Safe Medical Devices Act: Impact on a hospital-based home infusion agency

Abstract

The Safe Medical Devices Act (SMDA) was signed by President George Bush on November 28, 1990, and the Federal Drug Administration's (FDA's) final ruling became effective on August 29, 1993. This act has brought about significant changes in the regulation and reporting process of medical devices within the health care industry over the past 3 years. This law has altered the structure of medical device regulatory mechanisms, and it has expanded the scope of the FDA's practice to enforce the provisions. Not only has the SMDA placed a great burden on companies that develop, produce, and distribute medical technology, but it has directly affected the hospi tals and health care facilities that use medical devices. Implementation of the current FDA regu lations for medical device tracking imposes a great deal of pressure on hospital-based home infusion therapy agencies. In order to comply with the regulations, hospital-based home infu sion agencies must develop a clear, concise system for tracking infusion pumps. These agencies must also incorporate a teaching module for all staff to become better informed on device mal function reporting. Key words: home health care, infusion pumps, Safe Medical Devices Act