Brooke Army Medical Center, the flagship of the Army’s health system and famous for its burn ward that has treated hundreds of war victims, has closed more than half its operating rooms and reduced elective surgeries after it found improper sterilization last month of instruments in 73 cases, including 16 incidents in which fragments of organic material such as bone, skin or blood were left on surgical tools.

BAMC commanders said they shuttered 16 of the 28 operating rooms because of a shortage of 600 sets of properly sterilized instruments. They could not say when the hospital would improve the sterilization department to the point it could reopen the ORs.

The temporary closure does not affect BAMC’s Level 1 trauma center, which gets priority for the sterilized equipment. One of 15 such centers in the country, it handles 48,000 emergency cases a year from 22 South Texas counties.

The hospital, which has treated thousands of troops from wars in Iraq and Afghanistan, did not directly say whether dirty instruments led to infections, noting that Army rules prevent such disclosure. One commander, Dr. Douglas Soderdahl, a colonel, said that “there’s no concerning spikes or things going in the wrong direction” regarding BAMC’s medical care.

BAMC, which disclosed the problem in an April 21 briefing with several hundred doctors and other medical personnel, wouldn’t confirm the number of cases but acknowledged the sterilization problem and closure of operating rooms. A physician familiar with the meeting provided the numbers to the San Antonio Express-News and said the hospital also recorded 24 cases of improperly processed surgical sets in December and 14 in September.

“It was a point of contention during the meeting. Several surgeons stood up and said, hey, this is an issue. We’re having poorly sterilized equipment, it’s a recurring issue and … it happens, if not on a daily basis, multiple times a week,” said the doctor, who asked to remain unidentified for fear of retribution.

“It doesn’t mean 16 patients had those instruments used on them. Those instruments may have come up to the operating room and while they were being opened and getting ready to be used on a patient were identified,” the doctor added. “But the way many people look at it, it’s evidence of an underlying problem, and if we’re catching 16 of those, then how many are out there, how many are we not catching?”

Soderdahl, BAMC’s deputy commander for surgical services, cautioned against drawing conclusions from the numbers provided to the paper, saying, “Charts can tell different stories and can be interpreted in different ways.” The hospital publicly announced its action in a short news release Friday after interviews the Express-News did with Soderdahl and others earlier in the week.

The potential danger of organic material left on sterilized instruments, called “bioburden,” was a point of contention for Soderdahl and a San Antonio expert. Soderdahl described bioburden as “unintended remained material” after sterilization. Asked whether it could survive sterilization, he said infectious disease colleagues have told him that “it’s unlikely for a living organism to make it through the process.”

Weston “Hank” Balch, director of sterile processing operations at San Antonio’s University Health System and president of the South Texas Association for Sterile Processing, said bioburden is a potential threat. He said a substance called “biofilm” can form on an instrument containing leftover organic material after it has been sterilized. The substance may cause illnesses if the tool is used on a patient, he said, adding that BAMC isn’t alone in confronting the problem.

“I think you would be hard-pressed to find a facility in the U.S. that has not had that issue. Enough people die every single day because of medical errors to fill a 747,” he said.

The hospital’s commander, Brig. Gen. Jeffrey Johnson, who’s also a doctor, said the hospital documented a backlog of more than 600 sets used in surgeries. Medical teams will use one or more instrument sets, depending on the nature and complexity of an operation.

The hospital did not say how many elective surgical procedures would be canceled, but Johnson said efforts are underway to boost staff at its Sterile Processing and Distribution facility, where 60 military and civilians work.

“We really found where the demand and the supply became unequal, and that’s why we had to slow things down,” he said. But he said BAMC would not limit its ability to treat trauma cases.

One patient whose surgery was delayed said she will wait to have a hip replacement procedure and doesn’t know if she’ll have it at BAMC.

Her doctor, who is her first choice to do the operation, is expecting to deploy.

