EPA, CDC and ASPR top October's regulatory issues

EPA releases proposed rule on drug waste

Environmental services // The Environmental Protection Agency administrator recently signed a proposed Management Standards for Hazardous Waste Pharmaceuticals Rule, which puts forth a tailored, sector-specific set of regulations for the management of hazardous waste pharmaceuticals by reverse distributors and health care facilities, including hospitals, clinics and retail stores with pharmacies and reverse distributors. According to the agency, the proposed rule will provide standards to ensure that management of hazardous waste pharmaceuticals is safe and workable within the health care setting.

CDC updates Ebola PPE guidance for facilities

Worker safety // The Centers for Disease Control and Prevention recently issued updated guidance regarding personal protective equipment (PPE) for health care personnel who care for patients with suspected and confirmed Ebola in U.S. health care facilities. The changes clarify the use of fluid-resistant and impermeable gowns and coveralls, and provide specifications to assist facilities in selecting and ordering the recommended garments. The updates also provide additional explanation related to PPE for patients with a confirmed Ebola diagnosis.

Toolkit helps providers to serve homeless in disaster

Emergency management // The Health & Human Services’ Assistant Secretary for Preparedness and Response has released a toolkit to help health care providers prepare to address the unique needs of homeless individuals in a disaster or public health emergency. It is part of a larger interagency toolkit being developed by the Veterans Emergency Management Evaluation Center to integrate homeless populations into disaster planning. The final toolkit also will include sections on emergency communication, and training and technical assistance for community-based organizations.

Agency posts update to accessibility guide

Design // The U.S. Access Board recently posted the latest installment of its online guide to accessibility standards issued under the Americans with Disabilities Act (ADA) and the Architectural Barriers Act (ABA). This material features a series of technical bulletins covering requirements for accessible routes in Chapter 4 of the ADA and ABA standards, including doors and gates, ramps and curb ramps, and elevators and platform lifts. There is also a bulletin on referenced requirements for accessible means of egress. The documents explain and illustrate requirements in the standards, answer common questions and offer best-practice recommendations. The U.S. Access Board is a federal agency that promotes equality for people with disabilities.

FDA issues warnings to duodenoscope makers

Biomedical // The Food and Drug Administration (FDA) has issued “warning letters” to three duodenoscope manufacturers alleging certain regulatory violations. Olympus Corp. of the Americas and Hoya Corp. were cited for failing to report infections associated with their devices to FDA within 30 days and to adequately develop, maintain and implement written Medical Device Reporting procedures. Hoya also was cited for certain alleged violations related to design validation, corrective action and process control. Fujifilm Medical Systems USA Inc. was cited for alleged violations related to design control, corrective action, parts inspection, process validation, complaint handling, equipment testing, production processes, and device correction or removal.