President and CEO, STERIS
Corporation
before the
Senate Environment and Public
Works Committee
December 4, 2001
Mr.
Chairman and members of the Committee, good morning. My name is Les Vinney. I
am President and Chief Executive Officer of STERIS Corporation. I thank you for your invitation and welcome
the opportunity to address this critically important issue given the
unprecedented challenge that we face as a nation.
I
am accompanied this morning by Dr. Peter Burke, STERIS Vice President and Chief
Technology Officer, and Mr. Gerry Reis, STERIS Senior Vice President, Corporate
Administration. Also joining me is Ms.
Karla Perri, Senior Environmental Consultant of Versar, Inc.
STERIS Corporation has $800 million in revenues and is a New
York Stock Exchange publicly traded company.
STERIS technologies are used every day in environments where the highest
levels of sterility are required.
Healthcare professionals in virtually all hospitals across the United
States, and scientists and researchers in the pharmaceutical industry –
including the Fortune 50 pharmaceutical companies – use STERIS products
to sterilize and decontaminate items, from surgical instruments to their
equipment and facilities. These
technologies help ensure positive outcomes of such critical activities as the
production of antibiotics, the development of vaccines, and the safety of
sensitive medical devices and implants for human beings.
In its simplest form,
the primary business focus of STERIS is to develop and produce formulations
that prevent infection and contamination, and the delivery systems to enable
their most efficient use. When properly
utilized, these technologies can provide safe and effective remediation of
contaminated materials in whatever form they may take, including entire rooms
and their various contents. These
technologies can also be put in place to prevent recontamination and assure
ongoing safety, just as is their purpose in the industries we currently serve.
In light of recent events
in our country, we welcome the opportunity to offer our experience to help
prevent infection and contamination, and to clean and restore biologically
contaminated facilities for normal use.
Our persistence in offering our technologies for these applications is
driven by the belief that our technologies can help to optimize and improve the
safety of the current remediation efforts, both in their application and
potential residual effects.
Toward that end, we have joined with Versar, Inc., a leader in providing counter-terrorism, environmental, architectural, engineering and related services. Together, STERIS and Versar offer a broad array of contamination risk assessment and remediation services.
Mr. Chairman, we
firmly believe that methods now in use in healthcare and scientific settings
can effectively decontaminate facilities infected with anthrax. The reason that you have not previously seen
us before your committee is that the large majority of STERIS products are
traditionally used in hospitals and by pharmaceutical companies. As such, we normally have had our
technologies and processes accepted for use under the purview of the Food and
Drug Administration.
While many of our formulations have been registered for specific uses with the Environmental Protection Agency, our decontamination processes have not previously been registered for specific applications, such as mail and building decontamination, of the kind our nation is now addressing.
Since the initial anthrax contamination events, we have had numerous meetings with officials on Capitol Hill and in various federal agencies to discuss the possible uses for our products and services. While our past experience gives us very high confidence in the effectiveness of our technologies, we strongly endorse the regulatory requirements to test and validate a product technology prior to allowing its use in specific treatment applications.
In that regard, we
have been seeking the opportunity to demonstrate the efficacy of our product
technologies to meet various remediation needs – and allow people to safely
return to their work environment. We
hope a bridge can be created across regulatory jurisdictions to enable the more
rapid application of these existing capabilities to meet emergency decontamination
needs.
We are now working
closely with the EPA in the attempt to secure the necessary approvals to permit
the use of these available applications.
We are also in advanced discussions with the Department of Justice on a
potential demonstration project, which would serve to validate the
effectiveness of these technologies in
decontaminating anthrax infected facilities.
In recent years,
hazardous materials decontamination efforts have largely focused on remediation
of contaminated water and soil. Buildings
contaminated with anthrax present an unprecedented challenge. Effective remediation requires multiple technologies to deal with both microbial
and biochemical contaminants.
The healthcare and
pharmaceutical industries have dealt with microbial control challenges for many
years. As a result, highly
sophisticated prevention and treatment methodologies have been developed within
these industries. While older technologies
such as formaldehyde and chlorine dioxide have, in fact, been used in these
industries, newer technologies, such as vapor hydrogen peroxide and the
combination of hydrogen peroxide and peracetic acid sporicidal compounds, have
been developed. These emerging
technologies have displaced the earlier technologies because they offer reduced
toxicity, limited corrosiveness, minimal residual effects, and easier
application.
