HEALTHCARE SELF-STUDY SERIES

PURCHASING EWS N
January 2021 Are you reprocessing
your instrument
The self-study lesson on this central service topic
was developed by STERIS. The lessons are admin-
istered by Endeavor Healthcare Media.

Earn CEUs
After careful study of the lesson, complete the
containers correctly?
examination at the end of this section. Mail the by Pamela Carter
completed test and scoring fee to Healthcare
Purchasing News for grading. We will notify

W
you if you have a passing score of 70 percent
or higher, and you will receive a certificate of
hile conducting a processing cess. This could result in patient exposure
completion within 30 days. Previous lessons are
assessment at a healthcare facil- in the OR, which could lead to an infection.
available at [Link].
ity, I noticed a steady flow of OR In addition, residual procedural chemicals
personnel arriving with used rigid contain- or disinfectants transferred to instruments
Certification ers. Instead of placing them in the queue can injure patient tissue during the proce-
The CBSPD (Certification Board for Sterile for cleaning, they inverted the containers, dure, which can complicate recovery and,
Processing and Distribution) has smacked their sides, wiped them with a in some cases, cause permanent disabilities
pre-approved this in-service for dry towel and placed new filters in them. like blindness.
one (1) contact hour for a period After this process, the containers and their Injuring patients and staff can have large
of five (5) years from the date of lids were stacked on a wire shelf in the ramifications for the facility. For example,
original publication. Successful assembly area. The SPD technician then in addition to the personal consequences
completion of the lesson and post-test must retrieved these rigid containers to place to patients and staff, both the facility and
be documented by facility management and newly cleaned instruments for steriliza- the patient can incur increased costs due
those records maintained by the individual until tion in them. to required additional treatment. Facility
recertification is required. DO NOT SEND LESSON When asked about the process, the tech- reputations can also suffer, which can
OR TEST TO CBSPD. For additional information nician stated, “If the container leaves the reduce the number of elective patients and
regarding certification, contact CBSPD - 148 Main surgical suite before the patient comes into ultimately reduce revenue. Ultimately, the
Street, Suite C-1, Lebanon, NJ 08833 • www. the suite, we don’t send the containment failure to properly follow the IFU can lead
[Link]. devices back to the SPD decontamination to accreditation citings and the potential of
area for cleaning. Instead, we bring the losing reimbursement status.
IAHCSMM (International Association of Health- containers directly to the clean side for Instrument containers serve a critical
care Central instrumentation assembly and packaging. function in the surgical department. Staff
Service Materiel We don’t have the time or space to clean must take the time needed to properly
Management) them and they’re not dirty anyway. We care for them.
has pre-approved this in-service for 1.0 Continuing have been handling our containers this
Education Credits for a period of three years, until way for years!” Guidance for manufacturers
December 4, 2023. The approval number for this Stunned, I turned to the sterile processing A number of organizations provide guid-
lesson is STERIS-HPN 200412. manager, who immediately recognized the ance to packaging manufacturers and to
For more information, direct any questions to problem and knew corrective action was users. The sources most commonly used
Healthcare Purchasing News (941) 259-0832. required to achieve best practices. Not only in the U.S. are the Association for the
were the containers’ instructions for use Advancement of Medical Instrumentation
(IFU) not being followed, but it was clear (AAMI), Association of peri-Operative
that staff didn’t realize they were jeopar- Registered Nurses (AORN), and Interna-
LEARNING OBJECTIVES dizing patients, colleagues and the facility. tional Association of Healthcare Central
Service Materiel Management (IAHC-
1. List the standards and guidance Why clean all containers SMM).
documents for container care every time? There are several different types of
Container systems, which are medical packaging used to maintain the integrity
2. Explain the importance of cleaning devices, protect instrumentation during of sterilized medical devices. These include
and decontaminating rigid and after sterilization. In the course of their peel pouches, woven fabric (muslin, which
containers after every use use, containers may be exposed to envi- is rarely used now), non-woven dispos-
3. Describe the rigid container ronmental and procedural contamination. able wrap, and rigid containers. Packag-
quality inspection process Without proper cleaning and decontamina- ing manufacturers must validate that the
tion, those contaminants can be passed on packaging/containers they offer ensure
to sterile processing staff who work with sterilant penetration into the contained
the containers, potentially causing injury medical devices, and that they prevent
or illness. ingress of microbial contaminants and
Sponsored by: Those same residual contaminants could maintain instrument sterility throughout
contact instruments and shield microbes handling, storage, transport and aseptic
from the disinfection or sterilization pro- presentation in the OR.

