Medical Equipment Compliance Checklist

How It Works

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Work Through Each Section

Go section by section through the compliance areas. Check off each item as you verify it is in place for your business.

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Progress Auto-Saves

Your checklist progress saves automatically in your browser. Return anytime to continue your compliance review.

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Print for Your Records

Print the completed checklist as documentation that you have reviewed all compliance areas. Useful for audits and inspections.

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Frequently Asked Questions

Do I need FDA registration to rent medical equipment?

Yes, if you rent FDA-regulated medical devices (wheelchairs, hospital beds, oxygen equipment, etc.), you must register your establishment with the FDA and list the devices you distribute. Registration is done annually through the FDA's FURLS system. Failure to register can result in warning letters and enforcement actions.

What is required for HIPAA compliance in a DME rental business?

Any business that handles patient health information (PHI) must comply with HIPAA. This includes having a written privacy policy, training all employees, using encrypted systems for PHI, signing Business Associate Agreements with vendors, and conducting annual risk assessments. Violations can result in fines from $100 to $50,000 per violation.

How often should I sanitize rental medical equipment?

Every piece of equipment must be thoroughly cleaned and disinfected between each patient/rental using EPA-registered disinfectants. Single-use components like cushion covers, tubing, and masks must be replaced. Document every cleaning with the date, device serial number, and staff member who performed it. This documentation is critical for inspections.

FDA Registration

State Licensing

Insurance Requirements

Sanitation Protocols

Documentation & Record Keeping

Patient Privacy (HIPAA)