements that apply to original equipment manufacturers, including premarket submission requirements when applicable.³

Reprocessing is not an informal or unregulated practice. Reprocessors must comply with FDA expectations related to safety, effectiveness, labeling, reporting, quality systems, and other regulatory responsibilities.

"Using reprocessed devices creates more liability."

Some healthcare organizations worry that reprocessed devices expose them to additional risk. Risk considerations may differ depending on whether devices are reprocessed through a compliant FDA-regulated program, as well as institutional policies and risk management practices.

FDA-cleared reprocessed devices are legally marketed medical devices. Healthcare facilities have used these programs for years as part of cost-saving and sustainability strategies.¹ The question is not whether a device is "new" or "reprocessed." It is whether it has been properly processed, tested, documented, and cleared through the appropriate regulatory pathway.

"The cost savings aren't real."

Cost savings are one of the primary reasons healthcare facilities use reprocessed devices, and the numbers back it up. Industry-reported estimates suggest that hospitals and surgical centers using reprocessed devices may realize significant cost savings, with some analyses reporting hundreds of millions of dollars in annual savings. Reprocessed devices are commonly priced 30% to 50% less than new equivalents.⁴

A 2026 systematic review also found consistent evidence of meaningful annual hospital savings across facilities with active reprocessing programs.⁵ Savings vary by device type, collection volume, and program participation, but the financial benefit is real when eligible devices are properly collected and reprocessed.

"Reprocessing doesn't really help the environment."

Healthcare generates a significant amount of waste, and single-use medical devices are a major contributor. Reprocessing extends the life of eligible devices and reduces the need to manufacture and dispose of a new one every time.

The FDA notes that reprocessed single-use devices may reduce environmental impact by limiting use of non-renewable resources and decreasing medical waste requiring treatment and disposal.¹ Cardinal Health reported that its Sustainable Technologies division collected 21.6 million single-use devices in fiscal year 2025 and diverted 6.6 million pounds of waste from landfills.⁶

"OEMs oppose reprocessing because it's unsafe."

Safety concerns should always be taken seriously. But it is also important to recognize the economic reality: when eligible devices are reprocessed and reused, healthcare facilities purchase fewer new devices, which may have economic implications for the original equipment manufacturer.

Healthcare leaders should evaluate reprocessing based on the evidence: FDA regulation, device eligibility, validated processes, safety data, performance testing, cost savings, and environmental outcomes.

"Single-use means it can only be used once. Period."

The "single-use" label can make reuse seem automatically unsafe. But the FDA explains that some single-use devices may be suitable for reprocessing, while others are not.² A device must be able to withstand cleaning, sterilization or disinfection, and continued performance requirements. If it cannot, it should not be reprocessed.

"Reprocessing is a fringe practice."

Reprocessing is not new. The FDA notes that reprocessing single-use devices began in hospitals in the late 1970s and became widespread as a cost-reduction and waste-reduction strategy.¹ Today, it is used by hospitals, surgical centers, and other healthcare facilities looking to reduce expenses, strengthen supply chains, and support sustainability goals.

As healthcare organizations face rising costs and increasing pressure to reduce waste, reprocessing continues to be a practical, mainstream strategy.