“It’s very sad to know they don’t have enough staff to keep their equipment properly sterilized so they have to cancel surgeries,” said Marion Hempenstall, 77. “That’s very unfortunate … because I’m older, but all these young troops that are coming back. I think they can still do all the trauma stuff, but then they can’t do all this other stuff at the moment.”

How BAMC rates

Touted as the Army’s premiere medical facility, Brooke Army Medical Center replaced a Depression-era facility in 1994. It’s the Army’s sole Level 1 trauma center and operates the Defense Department’s only burn treatment facility.

The hospital underwent a $724 million expansion a decade ago and now includes 425 military and civilian inpatient beds, and it can expand to 613. The project also added a rooftop helipad that allows trauma patients to be moved directly to the emergency rooms.

The 1.5-million-square-foot facility boasts six outpatient clinics that draw 4,000 patients a day. The hospital employs 8,500 military and civilian workers and has alliances with Army researchers and others throughout San Antonio, as well as Bexar County’s University Hospital.

BAMC’s doctors, nurses and technicians have rotated to Iraq and Afghanistan, and an elite team of specialists flew critically injured patients from Germany to the hospital as it emerged as a hub of care. The survivors have rehabilitated at the nearby Center for the Intrepid, which is a short walk or wheelchair ride from BAMC.

The survival rate for troops, at 80 percent in the Gulf War, has risen in the post-9/11 era to more than 9 in every 10 as BAMC’s physicians collaborated with researchers working at the Army’s Institute of Surgical Research, which is next door to the hospital.

Johnson noted that BAMC has earned good marks from organizations that study medical facilities across the country, one of them the American College of Physicians, making it into the top 10 percent of hospitals in delivering safe care.

The scrutiny hasn’t always brought positive headlines.

A 2014 comprehensive review of the Military Health System, one of the nation’s largest, with spending of over $50 billion a year, found that BAMC met the standard for surgical mortality rates but needed improvement for complications from surgery. The study revealed that BAMC was one of four military hospitals with high rates of complications for two or three years in a row, the New York Times reported.

The College of Physicians’ National Surgical Quality Improvement Program, surveying mortality outcomes in specific areas over a three-year period, also found that the hospital needed improvement in urinary tract infection care and surgical site infections.

Several other areas were listed as needing improvement, but NSQIP said BAMC met the standard in most of the nine categories of the 2010-13 survey.

In its latest report, NSQIP gave BAMC an exemplary rating in 12 surgical areas. The hospital, in an April 11 news release announcing the results, also said BAMC earned the best possible rating for mortality after surgery. It quoted Army Lt. Col. Alex Mckinlay, staff otolaryngologist and NSQIP surgeon champion, as saying the hospital was “in the top 10 percent when it comes to our patients’ survival rate after surgery. This is a gigantic accomplishment for our surgical department.”

Johnson, Soderdahl and Air Force Col. Kimberly Pietszak, a doctor and BAMC’s deputy commander for quality and safety, pointed to the NSQIP database and another maintained by the Centers for Disease Control and Prevention in Atlanta as proof that BAMC has done well, especially compared with major hospitals around the nation.

Soderdahl referred to the NSQIP database as “kind of the all-star team of hospitals.”

“And there’s about 650, right around that many, hospitals that participate, and they’re all the well-known hospitals — Johns Hopkins, Mayo, Cleveland Clinic … and it does give us a nice benchmark (that shows) we have done very well in those databases,” he said.

Problems elsewhere

Problems with unsterilized surgical instruments have claimed lives elsewhere.

A few years ago, deadly infections linked to contaminated gastrointestinal scopes made by Olympus Corp. resulted in at least 18 deaths at Virginia Mason Medical Center, Kaiser Health News reported. Seventeen others suffered infections.

The hospital said the deceased patients suffered from other illnesses.

A Michigan investigation uncovered problems with the Detroit Medical Center’s central sterile processing department, finding numerous issues with the way new and existing workers and managers were trained. The state reported last year that employees failed to attend training sessions and that some never received follow-up instruction.

