Developing a Biological Safety Evaluation

The three main steps in developing a Biological Safety Evaluation (BSE) are:

• 1) Biological Evaluation Plan (BEP)
• 2) Perform Testing and Written Risk Assessments
• 3) Biological Evaluation Report (BER)

A BEP is developed based on the risk of the device to the patient. With this in mind, several factors need to be considered to ensure that unnecessary testing is avoided. A useful testing plan will address the device as a whole, starting with materials and processes and ending with patient exposure (type and duration).

An understanding of testing options is crucial as the approach to determining the safety of a device is moving away from check box based decisions to scientific justification for when testing is necessary and when it is not. This will include a discussion about changes in the regulatory world that include an important use for chemistry testing.

As biological safety evaluations become more complex, a summary report is essential to draw the right conclusions from the data submitted to support the overall safety of a medical device. A written assessment is requested in ISO 10993-1 as well as in the FDA guidance document. The webinar will go over the information needed and the important points that should be included in the report.

This webinar will also include discussion of how to assess the biocompatibility of device  and process changes. Composed of a 50-minute presentation followed by a Q&A session, the webinar will cover the broad scope of developing a biological safety evaluation. This webinar will be based on ISO 10993-1 and the FDA Guidance document on ISO 10093-1 (effective September 2016).

Speaker

Audrey Turley, B.S., RM (NCRM), CBA (ASQ), Research Scientist, Nelson Labs

Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Laboratories, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM and NIH methods), and genotoxicity (Ames and chromosome aberration).

Audrey is an active committee member of many working groups with the Association for the Advancement of Medical Instrumentation (AAMI):

• BE/WG 06 – Mutagen, carcinogen, reproduction toxicity
• BE/WG 07 – Systemic toxicity
• BE/WG 08 – Irritation and sensitization
• BE/WG 10 – Implantation
• BE/WG 11 – Allowable limits for leachable substances

Message Presenter