The Multifire Endo TA30 stapler is a medical marvel, capable of threading inside a patient and firing a tiny row of titanium staples that hold back tissue so surgeons have space to operate.
There’s just one potential problem: The gunlike device has a tiny white tip that could fall off during surgery.
Innovative devices have revolutionized surgery, increasing the number of procedures that can be done through tiny incisions and reducing both medical complications and recovery times. But the trade-off is the potential for pieces to break off these delicate devices inside patients, which poses new safety complications for hospitals.
The new devices help explain why Minnesota hospitals are reporting an increase, from 27 to 33, in cases of foreign objects left inside patients after surgeries last year.
The trend is one of several revealed Thursday in the Minnesota hospital “adverse event” report, an annual tally designed to reduce medical mistakes by counting and analyzing them.
The report listed 308 mistakes overall, along with 13 related deaths and 98 serious injuries that occurred in the 12-month period ending last Oct. 6. The list included 79 disabling or fatal falls, 107 painful bed sores for patients in hospital beds, and 16 surgeries or procedures performed on the wrong body parts. Patient falls were the most common cause of death.
The total number is up from last year’s report, which listed 258 hospital adverse events, but it includes four categories of medical errors tracked for the first time in Minnesota and broader definitions of some existing errors.
Hospitals, for example, had not counted fragments of medical devices when they reported items retained in patients — not when they were worried about entire needles or sponges being left behind. Their addition to the tally reflects continued progress in the other areas, which is why Dr. Ed Ehlinger, the state health commissioner, didn’t view an increase in these events as necessarily a bad sign.
“We’re doing a much better job with the instruments, the sponges, the bigger things,” he said. “So this is part of our continuous quality improvement effort — looking for things we have overlooked in the past.”
The University of Minnesota Medical Center reported 31 adverse events last year, including eight incidents of objects left behind in patients after surgeries or other invasive procedures. All involved the new reporting category of device fragments. The tiny objects typically don’t create medical complications, but cause anxiety for patients when they show up later on X-rays or, in the case of fragments left in the lung, are coughed up, said Carolyn Wilson, co-president of University of Minnesota Health and chief operating officer of Fairview Health, its partner.
“We believe that any events are too many and we have to work toward zero,” she said.
Fairview has deployed a variety of strategies to prevent objects from being left inside patients. Wiring threaded into patients for minimally invasive surgeries can break off, especially the little “j-hooks” at the ends that pull out tumors or lesions, explained Rich Lloyd, an operating room nurse manager at the university hospital.
So the hospital now uses tape measures to record the length of wiring before it goes into patients, and then after it comes out. Devices such as the auto-stapler are visually inspected before patients are stitched up, and Wilson said the hospital is discussing whether operating room staff should compare used devices with pictures to be certain they are intact.
Retained foreign objects during surgery is one of 29 adverse events reported in Minnesota, which was the first state and now one of only three to report such hospital errors publicly.
Many errors reported by the 69 hospitals last year weren’t related to direct patient care, but rather to misunderstandings of who was responsible for what afterward.
Hospitals reported 20 cases of losing irreplaceable biological specimens — mostly polyps removed from colons — but also three placentas from childbirth. Investigations found hospitals weren’t consistent in the personnel assigned to deliver specimens to pathology labs for analysis.
Two such losses of specimen samples occurred in Allina Health hospitals, both involving biopsy samples smaller than Tic Tacs, said Dr. Penny Wheeler, Allina’s president and chief executive. The hospitals now use a buddy system to verify that such small specimens are successfully delivered to labs, she said.
Wilson envisions a technological solution someday: tagging lab specimens with bar-codes, which many large hospitals use to monitor pharmaceuticals. That would be especially important in academic health centers, where specimens are also examined for medical research, she added.
Test result blunders
The adverse event report also showed that one person died and four were seriously injured because of miscommunication over forwarding vital test results, such as imaging scans or blood draws, to patients.
Such errors are possible when hospitals don’t clearly designate the caregivers responsible for communicating with patients, said Rachel Jokela, who directs the adverse events reporting program for the state Health Department. “We can’t assume that communication is effective, that it’s occurring. That’s what facilities are learning.”
Preventable falls also resulted in six deaths and 73 disabling injuries to patients last year, and have resulted in 67 deaths since Minnesota’s first public adverse event report in 2005. Hospitals have spent considerable time and resources addressing the problem — increasing the use of alarms and motion sensors to alert staff if weak patients move, and purchasing adjustable beds and other safety gear.
The lack of progress, however, suggests the need for fresh ideas, Jokela said. That might include redesigning hospital rooms so that the most common occasions for patient falls — trips to the bathroom — become safer.
“We can’t just keep doing the same things we’ve been doing because the numbers are staying the same,” Jokela said.
Eight Minnesota hospitals reported at least 10 adverse events last year, including Allina’s Abbott Northwestern Hospital, the Mayo Clinic in Rochester, and all three trauma centers in the Twin Cities.
Whatever public relations hit hospitals take from reporting their errors, the benefit of learning from mistakes and sharing experiences is far greater, Wheeler said.
“We don’t want to be legends in our own minds,” she said. “We want to know exactly what we are doing and what we can do better.”