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Flash Sterilization The Fundamental Issues
By Jack Donaldson, BSN, CNOR, CSPDM; and Kathy Donaldson, RN,CNOR, CSPDT
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO)directs that within healthcare organizations, "data are collected tomonitor the stability of existing processes, identify opportunities forimprovement, identify changes that will lead to improvement, and sustainimprovement."1 The JCAHO also directs hospitals to take actions"to prevent or reduce the risk of nosocomial infections in patients,employees, and visitors."2 From 1992 to 1999, a major CaliforniaAcademic Medical Center Operating Room (OR) assessed its flash sterilizationpractices, educated for identified deficiencies, developed new policies andprotocols for the practice, and used educational audits to gauge the success ofthese endeavors. The successes and failures of these processes highlight theissues surrounding the practice of flash sterilization. The following is adiscussion of the process followed by the medical center and the issues ofconcern for the practice of flash sterilization in contrast with the practice ofwrapped sterilization in a sterile processing department (SPD).
In 1992, it was observed that one flash autoclave had been set to the wrongtemperature setting and used to flash sterilize several loads of instruments ina single day without any of the professional operating-room staff taking notice.A more extensive audit of the printed records of the autoclave was performed. Itfound that the autoclave was set to the wrong temperature settings up to 50% ofthe time the previous year. No professional staff had reported anything amisswith the autoclave. It also was observed that except for the printed records ofthe autoclave, no other information was being recorded about theflash-sterilized loads. Professional organizations concerned with flashsterilization recommended that each flash load record should identify thepatient, the items being sterilized, the temperature setting, the length of thesterilization process, and the results of the biological and/or chemicalintegrator sterility assurance indicator.3,4
Immediate changes were made in the flash-sterilization process. Chemicalintegrators were to be placed in each tray undergoing flash sterilization.Integrators, designed to respond only in the presence of the three physicalparameters necessary for sterility--pressure, temperature, and saturatedsteam--provided the clinical staff with instantaneous visual confirmation thatthe physical environment inside the autoclave was capable of achievingsterilization. A daily flash log was introduced to record the recommendedsterilization load data (Table A). Education programs were developed tointroduce these practice changes to the operating-room staff. Daily rounds wereperformed by the manager of the SPD during peak flash-sterilization hours, andafter six months, a second audit was performed on all flash-sterilizer recordsto assess the success of the process changes to improve practice. The findingswere discouraging.
Direct observation identified four occasions when whole trays, includingtrays with orthopedic implants (screws and plates), had been placed onto thesurgical field and used during surgery without ever being subjected to theflash-sterilization process. These occurrences all had a common denominator. Afirst nurse had placed the instruments into the autoclave, but the autoclave wasnot successfully started. A second nurse (relieving the first) opened theautoclave, did not record the data on the record sheet, and offered theinstruments to the scrub nurse. In three instances the trays had no chemicalintegrators, which, secondary to new policy, should have caused the scrub nurseto reject the trays automatically. The integrator in the fourth case clearlyindicated that the tray was not sterile.
The results of the six-month audit were cause for further concern.Recommended data was recorded 40 to 50% of the time. The goal was 100%. From thedata recorded it was identified that mistakes in choices of the correctsterilization parameters also occurred. Staff were sterilizing simplenon-complex instrumentation for too long. Professional associations recommendthat simple non-lumen and non-porous instrumentation be flash-sterilized forthree minutes (Table B). The audit discovered some of these items beingsterilized for 10 and 20 minutes. Although this practice was not a danger forthe surgical patient, it can inhibit OR efficiency. The audit found that in morethan 120 cases, the wrong settings had been used for flash sterilization runsand that the sterility of the instruments used in the cases could not beassured. These findings led to further education programs and audits.
The next series of audits showed improvements in compliance to the 70% level.Staff were beginning to accept the process as part of the operating roomculture. A further education process included discussion of autoclave errorsdirectly with the individuals who were making them to clarify any confusion theymay have regarding the appropriate process. Practice seemed to be improving.Then in 1995, a rapid-readout biological indicator read positive for growth forone of the flash autoclaves. An audit of the autoclave's mechanical recorddisclosed that for 1-1/2 months it had been intermittently malfunctioning. Themechanical record had been recording run failures and abortions more than 50% ofthe time. Unfortunately, the failures did not occur when the biological testindicators were used to assess the autoclave function. More than 35 surgicalstaff used the autoclave during that period of time and none reported it to asupervisor. Nor were the run failures being recorded. This resulted in moreintensive education efforts and a management announcement that staff would beheld accountable. Following audits showed improving compliance with the flashsterilization protocols and significantly reduced error. Flash sterilizationeducation and compliant practice had become a part of the practice culture.
