Are your phaco handpieces in good hands when they're out of your physicians' hands? At about $3,000 to $5,000 each and responsible for making microsurgical cataract removal possible, they'd better be. Given the sensitive task asked of them, cutting corners on handpiece maintenance isn't in anyone's best interest. Keep the following advice in mind to keep yours running smoothly for years.
1. Consider automatic flushing.
Flushing the instrument's irrigation and aspiration lumens with sterile or distilled water, followed by air, after each use is labor intensive. Many manufacturers' reps have recommended a device for the decontamination room that attaches to a handpiece and pushes a set volume of water, then air, through the lumens. Automating flushing with this device not only reduces the amount of manual labor involved, but also ensures consistency in the process. The dangers of inadequate flushing are many. Not properly removing biological material from the lumens increases the risk of toxic anterior segment syndrome or endophthalmitis. Inadequate flushing may also let the balanced salt solution build up in the lumens and clog the handpiece.
2. Comply with single-use and reuse guidelines.
A handpiece's phaco tip, or needle, and the silicone irrigation sleeve fitted over it to insulate tissue against the heat generated by the tip are available as single-use components or certified for a limited number of reuses, depending on the manufacturer. While there's a tradition of reuse in ophthalmic surgery, concerns about the rise of TASS and endophthalmitis have put reuse under greater scrutiny. Make sure that your staff complies with accreditors' and regulators' guidelines on the subject, using items labeled "single-use only" only once.
For handpieces and components that are reusable, steam sterilization is generally preferred. Follow both the instrument's and the sterilizer's directions for reprocessing, paying particular attention to time, temperature and pressure parameters, to ensure that the cycle meets the goals of sterilization. Even if all the components are reusable, you should remove the irrigation sleeve and phaco tip for reprocessing to allow for a more thorough cleaning and penetration of steam.
3. Reassemble with care.
Reassembling these components after reprocessing may require some staff instruction by manufacturers' reps or physicians. Overtightening the phaco tip on the business end of the handpiece can crack its coupling. Undertightening, on the other hand, creates the risk of throwing shards of the tip into the anterior chamber — although most modern phaco machines will not tune the handpiece and machine, and won't function, as a safeguard if the tip is undertightened.
4. To cool or not to cool?
Some manufacturers' directions state that you must let an autoclaved handpiece cool to room temperature before it is used. The reason for this is to prevent damage to the piezoelectric crystals inside the handpiece that, through their conversion of electrical energy into mechanical energy, generate the ultrasonic motion of the phaco tip.
If you've retrieved a wrapped handpiece from a storage shelf for its first case of the day, this won't present a problem. But if a freshly reprocessed handpiece's crystals are still hot from the sterilizer when cold or room-temperature saline is irrigated through the handpiece during setup for a case, the temperature difference can, over time, cause the crystals to crack and the handpiece to fail.
The reality is that very few, if any, surgical facilities let the handpiece return to room temperature, simply because there is not sufficient time in a turnaround cycle. Between the high-efficiency demands of the surgical schedule and the required parameters of reprocessing, you likely find that waiting to deliver the instrument to surgery is just too long. In this situation, practicality seems to go against the grain of the directions for use, especially since most facilities' experiences with phaco handpieces is that they still function very well even when they've been turned around without the specified cooling time.
While the gradual impact this has on the crystals poses no risk to the patient, it will eventually impair the performance of the instrument. If you want to maintain your surgeon's tool and your surgical efficiency, you may have to go against what works in practice. If the cooling-off period and other turnaround considerations are routinely throwing complications into your schedule, perhaps the solution is budgeting for and acquiring additional handpieces.
5. Don't stray from directions.
The proper handling of phaco handpieces should begin with policies that conform to directions and guidelines to standardize the practices of flushing, autoclaving, rotation and other efforts. Staff should be trained to those policies, and even administrators and managers should know the granular details of the instruments in use at your facility. The paperwork should reflect what you're actually doing, and vice versa.
Manufacturers' directions exist for good reason. These directions are, for the most part, similar from manufacturer to manufacturer and from handpiece to handpiece. They detail appropriate handling, assembly and sterilization methods, specify time, temperature and pressure parameters for reprocessing and comment on drying and cooling times, the use of enzymatic cleaners and other considerations. If you stray from the directions, you risk damaging your instruments, voiding their warranties and incurring expenses. If you don't comply with the guidelines, you risk patients' safety as well as your accreditation status and thus insurers' reimbursement for cases.
Recondition or Replace a Failing Handpiece? |
From a budgeting standpoint in a tight economy, it's less expensive to recondition a failing handpiece, but replacing it with a new one guarantees your surgeons quality care in their hands. From a risk management standpoint, that may even be the less expensive option. Cutting corners is not in the best interests of your facility, physicians or patients. A phaco handpiece should last you several thousand cycles. Its workable life-span depends on several factors, including your case volume, care issues and general handling (sometimes instruments do get dropped). But every handpiece will in time fail. As a result, you should regularly inspect the devices, log reported problems or physicians' complaints on each one (such as when a handpiece fails to tune or registers an error message), and budget for eventual repairs or replacement. Your manufacturer's stance on the issue may influence whether you repair or replace a handpiece. For example, at least 1 ophthalmic manufacturer's policy on handpiece repair is fairly straightforward: They don't. They conduct extensive performance testing on each handpiece returned to them for inspection. But they make the argument that, if repairs were necessary, they couldn't ensure that every component would continue to meet their quality standards unless they replaced every piece, at which point the repair would actually become a replacement. If you've arranged a maintenance contract with this company, you're able to secure a price break from them for buying a replacement handpiece, with an additional discount if you return the handpiece in need of repair. There are third-party companies, however, that will tear down a malfunctioning handpiece, recondition it and replace the crystals or other components. Back in your surgeons' hands, the instrument may function very much like what they're used to, although the replacement of the cord and fitting at its back end will make it evident that outside repairs have taken place. The quality of the repair may be as reliable as that which you might expect from the manufacturer, but there's also the possibility that the handpiece will fail again, sooner rather than later. Plus, you're taking on additional liability here. If a handpiece should fail or malfunction during a case and a resulting complication or needlessly prolonged case ends up injuring a patient, the manufacturer could not and probably would not stand behind the repaired device. If the phaco machine suffered damage due to using a repaired handpiece, the warranty would almost certainly be voided and repairs to the machine could be costly. — Jason Jones, MD |