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Summary
Residual formaldehyde and paraformaldehyde were detected in steam-sterilized polymers like EVOH, PA-6, and NR. Material wettability impacts residue levels, and some residues showed toxicity, necessitating further toxicological investigation.
Area of Science:
- Polymer Science
- Sterilization Technologies
- Toxicology
Background:
- Steam-formaldehyde sterilization is a common method for medical devices.
- Concerns exist regarding residual sterilant chemicals in sterilized polymeric materials.
- Understanding residue levels and potential toxicity is crucial for material safety.
Purpose of the Study:
- To quantify residual formaldehyde and paraformaldehyde in polymers after steam-formaldehyde sterilization.
- To investigate the correlation between material properties (wettability) and residue levels.
- To assess the acute toxicity of detected residues in selected polymeric materials.
Main Methods:
- Steam-formaldehyde sterilization of polymeric materials in a commercial sterilizer.
- Quantification of residual formaldehyde and paraformaldehyde.
- Measurement of material contact angle with water.
- Acute toxicity screening using the HFL-test.
Main Results:
- Appreciable formaldehyde and paraformaldehyde residues were found in ethylene-vinyl alcohol copolymer (EVOH), polyamide-6 (PA-6), and natural rubber (NR).
- Materials with a low contact angle (high wettability) showed higher residue amounts.
- Residues in EVOH and polyamide-6,6 (PA-6,6) filter material exhibited toxicity in the HFL-test.
Conclusions:
- Material wettability is a significant factor influencing residual sterilant levels.
- The presence of toxic residues in some steam-formaldehyde sterilized polymers warrants further toxicological evaluation.
- Additional research is needed to understand the long-term health implications of using these sterilized materials.