AAMI President Pamela Arora on Advancing HTM Standards

Keri Stephens
hi, welcome to the HTM 24×7 podcast. I’m your host, Keri Stephens. For this episode, I’m joined by someone I’ve wanted to talk to for years, AAMI’s president and CEO Pamela Arora, who took over in 2022. Pamela, thank you for joining me today.

Pamela Arora 
Thank you, Keri I really appreciate the opportunity to visit with you and your listeners. And I am honored to be here. We love 24×7

Keri Stephens
Well, we love AAMI And again, you are someone that I really wanted to talk to for a while. And, you know, just to dive in, let’s talk about your role. So you have been in your role for about two and a half years. So what has been your primary focus since taking over as AAMI’s President and CEO in 2022?

Pamela Arora 
Good question. Since stepping into this role, my primary focus has been ensuring that AAMI continues, and I use that word really with respect, continues to serve as a critical leader in advancing health technology. AAMI has been around for over 55 years, so we don’t want to break what has been just a great recipe over the years.

AAMI is uniquely positioned as a neutral convener of all the major stakeholder groups involved with medical devices and sterilization. That includes manufacturers, sterilization services, regulators, and healthcare delivery organizations. AAMI’s work related to HTM is driven by our Vice President of HTM, Danielle McGeary who is heavily involved with our strategic initiatives that support the HTM community.

and promotes the safety, innovation solutions, and evolving needs of the industry. I know that Danielle has been on your podcast several times, and we just love your 24×7.

Keri Stephens 
Well, and we love AAMI and Danielle. mean, she’s amazing. I respect her so much and you too. And no, we love AAMI here.

Pamela Arora
Yeah, I do want to clarify some things though, because in the HTM community in particular, they’re not as familiar with what is AAMI’s core, which is being a standards development organization. And that really actually puts us in a great position to advance the HTM profession by leveraging these standards processes. In my role, what I’ve been doing is putting an emphasis on these processes relative to HTM.

And standards are consensus -based. Some of the, I would say some of AAMI stakeholders are really versed and that’s why they come to AAMI. In the case of HTM, it varies quite a bit, but our standards are consensus -based and followed a structured development process using ANSI, the American National Standards Institute. Now there are also international standard processes, but in the HTM space, we’re primarily using the ANSI processes.

And that works in collaboration, not only within the HTM community, which is like BMETs clinical engineers, healthcare providers, but it’s broader than that. It’s third -party servicers, manufacturers, regulators, really, really partner well with the FDA Joint Commission. This actually ensures that AAMI standards are comprehensive, relevant, and reflect the latest technology and clinical advancements.

This structured approach is rigorous. It includes public commenting, revisions, balloting. And because of all of that aspect, it creates a well -rounded and widely accepted standard. And for the most part, we’ve been driving that process within the HTM community by enhancing the quality, safety, education, and innovation. But that one I want to call out because I think the HTM professionals

They know a lot about our education and our certifications, but these standards actually help them manage the complexities of modern healthcare technology, so we really want them to be aware of it.

Keri Stephens 
No, I’m glad you’re mentioning the standards because there’s one that I really want to talk about in this podcast. So EQ103, which is a standard on alternative equipment management. Can you talk about that and what inspired its development and what are its key features?

Pamela Arora
Yeah, great question. And I’m glad you asked because it’s so relevant to our HTM professionals and clinical engineers. EQ 103, it’s a forthcoming standard about alternative equipment. And I would say the HTM folks really know AEMs well. And really working through that, the development of EQ 103 was inspired by the need to create a more flexible

and practical element for managing equipment and healthcare studies, but do it in a standardized manner. So the Centers of Medicare and Medicaid Services, CMS, they permit HTM professionals to use their expertise and equip history data to develop maintenance strategies that may differ from the OEM’s recommendations. Now, our HTM group knows that quite well.

The thing about it is CMS has not been specific on how to safely and effectively deploy this flexibility, and that is crucial in certain situations. At the same time, you have the OEM maintenance procedures, and they may not consider all the possible uses, environmental conditions, or availability of alternative diagnostic or monitoring tools.

AAMI and our stakeholders aim to outline effective implementation approaches that provide flexibility while ensuring safe and effective choices. AEM programs that comply with EQ 103, it will help with the performance and safety of the equipment and make sure that they’re not compromised. And as all of us are patients and our loved ones are patients, we want to make sure that the devices are working appropriately.

from the standpoint of healthcare organizations, if they include the AEM program with EQ 103, it’ll provide that framework for assessing equipment eligibility, emphasizing adaptability, risk -based assessments, and thorough documentation. So there’s been a lot of work that has gone into this standard, but it impacts the front lines within the health delivery organizations.

on a day -to -day basis. So we’re very excited about it.

