The Roundtable: Sterilization Equipment
7/1/2010 12:00:00 AM by: MD Publishing This month, Medical Dealer asked experts on
sterilization equipment to give us their insight
into what lies ahead in the sterilization arena.
Herman Dennington, owner of Medequip Engineering
Service, has worked with sterilization for more
than 70 years. He provides us with a history of sterilization
and shares his opinion on the equipment’s
future. Jeff Fitzgerald, owner of Medical Technologies,
also provides his expert insight, and Stephen Loes, vice
president of marketing, Infection Prevention Technologies
at Steris gives us the manufacturer’s perspective.
MEDICAL DEALER: WHAT ARE THE BIGGEST TRENDS
REGARDING STERILIZATION EQUIPMENT?
Jeff Fitzgerald: Low temp sterilization and disinfection seems to
be changing. There has always been a need for the sterilization of
temperature sensitive items. Recent ruling by the FDA has made
some heavily relied upon devices obsolete.
Herman Dennington: When I left the aircraft maintenance business
in 1975 to work for American Sterilizer Company, I routinely
visited country hospitals that were still using equipment built
back in the early forties, so my familiarity with sterilization equipment
and processes now spans some 70 years.
The discussion of signifi cant changes in design or function of
sterilizers should begin with the separation of steam sterilization
from other types such as ethylene oxide (ETO), vaporized hydrogen
peroxide (VHP), peracetic acid, and other chemical sterilants.
The concept of steam sterilization hasn’t changed since the fi rst
pot of boiling water had a lid put on it. What has changed is the
control, regulation, and monitoring of the prescribed parameters
that have been determined to be effective for the process. From the
late 1800s through the 1940s, sterilizers were mechanical devices
that required the operator to be responsible for insuring that time
and temperature were attained. This was accomplished by opening
and closing hand valves on the machine to proceed through
the desired cycle.
In the early 1950s, electromechanical controls became common
on sterilizers. This control used a temperature sensor, timer,
and drive motor to circumvent most of the need for manipulation
of hand valves by the operator. This was, as they say, a quantum
leap in the industry as it freed the operator to do other things
and provided better assurance that the sterilization parameters
were met.
In the 1960s, the most signifi cant trend in sterilization was
away from “Gravity” type cycles in favor of “Vacuum” sometimes
referred to as “Hi vac” cycles. The use of a vacuum pump to remove
air from the chamber both before and after the sterilize phase
greatly reduced the time necessary for the conditioning and drying
of porous loads such as wrapped packs of instruments. The vacuum
cycle increased the productivity of the sterilizer by about three
times what the same size chamber could do with gravity cycles.
The signifi cant change in the late 70s was away from electromechanical
controls in favor of microprocessors. Cost and marketing
issues aside, the use of a computer to control the cycle allowed
for the incorporation of logic, redundant monitoring, and trouble
reporting to assist the operator with sterility assurance. The evolution
of microprocessor-controlled systems through the 80s and 90s
resulted in equipment that was simpler to operate and maintain
yet more effi cient and cost effective.
We’ll probably see more changes with the bells and whistles
in the years to come, but the glorifi ed pressure cooker we call the
autoclave will always be just that.
Regarding low temp sterilization, a book could be written
about what has happened and another about what may happen in
the future. In the interest of brevity for this article, I’ll only make
reference to what I consider the most signifi cant change since the
1930s when ethylene oxide was introduced as a sterilant for temperature
critical items.
The decline in the popularity of ETO began in the 80s with the
association of Freon 12 to the hole in the ozone layer over the North
Pole. The common method of distribution of ETO at that time was
a mixture of 12 percent ETO and 88 percent Freon 12. A declaration
by the EPA to stop the production of Freon 12 along with the
listing on the federal register of ETO as a hazardous substance (in
another book) intensifi ed the search for a substitute method of low
temp sterilization.
Most facilities that still use ETO now use 100 percent ETO canisters
rather than the CFC or HCFC blends. Although it is inferior
to ETO as a sterilant, vaporized hydrogen peroxide has become the
low temp method of choice due to much shorter cycle times. VHP
doesn’t penetrate porous items as well as ETO, so it doesn’t need a
long aeration period.
Stephen Loes: This depends on the modality of sterilization we
are discussing:
For gas sterilization (ethylene oxide, ozone, vaporized hydrogen
peroxide (VHP), or hydrogen peroxide gas plasma), there are
two major trends: First, there is the development of cycles to sterilize
long-lumened single and dual channel fl exible endoscopes
with reduced cycle times. Second is the ongoing trend towards
eliminating ETO sterilization in hospitals.
In liquid chemical sterilization, the major market initiative is
the transition from STERIS SYSTEM1® Sterile Processing Systems
to alternate technologies such as the recently cleared SYSTEM
1E™ Liquid Chemical Sterilant Processing System and gas-based
sterilization technologies.
There are several trends happening in steam sterilization
as well. One is the reduction in utility costs for water and steam
generation. We are also seeing improved productivity through
equipment design and cycle development (example: the new Amsco
® Evolution™ Steam Sterilizers, which can now handle over 90
percent more instruments by weight than the previous Century®
sterilizers in the same amount of time). There is also improved
uptime through real-time monitoring of equipment performance
and predictive maintenance. A major hospital trend is the reduction
of fl ash sterilization, which is based on the recommendations
of standards-setting organizations.
MEDICAL DEALER: HOW HAS THIRD-PARTY
PARTS SALES AFFECTED YOUR BUSINESS?
Jeff Fitzgerald: Third-party parts sales have allowed
us to sell equipment and parts to customers
that might not otherwise be open to us.
Herman Dennington: Parts can usually be obtained
from the original manufacturer as long as
that model is still “supported.” However, there is
a wide variety of sources and pricing for O.E.M.
specifi c repair parts. Medequip maintains parts
and equipment catalogs from suppliers throughout
the United States and continually shops for
the best price to minimize our customers’ costs
for parts and supplies. We also have a good supply
of proprietary parts for models that are no
longer supported by the manufacturer.
MEDICAL DEALER: IN WHAT AREAS ARE YOU SEEING THE
BIGGEST BUSINESS OPPORTUNITIES?
Jeff Fitzgerald: With more facilities purchasing equipment from
different vendors, there is a need for an independent service company
that is able to work on all leading manufacturers’ equipment.
Additionally, the need for second sourcing parts and supplies has
also increased dramatically in recent years.
Herman Dennington: I think the awareness of the need to be resource
conscious will continue to increase in the coming years,
resulting in more effective preventive maintenance programs and
reconditioning of older equipment. Maintenance and refurbishing
rather than replacement will increasingly represent the best bang
for your buck in sterilization and will present good business opportunities
for companies that can do the job correctly.
Stephen Loes: For sterilizers the largest opportunity is replacement
of the installed base. Sales of sterilizers have been depressed
for the last few years due to the economy. With the economy turning,
there is pent-up demand for sterilizers. Recent innovations
around controls, utility savings, automation, productivity, and
regulatory requirements make the current installed base of sterilizers
less viable.
MEDICAL DEALER: HOW DO YOU ENVISION THE STERILIZATION
EQUIPMENT INDUSTRY EVOLVING IN THE NEXT FIVE TO 10 YEARS?
Jeff Fitzgerald: Unfortunately, there seems to be less competition as larger companies
are buying up their smaller competition.
Herman Dennington: I’m optimistic that healthcare reform will ultimately result
in additional funding for healthcare facilities at all levels. In recent years, hospitals
nationwide have faced budget cuts and staff reductions and we are routinely asked
to make offers on used equipment from hospitals that have closed. The current administration
in Washington has committed to brokering funds (brokering in that
the government merely reassigns value taken from other sources) to provide healthcare
to an additional 33 million Americans. Added staffi ng and equipment will be
needed at about the same time the nation recovers from its current economic slump.
There should be no shortage of opportunities for providers of healthcare products
and services in the years to come.
Stephen Loes: In the healthcare segment of sterilization specifi cally, we will see continuing
improvements to sterilization equipment, particularly in regard to improving
process cycles, improving material compatibility, increasing material-handling
automation and reducing the total cost of ownership of the equipment. However, I
believe the biggest improvements in sterilization will be achieved when hospitals
optimize their sterilization workfl ow and processes by applying lean manufacturing
practices and improving their information management systems. In order to do
this, their sterilizer controls and software will need to be able to handle the data
demands being placed upon them by advanced process improvement technologies.
MEDICAL DEALER: WHAT ELSE DO YOU
WANT MEDICAL DEALER READERS (HOSPITAL
PROFESSIONALS AND CAPITAL EQUIPMENT
VENDORS) TO KNOW ABOUT THE
STERILIZATION EQUIPMENT INDUSTRY?
Jeff Fitzgerald: There are choices out there for
rebuilt equipment, service, and parts. Rather than
paying higher prices that are often charged by
OEMs, purchasing departments are conserving
revenues by utilizing third party organizations.
Herman Dennington: Experience is the key.
Quality and reliability are typically the result
of repetition in the successful completion of a
task. Training provides the foundation for a technician
and experience provides the value. The
most common virtue advertised by a manufacturer
is experience, but when it comes to used
equipment such as sterilizers, pitfalls abound. A
properly refurbished sterilizer can be expected
to provide superior service and reliability with
the same life expectancy as a new unit. However,
many refurbishers are known in the trade
as spray and pray operations. Gaskets and repair
kits may be replaced, but the unit is put back
into service with the same plumbing and wiring
that may have caused it to be removed in the fi rst
place. My advice to medical facilities wanting to
save money with used equipment is to ask your
dealer how may sterilizers they have refurbished.
The number should be in the hundreds.
Stephen Loes: Sterilization of surgical instruments
is only a small segment of the “manufacturing
process” that provides clean, sterile,
on-time and ready-to-use surgical instruments
to the operating room. As manufacturers of products
and services for the sterile processing department,
we need to ensure that all facets of the
process are optimized and that the equipment we
provide meets the needs of the entire hospital. |