In the setting of cataract surgery, much attention is rightly paid to proper preoperative workup and postoperative care. Just as important, however, is the cleaning and sterilization of surgical instruments that go into the eye. Here, Nick Mamalis, MD, co-chair of the Ophthalmic Instrument Cleaning and Sterilization (OICS) Task Force, reviews the highlights of the comprehensive new “Guidelines for the Cleaning and Sterilization of Intraocular Surgical Instruments,” published in the Journal of Cataract and Refractive Surgery.1

The OICS Task Force, chaired by David F. Chang, MD and Dr. Mamalis, consists of surgeons from three specialty organizations: ASCRS; the AAO; and the Ophthalmic Outpatient Surgical Society (OOSS).

Intraocular Tools are Different
Since the last specialty-specific guidelines for properly cleaning intraocular surgical tools were published in 2007, an update was necessary, according to Dr. Mamalis. “Our last guidelines were written almost 12 years ago, and so they were in need of updating,” he says. “What was also very important was the need to develop specialty-specific guidelines based on scientific evidence.”

The guidelines emphasize that best practices for sterilizing and cleaning surgical tools is not a one-size-fits-all proposition: Because intraocular procedures are generally quicker than general surgery, the surgical tools may be cleaned and reused more times per day than other instruments. Intraocular instruments are also typically much smaller than other tools. The authors add that although intraocular instruments don’t typically emerge from the eye with a large amount of tissue adherent to them, it only takes a little bit of residual tissue, OVD or enzymatic detergent to potentially cause a severe intraocular reaction, whereas similar exposures might not similarly affect other body parts.

Short-cycle Sterilization
Dr. Mamalis says that one important distinction set forth in the new guidelines clarifies that short-cycle sterilization of instruments is appropriate for intraocular surgical tools, and distinguishes the technique from a method used in emergent situations. “Some issues had come up because the Joint Commission, which does a lot of the inspections and accreditations of ambulatory surgical centers, wanted to require that ophthalmic instruments be wrapped, put into the sterilizer for 45 minutes, which would mean it would take almost an hour per sterilization cycle in between uses. That would have huge consequences for surgical centers with high volume. You’d have to buy all kinds of additional instruments,” he explains.

“So we worked with the Joint Commission through the ASCRS and the AAO and we got them to modify their position to say that for ophthalmic instruments, the short cycle was safe,” he continues. “One of the first things that our task force did was set out to actually show that short-cycle steam sterilization used for sequential same-day ophthalmic surgery is safe and effective for killing bacteria. We designed a series of studies that looked at shortcycle steam sterilization of phacoemulsification handpieces. We used a standardized testing method to show that it did indeed adequately kill bacteria, by contaminating each handpiece with a specific amount of bacteria and testing them under specific conditions to show that the short-cycle steam sterilizations are adequate and safe. The results of these studies will be published in Ophthalmology.2 Then we incorporated these results into the guidelines. I think that it was very important to actually use a scientific method and to put it into our guidelines.”

“Short-cycle sterilization for a contained or wrapped load is appropriate for sequential same-day instrument use,” the new guidelines state. The guidelines also stipulate that the transit time of unwrapped instruments emptied from the sterilizer should be three minutes or less.

Additionally, the OICS Task Force has clarified that short-cycle steam sterilization is distinct from immediateuse steam sterilization (formerly called “flash” sterilization), a method used when a necessary instrument lands on the floor in the middle of a case, for instance. “We wanted to make clear to CMS that our short-cycle steam sterilization is something that is legitimate for ophthalmic surgical instruments, in that it is not the same as immediate-use sterilization,” explains Dr. Mamalis.

