Expired Or Reused Medical Devices (Class II): Navigating FDA Rules And Risks
Healthcare teams juggle many priorities – patient safety, cost savings, and compliance with a maze of regulations. One area where these priorities collide is the management of medical devices that are expired or labeled “single-use.” Especially for Class II medical devices (moderate-risk devices like catheters, surgical instruments, diagnostic probes, etc.), using them beyond their intended shelf life or reusing disposable items can land providers in hot water. In this post, our Hillsboro, OR whistleblower lawyer breaks down what it means for a device to be “expired” in FDA terms, why that matters, when (if ever) a single-use device can be reused, the roles of manufacturers and healthcare providers in this arena, and what can happen if the rules are ignored. We’ll also look at real enforcement examples – including a recent Department of Justice case – and end with practical tips for staying on the right side of the law (and keeping patients safe).
When Is A Device “Expired” And Why Does It Matter?
What makes a device “expired”? In FDA-regulated terms, an expired medical device is one used past the manufacturer’s recommended shelf life or “use by” date. Medical device makers determine these dates through testing to ensure the product remains safe and effective up to that point. For many sterile disposable devices (think of things like catheters in sealed packaging or surgical implants), the expiration date often reflects how long the packaging can reliably keep the device sterile and functional. After that date, the manufacturer no longer guarantees sterility or performance. In other words, once the stamped date passes, all bets are off on whether the device might have degraded, become contaminated, or otherwise not work as intended.
Why does using an expired device matter? Using an expired device isn’t just a minor technical violation – it can pose real safety risks and legal consequences. From a clinical perspective, the biggest concern is that sterility or integrity may be compromised, potentially leading to patient infections or other harm. Even if the device looks fine, factors like materials breaking down or packaging seals weakening over time mean it may not be safe. No caregiver wants to find out a post-surgery infection was traced back to an old catheter used past its expiration date.
Beyond patient safety, there’s a regulatory and liability aspect. Hospitals are expected (by accrediting bodies like The Joint Commission and by FDA-related standards) to have systems that prevent the use of expired supplies. If an inspector finds an expired surgical implant on your shelf – or worse, a patient discovers an expired device was used in their procedure – the facility could face serious fallout. Patients have sued hospitals after learning an expired product was used on them. The Joint Commission has warned that using expired or compromised sterile devices “poses risk of infection and other harm” and stresses educating staff to recognize expiration labels and symbols on packaging. In short, an expired device is considered unsafe and out-of-bounds by default. Continuing to use it not only jeopardizes patient care but also puts the hospital at risk of legal trouble, from malpractice claims to regulatory penalties.
Reusing Single-Use Devices: What’s Allowed And What Isn’t
We’ve all felt the budget pinch in healthcare. It might be tempting to reuse a disposable device to save money – after all, some of these items seem sturdy enough for multiple uses. However, the FDA’s rules here are very clear: if something is labeled “single-use” (or “single-patient use”), it’s intended for one patient and one procedure only. Manufacturers label devices with terms like “single use only,” “do not re-use,” or with the universal symbol for “do not reuse,” precisely to indicate this. These single-use devices (often abbreviated SUDs) do not come with reprocessing instructions for cleaning or sterilization because they weren’t designed to be reused. Reusing them without proper reprocessing can be dangerous – blood, tissue, or bacteria might remain, or the device might degrade (rust, warp, crack) when you try to sterilize it for the next use. In short, a device marked disposable is typically made with materials and construction meant for one-time use, and trying to clean and reuse it can compromise its function and patient safety.
Is there any safe way to reuse a “single-use” device? Yes – but only under very specific conditions. In the U.S., the only permitted way to reuse single-use devices is by having them reprocessed by an FDA-authorized third-party reprocessor. Over the past two decades, FDA has developed a regime where third-party companies (or hospital reprocessing programs) can get clearance to reprocess certain disposable devices. These reprocessors must meet the same regulatory requirements as the original manufacturer – meaning they have to prove to FDA that the cleaned, refurbished device is as safe and effective as it was new. They provide validated instructions on how to clean, test, and sterilize the item and must show the device still meets original specifications after reprocessing. In essence, an FDA-cleared reprocessor becomes a legal “manufacturer” of a reused device, ensuring quality and safety. Many hospitals contract with such reprocessing companies for high-cost disposable items (for example, certain catheters, laparoscopic instruments, or orthopedic blades) as a cost-saving measure that still complies with FDA rules.