28 January 2021 • HEALTHCARE PURCHASING NEWS • [Link]

 Sponsored by SELF-STUDY SERIES
Manufacturers of rigid container systems a. Follow the manufacturer’s written IFU Manual cleaning may involve several
turn for guidance to ANSI/AAMI ST77 b. Include instructions for manual cleaning, steps, and every step must be completed.
Containment devices for reusable medical mechanical cleaning or both The cleaning methods and chemistries
device sterilization. ST77 covers minimum c. Use cleaning agents that don’t damage must be compatible with the rigid con-
labeling and performance requirements the container or its components (seals, tainer system. Abrasive cleaning agents
for rigid sterilization container systems and filter retention plates) can cause corrosion or damage external
for instrument organizers. Rigid container d. Follow accepted practices for decontami- surfaces of the container, which could
manufacturers are responsible for providing nation and employee safety, including cause cracking or degradation. For alumi-
thorough IFU that include safety and effec- wearing of PPE num and plastic containers, a neutral pH
tive use, routine maintenance and inspec- detergent is often recommended to avoid
tions, generalized information on their Cleaning and decontamination the adverse effects of harsher chemistries.
medical device validation testing, weight processes Following manual cleaning, all com-
limitations and design characteristics, and Container systems follow the same clean- ponents of the container system must be
the proper cleaning and decontamination ing and disinfection processes as other rinsed with critical water to remove deter-
modalities to use. For example, Section 4.3.2 reusable medical devices. First, used gent and soil residuals. After rinsing, they
– Decontamination states that containment containers must be disassembled, and all are dried with a soft, clean, lint-free cloth.
devices and their reusable accessories need disposable components discarded. Exter- If any residual soils or cleaning chemistry
to be properly cleaned and decontaminated nal process indicators and locks, single-use are found during visual inspection, the
after each use via manual or automated pro- filters and retention plates, silicone mats cleaning process must be repeated.
cesses per the manufacturer’s IFU. Section and liners are removed, and accessory The disinfection step is necessary to make
4.5.2 – Instructions for use discusses several devices are disassembled per IFU. the containers safe to handle. To assure an
components needed by the end users to effective process, it’s important to use com-
assist with the use of the manufacturer’s patible disinfectants formulated specifi-
containment devices. cally for disinfecting medical devices and
thoroughly removing cleaning chemistries.
Guidance for container users
Users of rigid sterilization container systems Automated cleaning
typically defer to the appropriate guidance Container cleaning can also be automated.
document for each sterilization method Mechanical cleaning equipment cleans,
used at the facility. These include: rinses and thermally disinfects the contain-
• ANSI/AAMI ST79: 2017. Comprehensive ers. When using mechanical equipment to
guide to steam sterilization and sterility clean containers, end users must follow the
assurance in healthcare facilities. system’s IFU and must use the required
• ANSI/AAMI ST41: 2008/(R)2012 Eth- washer accessories to avoid negative out-
ylene oxide sterilization in healthcare comes or a lapse in the processing cycle.
facilities: safety and effectiveness. It’s also important to note that even if an
• ANSI/AAMI ST58:2013 Chemical ster- automated process is being used, contain-
ilization and high-level disinfection in ers must still be disassembled and rinsed
healthcare facilities thoroughly per container IFU before they
• AORN Guideline: Packaging Systems are placed in the automated system for
These guidance documents help SPD man- processing. It may also be necessary to
agers establish standard policies and pro- perform some manual pre-cleaning.
cedures for workflow instructions in their When loading containers into a washer-
departments. The container manufacturers’ disinfector, it’s important to use the racks
IFU also play a vital role in establishing care and other accessories designed specifically
and use instructions. Before purchasing a for processing containers in that system.
new container system, sterile processing Special racks are often needed to assure
management should conduct a pre-purchase thorough cleaning of container systems
evaluation and request written manufac- and their accessories. Some washer-
turer’s IFU to ensure that their department disinfectors use a single rack or basket,
can follow the validated cleaning and while others can have multiple shelves or
decontamination steps required for that baskets. Knowing how to load a rack is
containment system. The validated method essential. Detergent can only clean what
of cleaning containers can be very detailed it reaches. Shadowing, stacking and other
and can include the required cleaning agent, Next, all surfaces and accessories must improper loading techniques block proper
manual cleaning steps, mechanical cleaning be thoroughly pre-cleaned using a proper distribution of water and cleaning chemis-
steps, and disinfection process to use before brush or sponge as directed by the con- tries within the equipment, which prevents
loading instrument sets for sterilization. tainer manufacturer. Remove and rinse cleaning and thorough rinsing.
Both AAMI and AORN state that contain- out any excess debris, soil, and pretreat- Automated systems often have impinge-
ers should be cleaned and disinfected as ment cleaning product with the sponge ment technology that disperses water
soon as possible after each use. They also or brush before the manual or mechanical and cleaning chemistries to all surfaces
advise to: cleaning process. of the containers. Spray arms and nozzles
Self-Study Test Answers: 1. C, 2. D, 3. A, 4. D, 5. A, 6. D, 7. B, 8. D, 9. D, 10. A
Page 30

