HEALTHCARE
`
`PURCHASING NEWS
`
`July 2008
`The self-study lesson on this central service topic was
`developed by STERIS. The lessons are administered by
`KSR Publishing, Inc.
`
`Earn CEUs
`The series can assist readers in maintaining their CS
`certification. After careful study of the lesson, complete
`the examination at the end of this section. Mail the
`complete examination and scoring fee to Healthcare
`Purchasing News for grading. We will notify you if you
`have a passing score of 70 percent or higher, and you
`will receive a certificate of completion within 30 days.
`Previous lessons are available on the Internet at
`wwwhpnonline.com
`
`Certification
`The CBS PD ( Certification Board for Sterile Processing
`and Distribution) has pre-approved this in-service for
`one (1) contact hour for a period of five (5) years from
`the date of original publication. Successful completion
`of the lesson and post test must be documented by
`facility management and those records maintained by
`the individual until re-certification is required. DO NOT
`SEND LESSON OR TEST TO CBSPD.
`
`For additional information regarding certification con(cid:173)
`tact CBS PD - 2 Industrial Park Road, Suite 3, Alpha, NJ
`08865. For more information Direct any questions to
`Healthcare Purchasing Ne'NS (941) 927-9345, ext 202.
`
`Leaming
`Objectives
`1. Compare the uses of various
`low-temperature sterilization
`processes for packaged devices
`
`2. Discuss the newest healthcare
`technology - vaporized hydrogen
`peroxide (VHP) - and its history
`and various applications
`
`3. Understand the benefits and
`drawbacks of available low(cid:173)
`temperature sterilization systems
`in order to make educated decisions
`for the readers' facilities
`
`Sponsored by:
`
`ST ~ I s·
`::-::: -
`
`and
`
`STER I s·
`
`Sponsored by
`
`SELf-STUDY SERIES
`The lowdown on low
`temperature sterilization for
`packaged devices
`
`by Pamela Carter, RN, BSN, CNOR, and Michael Wright
`
`W ith so many surgeries, so many
`
`delicate instruments, so many
`sterilization options and so
`little time, even the most seasoned sterile
`processing manager's head can be left
`spinning. The intent of this self study
`guide is to improve your understanding
`of the available low-temperature steriliza(cid:173)
`tion technologies for packaged devices
`(including a very new low-temperature
`alternative) by comparing their capabili(cid:173)
`ties and challenges. Once armed with this
`information, you can potentially simplify
`your processing and equipment decisions.
`With so many low-temperature sterilizers
`to choose from, how can you narrow down your
`choices?
`All the systems and methods we will
`discuss here are FDA cleared technologies,
`so they are all effective at sterilizing pack(cid:173)
`aged devices. Each modality, however,
`has its own costs and benefits, and should
`be weighed based on the goals of your
`sterile processing department Unfortu(cid:173)
`nately, there is no "silver bullet" that pro(cid:173)
`vides the perfect combination of a fast
`cycle time and a broad range of material
`compatibility. According to the Interna(cid:173)
`tional Association of Healthcare Central
`Service Materiel Management, sterile pro(cid:173)
`cessing professionals must consider eight
`basic requirements when evaluating low(cid:173)
`temperature sterilization systems; effec(cid:173)
`tiveness, safety, monitoring, quality
`assurance, sterilant penetration, material
`compatibility, adaptability and approval.
`In this self-study article, we will briefly
`discuss the sterilization parameters and
`special requirements for sterilization, and
`compare the "pros" and "cons" of each
`technology.
`
`A day in the life of a packaged
`device
`Sterile processing departments (SPDs)
`must process heat- and moisture-sensitive
`instruments for same-day, next-day and
`emergency uses. They typically sterilize
`
`packaged delicate medical devices during
`the day for re-use later in the daily sched(cid:173)
`ule, and at the end of each day, to store in
`preparation for the first surgical cases
`scheduled the following morning. They
`also proactively sterilize packaged sets
`and devices that can wait in sterile stor(cid:173)
`age for unplanned emergencies. Until
`2008, there were three options for these
`purposes; ethylene oxide (EO), gas
`plasma, and ozone systems.
`
`EO gas sterilization
`Ethylene oxide was first used in the 1950s
`to sterilize heat and moisture-sensitive
`medical devices. Today, EO systems are
`manufactured by 3M and STERIS Corpo(cid:173)
`ration, among others. EO is a colorless gas
`that readily and rapidly permeates medi(cid:173)
`cal devices, and is sporicidal and non-cor(cid:173)
`rosive. However, it is also flammable and
`combustible at high concentrations and
`high volumes. Today, 100% EO is used as
`an alternative to the blended mixtures as
`it does not contain environmentally haz(cid:173)
`ardous compounds (hydrochloroflouro(cid:173)
`carbons or HCFCs) . 100% EO does not
`contribute to ozone depletion.
