Combined fluid waste management system recalled in regulatory mix-up

The Stryker Neptune system comprises a range of  totally closed fluid waste management and smoke evacuation systems consisting of a Rover and Docking Station. The mobile Rover unit collects surgical waste in the operation room and then quickly disposes of the fluids through the Docking Station with virtually no exposure to healthcare workers. Capable of smoke and fluid evacuation at the same time, Neptune 2 Ultra provides efficient waste collection and disposal while reducing staff and patient exposure to surgical fluid.

In many ways, the system is the big daddy of clinical suction apparatus, capable of dealing with fluids and smoke (from cautery and laser colposcopy). Smoke is filtered and condensed – it is a real problem as the density of smoke during laser colposcopy in particular can be sufficient to activate a smoke alarm and causes distress to patients and gynecologist. Fluids are collected into a suction canister of up to 20 litre capacity; fluid can be discharged to foul sewer with or without disinfectant additions, or removed for disposal with other clinical wastes.

Now, Stryker have issued an urgent medical device recall notice noting that it was expanding the recall to newer models of a waste management product recalled previously because it was selling those products without the necessary regulatory clearance.

The recall of the Neptune Rover Waste Management System appears to be a worldwide recall. The devices are being recalled because “Stryker has received two reports of serious injury as a result of tissue damage associated with the use of the Neptune 2, including an event in which one customer connected the Neptune 2 System to a passive chest drainage tube postoperatively,” killing the patient.

The company said that the US Food and Drug Administration informed Stryker that the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) Waste Management systems do not have the requisite 510(k) clearance and customers should stop using these devices.

Suction drainage systems are troublesome at best, but nonetheless essential in all areas of acute hospitals. Safety is essential, with these deaths being overshadowed by the many more deaths attributed to the use of contaminated suction apparatus.

Every incident is hugely regrettable, and the risks to those responsible for the disposal of wastes must cannot be  overstated as the containers from these and the more common suction devices, even when contained in disposable canisters, represent a pool of blood and bloodstained body fluid in a container that is never totally leak-proof. Gel granule additives may help, but there are contraindications to their use in several clinical circumstances.

 

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