Ahead of the upcoming Extractables & Leachables China 2021 conference, we caught up with the experts from Medtronic. They gave us a sneak peek of what we can expect from the presentation on day two, taking place during our 'Risk Assessment and Risk Management on E&L' session.
Current Industry Focus:
Q. What are the biggest challenges facing the E&L sector (in China)?
In China, as equipment has more and more types and materials used also become more complex and diverse, E&L becomes very complex. With the limitation of current analyzing equipment and methodologies, it is hard to accurately qualify and quantify each type. Therefore, how to effectively identify and accurately quantify the E&L with current technical level is the biggest challenge.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
Given E&L is the critical step of assessing biocompatibility of medical device, we prefer reasonable, effectiveness and reliable laboratory strategies and laboratories that conduct these strategies.
Q. What technical issues to you think still need to be addressed in the future?
As E&L test results are related to the safety of patients, the requirements for data integrity, rationality, and accuracy become more and more stringent. Thus, improving the detection accuracy of equipment, exploring the pyrolysis principle of polymer liquid chromatography, and collecting data of various polymer pyrolysis products into a database will be effective ways.
Q. How do you think the future regulatory landscape will impact E&L studies in China?
With the increasing recognition of chemical characterization and toxicological evaluation approaches for CDME, domestic regulations and guidelines will be constantly updated and improved, which will also prompt E&L research to move towards a reasonable and effective direction.
Q. Your presentation at E&L China this year is titled "Application of the Threshold of Toxicological Concern (TTC) to Biological Evaluation of Medical Devices — Case Sharing". Why is it important for others in your industry to hear this message? What are some of the key take-aways?
TTC has a relatively mature application in food packaging, food additives and drug industry, but the time applying to evaluation of toxicology in medical devices is relatively short. With the change of concept of biocompatibility evaluation for medical devices and the implementation of the new version of ISO10993, chemical characterization and toxicological risk assessment play an important role in biological evaluation of medical devices. Because medical device has various materials and complex components, and leachable substances also has diversified compounds, toxicological risk assessments based on E&L results can also face difficulties if some compounds do not have sufficient toxicological data. In this case, the application of TTC method is very important because it can help toxicologists scientifically predict the toxicological risks of compounds without adequate toxicological data and therefore reduce unnecessary biological tests.
Although TTC is still facing some challenges in the application of medical devices and even other industries, the continuing research and analysis of researchers will certainly prompt TTC to develop wider and more scientific value.
Q. What are you most looking forward to at the conference of E&L China?
I am looking forward to hearing the share related to assessment methods of E&L and toxicology.