By Dale Hockel
In today’s hospital, understanding and achieving regulatory compliance can be a daunting, but necessary task. Rigorous requirements from the Centers for Medicaid & Medicare Services, accreditation requirements (TJC, HFAP, DNV), state department of health compliance, and recalls/alerts from the FDA and OEMs demand a full-time professional to understand all standards and regulations for every device in a hospital. Instead, many hospitals rely on already taxed clinical engineers (CEs) to do the job. Although capable, CEs lack the time required to effectively engage with each regulatory body or stay current with every device.
Let’s examine a few regulatory requirements for documenting medical maintenance and determine if you have compliance covered.
Compliance starts with a medical equipment management plan (MEMP).
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DOTmed daily news published January 9, 2014.
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