GRAND RAPIDS, MICHIGAN — The director of clinical services at a major medical manufacturer admitted to training medical practitioners to reuse single-use rectal devices on multiple patients.
Denise D’Andrea, director of clinical services at New Hampshire-based Prometheus Group, pleaded guilty in the U.S. District Court Western District of Michigan, to one count of causing the adulteration of a medical device, a Dec. 14 news release from the U.S. Attorney’s Office states.
D’Andrea trained professionals to reuse a single-user rectal pressure sensor on multiple patients by covering it with a surgical glove between uses, according to U.S. Attorney Andrew Birge. The device is used in a form of therapy known as pelvic muscle rehabilitation.
FDA regulations stipulate the use of the sensors is restricted for single-person use only. Use by another person is strictly prohibited.
“When device manufacturer representatives and medical practitioners flaunt the rules, they jeopardize the wellbeing of patients in our community,” Birge said in a statement. “My office is committed to working with FDA and other law enforcement to hold any other responsible parties accountable for this or other similar misconduct.”
D’Andrea’s conviction comes on the heels of the May 2020 convictions of Dr. Roger Beyer and Susan Wright who, in addition to convictions related to healthcare fraud, both pleaded guilty to counts of adulteration involving the reuse of the Prometheus rectal pressure sensor on multiple patients at Beyer’s practices.
Beyer, who practiced throughout West Michigan, is the former owner of Urological Solutions of Michigan and Women’s Health Care Specialists located in Kalamazoo County’s Oshtemo Township.
Related: Former Kalamazoo doctor sentenced to prison for reusing rectal devices, health care fraud
Beyer was sentenced on Oct. 29 by U.S. District Judge Janet T. Neff to serve 4 years, 9 months in prison. Wright was sentenced in September to three years of probation and over 3,000 hours of community service.
Beyer and Wright, along with an office manager, Mark J. Sabor, paid separate civil settlements under the Federal False Claims Act totaling over $1.25 million. Sabor was sentenced to 2 years in prison.
As part of her guilty plea, D’Andrea acknowledged that reusing the rectal pressure sensor on multiple patients, even when covered with a glove, results in the adulteration of the device given the risk of cross-contamination of viral and bacterial diseases, Birge’s office stated.
D’Andrea faces a potential sentence of up to one year in prison.
“The FDA requires medical device manufacturers to provide healthcare professionals with the important safety information, including single-use and single-user designations, that is required to protect patients’ health,” said Lynda M. Burdelik, special agent in charge with the FDA Office of Criminal Investigations.
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