The Safe Medical Devices Act and Home Health Care: Risk Management Issues and Solutions

Abstract

On July 31, 1996, new regulations took effect that were promulgated under the Safe Medical Devices Act (SMDA). These regulations squarely address the home health care provider, creating new reporting and communication challenges for home health care agencies (HHAs). As the months have elapsed, questions have begun to emerge regarding the SMDA regulations that reflect the unique nature of home health care in the distribution and use of durable medical equipment. Reasonable minds might differ on the best way to tackle these issues and the practical aspects of addressing SMDA in home care. This article addresses some of these issues, emphasizing the importance of cogent policy, procedures, inservice education, documentation, and lines of communication.

Keywords

risk management Safe Medical Devices Act

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References

Safe Medical Devices Act of 1990, 21 USC §§360 et seq.

21 CFR §803.20 (1996).

21 CFR §803.33 (1996).

21 CFR §803.17 (1996).

21 CFR §803.18 (1996).

21 CFR §803.20 (1996).