During a surgery at Brooke Army Medical Center on June 9, an operating room staffer discovered a bone fragment from a previous patient lodged in a sterilized surgical tool.
A surgical team member set aside the tool tray and scrambled to find a non-contaminated set to continue the operation to repair the fractured hip of an elderly accident victim.
Over the next few hours, the military hospital’s Sterile Processing Department, responsible for cleaning and sterilizing thousands of instruments each day, sent five more sets to the operating room. Leftover tissue, bone or blood contaminated tools in each of those trays, too, according to a memo that BAMC orthopedic surgeons sent to hospital leaders in July.
The sixth set was clean, and the surgery proceeded, but the delay had kept a fragile patient under general anesthesia for an extra three hours, heightening the risk of complications, the memo stated.
On the same day, in other BAMC operating rooms, contaminated or broken instruments forced surgeons to cancel procedures for five other patients, three of whom had already received local anesthesia, according to the memo.
The tissue found on the instruments, called bioburden, appears as a hardened, reddish-brown substance. It clings to parts of surgical tools even after they’ve been through the hospital’s disinfection and sanitization processes. The small pockets of human material can breed bacteria and spur infections that are dangerous and hard to detect.
All told, over 41 days last summer, BAMC’s sterile-processing problems resulted in the delivery of at least 49 unusable sets of surgical tools, the cancellation of more than two dozen surgeries and delays of at least four procedures of between 90 minutes and 4 1/2 hours, the memo stated.
Ongoing problems with contaminated equipment, as well as missing, incorrect or broken tools, drove the hospital’s entire orthopedic surgery staff — 19 surgeons — to sign the 10-page memo to BAMC commanders detailing the problem and measures the doctors have taken to lessen the risk to patients.
The surgeons said in the memo that they have stopped doing most elective surgeries, such as joint repair or replacement, ligament reconstruction and spinal fusion and decompression. They said they ended those non-emergency procedures to ensure they have the necessary equipment ready for the unpredictable trauma cases that arrive at the hospital every day.
The department has also stopped accepting certain transfers from other hospitals and halted surgeries to reattach severed fingers, which require sets of highly specialized equipment.
Without improvements to the hospital’s sterile processing unit, the “conditions will lead to unacceptable risk to patient safety, potential harm from poor sterilization of sets and create an environment of insurmountable liability,” the memo stated.
Their message: dirty instruments shouldn’t make it to the operating room.
BAMC officials would not comment on the surgeons’ memo. However, they said hospital operations continue largely unhindered despite staffing shortages across the facility, including its Sterile Processing Department.
“We’re doing quite well. We have not had any surgical site infections as a result of bioburden or any type of hardware issue in any of our orthopedic cases,” said Army Col. Wylan Peterson, the hospital’s chief of surgery. He noted that no contaminated surgical tools had reached a patient.
Dr. Evan Renz, deputy to the commander for quality and safety at BAMC, said the hospital strives for “zero patient harm.” He noted the facility carefully tracks infections linked to human tissue found on instruments and that no illnesses had been tied to the problem.
Renz conceded that some surgeries were canceled over the summer, but he said contaminated instruments weren’t a factor.
“I don’t know of anything that was canceled because of bioburden,” Renz said in a July 24 interview. “I guess if we’re being very honest it may have been delayed long enough to go down and get another set, but there’s a big difference there. So, canceled? I don’t know of any that have been canceled.”
Peterson couldn’t say how many surgeries had been delayed because human tissue found on surgical tools.
However, he added, “We are able to continue to meet our daily demand of our operative cases and are able on a daily basis to ensure that all of those patients get the operation that they need.”
Risk of ‘deep infections’
Touted as the Army’s premiere medical facility, BAMC is the service’s sole Level 1 trauma center and operates the Defense Department’s only burn treatment facility. The hospital underwent a $724 million expansion more than a decade ago and now has 425 military and civilian inpatient beds.
BAMC and University Hospital in the South Texas Medical Center are the region’s only Level 1 trauma centers. They handle all aspects of care for the most severe injuries and illnesses for patients across a 22-county region.
The American College of Surgeons “reverified” BAMC as a Level 1 trauma center in 2022, but its review did not assess the facility’s sterile-processing operations.
