Cataract/Anterior Segment, Comprehensive Ophthalmology, Cornea/External Disease, Glaucoma, Oculoplastics/Orbit, Pediatric Ophth/Strabismus, Refractive Mgmt/Intervention, Retina/Vitreous
The main culprit involved in many cases toxic anterior segment syndrome (TASS) is improper cleaning of surgical instruments. So what's the best sterilization method?
Robert Wise, M.D., vice president, Division of Standards and Survey Methods of the Joint Commission, provided a measure of clarification on the issue of cleaning and sterilizing intraocular surgical instruments at an ASCRS session highlighting the latest on TASS and endophthalmitis.
In order to avoid confusion as to the technique used for sterilization, he advised against using the term "flash sterilization." It's an obsolete term. Instead, use the term short cycle steam sterilization. Ultimately, as long as manufacturer guidelines (also known as Directions For Use) are followed, users should be within the guidelines, Dr. Wise said.
The American Academy of Ophthalmology Clinical Statement on TASS mirrors Dr. Wise's message.
TASS causes can be linked to anything that is placed in the eye, including irrigating solutions, anesthetics, ophthalmic viscosurgical devices, antibiotics or other medications. A 2005 outbreak of TASS was linked to a specific balanced salt solution contaminated by endotoxins. But the cause of the second outbreak, in 2006, was never determined.
In response to the 2006 spike in reported TASS cases, Drs. Nick Mamalis and Henry F. Edelhauser, PhD, created an ad hoc investigative task force with the support of the American Society for Cataract and Refractive Surgery (ASCRS) and funding from the ASCRS Foundation. They did this in collaboration with the Academy, the FDA, Walter Hellinger, MD, an epidemiologist from the Mayo Clinic, and other representatives of the ophthalmic community.
Dr. Mamalis quipped during the meeting that "ad hoc" is actually Latin for "goes on forever" because that ad hoc committee is still operating today. And it's still providing valuable information.
Acting as a clearinghouse for information, the ASCRS TASS Task Force created two standardized questionnaires, which were designed to obtain information about the products and instruments used during cataract surgery and to build a database for the vast amount of information being collected.
At the ASCRS meeting, Carolee M. Cutler Peck, MD, MPH, reported the results from 40 questionnaires submitted to ASCRS. Information was also collected from 43 surgical site visits. Out of 25,441 cataract surgery procedures, 437 cases of TASS were reported.
They found that 79 percent of surgery centers surveyed cleaned their handpieces with 10 cc to 100 cc per flush; however, the recommended dose is 120 cc per port.
Ultimately, only you can prevent TASS. The success of programs such as the ASCRS TASS Task Force are dependent on surgeons and surgical centers keeping detailed records of all products and equipment used during cataract surgery, and to report cases to the U.S. Food and Drug Administration when they occur.
Voluntary reporting takes place under the FDA's MedWatch reporting program, which allows health care professionals and consumers to report serious problems that they suspect are associated with the medical devices they prescribe, dispense or use.
When a report is filed with the FDA about a case of TASS, privacy is guaranteed. Under the Freedom of Information Act, the FDA will not disclose the reporter's identity in response to a request from the public. The reporter's identity, including the identity of a self-reporter, may be shared with the manufacturer unless requested otherwise by checking a box on the form.