Description of Event or Problem · 0
IN THE LAST WEEK OF[REDACTED]-THE MONTH, OUR ORGANIZATION RECEIVED NOTIFICATION FROM MEDLINE REGARDING A RECALL OF MEDLINE-BRANDED NEUROSPONGES DUE TO HIGHER-THAN-EXPECTED ENDOTOXIN LEVELS IDENTIFIED IN CERTAIN SPONGE LOTS. THESE NEUROSPONGES ARE ROUTINELY USED ACROSS MULTIPLE SURGICAL SPECIALTIES, INCLUDING NEUROSURGICAL INTRACRANIAL AND SPINAL PROCEDURES AND ORTHOPEDIC SPINE SURGERIES, WHERE THEY ARE CONSIDERED CRITICAL SURGICAL ADJUNCTS. AT THE TIME OF NOTIFICATION, CURRENT INVENTORY OF ALTERNATIVE PRODUCTS WAS LIMITED TO APPROXIMATELY 10 DAYS OF SUPPLY ON HAND, AND ONGOING NATIONWIDE DEMAND FOR SUBSTITUTES HAS RAISED CONCERNS ABOUT IMMINENT SHORTAGES OR UNAVAILABILITY OF FUNCTIONALLY EQUIVALENT PRODUCTS. PEER DISCUSSIONS WITH OTHER HEALTHCARE ORGANIZATIONS INDICATE WIDESPREAD CONCERN REGARDING THE ABILITY TO SAFELY PROCEED WITH URGENT AND EMERGENT SURGERIES SHOULD THESE NEUROSPONGES OR COMPARABLE ALTERNATIVES REMAIN UNAVAILABLE. WITHIN OUR HEALTH SYSTEM, SURGEONS WHO ROUTINELY USE THESE PRODUCTS HAVE EXPRESSED CONCERN THAT LACK OF AVAILABILITY OR SUBSTITUTION WITH LESS EFFECTIVE ALTERNATIVES MAY INCREASE THE RISK OF ADVERSE SURGICAL EVENTS, PARTICULARLY IN HIGH-RISK NEUROSURGICAL AND SPINAL PROCEDURES. MEDLINE¿S RECALL COMMUNICATION INDICATED THE RISK OF PATIENT HARM RELATED TO ENDOTOXIN EXPOSURE WAS CONSIDERED ¿VERY LOW,¿ AND NO ADVERSE PATIENT OUTCOMES HAVE BEEN REPORTED TO OUR ORGANIZATION TO DATE RELATED TO PRIOR USE OF THE AFFECTED NEUROSPONGES. THIS REPORT IS SUBMITTED TO INFORM THE FDA OF THE POTENTIAL PATIENT SAFETY IMPACT ASSOCIATED NOT ONLY WITH THE RECALLED DEVICE, BUT ALSO WITH THE RESULTING SUPPLY DISRUPTION, WHICH MAY POSE A SECONDARY RISK TO PATIENT CARE SHOULD ACCESS TO CRITICAL SURGICAL MATERIALS REMAIN LIMITED. OUR ORGANIZATION REMAINS AVAILABLE TO PROVIDE ADDITIONAL CLINICAL CONTEXT OR PARTICIPATE IN DISCUSSIONS TO SUPPORT SAFE RESOLUTION OF THIS ISSUE.