What’s not allowed is a hospital or doctor deciding to simply wash and reuse a single-use device on their own (at least not without going through the FDA clearance process themselves, which is a heavy lift). If you reprocess a single-use item in-house without FDA oversight, you’re essentially operating outside the regulatory safety net. Not only could that lead to patient harm, but it also might be viewed as creating an “adulterated” or misbranded device in FDA’s eyes (since it’s being used in a way not intended or cleared). In fact, some other countries flat-out prohibit reusing single-use or expired medical items by law. The U.S. approach allows it only with proper controls in place. The takeaway: unless you’re using an FDA-approved reprocessor service, a single-use device should remain single-use.
Responsibilities Of Manufacturers And Providers
Both device manufacturers and healthcare providers play critical roles in ensuring expired or single-use devices don’t endanger patients. Think of it as a shared responsibility: manufacturers must give clear guidance and safe products, and providers must follow that guidance.
Manufacturer responsibilities: Medical device manufacturers are on the hook to design and label their products appropriately. For Class II devices, part of the FDA clearance involves setting specifications for sterility, shelf life, and usage. If a product can degrade or lose sterility over time, the manufacturer must determine a reasonable expiration date and print it on the packaging. They also must ensure packaging and storage instructions are provided so the device stays in good condition until that date. For devices that are intended to be reusable, the manufacturer must provide detailed reprocessing instructions (cleaning, sterilization procedures) as part of their FDA clearance. Conversely, if a device is intended only for one use or one patient, the manufacturer’s labeling should make that unmistakably clear – using terms like “single use only – do not reuse” or equivalent symbols. In short, manufacturers must set the rules of the road for each device’s safe use, and not encourage any use outside those approved instructions.
Manufacturers also have an ethical and legal duty not to promote unsafe or off-label uses of their devices. They cannot tell or tacitly encourage healthcare providers to, say, reuse a disposable device or use a product beyond its expiration. A real-world cautionary tale: The Prometheus Group case. In that case, a device company made specialized rectal probes and catheters and sold them with clear labeling as single-patient or single-use devices (the rectal sensor even came with a warning “restricted for single person use only… use by another person is strictly prohibited”). However, the company’s leadership allegedly encouraged doctors and clinics to reuse those probes on multiple patients – advising they could cover the probe with a glove or condom as a makeshift barrier – all to help customers “save money” on disposable supplies. This kind of manufacturer behavior violates FDA rules (since it directly contradicts the device’s cleared labeling) and, as we’ll see in the next section, led to serious legal consequences under the False Claims Act. Bottom line for manufacturers: provide accurate expiration dates and usage instructions backed by science, and don’t push providers to break the rules. If you do, you not only put patients at risk but also expose your company to liability.
Enforcement And False Claims Act Risks: Lessons From Real Cases
What happens if these rules are ignored? The short answer: bad outcomes for patients and serious legal trouble for those responsible. The U.S. Food and Drug Administration primarily regulates manufacturers, but when improper device use compromises patient care – especially if federal health programs like Medicare are billed – it can trigger the False Claims Act and other enforcement actions. The False Claims Act (FCA) is a federal law that imposes liability for defrauding government programs. In healthcare, billing Medicare or Medicaid for services that weren’t provided in accordance with required standards can be viewed as a “false claim.” Using expired or improperly reused devices can fall into that category because the care rendered might not be considered reasonable and necessary (a key Medicare requirement) if it’s delivered with substandard or non-compliant equipment (justice.gov).
A prime example is the DOJ’s case against The Prometheus Group, mentioned earlier. The Department of Justice alleged that Prometheus Group (and its owner) caused healthcare providers to submit false claims to Medicare by training and encouraging them to reuse single-patient rectal sensors and single-use catheters on multiple patients (justice.gov). By doing so, the company essentially helped clinics bill Medicare for a service using devices in a way that violated FDA requirements and put patients at risk. The government’s position was that these services were not eligible for Medicare coverage because reusing those devices was “not reasonable or necessary” given the infection risks and the clear single-use labeling (justice.gov). In 2025, Prometheus Group agreed to pay $550,000 to settle these FCA allegations (justice.gov). (Notably, the settlement did not require an admission of wrongdoing – as is common in such cases – but it clearly reinforced the government’s stance on the issue.)
