Consensus guidelines for product sterilization

Sterilization requires a thorough understanding of both technical and regulatory requirements. The development of consensus guidelines has proven to be an effective method of establishing sterilization practices that can meet both regulatory and technical requirements. Regulatory rules prepared without industry participation have proven to be more costly and less effective than consensus guidelines. The AAMI recommended practice, Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices, exemplifies the value of the consensus approach.