The FDA has cleared Stryker's Neptune 2 Waste Management System for a return to the marketplace after a 2012 recall over improper use and lack of FDA approval that forced surgical managers nationwide to rethink their case turnovers.

The popular fluid waste and surgical smoke disposal device's reintroduction is being accompanied by operational improvements and training opportunities to ensure safety as well as efficiency in the OR, says the company, which it developed through regulatory and on-the-job reviews. Among the improvements that have been added to the Neptune 2 are the following safeguards:

• Suction power codes. The top cover now features low-, medium- and high-range color coding to denote the suction power in use.

• Updated software makes the unit's operation more interactive and responsive. It includes added warnings against the use of suction with wound drains and chest tubes that users must acknowledge before suction is activated. High-range suction includes additional audio and visual signals, including the display screen's color changing from blue to white. User controls in the low and medium range have also been improved, and vacuum units are displayed in mmHg only.

• Safety warning labels have been added to the top, front and rear of the device. The quick reference card has been updated in content and increased in size. Plus, a warning flag has been added to the IV pole for visibility.

"Stryker worked for over 2,900 hours with 325 healthcare practitioners, including circulating nurses, surgeons, surgical assistants, anesthesiologists, CRNAs and independent human factors experts," says a company representative. "The result is the same product our customers depend on, with enhanced safety and user-friendly features."

Stryker is also scheduled to launch its Surgical Suction Academy (strykerOReducation.com) this month, a new, complimentary, hands-on continuing education program. This training provides insights not only on the assembly and use of the Neptune 2 system, but also on the hazards of suction (improper use of a Neptune unit resulting in tissue damage and a patient's death was one reason for the recall), the science of volumetric pressure, technology and techniques for fluid waste management and smoke evacuation, and the safety responsibilities of every surgical staff member.

So when will you be able to put Neptune back to work in your fluid-heavy orthopedic ORs? "Our first priority is to the customers who have existing Neptune 2 units. These units will need to be upgraded to the cleared device standards," says the company representative. "Customers who would like to purchase new units may do so now." Contact your Stryker sales rep for more details.

— David Bernard

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