STRYKER NEPTUNE WASTE MANAGEMENT SYSTEM

Description of Event or Problem

THE STRYKER NEPTUNE SYSTEM [STRYKER NEPTUNE WASTE MANAGEMENT SYSTEM (NEPTUNE 2 / NEPTUNE 3; ROVER AND DOCKING STATION)] IS DESIGNED SO THAT WHEN THE ROVER DOCKS, COLLECTED SURGICAL FLUID WASTE AND RINSE WATER ARE AUTOMATICALLY PUMPED INTO THE HOSPITAL SANITARY SEWER SYSTEM. MANUFACTURER DOCUMENTS CONFIRM THIS DISCHARGE PATHWAY. STRYKER'S OWN MATERIALS ACKNOWLEDGE THAT SURGICAL FLUID WASTE IS POTENTIALLY INFECTIOUS AFTER COLLECTION. ON (B)(6) 2025 THE HOSPITAL I WORK AT IN (B)(6) HAD A PLUMBING BACK-UP AND IT WAS IDENTIFIED THAT SIGNIFICANT AMOUNTS OF BLOOD RAN DOWN TWO FLOORS BELOW THE NEPTUNE DOCKING STATION. AFTER INVESTIGATING THE SYSTEM AND IFU IT IS CLEAR THAT THE WASTE IS NOT PROPERLY TREATED OR DISINFECTED PRIOR TO DISCHARGING DIRECTLY INTO THE SANITARY SEWER SYSTEM. IT IS ILLEGAL IN (B)(6) AND ALMOST ALL OTHER OF THE 50 STATES TO DISCHARGE INFECTIOUS MEDICAL WASTE. THE INSTRUCTIONS FOR USE (IFU) STATE ONLY: "ALWAYS FOLLOW LOCAL REGULATIONS REGARDING PROPER HANDLING AND DISPOSAL OF BIOHAZARD WASTE." THE IFU DOES NOT DISCLOSE THAT THE DEVICE'S INTENDED OPERATION DISPOSES UNTREATED INFECTIOUS WASTE DIRECTLY INTO HOSPITAL WASTEWATER PLUMBING. THIS CREATES A REGULATORY CONFLICT: HOSPITALS ARE USING THE DEVICE AS DESIGNED, BUT INFECTIOUS WASTE IS BEING DISCHARGED UNTREATED, IN CONFLICT WITH (B)(6) MEDICAL WASTE REQUIREMENTS AND MUNICIPAL WASTEWATER REGULATIONS. THE IFU SHIFTS LIABILITY TO THE FACILITY WHILE CONCEALING THE FACT THAT SEWER DISPOSAL IS THE BUILT-IN OUTCOME OF NORMAL USE. THE NEPTUNE DEVICE APPEARS TO BE MISBRANDED UNDER 21 U.S.C. §352, AS IT FAILS TO DISCLOSE SIGNIFICANT HAZARDS IN LABELING AND MARKETING. BY ADVERTISING INFECTION-CONTROL BENEFITS WHILE OMITTING THAT UNTREATED INFECTIOUS WASTE IS SENT DIRECTLY TO THE SEWER, STRYKER MAY BE MAKING FALSE OR MISLEADING CLAIMS ABOUT DEVICE SAFETY AND REGULATORY COMPLIANCE. USERS ARE MISLED INTO BELIEVING THE SYSTEM COMPLIES WITH WASTE-HANDLING LAWS WHEN IN FACT IT MAY NOT. REQUESTED FDA ACTIONS: IMMEDIATE CLASS I RECALL OF ALL NEPTUNE WASTE MANAGEMENT SYSTEMS IN CURRENT USE. CEASE-AND-DESIST ORDER PREVENTING FURTHER INSTALLATIONS OR USE OF NEPTUNE UNITS CONFIGURED TO DISCHARGE UNTREATED INFECTIOUS WASTE TO SEWER. REQUIRED LABELING CHANGES TO FULLY DISCLOSE THE DESIGN'S HAZARDS AND INCOMPATIBILITY WITH MANY STATE/LOCAL MEDICAL WASTE LAWS. FULL INVESTIGATION INTO STRYKER'S LABELING AND MARKETING PRACTICES FOR POSSIBLE REGULATORY VIOLATIONS.