Why is Biocompatibility Testing of Medical Devices Critical?
Biocompatibility is defined as “compatibility with living tissue or a living system by not being toxic, injurious, or physiologically reactive and not causing immunological rejection.”
For medical devices, which come into contact with the human body for the purpose of treatment, diagnosis, or physical aid, making sure that every point of contact will not cause irritation, changes in blood composition, or toxic response is especially critical. Even if a material that makes up the medical device has been tested for biocompatibility, processes such as manufacturing, packaging, aging, and sterilization may have adverse effects on the material’s composition and how it reacts in different environments. Because of these potential changes, biocompatibility is an important test protocol that must be completed for every medical device end product prior to receiving global regulatory approvals.
As a medical industry professional, it is critical to be informed about topics that affect global regulatory approvals. To help keep you and your company updated on the global regulations and requirements for non-clinical testing, UL is planning a series of seminars led by one of the leading experts in non-clinical studies.
Jan Peeters, a 35-year industry professional from Germany, will be sharing his knowledge on non-clinical testing at five locations across the U.S. from California to Florida:
- Tuesday, January 27 – Brea, CA;
- Friday, January 30 – Fremont, CA;
- Monday, February 2 – Mounds View, MN;
- Tuesday, February 3 – Canton, MA; and
- Thursday, February 5 – St. Petersburg, FL.
All roadshow seminars are 10:00 – 2:30 and include lunch. The seminar will be complimentary, but registration is required. Learn more and register at: http://web.ullifeandhealth.com/Non-Clinical_Roadshow.
Presentations will include topics such as:
- Material Characterization for more focused testing and cost savings with Q&A;
- Validation needs for packages of medical devices – Packaging processes, shelf-life and transportation;
- ISO 10993 Series of Standards – Regulatory updates and requirements;
- UL capabilities for non-clinical testing; and
- Optional facility tour at some locations.
Peeters describes that the most important focus of the road show is to inform medical device executives and consultants about how best to meet the regulatory requirements.
“In our conversations with medical device companies, we frequently recognize that they are not aware of all the regulatory compliance requirements for bringing a device into market. The main aspect is thoroughly understanding material characteristics and biocompatibility of a medical device. Whether certain substance from a medical device can leach into the bloodstream and have a negative influence on the safety profile of the patient and/ or user of the device,” he explains.
“The second aspect is point of packaging – most medical devices are used and applied in a sterilized space – and so viability of medical device must be demonstrated by validating the sterilization and sanitation of the device. However, after storing a sterile a medical device or transporting a medical device, the manufacturer must be sure that the sterility of the device is still maintained, and so must perform validation studies to confirm the impact of sterilization throughout transportation and storage,” Peeters adds.
Through the road show, UL wants to help the audience gain a better understanding of which kind of validation, and evaluation they would need to do to demonstrate the safety of their device. Peeters would also like to show manufacturers and consultants that UL is able to be a service provider of these kinds of services. “UL is well known in the U.S. for electrical safety and other similar safety aspects, but with medical devices, we are still not widely known for our capabilities. So we are starting with various tests within the field of material characterization, sterilization validation and also packaging validation to spread the message.”
For more information, visit http://web.ullifeandhealth.com/Non-Clinical_Roadshow.
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