In 2022, the hospital earned the Joint Commission’s “Gold Seal” after an evaluation that did look at its sterilization of surgical instruments. Neither the commission, which accredits more than 22,000 health care organizations and programs across the country, nor BAMC provided details of the evaluation of the hospital’s sterile processing operations.
BAMC said in a statement that leftover tissue is found in less than 1 percent of its surgical tools, a rate that’s “within industry standards” and “has remained stable over time.”
However, BAMC orthopedic surgeons say the rate would be higher if the statistics included only orthopedic tools instead of instruments from all the surgical specialties.
Orthopedic surgeons use tools that have analogs in woodworking shops: saws, mallets, drills, reamers, cutters, files, pliers, gouges, screws, rods, plates and scissors. These include several hollow tools, such as drill bits and reamers — which are rods with blade tips that tunnel through bone — that are especially susceptible to retaining human matter.
A single tainted instrument requires doctors to set aside an entire set of tools.
“I don’t know if I’d call them common, but they’re not rare, either,” a former BAMC leader said of contaminated surgical tools. “I think you’d be hard-pressed to find a surgeon who in the last year did not have something that had a tear in the wrapper, that had a bad indicator, or maybe even had bioburden.”
Contaminated instruments, if not discovered by a surgical team, can cause “deep infections” such as osteomyelitis (a bone infection) and septic arthritis (a joint infection). These develop slowly, weeks or months after surgery, and can severely damage bones before they’re diagnosed and treated.
Such infections can lead to lifelong problems, amputations and even death if left untreated.
No one at BAMC contacted by the Express-News knew of any cases of infection stemming from contaminated tools at the facility.
The Centers for Disease Control and Prevention reports that contaminated surgical instruments cause infections in 1% to 3% of surgical patients in the U.S. each year. Such infections increase the risk of death by as much as 11-fold, and the complications they create cost the national health care system $3.3 billion annually.
Scaling back
The orthopedic surgeons’ memo said that “to maintain patient safety and a ‘no preventable harm’ environment,” they had unanimously agreed that the hospital should “scale back surgical operations” until the Sterile Processing Department took steps to fix its instrument problems.
The Sterile Processing Department is short-staffed and has “training issues,” the surgeons stated.
Several doctors mentioned BAMC’s “Swiss cheese approach,” where multiple safeguards and procedures are in place to keep patients safe. The thinking is that if a problem slips through one safeguard, another will catch it.
Larger problems arise when all of the “holes” line up.
The problems last summer are similar to those in the spring of 2017, when BAMC closed 16 of its 28 operating rooms after finding 73 cases of improper sterilization in one month. That included 16 incidents in which fragments of leftover human material were left on surgical tools.
In response, the hospital reduced its elective surgeries to work through a backlog of more than 600 surgical instruments that needed to be processed and assembled.
After the spate of cancelled and delayed surgeries last summer, officials said there had been no overall drop in the number of elective surgeries, even though orthopedic surgeons have suspended some of the procedures. Peterson said elective surgeries continue at BAMC, as well as Wilford Hall and some civilian facilities.
Heavy workload
BAMC performs 30 to 60 surgeries a day across its operating rooms, and Sterile Processing is a crucial cog in the process. It sanitizes thousands of surgical tools a day — for BAMC and six military outpatient clinics across San Antonio. BAMC and its clinics serve 4,000 people a day.
With a staff of roughly 70 people, the hospital’s instrument sterilization unit operates 24 hours a day. It processes 400 surgical sets on average each day for 55 clinics in the hospital and around San Antonio, according to Army Col. Lance Taylor, BAMC’s chief of operative services.
Sterilizing instruments is a multi-step process that begins with an initial rinse of used surgical instruments with a water-soaked sponge in the operating room. A technician then douses the tools with an enzymatic spray before sending them to the sterilization department on a robotic cart.
Instruments then go through steam sterilizers that are pressurized and reach 275 degrees. After cooling, the instruments are inspected, assembled and packaged.
The surgeons’ memo cites 23 examples between June 9 through July 21 when operating room staff delayed or canceled surgeries after discovering instruments that were contaminated, missing or broken.
