Extractables and leachables are substances that may be extracted from materials used to manufacture medical devices and/or that may leach out of those materials into body fluids during use.
Extractables are any chemical entity that can be intentionally or unintentionally removed from a material or device by conventional extraction procedures. Leachables are any chemical entity that can be released from a material or device under conditions that may reasonably be expected during storage, shelf-life, or use.
The potential for extractable and leachables to cause harm to patients arises from three primary mechanisms:
1) Chemical toxicity: Some chemicals are known to be toxic at very low levels of exposure.
2) Immunotoxicity: Some chemicals can elicit an immune response, leading to inflammation and other problems.
3) Sensitization: Some chemicals can cause sensitization, an allergic reaction that can range from mild to life-threatening.
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