The Gadsden (Ala.) Surgery Center was among the many super-satisfied Stryker Neptune customers who were forced to at least consider abandoning their waste management system and transitioning to another method of collecting and disposing of fluid waste. In 2012, the FDA recalled the popular Stryker Neptune after patient injuries and at least 2 deaths were reported when nurses mistakenly applied high-flow, high-suction vacuums to passive chest drains. The 2-part recall was confusing and injuries associated with the use of the Neptune were the result of bizarre user error, but when the dust had settled, Neptune owners could either switch to another fluid waste management machine or jump through some administrative hoops if they wanted to continue using the recalled Neptunes (see "Not Your Typical Recall" on page 46).

Gadsen Surgery Center Administrator Harriet Willoughby, BSN, whose 6 Neptunes were in constant use inside her 4 ORs and 2 GI rooms, felt she owed it to her staff — and her curiosity about other fluid management options — to trial another system. She arranged for a closed, direct-to-drain system to be placed in 1 of the ORs for 30 days of surgeries that included a full slate of high-fluid orthopedic cases. The system performed admirably, says Ms. Willoughby. "It was a very good system, it worked fine for the staff," she says.

But Gadsen decided to stick with the Neptune, as well as the regulatory paperwork required for its continued use. Why? In a word: mobility. The trialed system needs to plug into wall suction to operate, and this limits where it can go in the OR. "My staff has gotten so used to the Neptune's mobility if they needed to pull it around to the other side of the table or across the room," says Ms. Willougby, a 10-year Neptune customer. "It was easier to manipulate." While surgical staffers tried connecting extension tubes to the trialed system to extend its reach, in the end, Ms. Willoughby says, there's just no substitute for untethered mobility.

Fluid situations
Besides its mobility, the Neptune owes its huge following to the fact that it eliminates the manual handling of infectious surgical waste. It uses closed collection carts with built-in vacuums to suction and collect liquids during surgical procedures and a proprietary docking station to automatically empty the liquid waste at the end of the procedure.

Most surgical facilities that have orthopedic cases on the schedule use portable suction units that roll to docking stations as their main method of collecting and disposing of fluid runoff, according to a recent Outpatient Surgery Magazine reader survey. There's a good reason for the predominance of this choice over the solidifying or manual dumping of canisters. Closed and automated direct-to-drain systems protect the nurses and techs tasked with fluid disposal and make their jobs easier. Those we surveyed cited safety — namely, infection prevention and ergonomic benefits — as the leading factor in their choice of fluid waste management system, followed by simplicity and economy.

ADMINISTRATIVE BURDEN
Not Your Typical Recall

Is it really a recall when you can continue using the recalled product? Facilities that wish to continue using the Neptune could submit certificates of medical necessity to Stryker, with which they could continue to use the recalled units, provided they undertook 3 steps:

• They train their staff in the proper use and potential hazards of the unit.
• The circulating nurse completes a 2-page pre-use safety checklist (tinyurl.com/cwjo4bh) before every procedure in which a Neptune device is in use. Failure to use this checklist prior to each procedure is grounds for a revocation of a facility's certificate of medical necessity. That's not all. On the reverse side of the form, the circulator must list all personnel that are in the OR during the Neptune's use.
• The staffer consults the FDA's most recent safety communication on the unit before each use.

— David Bernard

A cause for the cost?
For those who sought out fluid waste management alternatives, cost was a chief concern in their selection. Was the potential expense of implementing an upgrade justifiable? Or would it make more economic sense to handle fluid by hand?

Our survey told us that more than a few facilities affected by the recall have continued to use their rapid-cycle equipment under the manufacturer's new, FDA-mandated safety requirements. Ms. Willoughby puts it in perspective. "We did, at first, have some pushback to the paperwork," she says. "But now it's just another piece of paper in the chart. We don't hear complaints about it anymore."

Not everyone agrees. "Filling out the paperwork took as long to complete as to chart the entire case," says another Neptune user. Plus, she was apprehensive about the potential liability of continuing to use the recalled product, even under medical necessity guidelines. She wanted an alternative, and it had to be a self-contained, direct-to-drain system.

Another issue: Would a switch mean budgetary changes? After researching the product field on the Internet, networking with professional peers and identifying a suitable replacement system, Ms. Ramsey found herself embroiled in negotiations over acquisition costs. While the previous equipment's manufacturer had provided her facility with the unit in exchange for the purchase of a certain volume of disposable filters and cleaning solutions, the replacement's deal involved an outright purchase. Ms. Willoughby, on the other hand, found that the system she trialed and declined was actually a less expensive option.

The hike in pricing is likely even steeper for those ditching manual disposal methods for automated ones. The routine purchase and disposal of emptied or solidified canisters is one cost, but a standing order of filters and cleaning solution — and possibly even some plumbing renovations — ?is another cost entirely.

There's another cost to consider when selecting a fluid waste management method, and that's what sorts of risks or how much of a burden it imposes on the nurses and techs who use it.

"Would the cost of a system lessen the risk to your employees?" asks Ms. Ramsey. An exposure control plan to shield them against the infection risks of bloodborne pathogens might call for safer disposal methods. Do continuously running arthroscopy pumps leave your staff hefting full canisters down the corridor? "Those jumbo jugs are heavy. They're a liability for workers' comp injuries," she says.

Or is manual dumping in the utility sink, and the attendant need to suit up in a full complement of personal protective equipment, just a time-consuming hassle for staff and a drain on turnover times? If you've been using closed systems for long enough, you may have forgotten just how onerous that process is.

Simple and supported
The direct-to-drain system that Ms. Willoughby's staff trialed had an impressive advantage. Because it drained its collected fluid through wall suction, its self-cleaning cycle could be run without transporting it out of the OR, as opposed to devices that require emptying at a drainage dock before they can be rinsed out. "A lot of facilities going straight from canisters to [that product] are going to think that's the best thing going," she says.

For Ms. Ramsey's staff, the alternative option was as easy for her staff to use as the equipment it replaced. "Physicians have a great deal of input on equipment purchases, but when it comes to suction, if it works, they don't care what it looks like," she says. The big question is, how does it work for your staff? "Can they push it? Does it dock easily?"

CAPACITY COUNTS The ability to suction several cases' worth of fluid without stopping is an efficiency booster.

Another question to ask: If you needed to, could you use your fluid waste system for an entire day without having to empty and flush it between cases?

During the trial period, when you're determining whether a particular fluid management system works for you, it's a good sign for future service and maintenance support down the road if the manufacturer's representatives are reliably responsive in teaching you how it works. "Every nurse, tech and surgeon saw it," says Ms. Ramsey. "The reps took responsibility for setting it up. If something wasn't working right, the reps adjusted it for us to suit our needs. We may have taught them as much as they taught us."