A facility contaminated by highly aerosolized anthrax spores, which have been distributed to remote areas due to cross-contamination during mail delivery or through ventilation systems, involves a unique and severe challenge. While these conditions present a different environment than our more standard applications, we believe our technologies can be applied to the remediation and elimination of contaminants in this type of setting, as well.
To accomplish proper remediation, a carefully planned process similar to the Hazard Analysis and Critical Control Point approach would be used, just as is currently done in establishing the preventive process for healthcare and scientific requirements. In an appendix attached to my written testimony we have presented a detailed plan for systematic biological remediation of a given facility or area.
For any remediation effort, STERIS working with Versar recommends a series of steps to render a contaminated area safe for use. These include mapping the extent of contamination, reviewing the area and its contents, decontaminating using a combination of technologies and methods, confirming effectiveness and documentation.
It is also important to note that the length of any remediation process will depend on the scope of the project – including the level of contamination – and size of the building. All of the proper biological indicators and others tests must be completed before employees can be allowed to return to a building.
Mr. Chairman and members of the Committee, in our professional view
there is no single silver bullet for treating chemical or biological
contamination. This remediation
requires the selective use of multiple technologies, not reliance on a single
treatment type. This approach should
result in the least damage to items within contaminated facilities, assure that
each surface and material is treated with the agent best suited to its
individual needs and provide the highest level of decontamination.
In closing, we believe a coordinated
effort is needed among the appropriate government, academic, military and
private industry officials. This
coordinated approach will permit the identification, validation and utilization
of the safest and most effective technologies currently available. Careful development of the proper protocols
for this remediation process is critical to a successful outcome. What we must achieve is the restoration and
maintenance of safe working environments for all Americans. STERIS stands ready to help.
Thank
you for the opportunity to appear before you today. I would be happy to answer any questions you may have.
Appendix A: STERIS CORPORATION OVERVIEW
STERIS Corporation is a leading provider of infection
prevention, contamination prevention, and microbial reduction products,
services, and technologies to healthcare, scientific, research, food, and
industrial customers throughout the world.
Founded in 1987, and expanded with a series of acquisitions of companies
with over 100 years of service, STERIS has been at the forefront of meeting
customers’ needs to prevent infection and contamination, contain costs, and
improve efficiencies. STERIS products can be found wherever there is a need to
ensure the highest levels of sterility.
Headquartered in Mentor, Ohio, the Company has 4,500
employees, with production and manufacturing operations in 14 states plus
Puerto Rico, Canada, Finland and Germany. The Company has sales offices located
in 17 countries. STERIS has annual sales of over $800 million, and its stock is
traded on the New York Stock Exchange under the symbol STE.
STERIS
customers include more than 5000 hospitals, Fortune 50 pharmaceutical
companies, and many leading medical device manufacturers. The Company’s broad array of infection and
contamination prevention products and services are used every day by healthcare
professionals, scientists and researchers to ensure that materials and surfaces
are free of contamination and safe for human contact. STERIS technologies are
also used to decontaminate critical environments such as clean rooms,
isolators, and research work areas.
STERIS
professionals are committed to understanding the needs of each individual
customer and customizing the application of the Company’s technologies to
ensure positive outcomes of such critical activities as the production and
manufacture of medicines to prevent and cure disease, to eliminate the risk of
infection during surgical procedures, and to ensure that sensitive medical
devices and implants are safe for use on human beings.
The Company is committed to the development of new
technologies as well as the discovery of new applications of existing
technologies, to serve the infection and contamination needs of its customers.
The Company’s core technologies and services include:
·
High and low temperature sterilization systems utilizing
steam, ethylene oxide, vaporized hydrogen peroxide, and paracetic acid based
technologies.
·
Contract sterilization services provided through a network
of sixteen facilities in North America offering gamma irradiation, electron
beam and ethylene oxide sterilization technologies.
·
Surface disinfectants and liquid cold sterilants formulated
to disinfect and sterilize hard surfaces.
·
Personnel hand wash and rinse products that are used to keep
hands free of bacteria.
·
Surgical support products and services that enable
healthcare professionals to provide the highest levels of patient care.
