Alexandra: 0:15

Medical devices are more prevalent in our lives than we think. Ranging from simple bandages to MRI machines, every single one of us has used a medical device at some point in our lives. However, the pharmacovigilance of medical devices is anything but simple. Beyond the medical risks, there are technological and engineering risks associated with the use of devices. My name is Alexandra Coutinho, and this is Drug Safety Matters, a podcast by Uppsala Monitoring Centre where we explore current issues in pharmacovigilance and patient safety. Joining me on this two-part episode is Omar Aimer, the president of ISOP and the co-lead of the ISOP Medical Device Safety Special Interest Group. If you haven't listened to the first part of the interview, listen to part one linked in the show notes. In part two, Omar and I discuss underreporting in medical device pharmacovigilance, how AI is being used in this space, and why regulatory and data harmonisation remains the key to improving medical device safety. I hope you enjoy listening. To start, how does reporting for medical devices differ from drugs?

Omar: 1:38

Yes, great question. The reporting for medical devices differs from medicines or drugs in several key ways. There's the types of incidents reported. For drugs, for example, reports often focus on adverse biological effects in patients, like rash, like cough, like heartburn. For devices, the reports cover a wider range of issues, including malfunctions. Even before any interaction with the patient or with the user, the design flaws, like with devices, I can use my right hand, but I cannot use my left hand. This is an incident. Even, I mean, with the medicine, if you take a pill, you take it with the right hand or with the left hand, it's the same, but with medical device, because there's engineering, there's design flaws, it differs. There's user errors, there's software glitches for medical devices with software coupled to AI as well. There's also device-related injuries or deaths as well, that are common to both worlds, but the type of incident reported can be different. The reporting sources, while the drug-adverse event reporting is mainly from healthcare professionals and patients, the device reports also can come heavily from manufacturers, from clinical engineers and technical service teams who detect performance or safety issues. So there's again the manufacturing, the engineering that is involved if we compare with the drugs and the medicines. The complexity of the causality linking a device issue to patient harm can be more complex than with the drugs. As device problems may be due to usage, maintenance, or environmental factors, making the assessment and classification harder. There's also the regulatory frameworks, and we mentioned before the devices often have varied and evolving reporting requirements across the regions, while drugs generally follow more established pharmacovigilance systems. This inconsistency can lead to the under-reporting and fragmented data for medical devices.

Alexandra: 4:03

Yeah, and then I guess considering the source of the report, so you're talking about these engineers, I mean, they may not have a working knowledge of pharmacovigilance or what safety means, what is a side effect. So I guess that would affect the reporting as well, right?

Omar: 4:20

Yeah, exactly. And there's also the notion of the quality assurance as well, the product quality complaints. When the users, when the engineers report incidents or report complaints due to the product quality, the professionals don't think systematically of an impact on the safety. Because if the product is in bad quality, not only the quality of the materials, but also the quality in functioning, in the design, in the engineering, in the medical device overall, it can have an impact. The bad quality can have an impact on safety. So it's related, and that's why also a cross-functional collaboration between professionals in quality assurance, professionals in safety is also a key in preventing any problems related to medical devices.

Alexandra: 5:23

Right. Considering the different problems that we face with reporting on medical device safety versus pharmaceutical safety, I was doing some research on under-reporting to do with pharmaceuticals and vaccines. In my research, I read that only 5 to 10% of adverse drug reactions are ever reported. How does this rate then compare to that of medical devices?

Omar: 5:46

Oh, yes. So yeah, unfortunately, the under- reporting is indeed a major challenge across both medicines and medical devices. It's a common challenge. While exact figures vary by region and system, studies suggest that medical device adverse event reporting rates can be even lower than those for drugs, sometimes capturing only 1 to 5% of actual incidents. This lower reporting rate is often due to the complexity of device-related events. Sometimes we don't think that this event can compromise the safety, difficulties in recognising or attributing harm to a device, and less awareness among users and healthcare professionals about reporting mechanisms. This is very important, and this is also common to the medicines or drugs as we continue to raise the awareness about the importance of reporting incidents for medical devices. So improving education, trainings, simplifying reporting processes, and enhancing data integration are crucial to addressing this gap in medical device safety surveillance.

