Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation...

Area of Science:

• Analytical Chemistry
• Medical Device Safety
• Toxicology

Background:

• Leachables from medical devices pose potential patient health risks.
• Non-target analysis (NTA) using chromatography-mass spectrometry is crucial for profiling these substances.
• Variability in response factors complicates risk assessment strategies.

Purpose of the Study:

• To discuss challenges in applying the analytical evaluation threshold (AET) for leachables.
• To explore methods for accurate quantification of leachables and extractables.
• To address the balance between accuracy and protectiveness in risk assessment.

Main Methods:

• Screening of medical device extracts/leachates for organic substances.
• Utilizing non-target analysis (NTA) with chromatographic and mass spectrometric detection.
• Investigating practices for AET calculation, application, and quantification.

Main Results:

• Significant variation in chromatographic mass spectral response factors for leachables and extractables.
• Difficulties in interpreting the AET due to analytical uncertainty.
• Potential for false positive and false negative outcomes in risk assessment.

Conclusions:

• Response factor variability is a major challenge in medical device leachable analysis.
• Improved practices for AET application and quantification are needed.
• Balancing accuracy and protectiveness is key for reliable toxicological risk assessment.