This case is a wake-up call: It illustrates that both manufacturers and providers can be held accountable. In the Prometheus example, it was the manufacturer that paid, because they actively coached the providers to break the rules. But providers aren’t off the hook either. If a hospital or clinic on its own accord routinely uses expired devices or reuses single-use devices without proper reprocessing, and a whistleblower or investigator uncovers it, they too could face FCA liability or other sanctions. Remember, the False Claims Act has a whistleblower (qui tam) provision – often it’s an employee or competitor who tips off the feds when they see unsafe practices. Federal agents and prosecutors take patient safety violations seriously, not just as regulatory infractions but as potential healthcare fraud. In fact, the Prometheus settlement was the result of a coordinated effort involving the DOJ’s Civil Fraud section, HHS Office of Inspector General, the FDA’s Office of Criminal Investigations, and even the FBI. That’s a lot of enforcement muscle brought to bear on a company pushing reuse of single-use devices.
There have been other enforcement actions in related areas as well. For instance, the DOJ reached a $27 million settlement with a major device manufacturer (St. Jude Medical) for selling defective heart devices and not disclosing the problems, which led to implants that put patients at risk. And in another case, a medical device company in North Carolina paid over $780,000 to settle allegations that it marketed products without proper approvals – some of which had expired regulatory approvals – and thus billed Medicare for devices that weren’t considered necessary or covered. The common theme in these cases is the government using legal tools to hold companies (or providers) accountable when device-related issues cross the line into fraud or abuse.
The takeaway for healthcare folks is clear: Misusing expired or single-use devices isn’t just a technical foul – it can be seen as fraud against the healthcare system. If you knowingly do it and bill for it, you run the risk of heavy fines, repayments, and even exclusion from Medicare. Beyond FCA, there could also be product liability lawsuits or professional disciplinary action. It’s just not worth it. As one DOJ official put it in the Prometheus case press release, “Medicare beneficiaries deserve treatment that is reasonable and safe… [we] will hold those accountable who jeopardize patient safety or submit false claims” (justice.gov). That about sums it up – patient safety and honest billing go hand in hand.
Practical Takeaways For Healthcare Facilities And Providers
To wrap up, here are some practical tips and takeaways to ensure your facility stays compliant with FDA rules on expired and single-use devices, while keeping patients safe and your organization out of legal peril:
- Track and Remove Expired Inventory: Implement a robust inventory management system for medical supplies and devices. Regularly check expiration dates and remove or clearly mark expired items so they are never used on patients. Consider technology solutions (like smart cabinets or inventory software) that alert staff to upcoming expirations to prevent oversight.
- Educate and Train Your Staff: Make sure clinicians and support staff understand how to read device labels and packaging. They should recognize the expiration date symbol and “single-use” warnings at a glance. Periodically train and quiz staff on these symbols and the importance of following them. A Quick Safety bulletin from The Joint Commission emphasized that many staff simply aren’t aware of what these packaging symbols mean (beckershospitalreview.com) – education is key.
- Stick to Single-Use Rules (Use Reprocessors for Exceptions): Adopt a clear policy that single-use devices are never reused on another patient unless they’ve been sent out to an FDA-cleared reprocessor and come back certified for reuse. Do not allow ad-hoc in-house reuse or sterilization of disposable devices – it’s against FDA rules and could harm patients. If cost is an issue, work with reputable third-party reprocessing services for devices that are approved for reprocessing (for example, many hospitals safely re-use things like compression sleeves or certain catheters by using such services).
- Engage Manufacturers and Reps Appropriately: If a device rep or manufacturer suggests any use of a product that deviates from the labeling (for example, “Oh, between us, you can use that beyond the expiration if it looks okay” or “you can get a few uses out of that even though it’s disposable”), treat that as a huge red flag. Challenge it, ask for written documentation, or report it if necessary. Manufacturers should be partners in compliance, not encouraging shortcuts. Rely on the Instructions for Use and FDA guidance, not off-the-cuff advice that violates regulations.
- Foster a Culture of Safety and Compliance: Encourage staff to speak up if they notice expired products or improper reuse. Many enforcement actions start with an employee noticing something and feeling obligated to report it. It’s far better for those reports to be handled internally (and issues fixed) than to have them escalate to a whistleblower lawsuit or an unannounced regulator visit. Create an environment where patient safety and following the rules is everyone’s job, and where cost concerns never override compliance. Consider periodic audits or mock inspections focusing on device expiration and usage practices, so you can catch mistakes before an external surveyor or agency does.
By understanding and following the FDA’s regulatory framework around expired and single-use Class II devices, healthcare administrators and clinicians can protect their patients and their organizations. The mantra to remember: When in doubt, throw it out – and when it says single-use, it’s single-use. No budget savings or convenience is worth the risk of patient harm or a federal False Claims Act case. Stay safe, stay compliant, and you’ll keep both your patients and regulators happy. If you require legal assistance, contact Whistleblower Law Partners today.