Medical Device Safety & Maintenance Checklist [FREE PDF]
Biomedical engineers and clinical engineering staff use this checklist for medical device safety per Joint Commission Environment of Care standards and FDA Medical Device Reporting requirements.
- Industry: Healthcare
- Frequency: Monthly
- Estimated Time: 15-20 minutes
- Role: Biomedical Engineer
- Total Items: 8
- Compliance: Joint Commission EC.02.04.01, FDA 21 CFR Part 803
Preventive Maintenance & Inspection
Verify PM schedule compliance and device inspection results.
- Are all high-risk medical devices current on preventive maintenance schedule?
- Have electrical safety tests (leakage current, ground continuity) been performed?
- Are measurement and monitoring devices calibrated per manufacturer specifications?
- PM schedule notes
Recall Management & Adverse Event Reporting
Verify recall response and adverse event reporting compliance.
- Are FDA device recalls and safety alerts reviewed and acted upon promptly?
- Are device-related injuries and deaths reported per FDA MDR requirements?
- Is the medical device inventory accurate with unique device identifiers tracked?
- Recall and reporting notes
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Why Use This Medical Device Safety & Maintenance Checklist [FREE PDF]?
This medical device safety & maintenance checklist [free pdf] helps healthcare teams maintain compliance and operational excellence. Designed for biomedical engineer professionals, this checklist covers 8 critical inspection points across 2 sections. Recommended frequency: monthly.
Ensures compliance with Joint Commission EC.02.04.01, FDA 21 CFR Part 803. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Medical Device Safety & Maintenance Checklist [FREE PDF] cover?
This checklist covers 8 inspection items across 2 sections: Preventive Maintenance & Inspection, Recall Management & Adverse Event Reporting. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 15-20 minutes.
Who should use this Medical Device Safety & Maintenance Checklist [FREE PDF]?
This checklist is designed for Biomedical Engineer professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.