The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning Organ Recovery Packs and Medical Convenience Kits produced by AVID Medical. These updates pertain to an essential correction affecting specific components of the kits, which could pose significant safety risks to recipients of donor organs. Health care professionals, clinical teams, and regulatory personnel are advised to review these updates to ensure compliance and prioritize patient safety.
What devices are affected?
The recall involves certain Organ Recovery Packs and Medical Convenience Kits manufactured by AVID Medical. Specifically, the 24×30 Poly bags included in these kits have been identified as a safety risk. AVID Medical has acknowledged that these bags were incorrectly made with non-medical grade polymers, making them unsuitable for organ transport.
Additionally, some of the affected plastic bags may not be sealed properly at the bottom, compromising their containment capabilities. This flaw has raised significant concerns about the risk of damage or contamination to donor organs during use.
What are the risks and implications?
The use of non-medical grade plastic in the affected Poly bags introduces several critical risks:
- Post-Transplant Infection Risks: The potential for cross-contamination may increase the likelihood of donor organ-associated infections.
- Organ Viability Concerns: Toxic substances from the non-medical grade material, such as additives or heavy metals, could leach into the preservation solution or the organ, causing viability issues.
- Increased Need for Medical Interventions: Contaminated or compromised organs may result in delays, additional surgical interventions, or even retransplantation.
- Delayed or Cancelled Operations: The loss, contamination, or damage of donor organs could lead to transplantation delays or cancellations, particularly in life-critical situations.
- Transmission of Infectious Diseases: Improper handling or sterility issues could result in sepsis, organ rejection, or disease transmission.
As of December 18, ADVID Medical reported one instance of compromised organ containment but no serious injuries or deaths associated with this issue.
What steps should be taken?
Immediate Actions for Health Care Professionals
AVID Medical has recommended the following measures to users and distributors of the affected kits:
- Segregate and quarantine all affected kits within your inventory.
- Discontinue use of the 24×30 Poly bags included in these kits immediately.
- Affix warning labels to all affected kits, ensuring users are aware of the faulty component. AVID Medical has provided a labeling template to facilitate this process.
End-users should replace or remove the non-medical grade Poly bags before resuming use of the kits. Other components within the kits are deemed safe for continued use once the identified Poly bags are discarded.
Guidance for Distributors
Distributors who have supplied affected kits are required to:
- Notify all downstream users promptly and ensure that they are aware of the necessary corrective actions.
- Maintain detailed records verifying effective communication and actions taken to comply with these instructions.
How can adverse events or problems be reported?
Health care professionals and consumers are encouraged to report any adverse events or quality-related concerns associated with these products to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program. Alternatively, customers with product-specific complaints can contact AVID Medical at complaints@owens-minor.com.
Further information and resources
For detailed guidance on recognizing and verifying a Unique Device Identifier (UDI) on medical device labels, healthcare providers and organizations can consult the AccessGUDID database. A UDI enhances the ability to pinpoint specific medical devices in the event of safety concerns or product recalls and improves the efficiency of regulatory oversight.
Additional information can also be found in the FDA Enforcement Report and the CDRH Medical Device Recall Database.
Conclusion
This notification highlights a critical issue in AVID Medical’s Organ Recovery Packs and Medical Convenience Kits, emphasizing the importance of immediate corrective actions to prevent safety risks associated with organ transport. By adhering to the FDA and AVID Medical’s guidance, stakeholders can support safer transplant outcomes while ensuring compliance with regulatory requirements.
Disclaimer
This content is intended for informational purposes only and does not constitute legal or regulatory advice. Healthcare providers and organizations should consult official documentation or legal counsel for compliance-related actions.