·
Automated washing/decontamination systems and related
detergent and cleaning chemistries.
·
Facility planning and design services.
·
Contamination risk assessment and remediation services.
·
Education, training, installation and repair services.
Appendix B: Detailed Biological
Remediation Plan
Let us briefly
consider the technologies that are available and our objectives in their
use. These antimicrobial technologies
should be rapidly effective at killing bacterial spores, which of all
microorganisms are accepted as the most difficult to kill. Further, they should have minimum safety
hazards, not damage the room or its important contents, and if possible be
widely used and accepted for decontamination.
First, certain room
contents including rugs, drapes, personal items, and electronic equipment may
need to be removed and decontaminated separately from the room. STERIS recommends that these can be batch
sterilized by widely used methods including ethylene oxide or irradiation. It may be also prudent to consider the
overall cost of remediating these items compared to the alternative of
removing, appropriately disposing and replacing them.
Technologies
available to decontaminate rooms may be divided into two categories: liquid and
gaseous.
A variety of liquid
and foam-based technologies are available.
In general, most routinely used disinfectants in households and
hospitals demonstrate relatively slow or indeed no activity against bacterial
spores. For example, high
concentrations of chlorine solutions (like household bleach) are not
recommended due to limited activity against spores and damage to surfaces. STERIS recommends the use of EPA-registered
sporicidal products that are currently used for this purpose in high-risk or
regulated areas, which have past rigorous, standardized tests and have
demonstrated material compatibility.
Overall, liquids or
foams are excellent for small surface application, but are difficult to ensure
coverage and effectiveness over larger areas (including walls and
ceilings). They also require
significant time for application and clean up, and will not be practical for
certain surfaces, including electrical equipment.
Gaseous or vapor
technologies are recommended for rooms.
The most widely used are formaldehyde and Vaporized Hydrogen Peroxide
(VHP). Formaldehyde is less used today
due to variable efficacy and significant health and safety concerns. VHP has been widely used and accepted as a
safe alternative. This dry process has
been used for over 10 years in the pharmaceutical industry for room
decontamination and has been validated for use in a government facility for
anthrax decontamination. A simple,
mobile VHP system generates, supplies, controls and neutralizes the dry vapor
into a given area in one stand-alone process.
A low concentration of vapor is required to rapidly kill spores, but is
also very compatible with surfaces, including electronics and painted
surfaces. This technology is one of the
safest and an equally effective method for room decontamination.
STERIS recommends
that HACCP (Hazard Analysis and Critical Control Point) principles should be
applied, since in our opinion no single intervention to this situation will be
adequate to reduce the risk 100%. The
basis of HACCP is to identify and to conduct a hazard (or risk) analysis,
identify critical control points and introduce controls (or interventions) at
these points to reduce contamination from Bacillus
anthracis. It is further clear that
no single technology is applicable or capable of complete decontamination in
every area, but combining technologies and products that have been widely used,
registered and accepted for similar applications in other environments should
be adopted. A logical series of steps
can be taken to maximize the decontamination process:
o
Buildings should be
sealed and contamination mapped. High
and low risk areas should be identified and interventions (either single or
multiple) conducted to reduce infection risks associated with each area.
o
A combination of
methods employed for decontamination:
§ HEPA vacuuming or surface liquid treatment (this in many
cases may be sufficient, depending on the level and scope of contamination)
§ Boxing up of absorptive materials in heavily contaminated
rooms and sterilizing by irradiation, ethylene oxide or terminal destruction.
§ Preparation of area for decontamination and any pretreatment
with liquid sporicidal agents. Products
used should have demonstrated (and registered) broad-spectrum antimicrobial
activity on a surface as well as material compatibility.
§ Room fumigation with sporicidal, registered and material
compatible process. This may be alone
suitable as a preventative measure in room with low or suspected no
contamination where surface decontamination of room contents may be sufficient
depending on the determined risk.
§ Verification of process effectiveness by process monitoring
and documentation
§ Retesting for contamination following decontamination to
confirm effectiveness.
In general, the
remediation plans that are under discussion for anthrax-contaminated buildings
do adopt HACCP principles, identifying the overall problem and recommending
potential methods of remediation.