`EO is a reactive chemical that is an alky(cid:173)
`lating agent It contacts molecules in the
`presence of moisture, altering their size
`and shape. As a result, the molecules be(cid:173)
`come unable to perform necessary func(cid:173)
`tions, and this leads to the organism's
`death. 1
`Sterilization parameters: The important
`variables that ensure efficient sterilization
`with EO are time, temperature, EO con(cid:173)
`centration, and a relative humidity of at
`least 35 to 85%. These variables are con(cid:173)
`trolled during the sterilization process in
`the conditioning, sterilization and aera(cid:173)
`tion phases of an automated system.
`Special requirements: Effective Decem(cid:173)
`ber 29, 2008, 2 the new record-keeping by
`Environmental Protection Agency stan(cid:173)
`dards requires that hospitals without an
`air pollution control device (catalytic con-
`
`42 July 2008 · HEALTHCARE PURCHASING NEWS
`
`· www.hpnonline.com
`
`Regeneron Exhibit 1046.001
`
`

`

`verter or acid-water scrubber) record that
`a full load was run and if not, provide a
`statement indicating that it was "medi(cid:173)
`cally necessary" (air pollution control
`equipment reduces the quantity of EO
`from sterilization and aeration processes).
`In addition, aeration of toxic EO is re(cid:173)
`quired to remove it from instruments and
`devices for use or storage; environmental
`and personnel monitoring (equipment
`and badges) is required to determine the
`level of EO exposure; and record-keeping
`of each cycle is required.
`Pros of EO: Ethylene oxide sterilization
`offers superior penetration and compat(cid:173)
`ibility for devices including flexible
`endoscopes, has no lumen restrictions and
`no packaging restrictions, and offers
`broad compatibility with device compo(cid:173)
`nent and other materials.
`Cons of EO: The process requires pro(cid:173)
`longed, lengthy aeration cycles, environ(cid:173)
`mental and personnel monitoring, and a
`new record-keeping protocol per EPA; the
`cost of EO blend mixtures is high, there
`are specific installation requirements, and
`EO is toxic and flammable.
`
`to 75 minutes. Cycle times are dependent
`upon model type, device design, materi(cid:173)
`als types and load size.
`Special requirements: None.
`Pros of gas plasma: Gas plasma systems
`have rapid cycle times, and require no
`aeration and no personnel monitors. They
`have non-toxic by-products (water and
`oxygen) and are compatible with a wide
`variety of materials and devices includ(cid:173)
`ing limited single-channel flexible surgi(cid:173)
`cal scopes, instruments processed with
`gas plasma have a long shelf life, and the
`H202 sterilant cassette is self-contained.
`Cons of gas plasma: The process is ex(cid:173)
`tremely moisture-sensitive (the cycle may
`abort if excess moisture is present), cer(cid:173)
`tain models have limited capacity, and
`specific flexible scope materials may not
`be compatible with the process. High H202
`concentrations (up to 95% on certain mod(cid:173)
`els) are necessary, and there are special
`loading considerations (avoid contact
`with chamber walls, not too many metal
`instruments) due to the plasma coil. The
`process also has some penetration limita(cid:173)
`tions (follow lumen diameter and length
`guidelines). In addition, mechanical prob(cid:173)
`lems have been documented that can lead
`to H202 residuals within the load or the
`release of H202 from the chamber.1
`
`Gas plasma sterilization
`The gas plasma process has been in exist(cid:173)
`ence since the early 1990s and has become
`popular due to its short cycle times, which
`Ozone sterilization
`facilitate faster instrument turnaround.
`Low-temperature hydrogen peroxide gas
`Ozone is an effective low temperature
`plasma sterilization uses a combination of
`sterilization method. It requires no ster(cid:173)
`ilant purchase because the system itself
`hydrogen peroxide vapor and plasma.
`generates 0 3 using only water and oxy(cid:173)
`Hydrogen peroxide vapor is generated
`from 59% liquid peroxide. Some systems
`gen (this type of sterilizer is available from
`generate a metered dosage at a predeter(cid:173)
`TS03, Inc.). Ozone is diffused through the
`
`mined volume onto a heated vaporizer
`load by a vacuum/humidification process
`and introduce it into the sterilization
`and organisms are killed by oxidation,
`chamber, while others use a single-unit
`which attacks an organism's structure and
`dose cartridge that is punctured and
`makes it non-viable. At the end of each
`pulled into the evacuated chamber dur(cid:173)
`cycle, ozone is exhausted through a cata(cid:173)
`ing the sterilization process (this process
`lytic converter. The total cycle time is 4 to
`is used in STERRAD® sterilizers). Some of
`5 hours.