Keri Stephens
And I think one thing that’s notable is that EQ 103 has been developed and published in less than a year. Can you talk about the speed of that? Because that’s pretty impressive.

Pamela Arora
It is impressive, but I want to emphasize that standards can take years in the making because you’re bringing in all these voices to make sure that the right standard is being created. The rapid development of EQ 103 is notable because basically it’s showing the commitment of AAMI and our stakeholders and their ability to respond to these emerging needs in healthcare. This accelerated timeline, it was made possible through close

collaboration with industry experts, regulatory bodies, all of whom recognize the urgency of establishing this new standard, partly because there’s so much complexity out there with MED devices. So for the AEMs, this is a highly efficient, yet rigorous standard that was comprehensive and practical for immediate implementation. I credit our great stakeholders for the energy that they put

forth to make this happen. don’t, for those that aren’t heavily involved in standards, they may not realize sometimes it could take five years for a standard to come together. And for this to come together in about a year is really, really a testament to the stakeholders in the community.

Keri Stephens 
Right. No, absolutely. And I just have one more question because I know our listeners in healthcare technology management are going to be very interested in this, but how do you see EQ 103 standard influencing current practices and alternative management of existing equipment?

Pamela Arora
No, it’s a great question. And I will say that with the processes, we had comments throughout. And the public comments, there was just a groundswell. Because when you’re affecting day -to -day operations that way, you can expect there’s opinions, right? Well, it is going to significantly influence current practices. And part of it’s because it provides a structured framework that healthcare organizations can adopt to enhance their existing projects.

processes. It’s not like get rid of everything you’re doing. It’s take a look at what you’re doing and here’s how it can be improved to reduce risk. So this risk -based approach allows for more targeted maintenance strategies and this actually improves safety and reduces downtime and better resource allocation. The standard also as it’s promoted across organization

it’s gonna help to bridge the gaps in practices and ensure that all equipment receives appropriate attention. Over time, EQ 103 will become a cornerstone of alternative equipment management, and we believe setting a new benchmark for best practices in the field. And again, we’re all patients, we have loved ones that are patients. I believe that the patients will see the outcomes of this.

Keri Stephens 
No, that’s wonderful. And so I want to switch gears completely now. I want to hear about AAMI’s involvement in the Women in Leadership Project and its significance for the HTM field. I know because we do our salary survey every year, we know that this industry is predominantly male dominated. But to me, as a woman in this industry too, you know, in some capacity, I think it’s amazing. know, having you as a female president of AAMI, having Danielle, I think it’s…

It’s a really big message to the industry, but I want to hear about this project in particular.

Pamela Arora 
Absolutely. And I love this community. is just AAMI’s involvement in the Women in Leadership or WIL that’s their short name, community is a testament to the commitment around diversity, equity, and inclusion within HTM. And AAMI is incredibly grateful to Women in Leadership President and Founder AAMI April Lebo Have you talked with April Lebo as of yet on 24×7?

Keri Stephens
No, but I would love to.

Pamela Arora 
Yeah, I think that would be brilliant. Also, Kim Rowland, Amber Sportsman, Adriana England, and AAMI’s own Danielle McGeary were big leaders in making this all happen. But the president and founder is April Lebo. The community is designed to support and amplify women’s voices within HTM and help address this gender gap that you just brought up, Keri.

By providing mentorship, resources, and network opportunities, it empowers women in HTM and ensures their contributions are recognized and they have the tools to advance their careers. But I have a stat for you that just was eye -opening to me. In 2021, AAMI conducted an HTM demographic survey and found that less than 10 % of the field was female.

Keri Stephens 
that’s on par with ours too, yeah.

Pamela Arora
Yeah, 10%. And when you look at just how many people are moving out of HTM as they conclude their careers, we can’t afford to not have women. We need to really get that number up and encourage that. AAMI is committed to ensuring women in the HTM field have successful career trajectories through connection with Will.

This community is going to be crucial for creating a more inclusive and innovative HTM field. Ultimately, we hope to, this will lead to better health technology management outcomes. I strongly believe that we really need to have new entrants into the field. And AAMI is so honored to support this community. We love them.

Keri Stephens
I think it’s wonderful. Okay, so what are some other upcoming initiatives or projects that AAMI that you’re really excited about?