However, the plan appears to critically rely on chlorine dioxide (ClO2)
gas as the primary disinfecting/sporicidal agent to decontaminate the building,
as well as manual treatment with some foams and liquids, but relying in
particularly on chlorine dioxide and concentrated bleach solutions. A number of alternative registered products
that have been widely used for similar applications do not appear to have been
considered for remediation of biologically contaminated buildings. A review of the remediation plan and
products that could be used are discussed below.
It is important to
note that bacterial spores, such as Bacillus
anthracis spores, are traditionally considered the hardest of all
microorganisms to kill. These spores
are significantly more resistant than normal bacteria, viruses and fungi, and
are difficult to eradicate using standard disinfection or decontamination
methods. Therefore, in cases of
contamination with anthrax spores, decontamination methods are required to show
rapid and consistent sporicidal activity, but also compatibility with the surfaces
being treated. Although a variety of
simple microbiological methods may be used to indicate the possible
effectiveness of a given product against bacterial spores, a specific
registration is required in the United States. Any liquid, vapor or gas product
that is registered with the EPA has shown effectiveness relative to a rigorous,
standardized test, namely the AOAC International Sporicidal method. EPA registered and widely used sporicidal
products should be considered first for decontamination against anthrax spores.
Overall no single method
will be effective for all contaminated areas.
In some cases, certain room contents may not be compatible with, may not
be adequately decontaminated or may even inhibit the effectiveness of the
decontamination method. These items may
include rugs, drapes, personal items, electronic equipment and paper, depending
on the decontamination method used. It
is recommended that these items have specific treatment plans to assure
sporicidal effects. In some instances
treatment in place with certain gaseous products is appropriate, while external
treatment of other items should be employed.
Batch sterilization of isolated items can be performed by widely used
methods including ethylene oxide or irradiation, and returned to the room. Alternatively, following decontamination
certain items may be destroyed by incineration. It may be also prudent to consider the overall cost of
remediating these items compared to the alternative of removing, appropriately
destroying, disposing and replacing them.
STERIS offers more
than 28 years of sterilization experience and 16 sites throughout North America
for irradiation and ETO sterilization.
These facilities have processed more than 60 million cubic feet of
product in the last 12 months, including medical supplies, pharmaceuticals,
food containers, spices and cosmetics.
Irradiation is the process of exposing a product or material to ionizing radiation. Ionizing radiation is energy that exists in the form of waves and is defined by its wavelength. As the wavelength of energy gets shorter, the energy increases. Radiation destroys microorganisms by breaking chemical bonds in biologically important molecules such as DNA, and by creating free radicals and reactive molecules, which chemically attack the microorganism. Irradiation is not the same as radioactive. Many consumer products are sanitized, sterilized or modified by irradiation of the materials. Irradiation methods, their antimicrobial efficacy and applications are widely accepted and used for contract sterilization of wrapped and/or packaged materials and products, including medical devices and foods.
Ethylene oxide (ETO) is a
colorless gas, which is used for the low temperature sterilization. Developed in the 1940’s and 1950’s, ETO is
the primary gas used in hospitals to sterilize reusable items (e.g. medical
devices that contain plastics) that cannot tolerate high sterilization
temperatures. In addition, ETO
sterilization is used for contract sterilization of medical, dental or
veterinary devices that are delivered sterile to a consumer which are sensitive
to steam sterilization or that contain materials incompatible with irradiation
sterilization. The properties and broad-spectrum antimicrobial activity of ETO
have been well described in the literature.
Technologies
available to decontaminate potentially biological contaminated rooms, enclosed
areas, HVAC ductwork, fixed and mobile equipment, and general hard surfaces may
be divided into two categories: liquid and gaseous.
Liquid based
technologies include a variety of products, which include liquids and
foams. In general, most routinely used
disinfectants in households and hospitals demonstrate relatively slow or no
activity against bacterial spores.
Products that are generally not effective include phenols and quaternary
ammonium compound-based products.
Sodium hypochlorite solutions (commonly referred to as ‘bleach’ or
‘chlorine’) can be effective but the following points need to be taken into
consideration. At high concentrations,
bleach will demonstrate some activity against spores; however, it requires long
contact times, for example, purified spores placed directly into freshly
prepared 10% bleach for 15-20 minutes will give an average 3 log reduction of
spores. The effectiveness of bleach is
dramatically reduced by interfering surfaces and organic soils, which also
interact with the available chlorine.
