Office-based surgery feasible for phakic IOL implantation

July 15, 2005

Washington, DC—Refractive surgeons performing phakic IOL implantation with the iris-claw lens (Verisyse, AMO) should realize they can safely offer that procedure in their office-based surgery facility without obtaining formal certification from an ambulatory surgery accrediting organization, said Brian S. Boxer Wachler, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

Washington, DC-Refractive surgeons performing phakic IOL implantation with the iris-claw lens (Verisyse, AMO) should realize they can safely offer that procedure in their office-based surgery facility without obtaining formal certification from an ambulatory surgery accrediting organization, said Brian S. Boxer Wachler, MD, at the annual meeting of the American Society of Cataract and Refractive Surgery.

Dr. Boxer Wachler, director, Boxler Wachler Vision Institute, Beverly Hills, CA, told attendees that he learned through meticulous analysis of the credentialing criteria that the bulk of accreditation requirements from the Accreditation Association for Ambulatory Health Care (AAAHC) are administrative in nature with no bearing on procedural sterility or patient safety. Assessing the structure and practices in his existing office-based LASIK suite, he found that they already fulfilled many of the safety- and sterility-related criteria that would be needed to obtain AAAHC certification; the few deficits that existed were easily addressed.

"It is much nicer from the patient's perspective to have this type of elective procedure performed in an office-based setting. However, surgeons may fail to investigate that opportunity because they wrongly assume extensive measures are needed to assure safety and sterility. As we learned, it is easy to implement the relevant AAAHC criteria and even exceed that organization's safety and sterility standards without the superfluous administrative components," he said.

Section 8 is important because it provides a facility and environment checklist. However, most of its items are probably already in place in an existing office-based LASIK suite.

For example, that section stipulates the need for adequate lighting and ventilation, procedures to minimize sources and transmission of infections, and procedures for proper identification, management, handling, transport, treatment, and disposition of hazardous materials and wastes.

Facility cleanliness One part of Section 8 that may require modifications relates to cleaning and maintenance of the facility. As stipulated by those criteria, surgeons should be sure the surgery suite has covered floors, non-flaking ceiling tiles, and undergoes monthly cleaning of its walls, ceilings, and all other non-surgical surfaces, Dr. Boxer Wachler explained.

Section 9 of the AAAHC criteria focuses on anesthesia services. However, those standards are not applicable to phakic IOL surgery if the procedure is being performed without an IV line in place.

"We perform phakic IOL implantation with topical anesthesia and do not supplement it with IV sedation, and so there is no need for monitoring of cardiovascular and pulmonary function by an anesthesiologist or nurse anesthetist," Dr. Boxer Wachler said.

The last section of the AAAHC criteria relates to standards for room construction and sterility, and they too are likely already being followed in any facility that is being used for LASIK.

For example, Section 10H requires that the room be constructed and equipped in compliance with applicable state and local fire codes. Criteria in Section 10L describe the need for proper attire of all persons entering the operating room and their use of acceptable aseptic techniques, allowing authorized persons only in the surgical area, use of suitable equipment for regular surface cleaning, and the need to clean the operating area before each procedure, have suitable sterilization equipment, and have packaging and labeling procedures for sterilized materials to maintain sterility and identify sterility dates.

In his own practice, Dr. Boxer Wachler implements a few additional procedures that are designed to enhance safety and sterility when performing phakic IOL implantation. Similar to cataract surgery, all personnel are gowned, the patient is draped, the preoperative prep includes a povidone-iodine prep and scrub, and endophthalmitis prophylaxis is provided with use of a fourth-generation fluoroquinolone. In addition, the incision used for IOL implantation is sutured at the end of the procedure.

"The incidence of post-cataract surgery endophthalmitis has increased 15-fold comparing sutureless, clear corneal procedures against those performed with a sutured wound. Suturing the wound greatly reduces the risk of endophthalmitis because it prevents reflux of the bacteria-containing tear film through the incision and into the anterior chamber as shown by Dr. Peter McDonnell's recent study," he explained.

Dr. Boxer Wachler's personal record speaks to the ability to perform Verisyse IOL (AMO) implantation safely in the office-based surgery setting.