Intraocular instruments get a lot more use than endoscopes or laparoscopes, but they obviously don't get as heavily soiled with blood or bodily fluids because they're confined to the anterior segment of the eye. Yet some facilities are using outdated, impractical and even dangerous cleaning and sterilizing guidelines that were written for general surgical instruments, not for cataract instruments. Fortunately, a group of the world's leading cataract surgeons last month updated the specialty-specific reprocessing guidelines (osmag.net/vSEjJ8) that address the unique challenges of cleaning and sterilizing ophthalmic instruments.

Some of the advice runs counter to what instrument IFUs specify and surveyors expect, but you'll find mounds of evidence-based reasoning that support why, for example, routine use of enzymatic detergents is not safe for intraocular instruments and short-cycle sterilization is. A few highlights:

1Routine use of enzymatic detergents is unnecessary
The first guideline states that if you thoroughly rinse intraocular surgical instruments with critical water promptly after each use, the routine use of enzyme detergents is unnecessary and should not be required for routine decontamination of intraocular instruments.

Inappropriate use or incomplete rinsing of enzymatic detergents has been associated with outbreaks of toxic anterior segment syndrome (TASS), yet some instrument instructions for use (IFU) say you should use enzymatic detergents to decontaminate cataract instruments after every use.

"We are not aware of any study showing that enzyme detergent for intraocular instruments reduces the rate of endophthalmitis," reads the guideline. "Lacking proven efficacy for endophthalmitis prevention, enzymatic detergents might unnecessarily elevate the risk for TASS without providing significant benefit to the patient."

Enzymatic residue is notoriously difficult to rinse from instruments and the guideline notes that these detergents typically contain subtilisin or alpha amylase exotoxins, neither of which is denatured by autoclave sterilization. Even small amounts left on instruments are potentially toxic to the interior of the eye. You can usually remove the minimal bioburden that forms on intraocular instruments during eye surgery with a prompt and thorough rinsing with critical water, says ophthalmologist David F. Chang, MD, of Los Altos, Calif., who co-chaired the task force that created the guidelines.

2Short-cycle steam sterilization is appropriate
Unwrapped settings and short-cycle sterilization (not to be confused with "flashing") are appropriate for routine use in between sequential, same-day ophthalmic cases, state the guidelines.

For cataract cases, it's common practice to sterilize instruments, interrupt the drying phase and transport them — still wet — in a covered container to the OR where a scrubbed nurse removes the phaco handpiece, runs irrigation fluid through it and places it on the sterile tray for use.

"The IFUs for these sterilizers allow for the interruption of the drying phase for sequential, same-day use because following the full exposure time, the instrument is sterile whether it's wet or dry," says Dr. Chang, who adds that residual moisture is only a problem when you store wrapped instruments wet overnight or when non-sterile hands handle the packaging.

In 2009, the Joint Commission wanted to require a full, terminal dry and wrapped cycle for all intraocular instruments — it would have taken an hour to process instruments in between consecutive cases! — but an earlier version of the task force provided TJC with evidence that short-cycle sterilization was acceptable for sequential ophthalmic cases.

The guidelines also point to confusion about the differences between immediate-use steam sterilization (IUSS) — formally known as flashing — and short cycle sterilization. While both are short cycles of steam sterilization, agencies that license and regulate surgical centers sometimes mistakenly use "IUSS" to refer to what is in fact short cycle sterilization. They are different.

3You can re-use your phaco tips
When feasible and safe, reuse of some surgical instruments might improve the cost-effectiveness of cataract surgery, state the guidelines.

In many countries around the world, it is standard practice to re-use phaco tips. In the United States, however, there is a lot of variability between manufacturers' labeling on the number of times their tips can be used. Some manufacturers say their tips are single use while others say they can be used 50 times. One company sells 2 phaco tips: one is single-use and the other can be used 20 times. All phaco tips are made from titanium. In a study undertaken by task force members that simulated typical heavy use of the phaco tips, they found no ultrastructural damage that would be of any concern.

"This is just another example of an area where the surgeon should have some discretion," says Dr. Chang. "Like detecting a dull suturing needle, we can tell if a phaco tip is not cutting well. If we noticed that a phaco tip wasn't cutting well, we would replace it, regardless of how many times it could be reused."

About time

Many of the sterilization principles that manufacturers based their IFUs on were laid out back in the 60s and 70s, when phaco first came out, says Jeffrey Whitman, MD, of the Key Whitman Eye Center in Dallas, Texas, a member of the Ophthalmic Instrument Cleaning and Sterilization Task Force, whose mission was to compile evidence and conduct studies that would bring these recommendations into the 21st century.

"At the end of the day, all that matters is what's safe for patients," says Dr. Whitman. "Short-cycle sterilization is safe and efficient, and enzymes are not safe for our specialty. These specialty-specific guidelines provide evidence that these practices save administrators and physicians time and aggravation, and are safe for the patient." OSM