Furthermore, to our knowledge bleach is not a registered sporicide with
the US EPA. A further concern, which is
familiar to all of us, is compatibility with room materials and surfaces;
bleach, like other chlorine-based products can be damaging and even destructive
to a variety of surfaces. Bleach can be
effective over extended exposure times but only on clean, compatible
surfaces.
A variety of other
alternative liquid or foam formulations can also be recommended and maybe more
applicable. These include
oxidizing-agent based formulations, including liquid hydrogen peroxide,
peracetic acid, chlorine dioxide or combinations thereof. We propose that any of these products, with
demonstrated activity against a wide range of microorganisms, including
bacterial spores, demonstrated material compatibility, reasonable safety and
worker health profile, and, if possible, experience of use outside of a laboratory
setting can be used for decontamination of anthrax. An example of an EPA-registered sporicidal product is SPOR-KLENZ,
which is a liquid, synergistic combination of hydrogen peroxide and peracetic
acid, which is widely used and validated for use in the pharmaceutical industry
for its rapid spore killing activity.
A complete dossier of publications, pharmaceutical applications, case
studies, safety and user references are available.
There are also
registered chlorine dioxide-based products, but in general these may be more
damaging on surfaces. Certain foam or
nanoemulsions have also been recommended.
In comparison, these products require significantly longer contact
times, have not been widely used and should also pass the required rigorous antimicrobial
testing and safety profile for EPA registration.
Liquid or foam based
products do have some major limitations.
The most obvious is ensuring correct application of the product over all
contact surfaces, including walls, floors, ceilings and room contents for the
required decontamination time. For
example, these products are not practical for HVAC ductwork. Following decontamination, the product also
needs to be removed and dried prior to normal use. Additionally, surface compatibility with liquid or foam-based
products varies depending on the product. Of greatest concern is the use of
‘wet’ methods relative to electrical equipment (including phones and
computers), as well as other sensitive surfaces. In general, these products are not used or reliable for large,
uncontrolled surface areas.
Gas or vapor-based
technologies can also be considered, which possess acceptable registered spore
killing activity, material compatibility, and safety/worker health
profile. A summary of the advantages
and disadvantages of these methods is attached in Table 1. The most widely used methods for this
purpose are formaldehyde and Vaporized Hydrogen Peroxide (which is referred to
as VHP). Formaldehyde has been
traditionally used for over 100 years, although less frequently today due to
variable efficacy and significant health and safety concerns. Formaldehyde is extremely toxic and
carcinogenic. Further it leaves a white
residue on all surfaces following the decontamination process, which is toxic
and needs to be adequately removed prior to occupancy. From an effectiveness point of view,
decontamination is relatively uncontrolled and usually takes up to 36 hours for
completion. Of greatest significance is
the fact that these rooms need to be humidified before and during
treatment.
For these reasons,
VHP has been used as an effective alternative.
The VHP process is a rapid, dry, controlled technology using a low
concentration of hydrogen peroxide vapor.
Unlike liquid hydrogen peroxide, VHP is rapidly sporicidal at low
concentrations and has been widely used as a validated process for over 10
years for room and enclosure decontamination.
For example, the process is routinely validated for decontamination of
rooms and enclosures using bacterial spores, and in certain selected cases
against anthrax spores, to confirm process effectiveness. A simple, mobile system generates, supplies,
controls and removes VHP from a given environment in a one step process, which
can be monitored, verified and documented.
Being a ‘dry’ method, the process demonstrates excellent compatibility
with a wide range of materials, including paint and electrical equipment like
computers. The VHP process is the
safest method available for vapor /gas decontamination; for example decontamination
may proceed in a sealed room while personnel safely work in adjacent areas and
no clean up is required following the process.
One disadvantage is that the presence of significant cellulosic-based
materials in a given room may elongate the process time and multiple generators
are required to do areas larger than 7500 ft3. A new high capacity VHP delivery and control
system has recently been developed by STERIS to be available as soon as
possible for large-scale room decontamination.
A complete dossier of publications, pharmaceutical applications, case
studies, safety and user references are appended.
