State inspectors found that janitorial staff were doing a subpar job of cleaning the hinges on bed railings last fall at the Hospital of the University of Pennsylvania, according to a report made public this month.
By the time the Pennsylvania Department of Health visited the Philadelphia hospital in May, the problem had been corrected through enhanced training and internal inspections, agency officials reported.
The state's findings were based on interviews with employees and photographs from physician Hooman Noorchashm, whose wife, Amy Reed, noticed the problem during her treatment at the hospital for advanced uterine cancer. She died in May, after she and her husband had waged a national campaign to ban a surgical device that surgeons in Boston had used to perform her hysterectomy, spreading a previously undiagnosed cancer.
Noorchashm expressed dismay over the state's report on the bed railings, saying the fault lay with their design, not with Penn's cleaning staff. The hinges on the TotalCare beds, made by Chicago-based Hill-Rom Inc., have recessed "alcoves" that can trap debris and are extremely difficult to clean, he said. He warned that the railings would pose a problem at any hospital.
"You're going to see debris and crud on those beds because of the way they're designed," he said. "This has never been about HUP. This has never been about janitorial services."
Carlos Urrea, Hill-Rom's vice president for medical affairs, said the company had cooperated with the hospital and the U.S. Food and Drug Administration to address the matter.
"Patient safety is our number-one priority and we take the safety, performance and efficacy of our products seriously," Urrea said in a statement. "We were pleased to work with our customer and the FDA's Center for Devices and Radiological Health to successfully address the concern raised this past fall."
Asked about the state's report and the status of its own review, the FDA sent the following statement:
"The FDA cannot comment on this specific report, but we will evaluate it as part of the body of evidence we review to further our understanding about this issue. We are continuing to gather information at this time."
Penn Medicine worked quickly to address the problem, said Patrick Norton, the health system's vice president for public affairs.
"Infection control is among our highest priorities, and we are fully cooperative with all regulatory review processes," he said. "We are taking this matter very seriously, and have worked closely with the manufacturer to implement enhanced cleaning protocols to ensure patient safety."
The state report did not mention any evidence that patients were harmed by accumulated debris or any microbes it may have contained.
A Penn employee told state inspectors that the hospital did not test the debris, according to an interview excerpted in the report.
"We did not complete a microbiology analysis test on the material found in the alcove areas of the ICU patient beds," said the employee, whose name was not given in the report. "We believed the substance to be dust and lint."
The hinges where the debris accumulated are below the surface of the bed. But Noorchashm said that when patients are connected to plastic tubes for the delivery of medication into the bloodstream, the tubes are draped over the side of beds, near where the debris was found.