There’s been a lot of talk lately about medical device risk management, thanks to the EU Medical Device Regulation, ISO 14971, and even ISO 11607, notes Henk Blom. But as vice president of research and technology for PAXXUS, and in former roles, Blom has learned how important it is to learn from past obstacles, so he decided to explore the relationship between failure analysis and risk management, and how these two disciplines could improve patient safety.
Blom will be speaking in an upcoming webinar on July 13, “Failure analysis as a risk management tool.” He will explore:
- Basic failure analysis principles
- Sterile barrier system defect analysis and case studies
- Risk management and defect analysis
- Material durability and package material design
Blom hopes to address one of the biggest mistakes in failure analysis. “If you don’t define the problem you’re trying to solve, the chances of getting the right answer are really low,” he told MD+DI. “Having been in the industry for 25 years and performed a lot of failure analysis, I’ve seen it done poorly over the years. It is not often taught, and young engineers seem to be expected to pick it up on the job.”
When it comes to risk management, he acknowledges that most medical device professionals think of risks that happen at the product or patient level, but he says there are also risks at the packaging component level. And that’s where failure analysis could prove useful.
“Failure analysis is typically done in distribution studies, where pinholes or seal channel failures are analyzed,” Blom said. He wants to take the learnings from such analysis and feed them back into risk management.
Otherwise, “you could end up reinventing the wheel every 4 years or so. Maybe someone tried to use a certain material to package a product and it failed, but the learning from that never got shared in the organization,” he said. “Risk management tools are the perfect place to capture this knowledge.”
Most packaging professionals probably haven’t paid too much attention to risk management, particularly ISO 14971, but they are starting to because of MDR and ISO 11607, which is currently being revised to address risk management and will be balloted late fall, Blom said.
Join us July 13 for “Failure analysis as a risk management tool.” The webinar will also be available to watch on demand for one year.