Enzymatic Cleaners
“Although the enzymatic detergents can remove tissue burden from instruments, if there’s any residue of the enzymatic detergent left on the instruments, it can actually cause toxic anterior segment syndrome, or TASS,” says Dr. Mamalis. “So we wanted to be very careful when we wrote these guidelines to make it clear that ophthalmic instruments should not routinely be subject to the use of enzymatic detergents. But we needed to back up our recommendations with scientific evidence.” They did so by conducting a study at the Moran Eye Center that was funded through a grant from ASCRS, which demonstrated that phaco tips rinsed thoroughly in accordance with manufacturer instructions can still harbor enzymatic detergent residue detectable via scanning electron microscopy and energy dispersive X-ray spectroscopy.3 “Then we went further and did a study in an animal model that showed that these residues could cause TASS,4” says Dr. Mamalis. In light of the study results, the new guidelines state, “It is our position that if intraocular instruments are thoroughly rinsed with critical water promptly after each use, the routine use of enzyme detergents is unnecessary and should not be required for routine decontamination of ophthalmic intraocular instruments.”

CMS, however, still insists that surgical facilities follow the manufacturers’ instructions for use (IFU) if they still require the use of enzymatic detergents. “The issue that’s come up since we’ve put out these guidelines is that if the manufacturer’s IFU states specifically that you have to use enzymatic detergents, CMS says we still have to follow those,” Dr. Mamalis explains, adding that the Task Force is engaging with other stakeholders to try to change this. “We have met with the manufacturers of the ophthalmic instruments we use to try to work with them to change their IFUs to make it so that enzymatic detergents aren’t mandatory. We actually had a meeting with industry just this year during the spring ASCRS meeting. They responded very positively. We’re continuing to work with industry to try to update the instructions for use. We’re also going to meet again at the AAO meeting in Chicago this fall,” he says.

Ultrasound Options
Ultrasonic cleaners are another possible contamination point, according to the task force. “The issues arise when an ultrasound bath is not drained and thoroughly wiped down and cleaned between each use,” Dr. Mamalis explains. “A small amount of bacteria can remain within the ultrasound bath; they’re just filled with city tap water and even though it’s safe to drink, there are still minute amounts of bacteria in there. If you let those grow in a warm ultrasound bath for a period of time, there might be enough present that even if we put our instruments through the autoclave to kill bacteria, a heat-stable endotoxin from the bacterial cell wall can cause not an infection, but TASS.

“Therefore, one of the things that we really wanted to stress in our guidelines was that you shouldn’t need to use an ultrasound bath or enzymatic detergents if you adequately flush out and clean your instruments at the conclusion of the previous case,” he continues.

Greener, Leaner Choices
“Climate change, or global warming, is a serious public health concern, and the health-care industry is a major source of emissions, responsible for 10 percent of the total carbon footprint of the United States,” the authors write in the new guidelines. They also estimate that phaco in the U.K. emits as much CO2 as driving an American car 340 miles, with most of the environmental impact attributable to single-use supplies. To that end, the new guidelines give surgeons the latitude to inspect phaco tips and reuse them per their best clinical judgment.

“This is an interesting new area,” says Dr. Mamalis. He cites the example of India’s Aravind Eye Care System, which reported an endophthalmitis rate of 0.02 percent in 555,550 consecutive cataract surgeries where patients received intracameral and topical antibiotic prophylaxis.5,6,7 The authors of the new guidelines note that doctors and staff at Aravind Eye Hospitals don’t re-scrub or change their gowns and gloves after every case, and surgeries are performed simultaneously with other cases in a single room. These are examples of “numerous practices that would be forbidden in any licensed North American surgical facility,” the guidelines state. The authors say that Aravind’s endophthalmitis rates are statistically identical to those extrapolated from the 2014 OOSS survey of ASCs in the United States.

“This is a new area of study and that’s why we wanted to include it in our guidelines,” Dr. Mamalis says. “We wanted to raise awareness among surgeons but also among regulatory bodies, that we can still be safe and avoid problems with infections and endophthalmitis without using so many resources.”

Dr. Mamalis acknowledges that both individual surgeons and their institutions are constrained by rules and regulations, but thinks the new guidelines provide food for thought about decreasing waste. “An individual surgeon can’t really make changes or take shortcuts,” he says. “This is where our guidelines come in: We can now provide the surgeon and the surgery center with some guidelines that will help them stay compliant and safe from difficulties with regulators if they follow them. But we can also provide surgeons and surgery centers with enough information to see if they can make some new decisions on how to use their resources.

