Michigan Doc Accused of Using Dirty Devices; HIV, Hepatitis Risk

Ken Terry

June 14, 2019

The Michigan Department of Licensing and Regulatory Affairs alleges in an administrative complaint that Roger D. Beyer, MD, a urologist in Kalamazoo, Michigan, instructed his staff to re-use anorectal manometers on multiple patients. The devices are approved by the US Food and Drug Administration (FDA) only for single-patient use.

The state agency's complaint also charges that the anorectal manometers, which are used to evaluate patients with constipation or incontinence, were cleaned inconsistently between patients.

The Michigan Department of Health and Human Services is encouraging patients of Beyer to discuss HIV and hepatitis testing with their healthcare providers if they have undergone anorectal manometry services provided by Beyer or his clinical practices.

The department said in a news release that it has not received any reports of disease associated with the re-use of the devices. It pointed out, however, that the re-use of anorectal manometers on multiple patients represents a risk of infectious disease transmission between patients.

The licensing agency's formal complaint alleges that Beyer's conduct "constitutes a violation of a general duty, consisting of negligence or failure to exercise due care, including negligent delegation to, or supervision of, employees or other individuals…" This duty exists whether or not injury results, the complaint notes.

In addition, the complaint states that the physician's conduct fails to conform to the standard of care and that it involves the unlawful adulteration of a medical device.

If Beyer fails to answer the complaint within 30 days, the state says, the department of licensing and regulatory affairs will transmit the complaint directly to the disciplinary subcommittee of the Michigan Board of Medicine.

Multiple Instances Reported

Beyer owns two practices, Urological Solutions of Michigan and Women's Health Care Specialists. According to the state Department of Health and Human Services, these practices often performed medical procedures at long-term care and skilled nursing facilities in west Michigan.

The complaint does not say how the licensing agency discovered that the anorectal manometers were being re-used. But it does point out that the packaging materials from Prometheus Group, the device's manufacturer, state that it is to be used only once.

In February, the complaint says, a department investigator interviewed three nurse practitioners (NP) employed by Beyer's practices. They all told the investigator that they had re-used the devices on multiple patients. One nurse, the complaint says, "estimates that a [rectal pressure] sensor was used over 100 times before being replaced."

Another NP said the rectal pressure sensor "was cleaned occasionally and re-used on multiple patients."

Beyer could not be reached for comment at press time. A spokesman for the Michigan Department of Licensing and Regulatory Affairs, which includes the state medical board, declined to comment on the allegations.

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