New postmarketing surveillance regulations affecting the ophthalmic nurse

A new federal regulation, The Safe Medical Devices Act, mandates that nurses in hospitals, nursing homes, and ambulatory surgery centers report serious problems associated with the use of medical devices to the FDA. Deaths must be reported to the FDA and manufacturer in 10 working days. Serious injuries and illnesses are also to be reported. Summary reports are due to the FDA semi-annually. After August 1995, the FDA may be able to fine the facility up to $15,000 for each violation of the reporting requirements. This article describes ophthalmic nurses' roles and responsibilities pertaining to the new law.