On June 12, a surgery was canceled after team members found human matter on at least one of the instruments, as well as “dust from a training event,” the memo said.
Two patient procedures were canceled on June 16 after a “critical” instrument was found to be broken. The same thing occurred 11 days later, according to the memo.
On July 14, six orthopedic surgical sets were found to have human tissue on them. One person’s spinal surgery was delayed 4 1/2 hours.
BAMC officials said they could not discuss incidents referred to in the memo, but they acknowledged that extra time under anesthesia can increase risks to patients.
The memo said these examples “may only be the tip of the iceberg,” and that it’s hard to quantify the full effect on patients of delays or changes to surgical plans made on the fly.
For each cancellation or delay, surgical staff complete a “Patient Safety Report.” BAMC officials declined to offer any information or statistics about the forms, saying the data is “sensitive, confidential and privileged.”
An operating room source, who asked to remain anonymous out of fear of retaliation, said surgeons have submitted “at least a dozen, if not two to three dozen forms” to Renz, deputy to the commander for quality and safety, through September.
The July 21 memo said the sterile processing unit’s problems have led to “a backlog of greater than 400 unprocessed sets and a dramatic increase in the number of sets returned to SPD for sterility concerns and contamination.”
However, Renz said the number of surgical sets returned because of contaminated, missing or broken instruments matters less than the hospital’s response.
“Anything more than zero means that we’re responding to it,” he said. “If we were told there was bioburden on a set, we handle it the same way every time, which is we address it, we make sure that it’s taken care of, we thank and applaud the person who reported it.”
“Bioburden doesn’t rank very high in the list of things that we have to focus on,” Renz said. “It’s one thing, and we track it and we monitor it, but the number — anything over zero is just unacceptable to us — but it is just one thing of so many things.”
Trauma mission
Unlike elective procedures, BAMC can’t predict how many trauma victims will come through its doors on any given day, so it must keep numerous sets of surgical instruments ready at all times.
Orthopaedic surgery “treats a large percentage of trauma cases,” the surgeons’ memo said, and “the backlog of SPD has created a situation where even some of the most basic sets needed for orthopedic surgery are not being maintained.”
To ensure readiness for trauma cases, the department reduced the number of non-trauma and non-urgent procedures its surgeons perform.
The daily surgical schedule fell from 20 to 16 operating rooms around the time the surgeons sent the memo to commanders, according to the OR source. A BAMC spokesperson said in an e-mail that the hospital “was designed to have up to 34 operating rooms,” but the number of ORs used “each day varies greatly.”
The hospital’s four Level 1 trauma bays remain ready.
With 105 surgeons on staff, BAMC is part of the Southwest Texas Regional Advisory Council, or STRAC, which maintains a regional trauma and emergency health care system for up to 6 million people across 22 counties encompassing 26,000 square miles in southwest Texas.
‘Overburdened’
Many veterans suffer from musculoskeletal disease, and the memo pointed out that the problem is common across the military and in San Antonio. In other words, BAMC’s orthopedic surgeons are busy.
“On average the orthopaedic surgery product line receives 1,200 referrals per month, and this does not include consultations from the ER, trauma activations, or internal referrals between subspecialist surgeons,” the memo stated. “The orthopaedic surgical volume at BAMC alone averages 3,500 cases per year, and trauma activations typically involve more than one orthopaedic surgery per patient with multiple subspecialties involved.”
In an average week, BAMC performs up to six joint replacements, up to six spine surgeries and as many as 30 orthopedic trauma surgeries, according to the memo.
“This represents only three of the nine orthopaedic subspecialties currently practicing at BAMC and accounts for up to 400 sets per week,” the memo stated. “The resultant demand for SPD services from the full spectrum of orthopaedic surgery is overwhelming an overburdened section.”
Hospital officials say they welcome feedback, dissenting opinions and candor from staffers.
“In all honesty, we encourage our surgeons to speak up if they have concerns about anything, as well as we encourage our nurses, our OR techs, even our folks in SPD,” said Peterson, BAMC’s chief of surgery. “And we have that culture of safety, and we have these processes in place that optimize our ability to take care of our patients safely.”