Alexandra: 7:00

Yeah. Speaking of which, and you just touched on how we can address these challenges in medical device safety monitoring, and you touched on education. What role should education play, especially when it comes to improving reporting rates among healthcare professionals? I know that you didn't really highlight them as one of the main reporters, but I mean I guess they could be and they are reporters regardless.

Omar: 7:26

Yes. To improve the reporting rates among healthcare professionals, I can mention some key steps that can be taken, like simplifying the reporting process, make the reporting easy, quick. As healthcare professionals, time is precious. They are taking care of patients and they need more time to interact with the patients. The reporting is seen by healthcare professionals as an administrative task. I was a hospital pharmacist in my early career. But yeah, again, simplifying the reporting processes, making the reporting easy, quick, accessible through user-friendly digital platforms, integrated into daily workflows like in the prescription softwares, really something easy and supportive for healthcare professionals to report those events. Also, follow-up loops that I advocate a lot for. Follow-up loops are when healthcare professionals report incident and adverse events, give them the feedback and the results of the impact of their reporting. Like you reported this incident or this adverse event, that results in this study, that results in this risk management or risk minimisation measure. They will see the impact of their reporting. So they will continue to report and they will ask more for yeah, I reported this and this and this. Can you tell me what was changed in the label, in the manufacturing of the device, an enhancement in the design or in the use? So the impact of my action. And I think that we need to focus on that. Provide targeted education and training, offer ongoing education about how to recognise device-related issues, when and how to report them, and the impact of their reports on patient safety and system improvement. This is what I mentioned earlier.

Alexandra: 9:55

Yeah, I guess it encourages them to then report the next safety incident if they know that it's going to actually result in something positive.

Omar: 10:03

Yeah, exactly. And sometimes we are thinking only about adverse events or incidents in a negative way, which is safety. But sometimes when reporting, we can find also some benefits that can be used for medicines. When we see a benefit, we need to report it. It can evolve in a new indication for the drug. And we have several examples for that. But also for medical devices, when a healthcare professional or a user, it can be a patient or a caregiver for patient, use the device and discover another use, and then this beneficial use can be reported. Then with the reports, this medical device can evolve for another use and the intended one at the beginning.

Alexandra: 10:58

Oh, that's very interesting. I've read a little bit about positive side effects of different medicines and indicating other uses for that medicine. That's some really great drug discovery right there.

Omar: 11:08

Exactly, yeah.

Alexandra: 11:09

So, what about another important reporter of adverse events, that of the patient? What role do patients have to play in medical device safety, and how may we encourage reporting in this particular group?

Omar: 11:22

Yes, this is a great question. And it's crucial for the medical device safety. Patients play a crucial role in medical device safety as they are often the first to notice issues. They are using the inhalers, the insulin pens, contact lenses, most of the medical devices, the patients are often the first to notice the issues or adverse events during everyday use. Encouraging patient reporting helps capture the real-world experiences that might otherwise go unnoticed by healthcare professionals or manufacturers. If a patient receives a knee replacement, the surgeon will replace the knee of the patient. And if there's an incident, then he will or they will notice it during the knee replacement. But the patient will leave the hospital with the replaced knee, and then the healthcare professional will not notice any adverse event or incident because the knee is on the patient. So yeah, the patient has this experience in everyday use. So to foster this, it's important to provide patients with the clear, accessible information about how and why to report device problems using multiple channels such as we mentioned before, mobile apps, websites, or hotlines. Empowering also patients through education and outreach campaigns can increase awareness and confidence in reporting, ultimately enhancing the post-market surveillance and contributing to safer medical device use for everyone. And this is also part of the industry that needs to raise the awareness and the education of the patient on the use of their medical devices or their product.

Alexandra: 13:16

Considering how complex medical devices especially are, I can imagine that a patient's experience with a medical device will also make it a bit easier to infer causality, right? If they can kind of go like, oh, I've used this pump and now I've got breathing problems. There must be something up with my pump.

Omar: 13:33

Absolutely.

Alexandra: 13:34

Looking then toward the future, your paper mentions emerging technologies like blockchain for traceability and AI for predictive safety monitoring. Could you explain what those technologies are about and how they can help with safety monitoring of medical devices?

