Joint Commission crackdown: Are you doing flash sterilization properly?
Cost of more instruments leaves SDS managers in a quandary
The word on the street is that accreditation surveyors are issuing citations for flash sterilization. For its part, the Joint Commission on Accreditation of Healthcare Organizations says it has no set policy, and facilities are expected to follow industry guidelines. [For information on ordering guidelines from the Association for the Advancement of Medical Instrumentation (AAMI), see resource box, p. 103.] This leaves same-day surgery managers scratching their heads and wondering why facilities are being cited.
"It’s primarily human error," says Victoria M. Steelman, RN, PhD, CNOR, advanced practice nurse for Intensive and Surgical Services at The University of Iowa Hospital in Iowa City.
"One problem is just inadequate cleaning of lumens and joints — not taking instruments completely apart," she explains. "Another common area [for citations] is inadequate preparation for sterilization — instruments aren’t put into a tray so that steam can penetrate all parts."
Another human error is not selecting the correct parameters, she says. "Another one is not verifying that the correct parameters have been met." And last but not least, instruments are contaminated en route to the sterile field, Steelman says. "People who are doing sterilization for immediate use are doing many other tasks. National standards are based on that understanding."
Flash sterilization was originally intended as a last resort sterilization method when a unique instrument was unavailable for a procedure or was dropped on the floor, says Chris Lavanchy, engineering director at ECRI, a technology assessment firm based in Plymouth Meeting, PA.
Groups such as ECRI are concerned about the abuse of flash sterilization, Lavanchy says. "It has become a primary means of sterilizing some instruments rather than once-in-a-while, under unique circumstances, sterilization."
The Association of periOperative Registered Nurses (AORN) in Denver advises using flash sterilization "when there’s insufficient time to sterilize an item," adds Ramona Conner, RN, MSN, perioperative nursing specialist at AORN. AAMI guidelines don’t address this debate.
Routine flash sterilization appears to be a problem that is more common in the ambulatory surgery market, experts say. Particularly in ambulatory settings, providers often have only one or two sets of instruments for procedures with a quick turnaround, such as cataracts, Conner says.
"And I have heard of some hospital-based programs doing similar things, particularly with endoscopes and arthroscopes," she says. "Unless they purchase adequate instrumentation, they’re going to have very difficult time getting completely away from flash sterilization."
It’s expensive, Conner points out. "It’s a real dilemma that’s difficult to deal with. Certainly costs have to be weighed against the risks of flash sterilization."
Because a device that is flash sterilized doesn’t have any wrap around it, it is exposed to air and potentially contaminated when you remove it from the flash sterilizer, Lavanchy says. "The key is that you have to maintain sterilization." Use it immediately; flash sterilization can be compared to using a microwave, Lavanchy adds. "It gets you what you want quickly, but it might not be as controlled as a conventional oven."
Should you order more instrument trays?
To avoid routine use of flash sterilization, order more instrument trays or have a person dedicated to the reprocessing of those trays, Steelman advises. It would be expensive to completely eliminate flash sterilization, she acknowledges. "You’d have to have inventory that’s beyond your usage on a regular basis so that you could accommodate any situation that could possibly occur. I don’t think that’s reasonable or achievable. But you should have enough to manage daily operations. Many facilities, especially surgery centers, don’t have that because of the cost."
Implants should never be flash sterilized, so maintain an adequate inventory, Conner emphasizes. When done properly, flash sterilization can be a safe method of sterilizing nonheat-sensitive instrumentation, experts advise.
Consider these suggestions:
1. Investigate new technologies.
There are some technologies that offer short-term sterilization, Lavanchy points out. For example, gas plasma sterilizers have about a 75-minute cycle.
Liquid sterilization is another quick option. Conner points to the Steris Process offered by the Steris Corp. in Mentor, OH. The Steris Process is low-temperature sterile processing of immersible, heat-sensitive surgical and diagnostic instruments. Each cycle takes about 30 minutes. The cost of the system is $16,200. (For more information, see resource box, at right.)
However, providers should be attentive to the issue of compatibility, Lavanchy warns. "You have to be careful what you put into a sterilizer," he emphasizes.
2. Provide proper documentation.
Staff often fail to maintain proper records for flash sterilization, Conner says. AORN recommends that providers maintain a flash sterilization log with, at minimum, the name of the operator, identification number of the sterilizer, date and time of the cycle, general contents of the load, and the length and temperature of the exposure portion of the cycle. The patient’s name and operating room location also may be included in the log. (For further direction from AORN, see Same-Day Surgery, January 1998, p. 14.)
In addition, the log should include the results of monitoring and indicators, such as test strips, Steelman says.
3. Offer a sound quality assurance program.
After human error, the next reason most often cited by the Joint Commission for problems with flash sterilization is inadequate biological monitoring, Steelman says.
AORN’s Recommended Practice states, "Sterilizer function should be monitored with mechanical, chemical, and biological indicators to meet all of the monitoring standards established for pre-vacuum or gravity displacement sterilizers." (See AORN’s Recommended Practice regarding flash sterilization, inserted in this issue.)
4. Perform competency assessment.
Staff need annual competency assurance in flash sterilization, Steelman says.
"It’s an extremely important part of their job, and they need to know how to do it well," she says. "They have to understand it and understand the process of cleaning, not just that you clean, but how you clean, and how errors happen — why some of those practices are incorrect." (For information on an orientation and competency assurance tool that Steelman helped develop, see resource box, above.)