Single-Use Device Reuse: When Instructions to Save a Unit Create False Claims

Medical device single-use reuse fraud can arise when a manufacturer teaches clinics to reuse devices across patients and causes Medicare claims for unsafe services. In the Prometheus case, the government alleged that providers received instructions to put a glove or condom over a probe and use it on another patient to save money. For someone in clinical training, quality or a medical practice, the important connection runs from what the manufacturer taught to what the clinic did and what Medicare paid for.

Single-Use and Single-Patient Mean Different Things

A single-use device is intended for one use. The distinction matters because Prometheus sold systems that used different kinds of probes, with different restrictions.

Prometheus manufactures equipment for pelvic muscle rehabilitation, a nonsurgical therapy for pelvic floor disorders, including urinary and fecal incontinence. Its Pathway system used the company’s own rectal pressure sensor. Its Morpheus system used another company’s anorectal manometry catheter.

The Justice Department’s complaint announcement reproduces the sensor’s own instructions:

The catheter’s packaging said, “Do not re-use.” The government’s allegation was that the training taught clinics to work around those restrictions.

When Reuse Becomes a False Medicare Claim

The government alleged that Prometheus’s reuse instructions exposed patients to unnecessary infection risks, making the resulting services unreasonable or unnecessary and ineligible for Medicare coverage.

The clinic submitted the claim. The manufacturer allegedly helped cause it by teaching the clinic how to reuse the device. That is why the company’s clinical instruction mattered to a False Claims Act case even though the provider billed Medicare.

The financial incentive sat inside the treatment system. According to the complaint announcement, Prometheus promoted reuse to reduce its customers’ overhead. A clinic could keep using the same probe on different patients instead of replacing it. Under the alleged scheme, the clinic saved a probe, the patient took the infection risk and Medicare paid for the service.

For a manufacturer employee, the connection may begin with a training session or a sales promise about operating costs. For a practice employee, it may begin with the probe used during treatment. We connect those accounts to the services billed and the people who directed the reuse.

The Prometheus Instruction Behind the Claims

The government alleged that Prometheus and its owner knew the devices’ restrictions but encouraged cross-patient reuse for years. Providers were taught to cover the probes with a glove or condom. The complaint announcement also alleged that Prometheus made no attempt to determine whether the probes worked effectively under those reuse conditions.

The cost-saving instruction offered an answer about overhead without establishing that the device still worked as intended.

In March 2025, Prometheus and its owner agreed to pay $550,000 to settle civil False Claims Act allegations that their cost-saving instructions caused providers to submit false Medicare claims.

The Clinical Director’s Guilty Plea

In her guilty plea, Prometheus’s director of clinical services acknowledged the government’s evidence that reusing the rectal sensor across patients, even under a glove, left patients exposed to viral and bacterial cross-contamination. That was the device adulteration in her plea: unsanitary conditions that could contaminate the probe or make it harmful to health. The Justice Department’s December 2020 plea announcement also describes the criminal information charging that she trained Michigan practitioners to use the surgical-glove method.

The person teaching the practice worked for the manufacturer. The instructions accompanying the device restricted it to one patient, while the alleged training supplied a way to use it on others.

What the Practice-Side Cases Show

The criminal cases show how the probes were used inside the practices. The separate civil settlements addressed allegations about the practices’ Medicare billing schemes.

The Physician’s Practices Reused Both Kinds of Probe

According to the Justice Department’s account of the physician’s criminal case, Urological Solutions of Michigan and Women’s Health Care Specialists reused the rectal pressure sensor on different patients during pelvic muscle rehabilitation, covering it with the finger of a surgical glove. Staff at Women’s Health Care Specialists also reused the anorectal catheter for diagnostic studies, covering it with a condom.

Urological Solutions of Michigan provided mobile care in patients’ homes and assisted living facilities. Women’s Health Care Specialists was a gynecology practice in Kalamazoo.

The physician pleaded guilty to healthcare fraud conspiracy and device adulteration. The Justice Department’s criminal-case announcement reports that the court found the practices billed therapy under improper, better-paying diagnostic codes, billed for evaluation and management services that never occurred, and billed for an unlicensed nurse assistant’s services.

The same announcement describes the court finding that the practices continued using the diagnostic codes after an administrative ruling told them to stop. They submitted the billing under nurse practitioners instead. The instruction about how to use the probe and the decision about how to bill the treatment were visible in different parts of the practice.

The physician and his practices separately agreed to pay $610,000 to resolve civil False Claims Act allegations concerning the billing schemes.

The Nurse Practitioner’s Separate Role

The nurse practitioner pleaded guilty to failing to report ongoing health care fraud and to adulteration of medical devices. The Justice Department’s plea announcement for the clinical director identifies the nurse practitioner’s device offense as reuse of the Prometheus rectal sensor on multiple patients.

The nurse practitioner paid a separate $500,000 civil settlement. The practice manager paid $150,000 in his own civil settlement. Those payments resolved allegations concerning the practices’ billing schemes.

The manufacturer allegedly supplied the training, practice staff handled the probes, and the billing operation submitted the claims. Each part of that chain can be understood by someone who never controlled the whole business.

Can Single-Use Devices Be Reprocessed?

The Government Accountability Office’s January 2008 review of reprocessed devices described single-use devices cleared for marketing after cleaning, sterilization and performance testing, a process covered in our discussion of single-use device reprocessing.

What an Insider Can See That the Bill Leaves Out

The clinical instruction and the device’s use history can explain a Medicare claim in ways the bill alone cannot. According to the Justice Department, investigators found the glove and condom practices during the investigation of the providers’ billing in the Prometheus case.

A clinical trainer may know what providers were told and whether the instruction matched the product labeling. A practice employee may have seen the same probe used on different patients. Purchasing and device-processing records can help connect the products acquired to the products used. Treatment records and billing records supply the next connection.

A 2020 analysis in the Journal of Forensic and Investigative Accounting explains why inside knowledge matters to False Claims Act enforcement:

The article also connects Medicare payment to whether the service was reasonable and necessary. In a reuse case, we work with the insider to connect that payment question to the actual treatment and the instruction behind it.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

When You Know How the Probe Was Reused

If you know who taught the reuse, who put it into practice or how the resulting services were billed, speak to one of our Whistleblower Experts about how the probe was reused. We work beside you from the manufacturer’s instruction through the treatment and the Medicare claim to build your strongest medical device whistleblower case. We bring in medical device fraud whistleblower lawyers who understand clinical training and provider billing, and stay with you through the case.