Is Your Facility Compliant? Avoid ONC Penalties & Joint Commission Citations.

Are you confident your facility is fully compliant with the latest ONC and Joint Commission regulations regarding medical device safety and information access?

Failing to comply can lead to:

  • ONC Penalties: Up to $1 million per violation

  • Joint Commission Citations: Potential accreditation loss and financial repercussions

  • Patient Safety Risks: Delayed care, increased infection risk, and potential for harm

Xcelrate UDI provides comprehensive solutions to help healthcare facilities achieve and maintain compliance with all relevant regulations. Our expert team will conduct a thorough assessment of your current practices and identify any potential gaps in your compliance program.

Contact us for a free Risk Assessment today!

Here’s What’s Happening

ONC Enforcement in Action

  • The Office of National Coordinator (ONC) has allocated $15.3 million to the Office of Inspector General (OIG) to investigate and penalize information blocking violations.

  • Multiple compliance reviews are already underway, with financial penalties of up to $1 million per violation.

Rising Joint Commission Survey Citations

  • Recent surveys have resulted in citations due to missing or outdated manufacturer IFUs for medical devices.

  • Facilities have been cited for improper UDI validation and failure to document recalled devices in their EHRs.

  • These citations can lead to reduced accreditation status, loss of reimbursements, and damage to your facility’s reputation.

The Joint Commission’s 2024 standards require:

  • Compliance with manufacturer IFUs for device cleaning, sterilization, and usage

  • UDI validation for all devices in use

  • Real-time recall management to prevent patient harm

  • Documentation of MRI safety warnings to ensure devices are compatible

Risk Factors

  • Failure to Provide Manufacturer IFUs

    IFUs contain critical cleaning, sterilization, and usage instructions for medical devices. Without immediate access to these documents, it can delay care, increase infection risk, and lead to citations.

  • UDI Validation is Missing from EHR

    The Unique Device Identifier (UDI) must be validated through the FDA’s GUDID database and documented in the EHR. Unvalidated devices may be unregistered, recalled, or missing MRI safety information.

  • Recalled Devices & MRI Safety

    Are your staff aware of device recalls or MRI safety warnings in real time? Delayed or missing alerts can result in patient harm and Joint Commission citations.

Don’t wait until your facility is the next cautionary tale. Let’s work together to protect your patients, maintain your accreditation, and avoid ONC penalties.

Additional Resources to Help You Stay Compliant: