Regulatory and Environmental Consulting
Nathan Schiff, Ph.D. Tel(519) 645-8575
Fax (519) 645-1003
By Nathan Schiff, PhD
What are OR, or Sterile Packs
During an invasive medical procedure care must be exercised to prevent patients
from coming into contact with infectious germs. For this reason, linen, such
as towels or gowns which may contact blood or exposed
internal organs, must be sterile or totally free of all life forms, including
spores. When conditions are unfavorable for their existence, some bacteria
convert into spores which are extremely adept at surviving harsh conditions
and can easily be transferred to open wounds. Once the bacteria's environmental
conditions improve, the spores can revert back to their vegetative or normal
state, where they once again are capable of carrying on with their normal
metabolic processes including the production of toxins and the spreading
of an infection by multiplication. Therefore, garments destined for OR use,
require special, high tech processing and QA tests in addition to the normal
laundering procedures, to insure germ free and sterile products.
How the System Operates
The linen needed to supply each of the 4,200 daily OR packs are initially
inspected for holes or tears. If found, the garments
are repaired by using micro fiber thermal patches. At this step each fabric
is also marked, prior to further processing, in order to keep track of the
number of laundry cycles that it has gone through. Eventually
all laundry products will be replaced with those composed of micro fibers,
since they exhibit a longer useful hospital life, capable of withstanding
75 laundering cycles compared to current 65 cycles from cotton products.
The contents of each OR pack is filled according to specific hospital orders,
wrapped in micro fiber wrappers and placed on 3-tier shelving units, destined
for further processing.
The Sterilizing Process
Several shelving units holding the packs are wheeled into one of the 4 medium
sized sterilizers (36" w x 60" h x 60" d) for further processing of the OR
packs. During the 45 minute cycle the sterilizing chamber is steam heated
at a pressure of 29 psi (pounds per sq. in.) and to a temperature of 132oC-134oC ( 270 - 273oF),
and held at that temperature for 3 minutes to insure that sterilization has
occurred. The sterile packs are then transferred to an adjacent cooling down
room via a second door opening of the sterilizer. This
room is virtually bacteria free, and the sealed floors are disinfected daily.
The room is under a positive air pressure and the air volume is exchanged
20 - 25 times each hour. In addition the air is filtered through a 0.1 micron
filter (1/10,000th of a mm), which is capable of trapping most
bacteria and other airborne life forms. Access to the room is available only
to a few individuals with authorized access. The wearing of protective clothing,
gloves, shoe covers, gowns and appropriate masks are a requirement before
entering the room.
The Secret of Quality Packs Lies in the QA
Once the OR packs have cooled down random
samples from each pack are examined for product sterility. To that effect
Biological and color test indicators measuring sterilizer integrity, are
enclosed in each laundry packet
Using 3M's Attest Rapid Readout kit, vials of Bacillus stearothermophilus,
disease-causing, heat-resistant spores are placed in the packs prior to sterilization
and are removed and examined for biological activity after sterilization.
The lack of spore viability and the absence of microbial growth indicates
that the sterilization cycle has been successful. Additional tests including
the Bowi Dick Test are done to verify the integrity of the steam cycle, proper
air removal and sterilizer steam injection via color changes to the test
material. The pack contents are also examined for wetness, since its presence
could indicate a lack of splash proof integrity of the micro fibers which
is needed to prevent penetration of body fluids during medical procedures.
Finally, the contents of the packs are checked against the sticker label
to insure the accuracy of the package contents. Once opened and checked,
OR test packs are sent back for reprocessing and the others are transferred
to a cabinet, locked and transported to the hospitals
Benefits of Outsourcing
In order for a business to flourish it has to economically fill a need,
which is what Steripac does.
Among some of the
benefits include:
Savings are realized on a cost per use basis when hospital laundry is
outsourced.
Chemical and water usage are carefully monitored and environmental conditions
are met
Outsourcing, eliminates the need for hospitals to invest in capital
expenses and equipment such as sterilizers, laundry washers and dryers
With reuse of fabrics 75 times less land fill waste is generated, compared
to the use of disposables