`these systems condense water from the
`Sterilization parameters: The key vari(cid:173)
`sterilant, which results in a hydrogen per(cid:173)
`ables for sterilization are time, tempera(cid:173)
`ture, 0 3 concentration, relative humidity
`oxide concentration of approximately
`95% (please see sidebar). At the comple(cid:173)
`of at least 85 to 100% to precondition the
`tion of the cycle, the by-products are va(cid:173)
`load, and a sterilization temperature
`porized water and oxygen.
`maintained at 30 to 36 degrees Celsius.
`Sterilization parameters: The important
`Approximately 700 to 800 liters of oxygen
`variables that ensure sterilization are time,
`and few milliliters of water are used dur(cid:173)
`temperature, H 202 concentration, and
`ing the processing.
`Special requirements: Systems require
`vacuum level. The process phases include
`a leak test, conditioning, sterilization and
`medical grade oxygen and deionized
`aeration, with a cycle time variance of 28
`water.
`3 ·o~ '!) '6 'a '8 '3 'L '3 ·9 'V ·s 'a ·17 'a 'E '3 ·z 'V -~
`
`Sponsored by STER I S SELf-STLJDY SERIES
`
`Pros of ozone: Cycles are inexpensive
`and there is no sterilant to handle. No
`venting or personnel monitors are re(cid:173)
`quired, and the systems produce non(cid:173)
`toxic by-products and have a large
`processing capacity.
`Cons of ozone: The cycles are long and
`there are some penetration limitations
`(you must follow lumen diameter and
`length guidelines). There are safety and
`ergonomic concerns because of the large
`oxygen tanks supplying the system. In ad(cid:173)
`dition, ozone processes have no flexible
`scope sterilization claim, and not all de(cid:173)
`vice and packaging materials are compat(cid:173)
`ible with the process.
`
`New kid on the sterile
`processing block - VHP
`sterilization
`Vaporized hydrogen peroxide (VHP) technol(cid:173)
`ogy was originally developed by STERIS
`Corporation and introduced in the early
`1990s. It soon became a "gold standard"
`for pharmaceutical sterilization, in criti(cid:173)
`cal environments where drugs are pro(cid:173)
`duced and packaged. The applications of
`VHP have extended beyond pharmaceu(cid:173)
`tical production to include the steriliza(cid:173)
`tion of medical devices and room surfaces
`(research labs, etc.). More recently, the
`technology has been used to decontami(cid:173)
`nate entire buildings. During the anthrax
`attacks in the United States in 2002, VHP
`played an integral part in the clean-up
`effort. The systems were used to fumigate
`areas contaminated with the toxin. It was
`also used after the flood waters of Hurri(cid:173)
`cane Katrina receded in New Orleans and
`in hospitals abroad, to limit MRSA out(cid:173)
`breaks. Two new VHP systems have been
`introduced within the last 1 1/2 years for
`use in healthcare facilities; one for room
`sterilization and one for processing pack(cid:173)
`aged, heat and moisture-sensitive instru(cid:173)
`ments for terminal sterilization and
`storage.
`VHP is created by dropping liquid hy(cid:173)
`drogen peroxide onto a hot surface, in(cid:173)
`stantaneously transforming it into a dry
`vapor form. VHP is extremely effective
`as an antimicrobial (bactericidal, fungi(cid:173)
`cidal, virucidal and sporicidal) agent. In
`contrast, liquid H 202 requires a much
`higher concentration (370mg/L) than
`gaseous Hp2 (1-2mg/L) to achieve the
`same 1-log reduction of living organisms
`See SELF-STUDY on page 44
`
`:sJaMSUV isau1as
`
`www.hpnonline.com • HEALTHCARE PURCHASING NEWS · July 2008 43
`
`Regeneron Exhibit 1046.002
`
`

`

`SELf-STUDY SERIES
`
`Sponsored by
`
`STER Is·
`
`59%
`Hydrogen
`Peroxide
`(Liquid)
`
`Hydrogen
`Peroxide
`(vapor)
`
`H
`
`0
`
`0
`
`H
`
`Vaporization
`
`Bactericidal, virucidal,
`fungicidal and sporicidal at
`low concentrations
`
`H 0
`
`H
`
`+
`
`0
`
`0
`
`Water and
`oxygen
`
`Self-Study from page 43
`(D-value). Since VHP is injected under
`vacuum conditions to sterilize devices,
`the vapor easily permeates the packag(cid:173)
`ing and the load, contacting all surfaces
`and penetrating hard-to-reach lumens.
