The recent AAMI exchange REWIRED online event featured several expert discussions about techniques and technologies that could impact the future of the clinical setting. Be sure to follow OR Today and AAMI News for more.
Sterilization Insights: Updated AAMI ST91:2020 for Endoscope Reprocessing
“Where endoscopes are used and processed in the health care facility varies greatly from one health system to the next,” said Mary Ann Drosnock, director of clinical affairs for Healthmark Industries. “Everyone needs to be in sync when it comes to what standard practices are.”
On April 1, the FDA issued recommendations to help providers deal with infections caused by or related to reprocessed urological endoscopes, noting that the agency “has received numerous Medical Device Reports (MDRs) which describe patient infections post procedure or other possible contamination issues associated with reprocessing these devices.”
That’s why Drosnock and AAMI Working Group 84 are working toward an updated version of ST91. Drosnock explained what’s in store in an education session at AAMI eXchange REWIRED. The updated version of ST91, expected to be available this month, includes stronger guidance to help health care professionals best work to ensure the safety of their facilities’ scopes.
“What’s great about ST91 is it covers all kinds of endoscopes, from bronchoscopes to ureteroscopes … to GI scopes, you name it,” Drosnock said.
Some of the updates include:
- Adding classification for high-risk scopes, such as bronchoscopes and ureteroscopes
- Changing guidance for drying of scopes, as well as proper storage and handling
- Recommendations against manual disinfection
- Guidance for testing water in automated endoscope re-processors (AERs) to avoid the final-rinse water re-contaminating the scopes
- Guidance for determining the length of storage, or “hang time,” that a scope can withstand before needing to be reprocessed.
The updated document will also include “lots of references to support” the stronger guidance, making ST91 a more evidence-based document, Drosnock added.
In addition to ST91, there is also work being done on a technical information report, TIR99, which will cover the reprocessing of ultrasound probes and dilators. “[I’m] hopeful that next year we’ll have this … document, because there’s nothing that’s out there right now on how to properly process probes and dilators,” Drosnock said.
How Combining Clinical Informatics and Medical Devices Can Improve Care
On the first day of AAMI eXchange REWIRED, Dr. Christoph Lehmann, director of clinical informatics at UT Southwestern Medical Center, joined the hosts of “Good Morning HTM” as a special guest to talk about combining clinical informatics and medical devices for better patient care.
Leiman, who is also a pediatrician and professor in clinical science at UT Southwestern, said he started his foray into clinical informatics in a way that’s hard to talk about.
“It’s a difficult story for me to tell because it starts with the death of a patient,” he explained.
At just 18 months old, Josie King died at Johns Hopkins Hospital due to a number of medical errors made during her care. This terrible moment triggered several events – most notably, the founding of the Josie King Foundation for patient safety and a rapid transition among hospital systems in how they account for and prevent medical errors.
These events also ultimately created a patient safety center that Lehmann found himself a part of.
“That was my first opportunity to spend time on developing informatics solutions that could improve the quality and safety of patient care,” he said.
Since then, Lehmann has been working to improve patient safety and reduce costs of care using the immense amounts of data that are part and parcel to the modern health care system.
“It has been more fun than work. With informatics, we can turn this data into knowledge that helps us understand what works and functions better for patients and then turn those lessons into powerful applications,” Lehmann said.
An example of this powerful field applying to the clinical setting, Lehmann offered, is an automated calculator for infusion pumps. First, a physician will use the calculator to order the appropriate infusion speed and concentration. This also informs the printing of the correct label. Finally, a pump is used that similarly calculates the rate given the correct data. Nurses are trained to start an infusion only if the rate on the pump is identical to the rate on the order and also identical to the rate on the label.
“This drastically reduced the number of infusion errors we had been seeing,” said Lehmann.
However, overall, he wants to see much more of this kind of “cross-fertilization” between medical device design, informatics and device end-users.
“I see devices coming up with solutions to problems that really don’t exist,” he said, “but the fact that I’m here talking today with you and the AAMI community is a really good first step!”
He added that he’d love to see a future where there is a seamless integration between medical health records and medical devices.
“And the communication has to be bi-directional,” he added, envisioning a device which can update records in real-time.
AAMI eXchange co-host Danielle McGeary, whose career started on the front lines as a biomedical equipment technician (BMET), was thrilled by the possibilities.
“It’s all about safety,” said McGeary, vice president of HTM at AAMI. “In an emergency where there’s very little time to set up a device … if there’s decision support available, you want it right there at the point of care!”