Other technologies
that may also be reasonable alternatives to formaldehyde include chlorine
dioxide gas, which has shown good promise in the laboratory setting. Chlorine dioxide gas is rapidly
antimicrobial but has significant material compatibility concerns. It is
undetermined whether this process has been registered with the EPA, apart from
a special exemption for anthrax decontamination. Like formaldehyde, significant humidification of a given area is
required for chlorine dioxide gas to be effective in a room, which needs to be
kept in the dark to prevent breakdown.
Five hundreds times the concentration of chlorine dioxide gas is
required to be present and maintained to be sporicidal relative to vapor
hydrogen peroxide over a longer contact period (8 hours vs. 4 hours). Chlorine dioxide gas has a higher level of
safety risks associated with its use and can also leave a white residue that
requires immediate clean-up following decontamination. These safety risks also apply to its
production, transport and use, as the gas cannot be easily produced on
site. For all these reasons, chlorine
dioxide gas has not widely used or accepted for this application. Attempts to apply a controlled delivery and
removal process based on chlorine dioxide gas for the decontamination of
cleanrooms was unsuccessful in actual pharmaceutical, controlled applications.
STERIS has presented
a rational, detailed plan for decontaminating biologically contaminated areas
and their contents to render them safe for human contact. This plan recommends the use of multiple
technologies for this purpose and recommends the use of EPA-registered
products, which have been widely used for many years and remain the safest,
effective and most practical methods available for room decontamination.
TABLE 1. Comparison of room decontamination methods.
|
Fogging/foaming |
Formaldehyde |
Gaseous chlorine dioxide |
VHP |
|
Variable coverage and distribution |
Variable coverage and distribution |
Depending on mode of delivery, more reliable distribution. Difficult to maintain in gaseous state; can condense. |
Controlled delivery system for more
reliable distribution. Kinetics of
maintaining gaseous state is understood and important for process
effectiveness. |
|
Wet methods |
Requires significant hydration for
antimicrobial efficacy. Essentially wet process |
Requires significant hydration for
antimicrobial efficacy. Essentially wet process |
Dry sterilization method |
|
High concentrations required for
rapid sporicidal activity |
High concentrations required for
rapid sporicidal activity |
500ppm sporicidal over 8 hours (but
needs to be kept in the dark) |
1-2ppm sporicidal at 25oC. 1 log reduction every 1-2 minutes. |
|
Difficult to control and deliver over
large surface areas and ensure residence time for horizontal surfaces |
Significant risks and difficultly
providing to a large area. Overall
better coverage than fogging or foaming |
Significant risks and difficultly
providing to a large area. Overall
better coverage than fogging or foaming |
Controlled delivery contacts all
surfaces. New system available for
large area fumigation |
|
Difficult to validate |
Difficult to validate |
Validation possible. Can be biologically verified. |
Validation and documentation
routinely conducted. Can be
parametrically, biologically and chemically verified. |
|
Concerns over material compatibility;
extent dependant on contact time and antimicrobial agent/formulation. |
Can be damaging to surfaces |
Significantly damaging to a variety
of surfaces, even after single exposures.
Concerns already noted in cleanroom applications |
Broad range material compatibility |
|
Not safe on electrical equipment |
Not safe on electrical equipment |
Not safe on electrical equipment |
Safe on electrical equipment |
|
Efficacy inhibited by presence of
absorbing materials |
Stable, difficult to remove |
Efficacy inhibited by presence of
absorbing materials |
Efficacy inhibited by presence of
absorbing materials |
|
Occupational risks significant, dependant
on antimicrobial used |
Significant occupational and safety
risks |
Occupational risks significant, but
can be minimized |
Occupational risks minimal. Safest for environment and personnel
health |
|
Extended contact times and clean-up
required |
Extended contact times and clean-up
required |
Extended contact times and possible
clean up required. Chlorine
residuals. |
Most rapid method and room ready for
use directly following cycle. No
residuals. |
|
Limited registration, depending on
antimicrobial. |
Limited registration, traditional use |
Unknown registration situation with
process |
Sterilant used in the process
registered with the EPA |
|
Variable efficacy depending on the
product. |
Variable efficacy |
Broad spectrum antimicrobial
activity. |
Broad-spectrum antimicrobial activity,
including independent testing against and validation with B. anthracis. |