Flash Sterilization The Fundamental Issues

October 1, 2000

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.

Environmental Issues

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.

Clinical Focus

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 A: Sample Flash Sterilization Log

Table B: Standard Recommendations for Flash
Sterilization

Table C: Flash Sterilization Audit/Education
Program

Table D: Manufacturer's Sterilization
Recommendations*
(*not printable)

For a complete list of references click here