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 to monitor the stability of existing processes, identify opportunities for improvement, identify changes that will lead to improvement, and sustain improvement."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 California Academic Medical Center Operating Room (OR) assessed its flash sterilization practices, educated for identified deficiencies, developed new policies and protocols for the practice, and used educational audits to gauge the success of these endeavors. The successes and failures of these processes highlight the issues surrounding the practice of flash sterilization. The following is a discussion of the process followed by the medical center and the issues of concern for the practice of flash sterilization in contrast with the practice of wrapped sterilization in a sterile processing department (SPD).
The Audit and Education Process
In 1992, it was observed that one flash autoclave had been set to the wrong temperature setting and used to flash sterilize several loads of instruments in a 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. It found that the autoclave was set to the wrong temperature settings up to 50% of the time the previous year. No professional staff had reported anything amiss with the autoclave. It also was observed that except for the printed records of the autoclave, no other information was being recorded about the flash-sterilized loads. Professional organizations concerned with flash sterilization recommended that each flash load record should identify the patient, the items being sterilized, the temperature setting, the length of the sterilization process, and the results of the biological and/or chemical integrator sterility assurance indicator.3,4
Immediate changes were made in the flash-sterilization process. Chemical integrators were to be placed in each tray undergoing flash sterilization. Integrators, designed to respond only in the presence of the three physical parameters necessary for sterility--pressure, temperature, and saturated steam--provided the clinical staff with instantaneous visual confirmation that the physical environment inside the autoclave was capable of achieving sterilization. A daily flash log was introduced to record the recommended sterilization load data (Table A). Education programs were developed to introduce these practice changes to the operating-room staff. Daily rounds were performed by the manager of the SPD during peak flash-sterilization hours, and after six months, a second audit was performed on all flash-sterilizer records to assess the success of the process changes to improve practice. The findings were discouraging.
Direct observation identified four occasions when whole trays, including trays with orthopedic implants (screws and plates), had been placed onto the surgical field and used during surgery without ever being subjected to the flash-sterilization process. These occurrences all had a common denominator. A first nurse had placed the instruments into the autoclave, but the autoclave was not successfully started. A second nurse (relieving the first) opened the autoclave, did not record the data on the record sheet, and offered the instruments to the scrub nurse. In three instances the trays had no chemical integrators, which, secondary to new policy, should have caused the scrub nurse to reject the trays automatically. The integrator in the fourth case clearly indicated 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 the data recorded it was identified that mistakes in choices of the correct sterilization parameters also occurred. Staff were sterilizing simple non-complex instrumentation for too long. Professional associations recommend that simple non-lumen and non-porous instrumentation be flash-sterilized for three minutes (Table B). The audit discovered some of these items being sterilized for 10 and 20 minutes. Although this practice was not a danger for the surgical patient, it can inhibit OR efficiency. The audit found that in more than 120 cases, the wrong settings had been used for flash sterilization runs and that the sterility of the instruments used in the cases could not be assured. 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 room culture. A further education process included discussion of autoclave errors directly with the individuals who were making them to clarify any confusion they may have regarding the appropriate process. Practice seemed to be improving. Then in 1995, a rapid-readout biological indicator read positive for growth for one of the flash autoclaves. An audit of the autoclave's mechanical record disclosed that for 1-1/2 months it had been intermittently malfunctioning. The mechanical record had been recording run failures and abortions more than 50% of the time. Unfortunately, the failures did not occur when the biological test indicators were used to assess the autoclave function. More than 35 surgical staff used the autoclave during that period of time and none reported it to a supervisor. Nor were the run failures being recorded. This resulted in more intensive education efforts and a management announcement that staff would be held accountable. Following audits showed improving compliance with the flash sterilization protocols and significantly reduced error. Flash sterilization education and compliant practice had become a part of the practice culture.