[Link] • HEALTHCARE PURCHASING NEWS • January 2021 29

SELF-STUDY SERIES Sponsored by
process the containers in use at the facility.
Automated Equipment Depending on the case load, it may also be
Items to Know wise to invest in a small cart washer, which
• Maximum load weights would allow the washer disinfector to be
dedicated to instrumentation and the larger
• Dissasembly and loading instructions cart washer to case carts. This would enable
• Openings face down a better use of space and equipment, and
would support a continuous, more efficient
• Place lids and retainer plates in workflow and throughput for both instru-
loading slots ments and container systems.
• Correct cycle choice
Avoid container woes
include (but are not limited to) gaskets, No one wants to be the person standing in
valves, interior baskets, mating surfaces, front of the auditor explaining why con-
reusable filters, filter retainers and latches. tainers are not being properly processed.
Damaged containers and accessories must Rigid sterilization container systems are
be removed from the use inventory and the Class II medical devices and are cleared
manufacturer needs to be consulted. by the U.S. Food and Drug Administration
As part of a thorough quality system for (FDA) for use. Per FDA and other regula-
containers, a routine preventive mainte- tory guidance, facilities must adhere to the
increase the water pressure to apply force nance schedule should be established and container manufacturers’ IFU, which pro-
that dislodges residual soils. The pro- documented; this assures that tools are vide all the necessary information for cor-
grammed cycle used for containers is typi- in place to detect and/or avoid potential rect use, care, cleaning, inspections, routine
cally labeled “container” or “utensil,” but problems. Containers are not meant to last maintenance, sterilization methods, and
may vary depending on the equipment’s forever, so the container vendor can pro- storage. Facilities must develop policies
cycle names. vide information about the expected useful and a standardized workflow that support
Cart washers come in an array of sizes to life of each type of container. The depart- these instructions, and confirm staff com-
accommodate the needs of various sized ment or purchasing manager should then petency through training, education and
facilities, from small ambulatory surgery budget accordingly for timely replacement regular evaluation of staff performance.
centers to large hospitals. Using a cart of compromised or aging rigid containers. Be the one who finds and corrects any
washer to reprocess containers enables the problems in container processing, before
department to improve its reprocessing Space constraints the auditor does. HPN
workflows by not tying up smaller washer Regulatory inspectors will not allow space
disinfectors with bulky containers. This constraints as an excuse for skipping References
frees up the washer disinfectors to be used reprocessing steps or not fully following 1. ANSI/AAMI ST41: 2008/(R)2012 Ethylene oxide sterilization
in health care facilities: safety and effectiveness. Arlington, VA:
for medical device sets and surgical acces- manufacturers’ IFU. They will expect Association for the Advancement of Medical Instrumentation
sories, which assures greater efficiency and departments to maximize the space they 2. ANSI/AAMI ST58: 2013 Chemical sterilization and high-level
throughput overall. have by performing proper planning disinfection in healthcare facilities. Arlington, VA: Association for
the Advancement of Medical Instrumentation
that includes workflow, case demands
3. ANSI/AAMI ST77: 2013. Containment devices for reusable
Quality inspections and calculated expected throughputs. It’s medical device sterilization. Arlington, VA: Association for the
Inspecting rigid containers after clean- worthwhile to consider automating the Advancement of Medical Instrumentation.
ing and disinfection is as important as container cleaning process. Automation 4. ANSI/AAMI ST79: 2017. Comprehensive guide to steam ster-
ilization and sterility assurance in healthcare facilities. Arlington,
the cleaning itself. Inspection checks for allows consistent proper practice while VA: Association for the Advancement of Medical Instrumentation.
residual soils and cleaning chemistry, wear freeing staff to focus on case sets and other 5. Association of periOperative Registered Nurses: 2020. Guide-
and tear, and mechanical disfunction that instrumentation. lines for Perioperative Practice; Packaging Systems.

