|
Container validation; standard of care and
liability insurance; sterilizer mechanical charts
by Ray Taurasi
Q Our Central
Processing Department recently purchased 300 rigid containers. Prior
to placing the containers into service, I know that we will have to
validate the performance of the containers in our sterilizers. My
question is, do all 300 of the containers each need to be individually
validated?
A
As a user you are not equipped or responsible to
validate the performance of medical devices. That responsibility lies
with the device manufacturer. As part of the clearance process to
market medical devices, manufacturers must first obtain a 510k from
FDA. As part of that process the manufacturer must provide detailed
information relative to their product’s performance under specified
conditions and include scientific data to validate the device’s
satisfactory performance in accordance with any product claims for and
detailing any intended use. Prior to the purchase and use, you should
however, obtain a copy of the container manufacturer’s FDA 510k
documentation, technical data, instructions for use and documentation
of the product performance validation. Obviously you do not want to
purchase an item which cannot be used in your facility, does not
fulfill your needs or if you cannot comply with the requirements for
use set forth
by the manufacturer. As a user you are responsible to use medical
devices in accordance with the manufacturer’s specific instructions
and within the conditions for which the manufacturer has validated
their performance.
As a user, you are also responsible to verify
the device’s performance in your sterilizers and setting. It is not
necessary for you to verify the performance of all 300 containers. It
is acceptable to verify the performance of identical products by
testing a sampling of each identical device. Each specific size and
design should be tested/verified in each type of sterilization cycle
and sterilizer you will utilize.
Q
I often hear the term
"Standard of Care" and how as a certified CS technician we are legally
obliged to comply with such standards - what does that mean? Should
technicians carry individual liability insurance?
ABasically
as a technician you are responsible to follow your hospital’s policies
and procedures and to perform your duties in accordance with those
procedures under the guidance and direction of your immediate
supervisor/manager. Policies and procedures relative to reprocessing
and sterilization must be in accordance with standards set forth by
regulatory bodies such as, FDA, OSHA, DPH and EPA. Other entities such
as AORN, AAMI, IAHCSMM, CDC, APIC, and SGNA provide recommendations
and guidance documents for infection control, reprocessing and
sterilization based on sound scientific data which can assist managers
in the development of best practices policies and procedures.
Beyond the regulated protocols set forth by
legislative entities many hospitals uniformly comply with the
guidelines of the non-governmental professional entities such as those
previously mentioned. Because of the common use and acceptance of such
guidelines these non-regulatory "best practices" may be deemed as a
"standard of care".
From a legal sense, a protocol or practice which is
broadly and routinely applied in a majority of settings, can become
the accepted and expected practice. In a legal case of negligence
resulting in patient harm, the question posed would be, did the
healthcare facility’s procedures and policies follow the "standard of
care", or did the healthcare worker follow and meet the standard of
care and follow established procedures?
Certification is a testimony of one’s knowledge and
you are responsible, and obligated to apply your knowledge accordingly
in the work setting. You are accountable for your actions. The need to
carry individual liability insurance is not an expectation or common
among CS technicians. Your employer is ultimately responsible and
carries the necessary insurance to cover you in the work environment.
If you want specific information relative to your personal situation
you should consult your hospital’s Risk Management Department.
Q
When and how often should
the sterilizer mechanical charts be reviewed? Is it necessary to keep
these as permanent records?
A Physical/mechanical
monitors are a critical component of the sterilization quality control
process. These monitors provide a visible record of the sterilizer’s
functioning throughout the various phases of the sterilization cycle.
The essential conditions of temperature, time and pressure are
recorded.
Newer sterilizers have electronic controls which
provide digital print outs of the sterilizer’s activity. Older
sterilizers typically have a mechanical recorder utilizing a paper
graph with an ink pen stylus. Prior to the start of each cycle or
shift you should inspect the sterilizer to ensure that there is an
adequate supply of paper in the printer and/or graphs are replaced. It
is also important to be sure that ink, stylus and/or cartridges, where
applicable, are replaced when necessary and maintained in good working
order.
At the end of each cycle, prior to removing items from
the sterilizer the print out or graph should be reviewed and the
results interpreted by a qualified person to ensure and verify that
all of the required cycle parameters were met. The inspector should
initial the record after interpreting the results. If any
discrepancies in the cycle parameters are noted the load cannot be
released and the contents must be fully reprocessed. The sterilizer
should not be used until the necessary repairs/adjustments are
completed and the sterilizers’ proper performance is verified. These
records should then be maintained along with other sterilization
quality control and quality assurance documents, e.g. biological
indicator records.
Ray Taurasi is Eastern Regional Director of Clinical Sales and
Services for Healthmark Industries. His healthcare career spans over
three decades as an Administrator, Educator, Technologist and
Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past
president of IAHCSMM and has served on and contributed to many
national committees with a myriad of professional organizations,
manufacturers, corporations and prestigious healthcare networks.
Taurasi has been a faculty member of numerous colleges teaching in the
divisions of business administration and health sciences. In addition
to this column he has authored several articles and has been a
featured speaker on the international scene. |
