Sterilization Committee recommends further study of MSI labeling.
AAMI's Sterilization Committee has recommended that the Canadian government delay action on its proposal to require that medical device labels include a microbiological safety index (MSI) legend. The committee recommendations were prepared at the invitation of the Canadian Health Protection Branch, Health and Welfare Canada, to review and comment on its proposed amendment to its Medical Device Regulations. The proposal establishing a new concept in labeling information was offered to supplement current label information claims of device sterility based on end-product sampling. The committee has submitted to the Canadian government recommendations prepared by the MSI Ad Hoc Working Group and endorsed by the full committee, expressing certain reservations in enacting this amendment at this time, and suggesting further study on alternatives to improve the reliability of sterility claims.
D008829:Microbiology; D012449:Safety; D013242:Sterilization / Q000592:standards*