“What’s paramount is that patients’ safety always stays at the top,” Dr. Mamalis continues. “If it’s been shown that we don’t compromise patient safety by being more efficient and eliminating some steps, then that’s something we wanted to raise in these guidelines. We want to make both surgeons and regulatory agencies aware that these are issues that should be considered.”

1. Chang DF, Mamalis N, Ophthalmic Instrument and Cleaning Sterilization Task Force. Guidelines for the cleaning and sterilization of intraocular surgical instruments. J Cat Refract Surg 2018;44:6:765-73.
2. Chang DF, Hurley N, Mamalis N, Whitman J. Evaluation of ophthalmic surgical instrument sterility using short-cycle sterilization for sequential same-day use. Ophthalmol 2018;125: in press.
3. Tsaousis KT, Werner L, Reiter N, et al. Comparison of different types of phacoemulsification tips. II: Morphological alterations induced by multiple steam sterilization cycles with and without use of enzyme detergent. J Cat Refract Surg 2016;42:1353-60
4. Mamalis N. Toxic anterior segment syndrome: role of enzymatic detergents used in the cleaning of intraocular surgical instruments (editorial).J Cat Refract Surg 2016;42:1249-50.
5. Haripriya A, Chang DF, Ravindran RD. Endophthalmitis reduction with intracameral moxifloxacin prophylaxis: An analysis of 600,000 surgeries. Ophthalmology 2017;124:768–775.
6. Chang DF, Haripriya A, Ravindran RD. Reply to letter RE: Endophthalmitis reduction with intracameral moxifloxacin prophylaxis: An analysis of 600,000 surgeries. Ophthalmology 2017;124:e78–e79. Available at: S0161-6420(17)30748-0/pdf. Accessed July 15, 2018
7. Haripirya A, Chang DF. Intracameral antibiotics during cataract surgery: evidence and barriers. Curr Opin Ophthalmol 2018; 29:33–39.

In June’s Glaucoma Management, a layout error caused some of the text to be obscured by graphical elements on the page. To read the full text as intended, please see the version of the article by clicking here.
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CMS Proposes Changes

Last month, the Centers for Medicare & Medicaid Services issued a proposed rule that includes changes to many of the policies that currently govern reimbursement and how measurements of quality are made. Some of the proposed changes include alterations to evaluation and management policies in an effort to “reduce administrative burden and improve payment accuracy for E/M visits.”

Among other things, CMS proposes:

• to allow practitioners to choose to document office/outpatient E/M visits using medical decision-making or time instead of applying the current 1995 or 1997 E/M documentation guidelines, or, alternatively, practitioners could continue using the current framework;

• to expand current options by allowing practitioners to use time as the governing factor in selecting visit level and documenting the E/M visit, regardless of whether counseling or care coordination dominate the visit;

• to expand current options regarding the documentation of history and exam, to allow practitioners to focus their documentation on what has changed since the last visit or on pertinent items that have not changed, rather than re-documenting information, provided they review and update the previous information; and

• to allow practitioners to review and verify certain information in the medical record that is entered by ancillary staff or the beneficiary, rather than re-entering it.

CMS is also proposing to allow physicians to be reimbursed for brief consultations via a telecommunication device to help decide if an office visit is necessary. Physicians would also be paid for reviewing photos or videos submitted by patients.

CMS also wants to “help curb excessive spending” on Part B drugs by changing the add-on amount that’s applied to the medications. The agency explains that many Part B drug payments are based on an average sales price methodology and, by statute, include an add-on payment of 6 percent of the ASP amount. Other Part B drug payments, though, are based on the wholesale acquisition cost, such as for single-source drugs that don’t have ASP data. CMS proposes that WAC-based payments for new Part B drugs have an add-on of just 3 percent rather than the 6 percent currently used during the first quarter of sales when the ASP is unavailable.

For a complete rundown of the proposed Medicare payment changes, visit Newsroom/MediaReleaseDatabase/Fact-sheets/2018-Fact-sheetsitems/2018-07-12-2.html. REVIEW