In 1997, a new education/audit program was developed to assess the success of the 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 given to the inpatient OR staff. Sixteen stations were devised for the review of the professional OR staff. Each station represented a situation normally encountered by them in their daily practice of flash sterilization. Table C lists the stations, questions, issues being reviewed, and results of the education audits. Each station was monitored by the OR ancillary staff. They assured that the OR professional staff did not discuss the answers among themselves and spent only the allotted time at each station. The professional staff were allowed 10 seconds to assess each station. This was considered to be representative of the time they actually take to assess and confirm the sterility of items flashed in their daily practice. Following their rotation through all of the stations, a process that took about 10 minutes, all staff were assembled and the stations and correct answers with justifications were discussed. The process was well received because of the interaction between real practice situations and immediate follow-up. However, the audit results were again disappointing. The average OR professional missed five questions out of 16. New strategies currently are being designed.
This long-term process for improving flash sterilization practice with its successes and failures demonstrates the fundamental issues that surround flash sterilization. It demonstrates why the Centers for Disease Control and Prevention (CDC) strongly recommend, secondary to "experimental, clinical or epidemiological studies and strong theoretical rationale," that hospitals "not use flash sterilization for reasons of convenience, as an alternative 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 and expectations. The educational issues include numbers of access to, and stability of personnel. These issues are best illuminated when contrasted with the practice 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 a primary function. Often, the very location of the flash sterilizer compromises the process. One author observed a newly constructed ambulatory surgery center that placed its flash sterilizer in the hallway through which patients were transported from surgery to the recovery room. It had been changed to that location during the construction process to allow for the relocation of the physician's dictation room to surgery suites.
Many facilities place their flash autoclaves in sub-sterile rooms. Staff entering these rooms may or may not be required to wear masks. In many facilities, surgical staff step into the sub-sterile rooms during intra-operative portable X-ray proceedings. This potentially exposes the rooms to biological contamination from patients. Two surgical suites often share sub-sterile rooms. Thus, instruments transported from the sterilizer are exposed to any potential contaminates from the other surgical suite. A variety of surgical personnel pass through these rooms: sales representatives, attendants, anesthesia personnel, nursing personnel, and physicians. All of this activity exposes these rooms to potential contamination. In an SPD, the purpose of the department is designed for one thing: the preparation, assembly, and sterilization of instruments for surgery. Thus, the staff with access to the autoclaves is usually limited to the immediate SPD staff. The autoclave zone is not visited by staff who have patient contact. This minimizes the potential for contamination.
The functional environmental concerns focus on how the physical plant allows individuals to functionally achieve flash sterilization. Decontamination is an important component of the sterilization process. How often have instruments, dropped from the sterile field, been rinsed at the scrub-sink or sub-sterile sink and placed in the flash sterilizer? This poses a potential for contamination of those areas with bioburden and failure of the sterilization process secondary to residual bioburden. Recently, one staff member was handed two frazier suctions damaged by a neurosurgery burr. As the surgical nurse handed them to him, he asked if they had been cleaned. She assured him that they had. While transporting them to his office, he found that they had leaked bloody fluid onto his hand. He asked the nurse how she had cleaned the instruments. She stated that she had "rinsed them at the scrub sink." When asked why she had not run a brush through them and dried them with compressed air, she stated that were no brushes or compressed air available. How many locations exist in the OR with the proper brushes and chemicals needed to decontaminate instruments prior to sterilizing them? The SPD physically separates the decontamination area from the sterilization area. Personnel performing these tasks are physically separated.
The political environment also is cause for concern. Today's OR is a fast-paced environment. Tremendous pressure abounds to "reduce turnover time." This leads to an environment of haste relative to flash sterilization. This environment of haste may explain why the nurse who "cleaned" the frazier suctions did not clean them in the OR decontamination room that contained the brushes, chemicals, and compressed air necessary to decontaminate the instruments properly. There are also the not-uncommon instances when the physician, impatient for the article in the autoclave, demands that it be released after only three minutes, although recommendations may require longer. This environment of haste does not exist in SPD. The process, although fast-paced, has a sequential methodology and pacing to 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 on the surgical staff in the OR vs. the SPD. Surgical staff focus on patients, family, surgeon, and anesthesiologist needs, the technical requirements of the surgery, room setup, maintenance of sterile field, documentation, instrument count, billing, and the moment-to-moment demands of the procedure. Sterilization is a small component of focus among all of these demands. The SPD's clinical focus is the decontamination, assembly, sterilization and documentation, distribution, maintenance, and repair of instrumentation.
