By Megan Clancy
Gerry O’Dell is a past co-chair of AAMI’s Industrial Ethylene Oxide (EO) and Moist Heat (MH) Sterilization Working Groups, and she was named an AAMI Fellow in 2019. O’Dell is a Certified Industrial Sterilization Specialist (CISS) for ethylene oxide, moist heat, and radiation (RAD), and holds a master’s degree in microbiology from the University of South Florida. She is also the co-owner of O’Dell & Hodge Consulting, where she advises medical device, pharmaceutical, and biologics companies on sterilization, environmental monitoring, laboratory operations, and compliance. Additionally, she co-authored a chapter in the January 11, 2023 issue of AAMI Array, and has authored chapters in several publications on sterilization.
From Microbiology to Medical Devices: O’Dell’s Career Development
O’Dell landed her first job out of college as a lab technician for a medical device company owned by Johnson & Johnson. There, she was promoted to the sterilization services group and then to a role as laboratory supervisor, where she oversaw everything from microbiological processes to sterilization. “I enjoyed the lab piece of it, but it wasn’t as interesting as the sterilization aspect,” she said.
The company was involved in sterilization standards development, which introduced her to AAMI’s working groups early on. “I had a very good mentor in the area of sterilization,” she shared. That mentor, Jim Gibson, allowed her to participate in AAMI’s first EO sterilization standard meetings, though she wasn’t a member at the time.
And when Gibson retired and moved into consulting, O’Dell took on his role as the company representative for the group, for which she was eventually elected co-chair. This new position opened up opportunities to join several other working groups, and also introduced her to the ISO standards she participates in to this day.
Following a break from Johnson and Johnson, she continued along the path of her mentor and founded her own consulting firm. And after 10 years on the EO committee, she traded in that role to become the new co-chair for AAMI’s working group on moist heat sterilization. Though she no longer serves as co-chair for either group, she continues to be active in AAMI and ISO standards work, while serving as an instructor for many of AAMI’s sterilization courses – including three upcoming courses on ethylene oxide, industrial sterilization, and radiation.
Building Bonds – and Business – through AAMI
O’Dell has participated in AAMI’s standards work since 1985. From the beginning, that involvement was rooted in O’Dell’s business-forward thinking. “[When I started], if you participated in the working group, you got the standards and any Technical Information Reports for free,” she said. “But it’s not just the knowledge that you gain…and influencing the direction of the standards, but also meeting people that you can network with,” she said.
The tight-knit nature of the standards work has proven to be an asset. “Some of the people that I’ve worked with, we’ve worked together on standards for 30-plus years,” she explained. “You really get to know people pretty well … and to have a better understanding of where they’re coming from on different things. So, it does make a difference [in your career].”
Though O’Dell began working with AAMI on standards development early on, she didn’t start teaching for the association until 2009, when AAMI was developing their first ethylene oxide-specific sterilization course. “I was involved in initially writing that course and putting it together,” she said.
Noticing that many courses focused on theoretical knowledge, she strove to make the course applicable to the work of sterilization specialists. As a result, witnessing the real-life impact of her courses has turned out to be one of the greatest rewards of teaching.
One of O’Dell’s first students is now an instructor for AAMI whose career saw tremendous benefits from her hands-on teaching strategy. “He took a lot of the principles that we talked about when it comes to optimizing EO sterilization cycles, and he took them back to his company and implemented them,” she said. That successful optimization led to around a million dollars in savings for his company, along with a promotion.
Teaching Sterilization: Interactive Learning in a Changing Industry
According to O’Dell, hands-on learning has become even more important in recent years. Changes in the industry have led to fewer in-house sterilization processes at medical device companies, forcing many professionals to imagine the processes they are developing without ever seeing the equipment that performs them.
“There’s usually a good 25 to 30 percent of the class that has never been to the sterilizer,” she said. “That means there’s often a gap. Because we like to think that the product or the process is going to drive things, but sometimes we’re also limited by what the equipment capabilities are.”
For that reason, O’Dell works to ensure that her students understand those potential restrictions, not just in theory, but in practice.
From August 25 to 28, O’Dell will teach a course on Ethylene Oxide Sterilization, which will help experienced professionals optimize sterilization processes, identify problems in the cycle, and determine whether validation is needed. “I’ve been in the industry now for 42 years. And even at this point, I see new things. Stuff crops up that I didn’t expect, particularly with lower gas concentrations – so that gets transmitted in the course,” she said.
The Future of Sterilization and Standards – And How to Prepare
AAMI News asked O’Dell where she sees sterilization heading. “What I see in the future is more variability with how products will be sterilized,” O’Dell shared. “Ethylene oxide makes up about 50% of all of the sterilization that occurs worldwide, with radiation taking up a bulk of the other part of it … Eventually, that other piece is going to get bigger as people figure out other methodologies for sterilization that are not only niche-oriented.”
To stay on top of these changes, O’Dell advises professionals to get involved in the standards process now. “Because that’s where a lot of this information starts coming out,” she said.
But like technology, standards work is not immune to change. In the wake of the COVID pandemic, most standards meetings that were once held in-person are now virtual, making active participation more important than ever. “So, making sure that companies are picking the right people for being involved in the standards process – people that are willing to speak out and convey their opinions – that’s something that people need to push for within their organizations,” she said.
