News 'flash': JC, key groups get on same page on 'immediate-use steam sterilization'
Dropping flash sterilization name as confusion reigns
Meeting with key stakeholders and sterilization groups, the Joint Commission is nearing a landmark consensus position on the long-confusing issue of "flash" sterilization. With various groups already offering slightly differing definitions and interpretations, the Joint Commission tried to clarify its stance last year with a position statement that apparently caused as much confusion as it allayed.1
However, the Joint Commission is getting on the same page with all the other key players now, meeting August 3, 2010, as part of an ongoing series of conference calls with stakeholders on the issue.
"It was a pretty fruitful meeting," said Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, President/CEO of Seavey Healthcare Consulting, Inc, in Arvada, CO. "We are trying to reach consensus on exactly what we want to put out as a multi-society position statement."
A former director of the sterile processing department at The Children's Hospital of Denver, Seavey is a member of several leading organizations in the field and a participant in the ongoing multi-organization discussions. "The group is now being called the Immediate-Use Steam Sterilization Task Group. The title may give you a hint on the direction we are heading," she said.
Indeed, the "flash" sterilization term will likely be phased out as part of a consensus process that includes the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, the Centers for Medicare and Medicaid Services (CMS), the Association of Operating Room Nurses (AORN), the Association for the Advancement of Medical Instrumentation (AAMI), and the Association for Professionals in Infection Control and Epidemiology (APIC).
A principal goal of all the groups is to prevent patient infections amid the current pressure to rapidly clean and sterilize medical instruments. "There is potential for increase of infections [with flash sterilization] because we are in a hurry to turn things over," Seavey said. "If steps are skipped or they are not done correctly not done according to the manufacturer's recommendations then there is a very good possibility that the item did not get sterilized."
Consensus statement expected soon
In an update on flash sterilization in 2009, the Joint Commission primarily emphasized the issues of cleaning and decontamination, sterilization and return of instruments to the sterile field.
"If you are a Joint Commission accredited facility you may be cited for sterilizing or flashing the same items frequently [or] for failure to follow the manufacturer's written recommendations," Seavey said. Device manufacturer's instructions must be followed, she emphasized. Specialty instruments could require extended exposure time and some manufacturers of such devices do not recommend flash sterilization.
"The [Joint Commission] is going to come in and ask you to show them the manufacturer's written recommendations and you have to produce those," Seavey said. "You may [also] be cited for a failure to adequately clean instruments according to those manufacturer's recommendations or lack of appropriate use of chemical or biological indicators."
However, in drawing attention to flash sterilization in the 2009 statement, the Joint Commission cited an old CDC definition of the practice that did not necessarily cover the gamut of current use, Seavey said recently in New Orleans at the annual APIC conference. "They used an old CDC definition that says `flash sterilization is a steam sterilization cycle at three minutes at 270° F at 27 to 28 pounds of pressure,'" Seavey told APIC attendees.
That left a lot of issues unresolved, including non-porous instruments and whether they were wrapped or unwrapped, she added. There was also no mention of cycle types, dry times or implants, Seavey said.
"The result when they put that statement out there was very confusing," she added.
Some key groups not included in the initial discussions were brought in to hammer out a consensus, she said. The result was the ongoing task force meetings, which were expected to soon result in consensus recommendations as this issue went to press.
"Every Joint Commission surveyor now has access to the AORN recommended practices and they are getting information from AAMI regarding flash sterilization," Seavey said. "We are looking at working with them to create some programs to help train the surveyors so they are learning the same way we the users are learning."
The use of flash sterilization in healthcare facilities has been under scrutiny for many years, she noted. Technological advancements, new surgical instrumentation, the increasing focus on safe patient care and the need to follow evidence-based practices have resulted in many recommended changes. Some of the definitions vary by shades and degrees, but there is one underlying factor if you flash sterilize an instrument, you must immediately use it. "All [organizations] say it is for immediate use, so there is absolutely no shelf life," she told APIC attendees.
In addition, the AORN recommends the practice should be restricted to selected clinical circumstances. "It should be kept to a bare minimum it shouldn't be routinely used," Seavey said.
Items must be disassembled and thoroughly cleaned with detergent and water, with lumens brushed and flushed under water with a cleaning solution and rinsed thoroughly. Instruments must be placed in a closed, validated rigid sterilization container, but again, must be designated for immediate use and not stored for later use.
"[Flash sterilization] should never be used as a substitute for sufficient instrument inventory," she said. "Convenience or economics should never ever trump patient safety."
Moreover, flash sterilization ideally should be reserved for single items not batches of instruments. "But we know in the real world, large and multiple sets are being flash sterilized, especially with 'loaner' [instruments]," she said. "For one hip, knee or a big spine case, you might get 10 or 15 sets of instruments the 'day of' to sterilize. So you wind up flashing them."
Using an audit checklist
While there remains confusion about the issue, Seavey has created an audit tool that covers the basics for patient safety based on the most recent science. "It is a checklist that [infection preventionists] can customize to their facility," she said. "These are the kind of questions you want to be asking in your facility." (See audit)
In using the tool to assess your facilities practices and policies, Seavey emphasizes key points that include the following:
Four phases: The steam sterilization process has four phases that are significantly dependant on each other to produce and maintain a sterile product:
- Decreasing and limiting bioburden before sterilization.
- Appropriately preparing devices for sterilization.
- Using validated sterilization parameters for each device.
- Establishing and implementing controls to maintain the sterility of devices until used.
Definition: A process designed for the steam sterilization of patient care items for immediate use. (AAMI and AORN, 2009)
Clinical use: The use of flash sterilization:
- should be kept to a minimum, and not used for implants;
- may be associated with increased risk of infections to patients;
- should not be used as a substitute for having sufficient instrument inventory;
- may put pressure on personnel to eliminate one or more steps in the cleaning process;
- should be exposed to the same multistep process (including decontamination, preparation and documentation) as packaged items;
- and, should be containerized for transport from sterilizer to point of use.
Reference
- Joint Commission on Accreditation of Healthcare Organizations Update: The Joint Commission's Position on Steam Sterilization Joint Commission Perspectives. 2009;29:[7]:8-11.
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