`The newest VHP-based low-temperature
`sterilization system (V-PRO'M 1 Low
`Temperature Sterilization System) offers
`a more productive, less process-sensitive
`alternative to EO, gas plasma, and ozone
`systems.
`This system's VHP automated cycle is
`20 minutes faster than some gas plasma
`cycles, three to four hours faster than the
`ozone process, and so much faster than
`the EO process that up to 16 additional
`loads can be processed each day.
`Aborted cycles have become a chal(cid:173)
`lenge for the SPD because they result in
`repackaging, reloading and reprocess(cid:173)
`ing of the devices, and they cost the de(cid:173)
`partment in additional sterilant and
`staff time. Aborted cycles can also im(cid:173)
`pact surgical suite productivity in the
`form of delayed or cancelled procedures
`and a disrupted OR schedule. Aborted
`cycles can often be an issue with gas
`plasma systems, which are highly sen(cid:173)
`sitive to the way in which contents are
`loaded into the chamber, to residual
`moisture on the instruments, and to the
`amount of metal contained in the instru(cid:173)
`ment packs. Any of these factors may
`cause unnecessary cycle aborts. In con(cid:173)
`trast, the VHP sterilization process is not
`hypersensitive to load contents and po(cid:173)
`sitioning, and the cycle includes a pre(cid:173)
`conditioning phase that automatically
`detects and removes excess moisture,
`which helps to alleviate aborted cycles
`and their frustrating consequences.
`
`Sterilization parameters: Important
`variables to ensure sterilization are time,
`temperature, H 202 concentration and
`vacuum level. The process phases include
`conditioning, sterilization and aeration for
`a short cycle time (55 minutes).
`Special requirements: None
`Pros of VHP: The system offers a rapid
`cycle time and a larger processing capac(cid:173)
`ity than other systems. No plasma is nec(cid:173)
`essary for this process. A pre-conditioning
`phase detects and removes excess mois(cid:173)
`ture, and no aeration or personnel moni(cid:173)
`tors are required. The by-products of the
`process are non-toxic (water and oxygen),
`and the process is compatible with many
`devices. Instrumentation processed with
`VHP has a long shelf life, and the sterilant
`is generated from a closed H202 (Vaprox®)
`cartridge.
`Cons of VHP: There are penetration limi(cid:173)
`tations that require adherence to the
`system's lumen diameter and length guide(cid:173)
`lines, and the VHP process has no flexible
`scope sterilization claim. In addition, VHP
`should not be used to sterilize cellulose ma(cid:173)
`terials (disposable towels, paper, etc.).
`
`Select the best processes and
`systems for your needs
`In a busy SPD, even modest improve(cid:173)
`ments to processing volume and time can
`make a huge difference in the depart(cid:173)
`ment's productivity each day. Specifi(cid:173)
`cally, variables such as cycle time and
`aborted cycles can affect the total number
`of loads that can be successfully sterilized
`each day, so both should be reduced as
`much as possible.
`Patient and staff safety is another criti(cid:173)
`cal factor to consider when selecting ster(cid:173)
`ilizers. If exposure to potentially harmful
`
`44 July 2008 · HEALTHCARE PURCHASING NEWS
`
`· www.hpnonline.com
`
`agents can be minimized or avoided, the
`risks to the facility and its occupants can
`be reduced as well. At the same time, the
`facility must have technologies in place
`that provide them with the capability to
`process every material and device they re(cid:173)
`use, since contaminated instruments also
`pose a risk to patients.
`Achieving effective, safe and productive
`sterilization of packaged heat-sensitive re(cid:173)
`usable devices requires a balancing act.
`Sterile processing decision-makers should
`consider the sterilization options available
`in the marketplace and combine them in
`a way that best meets their hospital's cur(cid:173)
`rent and future needs. HPN
`
`Pamela Carter, RN, BSN, CNOR is a clinical
`education specialist with STERZS Corporation.
`Michael Wright is a product manager for
`STERZS.
`
`STERRAD® is a registered trademark of Advanced Sterilization
`Products, a Johnson & Johnson company.
`
`Vaprox® and V-PRO'~ are registered trademarks of STERIS Corpo(cid:173)
`ration.
`
`References
`
`1. Central Service Technical Manual, 7111 Edition, IAHCSMM.
`
`2. Federal Register/Vol. 72, No.248/Friday, December 28,
`2007 /Rules and Regulations, Environmental Protection Agency.