could potentially interfere with steriliza- Tight reprocessing spaces, like those in 6. Shaffer HL, Harnish DA, McDonald M., et al. Sterility mainte-
nance study: Dynamic evaluation of sterilized rigid containers and
tion or could fail to maintain sterility of ambulatory surgical centers, require equip- wrapped instrument trays to prevent bacterial ingress. American
the contents. If inspection identifies dam- ment with small footprints. In addition to Journal Infection Control. 2015; 43; 1336-41
aged containers or accessories, they need the washer, it’s important to have the cor-
to be repaired or replaced. Items to inspect rect number and types of racks needed to Pamela Carter, BSN, RN, CNOR, AGTS,
CRCST, CER is a clini-
Container System Inspection Item Examples cal education specialist for
STERIS Corporation. She
GASKET • No fraying, cuts or missing pieces
is a certified perioperative
BASKET • Broken or missing handles registered nurse with over
• Sharp edges or broken wires 27 years of experience in a
variety of specialties includ-
MATING SURFACES • No dents, chips, cracks
ing nursing management,
• Filter retainer fits with no gaps
surgical nursing, sterile processing education
REUSABLE FILTERS • Within its use limit and OR/SPD infection prevention and quality.
In addition, Pamela has written articles for
LATCHES • No missing components
HPN and AORN, and is an active member of
• Securely attached
AAMI, AORN, APIC, ASCA, ASQ, IAHC-
• Lid secures with even latch pressure
SMM, and SGNA.

30 January 2021 • HEALTHCARE PURCHASING NEWS • [Link]

 Sponsored by SELF-STUDY SERIES
CONTINUING EDUCATION TEST • JANUARY 2021

Are you reprocessing your instrument containers correctly?

Circle the one correct answer:

1. Which is a quality standard that provides 5. What is removed from containers during the 9. Why is inspection important?
guidance to manufacturers for rigid container initial rinse? A. It finds residual soils
systems? A. Gross soil and residual pretreatment chemistry B. It identifies containers needing repair or
A. ANSI/AAMI ST79 B. Bioburden and cleaning chemistries replacement
B. ANSI/AAMI ST58 C. Saline and disinfectants C. It discovers mechanical disfunction that could
C. ANSI/AAMI ST77 D. Bone cement and sterilants potentially interfere with sterilization
D. SGNA 6. Improper container loading techniques can: D. All of the above
2. Which is a quality standard that provides A. Block proper distribution of water and clean- 10. Rigid sterilization container systems are Class
guidance for users of rigid container systems? ing chemistries II medical devices cleared by the FDA for use,
A. ANSI/AAMI ST91 B. Enhance cleaning so facilities must adhere to the container
B. ANSI/AAMI TIR31 C. Impede thorough rinsing manufacturers’ IFU.
C. ANSI/AAMI ST90 D. a and c A. True
D. ANSI/AAMI ST79 7. Cart washers cannot clean and thermally B. False
3. Which is a method used to clean containers? disinfect containers.
A. Mechanical cleaning equipment A. True
B. Paper towels B. False
C. Metal brush 8. Using a cart washer to reprocess containers
D. Detergent enables a department to:
4. Why do all containers need to be cleaned? A. Eliminate the need for thermal disinfection
A. Container manufacturer requirement B. Allow smaller washer disinfectors to be used
B. Standards and guidance requirement specifically for surgical instruments
C. Contamination can occur at any time C. Help achieve greater efficiency and through-
D. All of the above put for containers and instruments
D. b and c

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STERIS-HPN 200412. Detach exam and return to:
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