In 1997, a new education/audit program was developed to assess the success ofthe previous five years of education programs and to serve as a yearly update.It was first given to the ambulatory operating room staff. In 1999, it was givento the inpatient OR staff. Sixteen stations were devised for the review of theprofessional OR staff. Each station represented a situation normally encounteredby them in their daily practice of flash sterilization. Table C lists thestations, questions, issues being reviewed, and results of the education audits.Each station was monitored by the OR ancillary staff. They assured that the ORprofessional staff did not discuss the answers among themselves and spent onlythe allotted time at each station. The professional staff were allowed 10seconds to assess each station. This was considered to be representative of thetime they actually take to assess and confirm the sterility of items flashed intheir daily practice. Following their rotation through all of the stations, aprocess that took about 10 minutes, all staff were assembled and the stationsand correct answers with justifications were discussed. The process was wellreceived because of the interaction between real practice situations andimmediate follow-up. However, the audit results were again disappointing. Theaverage OR professional missed five questions out of 16. New strategiescurrently are being designed.
This long-term process for improving flash sterilization practice with itssuccesses and failures demonstrates the fundamental issues that surround flashsterilization. It demonstrates why the Centers for Disease Control andPrevention (CDC) strongly recommend, secondary to "experimental, clinicalor epidemiological studies and strong theoretical rationale," thathospitals "not use flash sterilization for reasons of convenience, as analternative to purchasing additional instrument sets, or to save time."5
The issues surrounding successful flash sterilization are environmental,clinical, and educational. Environmental issues include physical, functional,and political concerns. The clinical issues include clinical focus andexpectations. The educational issues include numbers of access to, and stabilityof personnel. These issues are best illuminated when contrasted with thepractice environment in the SPD.
The purpose of the OR is to perform surgical procedures. Subsequently,sterilization is viewed as an activity used to assist this process and not aprimary function. Often, the very location of the flash sterilizer compromisesthe process. One author observed a newly constructed ambulatory surgery centerthat placed its flash sterilizer in the hallway through which patients weretransported from surgery to the recovery room. It had been changed to thatlocation during the construction process to allow for the relocation of thephysician's dictation room to surgery suites.
Many facilities place their flash autoclaves in sub-sterile rooms. Staffentering these rooms may or may not be required to wear masks. In manyfacilities, surgical staff step into the sub-sterile rooms duringintra-operative portable X-ray proceedings. This potentially exposes the roomsto biological contamination from patients. Two surgical suites often sharesub-sterile rooms. Thus, instruments transported from the sterilizer are exposedto any potential contaminates from the other surgical suite. A variety ofsurgical personnel pass through these rooms: sales representatives, attendants,anesthesia personnel, nursing personnel, and physicians. All of this activityexposes these rooms to potential contamination. In an SPD, the purpose of thedepartment is designed for one thing: the preparation, assembly, andsterilization of instruments for surgery. Thus, the staff with access to theautoclaves is usually limited to the immediate SPD staff. The autoclave zone isnot visited by staff who have patient contact. This minimizes the potential forcontamination.
The functional environmental concerns focus on how the physical plant allowsindividuals to functionally achieve flash sterilization. Decontamination is animportant component of the sterilization process. How often have instruments,dropped from the sterile field, been rinsed at the scrub-sink or sub-sterilesink and placed in the flash sterilizer? This poses a potential forcontamination of those areas with bioburden and failure of the sterilizationprocess secondary to residual bioburden. Recently, one staff member was handedtwo frazier suctions damaged by a neurosurgery burr. As the surgical nursehanded them to him, he asked if they had been cleaned. She assured him that theyhad. While transporting them to his office, he found that they had leaked bloodyfluid onto his hand. He asked the nurse how she had cleaned the instruments. Shestated that she had "rinsed them at the scrub sink." When asked whyshe had not run a brush through them and dried them with compressed air, shestated that were no brushes or compressed air available. How many locationsexist in the OR with the proper brushes and chemicals needed to decontaminateinstruments prior to sterilizing them? The SPD physically separates thedecontamination area from the sterilization area. Personnel performing thesetasks are physically separated.
The political environment also is cause for concern. Today's OR is afast-paced environment. Tremendous pressure abounds to "reduce turnovertime." This leads to an environment of haste relative to flashsterilization. This environment of haste may explain why the nurse who"cleaned" the frazier suctions did not clean them in the ORdecontamination room that contained the brushes, chemicals, and compressed airnecessary to decontaminate the instruments properly. There are also thenot-uncommon instances when the physician, impatient for the article in theautoclave, demands that it be released after only three minutes, althoughrecommendations may require longer. This environment of haste does not exist inSPD. The process, although fast-paced, has a sequential methodology and pacingto it. Although there may be pressure to not let the autoclaves sit idle,instruments are not placed into them until properly prepared.
The issue of clinical focus centers around the diversity of demands placed onthe surgical staff in the OR vs. the SPD. Surgical staff focus on patients,family, surgeon, and anesthesiologist needs, the technical requirements of thesurgery, room setup, maintenance of sterile field, documentation, instrumentcount, billing, and the moment-to-moment demands of the procedure. Sterilizationis a small component of focus among all of these demands. The SPD's clinicalfocus is the decontamination, assembly, sterilization and documentation,distribution, maintenance, and repair of instrumentation.
