NEPTUNE LOVER The FDA's recall of the Neptune 1 Silver and Neptune 2 Ultra systems might force Harriet Willoughby, BSN, to find some other way to dispose of fluid waste.

Neptune suction systems have been collecting and disposing of the fluid waste inside the 4 ORs and 2 GI rooms at the Gadsden (Ala.) Surgery Center for nearly a decade. "We bought them when they first came out," says Harriet Willoughby, BSN, the administrator of the multi-specialty facility. "We have 6, and we use them for most every case, with the exception of cataracts and pain management."

But a recall of the popular closed collection carts with built-in vacuums and the FDA's call for facilities to stop using Neptune and transition to approved devices may force Ms. Willoughby and thousands of other facility managers in hospitals and surgical centers across the country to find another way to dispose of infectious surgical waste.

What led to the recall?
Stryker issued a recall of the Neptune 1 Silver and Neptune 2 Ultra last year, saying the devices could cause hemorrhaging and damage soft tissues, muscles and organs if used improperly. The recall came after 2 patients were injured, one fatally, when a healthcare worker inexplicably connected the Neptune 2 Ultra to a patient's chest drainage tube after surgery.

Stryker says you should never use either high-powered device for respiratory tract suction, but didn't include such a warning on the label. Stryker sent all Neptune 1 Bronze, Neptune 1 Gold and Neptune 1 Gold International customers warning labels to apply to their devices. The warning states: "Do not apply high-flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low-vacuum or low-flow suction."

Months after the initial recall over the patient injuries, Stryker extended the recall to inform customers that it never obtained 510(k) clearance from the FDA for the Neptune 1 Silver, Neptune 2 Ultra and a higher-powered Neptune 2 Ultra. Unlike the Neptune 1 Gold, these devices hadn't received pre-market approval from the FDA.

Stryker plans to discontinue the Neptune 1 Silver and will withdraw all support for the use of this device by March 1, 2014. After that date, the FDA says you shouldn't use the Neptune 1 Silver. Stryker is working with the FDA to get clearance for the second generation of the Ultra. Ms. Willoughby says she hopes that happens by next March.

APRIL 17 WEB CONFERENCE
Get Advice Straight From the Experts

ECRI Institute has been reporting on the Stryker Neptune recall since its inception, issuing exclusive Health Devices Alerts and special reports addressing the implications. Now, to help healthcare providers comply with the various implications of this regulatory action, ECRI is presenting a web conference that will cover the facts about the recall, how risks occur when using the Neptune devices, the key steps to deciding what to do next and guidance for buying replacement devices. There will be an extended Q&A session. If you register by April 15, use discount code DAPR13 to save $60.

WHAT: Stryker Neptune Waste Management System Recall: What Now?

WHEN: 1 to 2:30 p.m. EDT, April 17

REGISTER: www.ecri.org/Conferences/AudioConferences/Pages/Stryker-Neptune-Waste-Management-System-Recall.aspx

Post-recall use of the Neptune
In the short term, the FDA is giving you the option to continue using the Neptune until next March — but only if you have no alternative systems for collecting and disposing of surgical fluid waste.

The FDA "is not currently asking Stryker to remove the Neptune 2 Ultra Waste Management System and the Neptune 1 Silver Waste Management System from the U.S. market due to concerns that removal would likely create immediate market shortages."

Considering that individual units range in price from $20,000 to $30,000 each and that many hospitals and ASCs have 1 per OR, the grace period is good news for Neptune lovers like Ms. Willoughby. Her plan is to continue using her 6 Neptunes until next March, and then hope the FDA approves next-generation Neptune Ultras so she can buy them.

"My nurses would die if we went back to the old way of collecting fluids with suction canisters," says Ms. Willoughby. "They would absolutely hate me, because the Neptune is so nice and clean."

If you continue using the recalled Neptune 1 Silver and Neptune 2 Ultra, you must request a certificate of medical necessity (CMN). Without a CMN, Stryker can't provide any disposable accessories, replacement parts or service for your devices. The deadline for obtaining the CMN was March 25. Contact Stryker directly if you need an extension at [email protected].

Stryker sent updated recall notifications to its customers on Feb. 20 to remind them of the 3 steps that must be followed as part of continued use of the device:

• Ensure all users of the Neptune 1 Silver or Neptune 2 Ultra are properly trained before using the device, and are aware of the device's risks.
• Implement use of the Neptune Pre-Use Checklist (tinyurl.com/cwjo4bh), which must be completed before every procedure for which a Neptune 1 Silver or Neptune 2 Ultra is used.
• Before using one of the recalled Neptunes, follow the recommendations listed in the most recent FDA Safety Communication on the devices to mitigate risks during use.

"That's a pretty onerous requirement to continue using the device," says an industry source.

The pre-use checklist is 2 pages. The first page guides the circulating nurse through the 9 steps that must be followed before use of a recalled Neptune device. The second provides space for listing the names and titles of "all hospital personnel that were in the OR during the use of the Neptune." The documentation must be signed, with time and date, by the circulating nurse every time the devices are used, then filed with the patient record. Failure to do so would mean a facility loses its CMN and, therefore, the ability to continue to use the devices post-recall.

"The Stryker Neptune recall is a really big deal because of the high-profile regulatory attention that it's received and the associated patient safety concerns. How you handle the recall is going to get a lot of scrutiny," says Jim Keller, vice president of health technology evaluation and safety at ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care. "You should develop a clear written justification for decisions related to the recall. If you continue with the short-term use of Stryker products, what's your justification for doing this? What's your timeline for purchasing replacement products?"

Product affinity
Stryker is the dominant player in fluid carts, by some estimates controlling as much as 85% of the market. Why such an affinity for a fluid-sucking machine? Perhaps the feature OR staff love most about the Neptune is that it's a closed, all-in-one unit with a built-in vacuum that collects and disposes of fluid waste without operator assistance, says Ms. Willoughby.

At the end of the procedure, you roll the device to a docking station, which automatically empties the fluid from the reservoir and then cleans it so it can go back to use. The Neptune can also clear the room of smoke generated from electrocautery and laser surgery.

For many years, the traditional approach to managing liquid waste had been to connect freestanding suction canisters to a vacuum on the wall that aspirates fluids. But the wall suction can be inadequate and staff might be exposed to infectious fluids. "Pouring canisters of fluid out can create splashing and aerosolization," says Chris Lavanchy, ECRI's engineering director of health devices. "With closed fluid management systems, the user never has to come in contact with the fluid."