When an OR nurse at a large teaching hospital noticed that the stripes on a surgical pack's ethylene oxide (ETO) indicator tape were still brown, she became concerned. The brown stripes change to red if properly sterilized. This pack's brown stripes indicated that it had not been properly sterilized, and presented a major problem for the operating room. A quick investigation found that surgical packs used on five previous OR cases that day were also not sterile. The surgery was stopped, and the incident was reported to the hospital's administration, OR chief, legal affairs department and the director of clinical engineering.
Bryanne Patail, now with the Department of Veterans Affairs National Center for Patient Safety, was the director of clinical engineering at that hospital at the time the incident occurred. He played a key role in its investigation. At a recent AAMI Annual Conference session, he used this incident to illustrate the use of root cause analysis (RCA) in an investigation and to highlight the role that clinical engineers and biomedical equipment technicians can play in such investigations.
First, Patail and his colleagues sequestered all surgical packs processed the previous day by the ETO machine and chartered a multidisciplinary RCA team. “A root cause analysis aims to answer three questions: What happened? Why did it happen? And what can we do to prevent it from happening again?” says Patail.
The RCA team conducted interviews to better understand the incident. They found that ETO packs processed the day before were the only ones affected. The ETO machine had been repaired the day before by an in-house BMET. Upon investigation, the Central Sterile Processing (CSP) supervisor noticed that the machine was programmed to cycle faster than normal. The clinical engineering director reviewed the work order and interviewed the BMET who serviced the ETO machine, who acknowledged that part of his routine was to cycle the ETO machine faster. On this occasion, he had forgotten to reset the machine to normal operation. As a result of this faster cycle, the surgical packs were not exposed to ETO for the required amount of time, and thus their sterility could not be ensured.
The team also looked at the procedural failures that allowed the questionable surgical packs to make it into the operating room. They found several contributing factors: verification of sterility was not part of the OR checklist; the OR staff was rushing because they were behind schedule; three OR staff had called in sick; those who were working had worked a double shift the previous day. “With pressure to meet OR schedules and bonuses based on volume, the financial culture trumped the safety culture,” says Patail.
Once the machine was reset to normal parameters, its proper operation was verified by both the BMET and the CSP supervisor. The five patients who underwent surgery before the sterilization problem was caught were notified of the event and offered free testing for infections; 30-day follow-up of these patients showed no problems as a result of the incident.
To prevent future incidents, Patail, the RCA team, and the clinical engineering department developed a new post-sterilization repair testing and verification procedure. Under the new procedure, technicians were no longer permitted to change the ETO settings to cycle the machine faster for testing. A checklist was added to verify that machine settings were at the hospital's standard protocol at the conclusion of testing. In addition, the CSP supervisor had to verify proper machine operation and sign off on the work order after testing.
“We had to disallow the fast cycle to prevent the same mistake from happening again,” says Patail. “It's not a perfect solution, because now testing will result in 2 hours of ETO exposure on a full cycle rather than 15 minutes on a fast cycle.” It was, however, the best solution that could be obtained under the circumstances.
While some may consider this response to be overkill, Patail argues that it is necessary to avoid a single point failure. “Although the service person has been ‘directed’ not to cycle the device, there is a chance that during the calibration and testing of the different functions of the machine, the clock could be reset to the wrong setting. Therefore, the checklist and the SPD supervisor checking in tandem will catch 99% of the vulnerabilities. The directive not to cycle will ensure 100%. With these safeguards, the culture of safety trumps the culture of cost/profits.”
Fixes resulting from root cause analyses can range from strong to weak, Patail says. The strongest changes are those most likely to eliminate or greatly reduce the likelihood of an event; they typically use physical plant or system fixes with the application of human factors principles. In this case, the best solution would involve the manufacturer redesigning the equipment to be more maintenance-friendly, providing a test cycle that automatically reverts to the standard cycle after testing.
Intermediate actions likely to control the root cause or vulnerability employ human factors principles, but also rely upon individual action, such as a checklist or cognitive aid. Thus, a checklist was added and a second review—the CSP supervisor's signature on the work order—provided confirmation. The weakest actions are those that rely on policies, procedures, and training (individual action) in isolation of other fixes.
“To my knowledge, the manufacturer has not yet changed the design of the machine,” says Patail. “Their usual answer is ‘perhaps at the next model change.’ I would like CEs and BMETs to join me in fighting for these kinds of changes. Rather than always looking internally to make changes, hospitals should consider trying to force changes at the device design level,” he says. CEs and BMETs, accustomed to working with manufacturers, filing device incident reports, and evaluating new equipment purchases, are uniquely positioned to spearhead these efforts.
As a biomedical engineer with the Department of Veterans Affairs National Center for Patient Safety based in Ann Arbor, MI, Bryanne Patail, MS, MLS, FACCE, is heavily committed to advancing the cause of patient safety at the VA's 154 hospitals across the nation. And, as a clinical engineer with more than 30 years of experience in the field, he is also committed to seeing clinical engineers and biomedical equipment technicians use their unique skills and training to become patient safety experts.
“Clinical engineers and biomedical equipment technicians are excellent candidates to share their knowledge and apply systems engineering and other tools to build a better healthcare delivery system,” says Patail. “CEs and BMETs can use their expertise in systems analysis and troubleshooting and their knowledge of equipment to change the culture of safety in health-care.” An excellent way to do this, he says, is to participate in multidisciplinary teams, such as technology assessment teams and root cause analysis or failure mode and effect analysis teams.
How do CEs or BMETs who don't already play a role in their hospital's safety culture break into that area? “Speak up, and be available at the table,” advises Patail. “Take advantage of opportunities. Back in the '90s, the user reporting requirements of the Safe Medical Devices Act offered a chance for equipment professionals to get involved with safety; now, the Institute of Medicine report on patient safety and other patient safety initiatives present new opportunities.”
He points out that the reporting chain is important. If you're part of an in-house department, you need a direct reporting line to medical administration. “Patient safety is a medical issue, there should be a reporting line somewhere,” he says. “If not, seek out a medical administrator in charge of quality assurance and work directly with them.”
If you're part of an outsourced department, he says, look at the language of your contract. “If your work is strictly repair, there is no avenue to get involved in safety. However, if you are providing total equipment services, then safety is part of your domain.”
Patail also advises equipment professionals to branch out into nonequipment areas. “Don't limit yourself to just medical devices,” he says. “Get involved with patient falls, IT systems, medication mistakes, IT interoperability standards, design of new hospital facilities. All of these areas involve patient safety and can benefit from the expertise a CE or BMET could bring to the table.”
What training do CEs and BMETs need to take on such a role? “They need to understand the whole risk management process, take courses in root cause analysis and failure mode and effect analysis, and be prepared to be part of a team,” says Patail. The VA's National Center for Patient Safety is an excellent source for classes on safety-related issues; see www.patientsafety.gov.
