Exactly what is the standard of care for the sterilization of cataract instruments, and what should it be? Those questions have some surgical facility managers steamed and ophthalmic associations scrambling as they try to navigate new AORN guidelines that proscribe routine flashing and Joint Commission surveys that reportedly ding facilities that violate the rules.
This year AORN added to its Standards, Recommended Practices and Guidelines that "flash sterilization should not be used as a substitute for sufficient instrument inventory .??? The process may be associated with increased risk of infection to patients. This increased risk of infection may be caused by pressure on personnel to eliminate one or more steps in the cleaning and sterilization process."
Although the guideline focuses on flashing, it's really aimed at parts of the process other than sterilization, says Ramona Conner, RN, MSN, CNOR, manager for standards and recommended practices at AORN. "The challenge comes in the pre-cleaning phase, because the tendency is to minimize or even skip steps prior to sterilization when expediting turnaround." The instruments can also become contaminated after the autoclave's door is opened and when the instruments are brought to the point of use if they're not kept in a container, she says.
"The problem with flash sterilization is that it's very difficult to control the potential for human error," says Ms. Conner. "That's why you should only flash in an emergency, when there's simply no other choice."
The Joint Commission agrees. Although spokespeople say there has been no step-up of enforcement since the AORN guidelines were published, surveyors have reportedly cited at least two Midwestern hospitals for routine flashing, and the OR director of a California hospital says she was warned that any pre-planned flashing would be grounds for a demerit.
Robert Wise, MD, vice president of the division of standards and survey methods at the Joint Commission in Oak Terrace, Ill., says the organization bases its actions on the AORN standards. He points out that a white paper from the American Society of Cataract and Refractive Surgeons on preventing toxic anterior segment syndrome (TASS) recommends against flashing. He notes that the CDC's 1999 Healthcare Infection Control Practices Advisory Committee (the document cited as the principle source for AORN's policy) also recommends against routine flashing.
Neither AAAHC nor AAAASF has taken a position on routine flash sterilization.
"It has become common among outpatient eye surgery and cataract centers to use flash as the only form of sterilization," says Dr. Wise. "That is not supported by the existing practice guidelines."
A difference of opinion
Though AORN and the Joint Commission agree on guidelines, an Outpatient Surgery Magazine survey of 160 facility managers who host cataract procedures reveals deep divisions in practice.
Our survey shows that almost two-thirds of all facilities hosting cataract surgery currently use some form of flashing for cataract surgery instruments. Fifty-eight percent of these flash in open trays and transport them to the OR covered by a tray lid or sterile towel, while 42 percent flash in sealed, closed-container sterilization trays. Nearly nine out of 10 use large-chamber built-in autoclaves; the rest use tabletop autoclaves.
Eighteen percent of facility managers who flash say they "strongly agree" with AORN's new guidelines and a little more than one-fourth say they "agree somewhat." Even though the Wills Surgery Center of Plymouth Meeting, Pa., flashes (in sealed trays) and has had zero cases of endophthalmitis, Administrator Victor Krzesinski, RN, says, "Flashing carries a higher chance of contamination due to variables of improper practices such as using open trays and poor individual aseptic techniques. Full-cycle wrapped sterilization eliminates the problem." A number of facilities that currently flash say they have purchased or are planning to purchase more instrument sets and additional autoclaves so that they can observe AORN's guidelines.
But nearly one-third (32 percent) of facility managers who flash cataract surgery instruments "disagree somewhat" and one-fifth "disagree strongly" with the guidelines. Their objections fall into three categories:
- Lack of scientific or clinical support. Although both infectious and non-infectious endophthalmitis appear to be on the rise, studies don't point to flash sterilization as the cause. A Cleveland Clinic study ties the increase in infectious endophthalmitis to the popularity of clear-corneal incisions that lead to wound leakage, but not to inadequate sterilization. Such non-infectious endophthalmitis as TASS may be related to poor cleaning of cataract instruments. Researchers have suggested that remnant denatured viscoelastic and enzymatic detergents may be to blame for some incidents of TASS. But sterilization has not been implicated. (See "10 Tips to Prevent a TASS Outbreak" on page 58.)
The 1999 CDC paper that is the basis for the AORN guideline admits that the evidence supporting its recommendation to avoid routine flashing is less than rock solid. It characterizes the guideline as "supported by some experimental, clinical, or epidemiological studies and strong theoretical rationale," but not by "well-designed experimental, clinical, or epidemiological studies."