Clinical expectations affect the importance that surgical staff place onvarious components of their practice. At the major academic medical centermentioned earlier, it wasn't until four years into the flash sterilizationaudit/education process that clinical managers began to reviewflash-sterilization records and require nursing staff to correct these logs.Following these actions, data recording compliance began reaching the 90thpercentile. Educational issues are the most complex for the practice of flashsterilization. Education will not be successful in the absence of environmentalcontrols, enhancements, and a clinical focus that perceives the issue asimportant.
Numbers of personnel may be a problem. How do you offer a quality program toa large number of personnel and assess the success of the educational programs?How do you access all personnel? Today's modern OR consists of core staffworking varying shifts, days of the week, and hours of the day. It is notuncommon for ORs to use the services of temporary or traveling staff who must beeducated to the department's practice standards. Lastly, new staff must beeducated to the practice standards. All of these issues and challenges lead bynecessity to the development of a comprehensive program designed to fosterproper flash sterilization practice, assess its success, and raise staffaccountability.
A program designed to address the milieu of issues surrounding the flashsterilization process can be accomplished in three phases. First, identify theproper practice standards for your department. Second, educate the appropriatestaff to these standards. Third, audit the process for success and deficiencies.Following the audit process, reinforce identified successes, educate foridentified deficiencies, and audit once again for successes and deficiencies.This process should become part of the OR's required annual training. Angelillo et.al (1999) found that "the use of all barrier techniques was more likelyachieved by (surgical) nurses who had attended continuing education coursesabout nosocomial infections preventive measures."6
Phase one requires the identification of the proper practice standards foryour department. The resources for this data are professional associations,manufacturer's recommendations, and external research or internal validationprotocols. Table B represents the standard recommendations for flashsterilization established by the Association for the Advancement of MedicalInstrumentation (AAMI) and the Association of Operating Room Nurses (AORN). Alimited but representative list of manufacturer's recommendations for specificinstrumentation may be found in Table D. Note that you are obligated to followthe recommendations of the manufacturers of your sterilizers and clarify anyissues you may have relative to their performance with specializedinstrumentation you may need to flash sterilize. Also important is that thestandards established cite the decontamination requirements, sterilizationparameters, and post-sterilization handling of the instrumentation. Blevins et.al (1999) found that incomplete decontamination coupled with flashsterilization of meniscal repair cannulas led to a cluster of septic arthritis.7
In the second phase, education, you will need to focus on standardrecommendations and any unusual challenges your sterilization practices presentfor your staff. At all times staff should be provided with the necessarysterilization parameters for complex instrumentation. This information should beposted at the autoclaves.
The type of program you design for your staff will be driven by thecomplexity of your environment. Small facilities will most likely be able toachieve success through staff meetings. Larger more complex facilities may needto use meetings, mentoring, self-learning guides, and the assessment ofidentified clinical competencies relative to flash sterilization, on a yearlybasis. All of these approaches have as their goal the dissemination andavailability of information.
Phase three, the audit process, is designed to assess the success of thefirst and second phases and will require a tool, target goals, and a time line.Table A is representative of a data collection record that may be placed at eachflash autoclave. It may assist the auditor to identify if (1) the properflash-sterilization parameters are being selected for the instrumentationidentified, (2) all loads are being recorded, (3) any particular staff arehaving problems with practice, (4) particular instrumentation seems to beexcessively flashed sterilized, (5) there is a relationship between flashsterilization and instrument repair costs, and (6) there is a relationshipbetween flash sterilization and post-operative infection. McConkey et. alfound that a comprehensive infection control program including a"minimization of flash sterilization" resulted in significantreduction of surgical-site infections following coronary artery bypass graftsurgery.8 Target goals can be specific or broad-based. One target maybe to bring data recording compliance to 80% within one year. A more specificgoal may be to identify instrumentation or trays of instruments that are flashedmore frequently than terminally sterilized. This may indicate a need to purchaseadditional instrumentation. A reasonable time line is six to 12 months. Thisallows assessment of the long-term retention of education program materials.
In this article we discussed one major medical center's seven-year process todevelop excellence in their flash-sterilization practice. The medical center'ssuccesses and failures highlighted the issues challenging the successfulpractice of flash sterilization. Flash sterilization in and of itself is not acomplex activity. However, it occurs within a rushed, complex, and dynamicenvironment. Identifying and establishing practice standards, educating for anddisseminating practice parameters, auditing for the achievement of thosepractice standards, and integrating these practice standards into expected staffcompetencies will lead to excellence.
Jack Donaldson, BSN, CNOR, CSPDM, is the nurse manager, SterileProcessing, Sutter Medical Center, Sacramento, Calif. Also, he is the editor ofthe Internet nursing site www.NurseCEU.comand co-editor of the Internet education provider, New Age Health.
Kathy Donaldson, RN, CNOR, CSPDT, is the nurse educator, Surgery,University of California Medical Center Davis, Sacramento, Calif, and co-editorof the Internet education provider, New Age Health.
For tables A-D and references, see below.
Table D: Manufacturer's SterilizationRecommendations*(*not printable)
For a complete list of references click here