Detailed inspection of the microkeratome blade
	Meticulous cleaning and rinsing of all parts
	Visually inspect microkeratome head
	Ultrasonic cleaning of microkeratome parts
	Intraoperative cleaning of head assembly
	Drying of all component parts
	Clean and inspect suction ring
	Steam sterilizer with data logger

"Basic cleaning procedures should remain consistent for all microkeratomes, whether the components are stainless steel or titanium, if the units are automated or manual, or the microkeratome heads have plates or not," Graczyk said.

The manual highlights the in-depth care of microkeratomes, as well as stainless steel instruments and blades. Chapters detail infection control in the operating room, prevention of disease transmission during tonometry, sterilization of patient care items, and other reference information.

Universal care

The desk reference is a universal protocol covering all the characteristics microkeratomes have in common. Graczyk said that:

· Similar metals (stainless steel) are used in the manufacturing of all microkeratome head assemblies;

· Microkeratome blades, blade-housing assemblies, and the way microkeratomes are activated are virtually the same in all microkeratomes; and

· Microkeratome handpieces, power consoles, cables, tubing sets (reusable or disposable), and foot switches all perform similar functions.

"Understanding these similarities allows each physician and technician to deal with each microkeratome and their associated component parts as individual surgical tools," he said. "Everyone can then apply a universal set of guidelines in handling, inspecting, and processing the component parts of the microkeratome, regardless of the microkeratome manufacturer."

Meticulous care is the key element, Graczyk said, in maintaining the equipment's highest level of performance. The manual reviews the other key elements to help surgeons maintain predictable and exceptional surgical outcomes.

Filling the void

Surgeons are busy people. It is difficult to keep up with all the aspects of owning and operating microkeratomes. The desk reference provides a comprehensive overview of the most commonly accepted industry standards from the Food and Drug Administration, Occupational Safety and Health Administration, Center for Disease Control, Department of Health and Human Services, American Association of Operating Room Nurses, Joint Commission of Allied Health Personnel in Ophthalmology, and other hospital governing bodies on the processing of surgical equipment and surgical instruments used in refractive surgery.

"Understanding these standards allows each surgeon to review what they are doing and evaluate changes, if any, they may wish to implement at their surgical facility," Graczyk said.

Guide to in-house checklist

While the individual requirements for the handling and processing of equipment, instruments, and supplies vary from one surgery center to another, the book outlines the basic requirements and guidelines.

"The desk reference manual provides the guidelines necessary for developing a refractive surgery center's own in-house processing steps and a checklist for specific equipment and instruments they will use at their facility," he said. "The manual can also be used as a training tool for all new surgical support personnel."

Using the manual as a guide, each physician can visually monitor all the processing steps associated with his or her facility's equipment and instruments, he said. If an unusual situation develops, the manual can be used to retrace processing steps to determine what changes may have occurred. Then, necessary changes can be made.

"Each facility can review weekly, biweekly, or monthly the overall performance of their equipment and surgical support instrumentation," Graczyk said.

The products included in the manual are used as a representative sampling of FDA-approved products used in U.S. refractive surgery centers.

The surgeon's input

"This is a must-have manual for every LASIK facility," said Stephen G. Slade, MD, assistant clinical professor, University of Texas, Houston. "The manual contains a lot of new information and more coverage of all the issues regarding microkeratomes than I have seen in the past."

He said that surgeons should read The Meticulous Care and Handling of Microkeratomes to improve the reliability of their keratome and surgical results. "Proper cleaning and keeping salt solutions off the unit are two of the most common aspects of microkeratome care that I believe surgeons are unfamiliar with," he said.

Slade said that the manual addresses proper cleaning and maintenance, especially how to inspect the blade and keratome; as well as instrument and autoclave care.

James J. Rowsey, MD, of St. Luke's Cataract and Laser Institute in Tarpon Springs, Fla., agreed that the manual is a must-read for every technician.

"One important emphasis of the manual is that Palmolive soap is no longer one of the appropriate cleaning solutions for cleaning the instruments," he said. "In addition, blade inspection, proper assembly, verifying the movement, and checking for the lack of debris on the blade or the head [are] also important parts of the manual. ..."

The recommendation of a high-magnification blade inspection immediately before surgery should be re-emphasized. "You should look especially for small pieces of debris, which can be attracted to the blade electrostatically during the assembly or as it sits on the back table, so that there is no debris transported to the recipient bed," Rowsey said.

He said that only after reading the manual could surgeons adequately recommend that their technicians read it and apply the principles to their own handling of the microkeratome. "They cannot expect the technicians to know that information if they have not actually read it themselves. Probably 80% of the information will be carried out by the tech, not by the surgeon. However, the surgeon should read it, appreciate the value, and emphasize the value to the staff," he said.

Contact Information
Caro: 773-685-5606, fax 773-685-6559
Graczyk: 630-871-2440, fax 630-871-7620
Rowsey: 727-938-2020, fax 727-942-9624
Slade: 713-626-5544, fax 713-626-7744

"At the St. George Vision Correction Center, we have put this review process in place, not to solve problems after they occur, but ... to eliminate potential serious problems before they occur," said Caro, a contributing writer to The Meticulous Care and Handling of Microkeratomes.

One such potential problem is diffuse lamellar keratitis (DLK). "DLK has been linked with heat-stable endotoxins that could survive in surgical instruments after sterilization or be released from sterilizer reservoir biofilms," he said.

Caro's facility has switched from using standard polyvinyl alcohol instrument wipes to Duo-Cell Bacteriostatic PVA instrument wipes and instrument pads. "We changed to this product because it inhibits the growth of microorganisms, traps fluids, contaminants, and reduces the risk of bio-burden cross-contamination during the cleaning and sterilization of our instruments," he said.

Understanding what type of sterilization system the practice uses is imperative. Each type of sterilizer has different instructions. Gravity-displacement, prevacuum or pressure pulse, ethylene oxide gas, and dry heat-hot air sterilizers are available.

"Read the owner's manual and know the manufacturer's recommendation for the proper placement of the sterilizer, leveling the unit, testing cycles, operation, cleaning and maintenance of the sterilizer. Always follow the manufacturer's recommendations to achieve the maximum performance from your sterilization equipment," Caro said.

"Every day, every week, and every month we need to continually monitor the conditions that the instrument and equipment are processed under. Then, change the things we can to improve our surgical outcomes and reduce the risk of infections through proactive, not reactive, internal programs," he said.

The manual, from B. Graczyk Inc., sells for $125; it is also available on CD-ROM for $50.