Omar: 13:50

Yes, it's long, but I try to summarise because it's very important and it's the near future for the medical devices. Blockchain is a secure, decentralised digital ledger technology that can create an immutable record of medical devices' entire life cycle from manufacturing, to the distribution, to the use of medical devices, the use by patient and healthcare professionals. This really enhances traceability, ensuring the transparency and also reducing the risks like counterfeit devices or also the missing safety data. AI, on the other hand, can analyse vast amounts of real-world data to identify early safety signals or to predict potential device failures before they occur by continuously learning from new information. AI helps create proactive, predictive safety monitoring systems that can improve patient outcomes and reduce risks more effectively than the traditional methods. From my perspective, together, these emerging technologies hold a great promise to transform how we ensure device safety in the future.

Alexandra: 15:14

What would successful implementation of these technologies then look like in practice? And what's realistic to achieve in the next five to ten years?

Omar: 15:22

This is a difficult question to predict, but a successful implementation of blockchain and AI technologies in medical device safety would mean having transparent, taper-proof records for every device that enable quick traceability of issues and seamless sharing of information among manufacturers, among regulators, and healthcare providers. AI-driven systems would continuously analyse the real world data to detect early warning signs of device malfunctions or safety risks, allowing proactive interventions before patient harm occurs. In the next 5-10 years, it's realistic to achieve widespread adoption of blockchain for supply chain traceability in key markets and to see maybe AI tools integrated into the post-market surveillance systems to enhance again the signal detection. However, full global harmonisation, data standardisation, and regulatory frameworks, I think, will take longer to mature for the medical devices if we compare it with pharmacovigilance harmonisation. The progress will likely be incremental, starting with the pilot programs and expanding as trust, infrastructure, and collaboration will be improved.

Alexandra: 16:52

But then don't you think that with us using AI more and more in our processes, that this might speed up this process going forward?

Omar: 17:01

Yes, there's a hope in strengthening this harmonisation and collaboration. The tools that we have, the AI and the global communication and exchanges between regulators, can speed up this for the near future.

Alexandra: 17:18

How realistic is the creation and use of a global medical device database like we have for medicines and vaccines? Do you know if anyone is pursuing this at all?

Omar: 17:27

Not currently. The global medical device database remains challenging due to different regulations, data standards, and infrastructure worldwide. Efforts like the FDA, Good ID, which is a database, the EU DAMED, and the World Health Organization MEDEVIS platform are key building blocks. But over the next five to ten years, if we align with the last question, progress will likely come from linking regional databases and harmonising standards rather than creating a single global system, I think.

Alexandra: 18:05

So if you could advocate for one key change, whether regulatory, technological, or cultural, that would have the greatest impact on medical device safety globally, what would it be and why?

Omar: 18:19

Great question. If I could advocate for one key change, it will be the global harmonisation. Really the global harmonisation of post-market surveillance standards, consistent reporting, data sharing, and performance monitoring across countries would close major safety gaps. I'm involved in ISoP. I have experience in working in Africa, in Europe, in North America, and that's why I mean it's very important for me the harmonisation, ensuring the safety of patients wherever the patient is. So yeah, close major safety gaps, accelerate signal detection, and ensure that lessons learned in one region benefit patients everywhere and globally.

Alexandra: 19:06

And what a great place to end this interview. Thank you so much, Omar, for joining me and for talking about a very interesting topic. I learned so much today, and I've done quite a bit of research on medical devices.

Omar: 19:18

You're welcome.

Alexandra: 19:32

If you want to know more about medical device pharmacovigilance, check out the episode show notes for useful links. And if you'd like more pharmacovigilance stories, visit our news site Uppsala Reports at UppsalaReports.org to stay up to date with news, research, and trends in the field. If you enjoy this podcast, subscribe to it in your favourite player so you won't miss an episode and spread the word so other listeners can find us. Uppsala Monitoring Centre is on Facebook, LinkedIn, X, and Blue Sky, and we'd love to hear from you. Send us comments or suggestions for the show or send in questions for our guests next time we open up for that. You can also visit our website to learn more about what we do to promote safer use of medicines and vaccines for everyone everywhere. For Drug Safety Matters, I'm Alexandra Coutinho. I'd like to thank my colleague Federica Santoro for post production support, and of course you for tuning in. Till next time!