Pamela Arora
Well, I have a long list, but I’m going to try to run through it quickly. I’m excited about a number of initiatives at AAMI One is the expansion of our digital health and cybersecurity programs. Obviously increasingly critical as healthcare embraces technology at an accelerated pace. Everybody knows it and there’s so many opportunities that come with it. So we need to go there. We can’t slow down that pace.

We’re also working on new standards and guidelines for emerging technologies such as AI and machine learning and medical devices. We want to make sure that when it’s applied, AI and ML, they are implemented safely and effectively. Additionally, I want to call out AAMI’s Vice President of HTM, Danielle McGeary. She’s been an integral part in enhancing our education and certification programs.

that support HTM professionals at all stages of their career. Now I have a bit of a list here too. These courses and certifications, they provide HTM professionals with the skills and knowledge needed to navigate the changing landscape of health technology. And they include AAMI’s BMET Apprentice Program. That’s starting to get more and more momentum where these apprentices are being taken into the field, which we need that given.

some of the folks that are concluding their careers and we need those resources. Two, we’ve launched a new CEO online journal. Now with that, active certified individuals can more easily submit their CEUs for recertification. And while it doesn’t sound that exciting, if you’re trying to submit it and it’s fussy and it’s difficult,

This is one our stakeholders are going to enjoy because they really do focus on certification, which is great and important for the industry. Third, AAMI’s training and expert insight courses. Also a key one. And then fourth, upcoming offerings such as our CBET study course and our HTM live on September 17th on cybersecurity adoption, really important.

But there’s an overarching fundamental initiative that I’d like to share. It’s AAMI is ensuring the HTM community understands AAMI’s role in health technology space. Our role as a standards development organization, it actually affects what we can and cannot do. We’ve seen some confusion in the course of the time that I’ve been here at AAMI. And in order to develop consensus based standards,

AAMI needs participation from all stakeholders involved in the medical device life cycle. That includes OEMs, HTM professionals, third party services, regulatory agencies, clinicians, healthcare employees. The list keeps getting long. Because of this, AAMI cannot advocate for law or legislation. That’s the part that gets confusing because we’ve had some of our stakeholders,

really upset because we’re not advocating for one position versus another. And that’s really our strength, but also what we offer to the community because that actually helps these great standards come forth. Our neutrality, neutrality allows us to maintain credibility and effectiveness as an SDO, a standards development organization, making sure all voices are heard. But ultimately that actually does

help with safety and efficacy rather than political or even commercial interests. So we’ve been spending a lot of energy to make sure that that’s clarified, especially with our HTM audiences, because in some cases, they’d like us to advocate in a particular direction. And it’s not uncommon in associations where they have a public policy group, right? In our case, our neutrality is our strength.

Keri Stephens
No, that’s really helpful because especially I know the right to repair is so contentious. I’ve noticed that AAMI has taken the neutral stance, which honestly, as a journalist, I’ve had to do the same thing. So I can respect that completely. okay, so for my last question, and I think you’ve covered this a lot, are there any, like, what are the biggest challenges and opportunities currently facing the HTM field and how is AAMI addressing them? If you haven’t already covered that.

Pamela Arora
Yes it is.

Really, HTM has significant changes. And with change, that does create challenge in the field. But really, those changes, I believe, will benefit both patients and HTM professionals. I’ll give you some examples. Accelerated pace of technology investment. That’s going to make it harder to maintain that equipment. But really, it really is a powerful way to have better tools for care delivery.

The complexity of medical devices comes with that interoperability and cybersecurity concerns as things are more networked and the data flows across the continuum of care. Safe implementation of AI and ML, we already talked about that. But from the standpoint of all of these types of things, even take different care settings. So now you’re going to have home health, but you’re going to have acute care health in the home setting.

That really rocks the world of what maintenance looks like in an HTM world. So you look at this and it presents exciting opportunities for growth and innovation. And we’re looking at these challenges, looking for robust standards, best practices to help HTM professionals with these changes and really work those partnerships and collaborations that I mentioned earlier and

bring together these diverse perspectives, expertise to tackle these issues head on. We really believe that HTM can remain resilient and adaptive to these change and as care receivers, as patients, and as their loved ones get care delivery, that’s really the true winner in all of this change that we’re talking about, but it doesn’t simplify the world of the HTM professional.

It’s going to complicate it, but AAMI’s going to be there along their side to help them along the way. We believe in it.

Keri Stephens
Well, thank you so much, Pamela. I know our listeners will be really excited to hear what you have to say. And to our listeners, thank you as always for your listenership. And be sure to check out www .24x7mag .com for the latest industry insights and news. Take care. Thank you.

Pamela Arora
Thanks so much, Keri.