`40 CFR Part 63: National Emission Standards for Hospital Eth(cid:173)
`ylene Oxide Sterilizers. Accessed: http:f / www.epa.gov/EPA(cid:173)
`AI R/2007 /December/Day-28/ a2 52 33. pdf
`
`3. Standards, Recommended Practices, and Guidelines, 2008,
`AORN, Denver, p. 581-585.
`
`4. McDonnell, GE, Antisepsis, Disinfection, and Sterilization,
`Types, Action, and Resistance, 2007, ASM Press; W ashing(cid:173)
`ton, DC.
`
`5. Reichert, M. and Young J., Sterilization Technology for the
`Health Care Facility, 1993, Aspen Publishers, Inc.,
`Gaithersburg, MD.
`
`Benefits of hydrogen peroxide
`Chances are you have a brown bottle of 3%
`hydrogen peroxide (H 20) in your medicine cabi(cid:173)
`net at home to clean scrapes or wounds. Be(cid:173)
`sides its traditional use as an antiseptic, H202
`has also been used in various applications
`around the world as a preservative, disinfec(cid:173)
`tant, fumigant and sterilant. While it is a strong
`oxidizing agent, it has very effective antimi(cid:173)
`crobial activity without being overly aggressive
`on surfaces. In its normal form at room tem(cid:173)
`perature, it's a colorless, odorless and stable
`liquid usually provided at concentrations less
`than 60%. It is available in concentrations from
`3% to 90%, but at concentrations above 60%
`it's considered to be more reactive and un(cid:173)
`stable, and may pose a health hazard. HA is
`environmentally friendly, since it breaks down
`into water and oxygen very easily.
`
`Regeneron Exhibit 1046.003
`
`

`

`CONTINUING EDUCATION TEST • JULY 2008
`
`The lowdown on low temperature sterilization
`for packaged devices
`
`1. VHP technology has been in existence for
`nearly 20 years and used in a variety of
`applications, including the sterilization of
`packaged medical devices and room
`surfaces.
`a. True
`b. False
`
`2. Which of the following parameters must
`be met to achieve sterilization using VHP
`technology?
`a. Time
`b. Temperature
`c. Vacuum
`d. Hydrogen peroxide concentration
`e. All of the above
`
`3. Which of the following factor(s)
`increase(s) the chance for an aborted
`cycle in gas plasma processes?
`a. Loading the chamber - contact with
`sterilizer walls
`b. Residual moisture on instruments
`c. The amount of metal contained in
`instrument packs
`d. All of the above
`
`Circle the one correct answer:
`
`4. VHP uses alkylation to deactivate harmful
`microorganisms.
`a. True
`b. False
`
`8. A large volume of hydrogen peroxide is
`necessary to create VHP.
`a. True
`b. False
`
`5. The EPA has mandated that all EO sterilizers
`must use an air pollution control device or
`document all loads.
`a. True
`b. False
`
`6. The benefits of EO sterilization include:
`a. No lumen restrictions
`b. Superior Sterilant penetration
`c. Flexible endoscope compatibility
`d. No monitoring required
`e. a, band c
`f. All of the above
`
`7. Which of the following is required for ozone
`sterilization?
`a. Oxygen
`b. Water
`C. Hydrogen Peroxide
`d. Nitrogen
`e. a and b
`f. c and d
`g. a and c
`
`9. Which of the following is the greatest benefit
`of EO sterilization?
`a. Cycle Time
`b. Penetration
`c. Material Compatibility
`d. No personnel monitoring
`e. a and b
`f. c and d
`g. band c
`
`10. Which of the following technologies is
`cleared for use in the SPD to sterilize
`packaged devices?
`a. EO
`b. Gas Plasma
`c. Ozone
`d. VHP
`e. All of the above
`
`CONTINUING EDUCATION TEST · JULY 2008
`
`Presented by
`HEALTHCARE
`
`PURCHASING N E W S
`
`Sponsored by
`STER IS"
`= = ~
`
`Request for Scoring
`• I have enclosed the scoring fee
`of $10. (Payable to KSR Publish(cid:173)
`ing, Inc. We regret that no refunds
`can be given. Multiple submissions
`may be paid with a single check.)
`
`Detach exam and return to:
`Continuing Education Division
`KSR Publishing, Inc.
`2477 Stickney Point Road, Suite 315B
`Sarasota, FL 34231
`PH: 941-927-9345 Fax: 941-927-9588
`
`Please print or type. Return this page only.
`Name
`Title
`Hospital Name
`Mailing Address
`Apt/Suite
`City, State, Zip
`Daytime Phone
`E-mail
`
`www.hpnonline.com • HEALTHCARE PURCHASING NEWS · July 2008 45
`
`Regeneron Exhibit 1046.004
`
`