Medical Device & Clinical Equipment Management Checklist #4
This checklist supports healthcare facilities in managing medical devices and clinical equipment in compliance with FDA Quality System Regulation, CMS expectations, and accreditation standards. It focuses on inventory control, preventive maintenance, calibration, recalls, and safe use.
- Industry: Healthcare
- Frequency: Monthly
- Estimated Time: 30-45 minutes
- Role: Biomedical Engineering Manager / Facilities Manager
- Total Items: 35
- Compliance: FDA 21 CFR 820 Quality System Regulation, CMS Conditions of Participation – Equipment Safety, AAMI EQ56 Medical Equipment Management, NFPA 99 Health Care Facilities Code, Joint Commission Equipment Management (EC) Standards
Inventory & Identification
Verify device inventory and identification.
- Equipment inventory current and accurate?
- Asset tags affixed and legible?
- Devices risk-classified?
- Photo of tagged equipment
- Notes
Preventive Maintenance & Calibration
Assess PM and calibration.
- Preventive maintenance schedule followed?
- Calibration current for applicable devices?
- PM records complete and retained?
- Photo of PM label/log
- Notes
Device Safety & Use
Verify safe use of devices.
- Users trained and competent?
- Safety alarms functional?
- Damaged devices removed from service?
- Photo of device in use area
- Notes
Cleaning, Disinfection & Storage
Ensure proper cleaning and storage.
- Cleaning/disinfection follows IFU?
- Devices stored properly?
- Loaner devices managed and cleaned?
- Photo of storage/cleaning area
- Notes
Recalls & Alerts
Manage recalls and safety alerts.
- Recall process defined and followed?
- Manufacturer/FDA alerts reviewed?
- Affected devices identified and actioned?
- Photo of recall notice/log
- Notes
Documentation & Audits
Ensure documentation readiness.
- Equipment management policies current?
- Prior audit findings resolved?
- Equipment metrics tracked?
- Photo of policy/log
- Notes
Quality Improvement
Integrate into QAPI.
- Included in QAPI activities?
- Equipment-related incidents trended?
- Improvements implemented?
- Photo evidence (if applicable)
- Notes
Related Healthcare Checklists
- Medical Device & Clinical Equipment Management Checklist #5
- Medical Device & Clinical Equipment Management Checklist #6
- Medical Device & Clinical Equipment Management Checklist #7
- Medical Device & Clinical Equipment Management Checklist #8
- Medical Device & Clinical Equipment Management Checklist #9
- Medical Device & Clinical Equipment Management Checklist #10
- Medical Device & Clinical Equipment Management Checklist #11
- Medical Device & Clinical Equipment Management Checklist #12
Related Medical Device Management Checklists
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Why Use This Medical Device & Clinical Equipment Management Checklist #4?
This medical device & clinical equipment management checklist #4 helps healthcare teams maintain compliance and operational excellence. Designed for biomedical engineering manager / facilities manager professionals, this checklist covers 35 critical inspection points across 7 sections. Recommended frequency: monthly.
Ensures compliance with FDA 21 CFR 820 Quality System Regulation, CMS Conditions of Participation – Equipment Safety, AAMI EQ56 Medical Equipment Management, NFPA 99 Health Care Facilities Code, Joint Commission Equipment Management (EC) Standards. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the Medical Device & Clinical Equipment Management Checklist #4 cover?
This checklist covers 35 inspection items across 7 sections: Inventory & Identification, Preventive Maintenance & Calibration, Device Safety & Use, Cleaning, Disinfection & Storage, Recalls & Alerts, Documentation & Audits, Quality Improvement. 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 30-45 minutes.
Who should use this Medical Device & Clinical Equipment Management Checklist #4?
This checklist is designed for Biomedical Engineering Manager / Facilities Manager 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.