Operational Bulletin on Repackaging of medical equipment

Summary: Maine EMS is issuing a statewide operational bulletin regarding the discovery of supraglottic airway devices stored in non-standard, household vacuum-sealed packaging. Agencies are highly advised to immediately inspect their inventory and verify that all medical equipment is sourced from genuine, authorized distributors.

The Issue: During a recent routine ambulance inspection, Maine EMS inspectors discovered invasive airway devices (Size 0 and Size 1 King Airways) that were delivered and stored outside of their original manufacturer packaging. The devices had been repackaged into household food preservation bags (e.g., FoodSaver vacuum pouches) with hand-written labels.

Why This Matters: Invasive airway devices must remain in their original, manufacturer-sealed packaging to ensure patient safety and device integrity. Repackaging medical equipment presents severe risks:

• Compromised Sterility: Household vacuum bags do not meet medical sanitation standards.
• Device Damage: The negative pressure from commercial vacuum sealers can distort and damage the soft plastics, inflation lines, and cuffs of airway devices, risking catastrophic failure during use.
• Loss of Traceability: Repackaged items lack vital lot numbers, manufacturing dates, and expiration dates, making it impossible to comply with FDA safety recalls.
• Questionable Sourcing: Receiving equipment in non-standard packaging is a strong indicator of unauthorized distribution, gray-market sourcing, or counterfeit products.

Recommended Actions for All Agencies: Maine EMS strongly urges all agencies, clinicians, and medical directors to take the following steps:

1. Inspect Inventory: Check all airway rolls, jump bags, and apparatus stock. Ensure all devices are in their original, uncompromised manufacturer packaging.
2. Verify Genuine Sources: Review your procurement records and incoming deliveries. Ensure your agency is exclusively purchasing medical devices from reputable, authorized, and genuine medical distributors.
3. Quarantine and Report: If you discover equipment that appears tampered with, repackaged, or lacks lot numbers, do not place it in service. Quarantine the items immediately and contact your Regional EMS Manager.

Click here to read the full Operational Bulletin (PDF) (8/31/26)

For questions or to report suspect medical supplies, please contact your Regional EMS Manager.

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