The state of Michigan opened an investigation Thursday into Detroit Medical Center prompted by news reports that physicians had for years raised complaints about dirty surgical instruments at five facilities on the Tenet Healthcare Corp. subsidiary's Midtown campus.
“Based on the Detroit News story, our bureau has initiated an investigation into issues related to the sterilization of surgical equipment at DMC facilities,” Larry Horvath, the director of the Michigan Bureau of Community and Health Systems, said in a statement. “We encourage anyone with a complaint regarding these issues to please contact the bureau.”
Michigan's Department of Licensing and Regulatory Affairs (LARA), the parent agency of the Bureau of Community and Health Systems, said it was unable to comment on the investigation.
The Detroit News broke the story after obtaining and reviewing more than 200 pages of internal documents showing that, for more than a decade, DMC surgeons voiced concerns to hospital administrators about surgical instruments that were broken, dirty or simply missing. The facilities described in the documents are Children's Hospital, Detroit Receiving Hospital, Harper University Hospital, Hutzel Women's Hospital and DMC Heart Hospital.
The problems with surgical tools put patients at risk, caused surgeries to be extended or canceled, and complicated others, the Detroit News reported. In one case, blood from a previous operation spurted out of a suction tube that was supposed to draw blood from a 7-month-old undergoing surgery for heart defects.
“We are putting patients at risk frequently and now canceling up to 10 cases this week,” Dr. Joseph Lelli, chief surgeon at Children's Hospital, wrote last year in an email to administrators that was quoted in the article.
Numerous factors—the design of a device itself, the way in which they're cleaned, who cleans them—can contribute to the problem of unclean devices, said Dr. Kenneth Kizer, a professor at the University of California, Davis School of Medicine and the former president and CEO of the National Quality Forum.
"With the advent of minimally invasive surgery robotic surgery, the complexity of the surgical tools has just increased dramatically, which then in turn makes it more difficult to clean them," Kizer said. Devices become more advanced, but procedures for cleaning them have not kept up, he suggested.
The issue of unclean medical devices tends to receive less attention than other areas of patient safety, Kizer added. One reason is that it can be tough to trace a hospital-acquired infection, for instance, directly to an unclean device. "I think, more broadly, the problem with contaminated instruments is probably much bigger than is generally appreciated," he said.
CEO Joseph Mullany said in a memo to physicians Thursday that central sterile processing services had not led to any “safety issues and/or known surgical site infections.”
The Detroit Medical Center said that it has taken steps to improve its central sterile processing department, which Conrad Mallett, its chief administration officer, has said was the source of the problem.
“After careful consideration over several months, on June 1 we entered into a contract with Unity Health Trust ... to manage our central sterile processing department and non-management DMC members,” the Detroit Medical Center said in a statement. “Our new contract with Unity will result in improved central sterile service performance and we have a high level of confidence in their ability to ensure the high standards of quality we expect.”
A spokeswoman for the Detroit Medical Center said she could not answer specific questions about the allegations or the investigation.
In 2015, the FDA published final guidance on reprocessing medical devices in healthcare settings. The document was supposed to reflect the fact that, due to scientific and technological advances, many of these devices "have become highly complex in design and are more difficult to reprocess."
When devices are not cleaned properly, blood, tissue or other biological remains in which germs can survive can be left behind, even after sterilization or disinfection. This debris can lead to infections, tissue irritation or other adverse outcomes.
One type of medical device that has been directly implicated in deadly hospital-acquired infections is the duodenoscope. At least 35 deaths from antibiotic-resistant infections have been tied to the use of tainted scopes in U.S. hospitals, according to Kaiser Health News. (None of those cases involve Detroit Medical Center hospitals.)
Overall, according to the FDA, "the risk of acquiring such an infection from an inadequately processed medical device is relatively low given the large number of such devices in use, although the potential for outbreaks of infection associated with their use remains an important public health concern."
The Detroit Medical Center consists of nine hospitals, with more than 2,000 beds, in metropolitan Detroit and southeastern Michigan. It has changed hands twice in recent years.
In 2010, the Nashville-based Vanguard Health Systems acquired Detroit Medical Center. The shift from a not-for-profit to a for-profit system later proved to be healthy for Detroit's finances. The system cut its operating losses by 90%, or $120 million, during its first two years under Vanguard and increased its profitability. Detroit Medical Center is now owned by Tenet, an investor-owned hospital operator based in Dallas. Tenet acquired Vanguard in 2013.