The clinical experience of our survey respondents also doesn't implicate flashing. Nearly 90 percent of all facilities that routinely flash say their endophthalmitis rate is "much lower" than the reported average of 0.13 to 0.7 percent. One facility had seen one case of endophthalmitis in 30,000 total cases, while another saw none in 5,000 cases. "The surgical site infection rates do not support AORN's statement at all," says the manager of a Missouri ASC.
- Done properly, flashing is safe. So say many of our respondents. Many who use sealed containers pointed out that this eliminates the concern of contamination during transportation and questioned whether using sealed containers should even be considered flashing.
Maura Cash, RN, BSN, operations manager for surgical services at Stony Point Surgery Center in Richmond, Va., says, "We need to develop guidelines for effective, safe flash sterilization, not just dismiss it." A Maryland ASC clinical director who flashes says her facility hasn't had one endophthalmitis case to date. She adds, "We don't cheat in any way, no matter how long the wait is. The only instruments that are flashed less than 10 minutes at 273 degrees are individual hand instruments. No cannulated instruments, phaco handpieces, cautery cords, rubber on instruments or matting. We do spore testing every day and check it 12, 24 and 48 hours." Lori Sterbenk, RN, CNOR, agrees. She is the clinical resource manager at Grand Valley Surgical Center in Grand Junction, Colo. "We have not had even one eye infection in eight years, so I think the issue is not flash sterilization as much as having the time to thoroughly clean and rinse the instrument sets between cases. We are able to take our time with six sets and have had no issues."
- Healthcare economics. Facility managers opposed to the guideline say implementing it would be cost-prohibitive, particularly in ASCs, where the reimbursement is only two-thirds that of hospitals. The typical ASC owns five instrument sets and does 18 cataracts per day, whereas the typical hospital owns four sets and does nine cataracts per day.
"For bigger-volume surgeons doing 30 cases a day or more, it isn't practical to have 30 or more full sets of surgical instruments wrapped and ready for use," says Gina Stancel, HCRM, CST, COA, surgical administrator at the Eye Centers of Florida in Fort Myers. "The cost would be prohibitive and the maintenance absurd."
"In order to be able to ???terminally' process and wrap every instrument tray to run for a 45-minute cycle for every cataract patient, we would need to purchase three or four more complete trays and a third autoclave and hire a full-time processing technician to allow for faster instrument turnover," says Heather Huffman, RN, CNOR, administrative director of the Surgical Eye Center of Morgantown in West Virginia. Her facility, which is accredited by the Joint Commission, typically hosts six to 18 cataract procedures on the days when those cases are performed and keeps three trays of instruments on hand.
Most of the facilities that are currently flashing say they have no plans to make any changes as a result of the AORN guidelines. "The sterilization process is not the problem with endophthalmitis; it's the process of flushing handpieces and cannulas thoroughly," says Jackie Dayton, RN, supervisor at the Surgery Center of Ophthalmology Consultants in Fort Wayne, Ind. "We looked into (changing), but we decided, why fix something that isn't broken?"
Additional clarity could be on the way. In response to the actions of the Joint Commission and AORN, the American Academy of Ophthalmology is co-chairing the Task Force on Ophthalmic Sterilization (T-FOS) with the American Society of Cataract and Refractive Surgery and the Outpatient Ophthalmic Surgery Society. The group has met with the Joint Commission, and AORN says it will be participating in the talks as well. At press time, OOSS had just e-mailed a sterilization survey to its members.
"Right now, we're simply talking with the Joint Commission to better understand their concerns, and educating them on how we currently handle sterilization of ophthalmic instruments," says Richard Abbott, MD, secretary for quality of care and knowledge base development at the AAO. "Once they understand the processes we use to sterilize instruments, we will have a common ground from which to work. Based on our low rates of post-operative infection, we feel that surgical sterilization procedures have not been an issue for us. But the Joint Commission has raised some concerns, and that is why (T-FOS) has been formed."
In April the AAO released a clinical statement recommending that eye surgeons and centers avoid the term "flash sterilization" and use more specific descriptions of the sterilization methods instead. "Many times these methods are ???full-cycle, FDA-approved, sterilizer-manufacturer-recommended' sterilizations," says the AAO.
Meanwhile, the CDC is expected to release new infection control guidelines this summer that will address sterilization.
"For now, facilities should continue following approved sterilization techniques, document the process they're using and monitor outcomes," says Bradford Shingleton, MD, a physician at Ophthalmic Consultants of Boston and president of ASCRS.
Mamalis N, Kearsley L, Brinton E. "Postoperative endophthalmitis." Current Opinion in Ophthalmology. 2002;13(1):14-18.