Clinical expectations affect the importance that surgical staff place on various components of their practice. At the major academic medical center mentioned earlier, it wasn't until four years into the flash sterilization audit/education process that clinical managers began to review flash-sterilization records and require nursing staff to correct these logs. Following these actions, data recording compliance began reaching the 90th percentile. Educational issues are the most complex for the practice of flash sterilization. Education will not be successful in the absence of environmental controls, enhancements, and a clinical focus that perceives the issue as important.
Numbers of personnel may be a problem. How do you offer a quality program to a 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 staff working varying shifts, days of the week, and hours of the day. It is not uncommon for ORs to use the services of temporary or traveling staff who must be educated to the department's practice standards. Lastly, new staff must be educated to the practice standards. All of these issues and challenges lead by necessity to the development of a comprehensive program designed to foster proper flash sterilization practice, assess its success, and raise staff accountability.
A program designed to address the milieu of issues surrounding the flash sterilization process can be accomplished in three phases. First, identify the proper practice standards for your department. Second, educate the appropriate staff to these standards. Third, audit the process for success and deficiencies. Following the audit process, reinforce identified successes, educate for identified 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 likely achieved by (surgical) nurses who had attended continuing education courses about nosocomial infections preventive measures."6
Phase one requires the identification of the proper practice standards for your department. The resources for this data are professional associations, manufacturer's recommendations, and external research or internal validation protocols. Table B represents the standard recommendations for flash sterilization established by the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of Operating Room Nurses (AORN). A limited but representative list of manufacturer's recommendations for specific instrumentation may be found in Table D. Note that you are obligated to follow the recommendations of the manufacturers of your sterilizers and clarify any issues you may have relative to their performance with specialized instrumentation you may need to flash sterilize. Also important is that the standards established cite the decontamination requirements, sterilization parameters, and post-sterilization handling of the instrumentation. Blevins et. al (1999) found that incomplete decontamination coupled with flash sterilization of meniscal repair cannulas led to a cluster of septic arthritis.7
In the second phase, education, you will need to focus on standard recommendations and any unusual challenges your sterilization practices present for your staff. At all times staff should be provided with the necessary sterilization parameters for complex instrumentation. This information should be posted at the autoclaves.
The type of program you design for your staff will be driven by the complexity of your environment. Small facilities will most likely be able to achieve success through staff meetings. Larger more complex facilities may need to use meetings, mentoring, self-learning guides, and the assessment of identified clinical competencies relative to flash sterilization, on a yearly basis. All of these approaches have as their goal the dissemination and availability of information.
Phase three, the audit process, is designed to assess the success of the first 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 each flash autoclave. It may assist the auditor to identify if (1) the proper flash-sterilization parameters are being selected for the instrumentation identified, (2) all loads are being recorded, (3) any particular staff are having problems with practice, (4) particular instrumentation seems to be excessively flashed sterilized, (5) there is a relationship between flash sterilization and instrument repair costs, and (6) there is a relationship between flash sterilization and post-operative infection. McConkey et. al found that a comprehensive infection control program including a "minimization of flash sterilization" resulted in significant reduction of surgical-site infections following coronary artery bypass graft surgery.8 Target goals can be specific or broad-based. One target may be to bring data recording compliance to 80% within one year. A more specific goal may be to identify instrumentation or trays of instruments that are flashed more frequently than terminally sterilized. This may indicate a need to purchase additional instrumentation. A reasonable time line is six to 12 months. This allows assessment of the long-term retention of education program materials.
In this article we discussed one major medical center's seven-year process to develop excellence in their flash-sterilization practice. The medical center's successes and failures highlighted the issues challenging the successful practice of flash sterilization. Flash sterilization in and of itself is not a complex activity. However, it occurs within a rushed, complex, and dynamic environment. Identifying and establishing practice standards, educating for and disseminating practice parameters, auditing for the achievement of those practice standards, and integrating these practice standards into expected staff competencies will lead to excellence.
Jack Donaldson, BSN, CNOR, CSPDM, is the nurse manager, Sterile Processing, Sutter Medical Center, Sacramento, Calif. Also, he is the editor of the Internet nursing site www.NurseCEU.com and 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-editor of the Internet education provider, New Age Health.
For tables A-D and references, see below.
Table D: Manufacturer's Sterilization
For a complete list of references click here