The Detroit News, citing more than 200 pages of internal documents, learned that doctors at the medical center told administrators that surgical instruments were broken, dirty and missing, Modern Healthcare.com reported. In one case, blood from a past surgery came out of a suction tube used to draw blood as a child underwent an operation for a heart defect.

The Food and Drug Administration issued new guidelines two years ago for reprocessing reusable medical devices, which it said had become “highly complex in design and are more difficult” to clean — especially robotic tools. It advised manufacturers of reusable surgical tools to “consider device designs that facilitate easy and effective cleaning, as well as any necessary disinfection or sterilization by the users.”

At BAMC, instruments get an initial rinse in the OR with a water-soaked sponge. Then a technician douses the tools with an enzymatic spray before sending them to the sterilization department on a robotic cart.

After further enzymatic washing, sets are placed in an ultrasonic cleaner for about 12 minutes, rinsed with deionized water and put in anautomatic washer/disinfector for a minimum of 32 minutes. Staffers conduct a quality check to ensure that all bioburden is removed. If contamination is found, the set is sent back for a repeat of the process.

If the set has passed quality control, a staffer assembles the tools and examines scissors and other items for bioburden, as well as functionality and sharpness. After another quality control check, the instruments are sterilized in an autoclave with the steam set at 275 degrees.

“We run one of these safety checks with each load that we sterilize. And so in the last six months, the last 12 months, we’ve had no indications that our sterilization process has failed,” Soderdahl said.

“Not only does the sterilizing indicator tell us the amount of steam, temperature and time was correct, it also has a biological indicator in each of the loads that says that load that went through the sterilizer received the amount of sterilization required to kill anything that’s living.”

Increasing demands

Johnson, BAMC’s commander, said the backlog in sterilized sets is rooted in an order to boost the number of elective surgeries, which was part of “a deliberate strategic initiative to increase the amount of care that we do here” and improve proficiency.

“So we increased the number of surgeries that we were doing in order to provide more readiness,” he said. “That increase in number of surgeries then created strains on the support team systems that go with that.”

Over the past six to nine months, Johnson explained, hospital commanders began to see “a variety of different strains on our surgical line” that went beyond Sterile Processing and Distribution.

“So some of those strains are equipment, some of it space, some of it people, some of it time, and they’ve all been trying do their own adjustments. … But in the long run, some of those adjustments actually made us less efficient,” he said.

Pietszak, the BAMC deputy commander, reasoned that if the surgical sets had not been sterilized, “the risk is really an infectious risk” and would be documented. She went on to say the sets have been sterilized “at the right temperature for the right amount of time, and so I do not believe that we have a problem with unsterile instruments going to the OR.”

University Health’s Balch, who has studied sterile processing issues for nearly 10 years, said the problem likely began in the operating room — after surgery — when OR teams do the initial cleaning.

“When places have issues with bioburden … the question is not is the sterilization process working. The question is, where is the cleaning process breaking down? And if you’ll read the findings of CMS at Detroit, you actually find it started in the OR,” he said. CMS is the Center for Medicaid and Medicare Services, which investigated the hospital.

Still, BAMC’s sterilization processing facility is under strain. The hospital, with 70,000 enrolled beneficiaries and 240,000 people eligible to visit facilities on the three installations that make up Joint Base San Antonio, has lost seven civilian workers in Sterile Processing and Distribution over the past year.

At the same time, BAMC has been seeing more patients — a rise of around 2,000 beneficiaries this fiscal year. Every month, the hospital sees a steady increase in its over-65 population. With so many civilians coming to the hospital, the rising number of incidents — one of them a dead insect found in an instrument set — has prompted many doctors at the hospital to become concerned about the trend.

“Doctors want to do the very best they can, and if something bad happens, ultimately the responsibility is theirs,” said the doctor who informed the Express-News. “The doctors are the ones that enter into the patient-doctor relationship. It’s us, there’s a team, the medical team, but when it comes down to it, the doctor’s the guy you have put your trust in, you have put your faith in. And these individuals, I think, are really, really feeling the stress here. So it’s disturbing, it’s very disturbing, very frustrating.”

sigc@express-news.net