We spoke to Hongyu Luo, Senior Scientist at Baxter, ahead of her presentation at E&L China 2019 this September to get an exclusive preview of what she'll be discussing, as well as her insights into key challenges faced by the industry, future changes and more.
You will be speaking on 'How to choose an appropriate simulation solvent for medical device assessment: A case study of DEHP analysis for blood-contacting device'. Can you give us a brief insight into what areas you covering in your presentation?
In terms of risk assessment for medical devices, it is necessary or required to determine chemical substances which may present in medical devices and could cause potential toxicological risk to patient. Theoretically, it is expected that the chemical safety assessment is based on leachable study and then followed with toxicological evaluation. However, in practice, not all devices can conduct the leachable study due to the diversity of exposure route as well as complex contact media like blood. Thus, it is reasonable and scientifically justifiable to use simulate solvent rather than actual contact media for the extraction experiments. This presentation will discuss the strategy for how to choose an appropriate simulation solvent, and considerations on properties of chemicals, contact media, extraction ability, etc. A successfully developed case study will be present to make better understanding on the strategy.
In your opinion, what is the #1 takeaway of your presentation?
Choose an appropriate simulation solvent based on justification and validation.
What do you see as the most significant changes coming up in the E&L regulations in China in the next 12-24 months?
From regulation aspect, since 2012, NMPA published a couple of guidances for compatibility study between pharmaceuticals and packaging materials like plastic and glass, which involving E&L study in China. Also In the end of April, 2019, another guidance for “Verification and validation of determination methods for target leachables released from medical devices” published for comments. So, in my personal view, in the next 12-24 months, E&L study will constantly be standardized and improved.
What are the biggest challenges that you see across the sector?
The biggest challenges across the sector might include: Consider how to establish a solid analytical system whether it intends to target leachables or unknown chemicals. Consider how to establish an internal database for best practices on E&L. Consider how to improve E&L study capabilities through technical communication and discussion to enable different laboratories achieving more consistent results for the same article, etc.
Why do you feel it’s important for companies to attend E&L China 2019?
As mentioned above, during the E&L practice, the industry still faces many challenges, and technical communication and discussion will always be one of the important ways to solve these challenges.
Who are you most looking forward to at E&L China 2019?
From my side, experts from a variety of fields with extensive E&L study experience, including toxicologists, are most looking forward to meeting in person at E&L China 2019.
Hongyu will be presenting as part of the 'Focus on medical devices' session. Other speakers in the session include:
- ISO 10993-18: Chemical characterisation of medical devices; latest developments and expectations - Ted Heise, VP Regulatory & Clinical Services, MED Institute
- Designing chemical characterisation studies to meet changes to ISO 10993 - Sandi Schaible, Senior Director of Analytical Chemistry & Toxicology, WuXi AppTec
- Chemical characterisation of acrylonitrile butadiene styrene 3D printed medical devices - Keaton S. Nahan Ph.D, ORISE Poctdoctoral Fellow, CDRH / OSEL / DBCMS, U.S. FDA
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