34 PROCESS NOVEMBER / DECEMBER 2021 www.iahcsmm.

org
 CIS SELF-STUDY LESSON PLAN
Lesson No. CIS 288 (Instrument Continuing Education - ICE)
Sponsored by:

Why Surgical Instrument

Grade Is Important
BY PAUL MURPHY, PRODUCT MANAGER, CENTRAL STERILE PRODUCTS
AND SERVICES—AESCULAP INC.

Certified Instrument Specialist (CIS) lessons

provide members with ongoing education in
LEARNING OBJECTIVES
the complex and ever-changing area of surgical
instrument care and handling. These lessons are 1. Define surgical instrument grades
designed for CIS technicians, but can be of value 2. Understand how surgical instruments are made/manufactured
to any CRCST technician who works with surgical 3. Determine how to optimize instrument selection for one’s facility
instrumentation.

I
Earn Continuing Education Credits

Online: Visit www.iahcsmm.org for n the Operating Room (OR), recognized, and new materials that
online grading. the use of high-quality surgical could withstand sterilization were
instruments is a critical factor needed for instrumentation. Stainless
By mail: For written grading of individual lessons,
send completed quiz and $15 to: in providing safe patient care steel was developed in the 1900s,
Purdue Online – Central Service and protecting the facility’s surgical providing material for instruments
Young Hall, Room 405 instrument inventory investment. that could withstand the challenges of
155 S. Grant St.
West Lafayette, IN 47907 Surgical instruments must be able repeated cleaning and sterilization and
to function accurately and safely making the manufacturing of high-
Subscription series: Purdue Extended Campus throughout a surgical procedure, and quality surgical instruments possible.
offers an annual mail-in or online self-study lesson
subscription for $75 (six specific lessons worth they also must be able to withstand The technology of modern instrument
2 points each toward CIS recertification of repeated reprocessing and sterilization. manufacturing developed in Europe.
6 hours). Call 765.494.0959 for details. Evidence of surgical instruments Master craftsman-level expertise
Scoring: Each quiz with a passing score is worth dates back as far as 2500 BC. Early and training for manufacturing
2 contact hours toward your CIS recertification (6 materials available to make instruments surgical instruments are still found
hours) or CRCST recertification (12 hours). included flints and animal teeth, which predominately in one area of Germany.
More information: IAHCSMM provides online were durable and able to be sharpened. Today, various steps in the manufacture
grading service for any of the Lesson Plan One military surgeon who advanced of instruments are performed in many
varieties. Purdue University provides grading instruments and techniques during the areas of the world. Identifying where
services ONLY for CRCST and CIS lessons. Direct
questions about online grading to IAHCSMM 1500s focused on treating war wounds, all the manufacturing steps are done,
at 312.440.0078. Questions about written including using a hemostat-type the involvement of master craftsman
grading are answered by Purdue University at instrument. In the late 1700s, surgeons in the manufacturing process, and the
765.494.0959.
created and designed instruments as quality of raw materials is the challenge
surgery evolved. Individual artisans healthcare personnel face.
developed expertise in making one Quality instrument manufacturing
specific instrument type, which includes quality controls when selecting
marked the beginning of the concept of raw materials and the type of stainless
instrument craftsmanship and expertise steel in addition to end-product
that remains today. quality control. Greater attention to
Around the turn of the 20th century, quality throughout the design and
the importance of sterilization was manufacturing process translates

www.iahcsmm.org NOVEMBER / DECEMBER 2021 PROCESS 35

 CIS SELF-STUDY LESSON PLAN

into greater instrument performance and carbon. There are more than 100 reusable stainless steel instruments.
and longevity. Understanding the different types of stainless steel, which Mid-grade instruments typically have
critical quality aspects of instrument are grouped by the American Iron and a greater variation in the pattern (e.g.,
manufacturing and labeling is key Steel Institute into sub-types based on tip length, jaw width) but are of similar
for healthcare personnel involved in mechanical properties and composition. design. For mid-grade instruments,
product selection and care. Several types of stainless steel are the specifications for steel quality and
used to produce surgical instruments; manufacturing are less stringent. These
Objective 1: Define surgical instrument however, the two main types of are: 300 differences can result in an instrument
grades series and 400 series. with less precision and durability.
In the U.S., there is no universally The 400 series stainless steel is Floor-grade instruments are generally
accepted system or terminology to hard and used for instruments that intended for single/one-time use.
define surgical instrument quality. require a cutting surface. Examples of Examples include suture kits used in the
All stainless steel instruments may instruments made of 400 series stainless Emergency Department. Instruments
appear to be equivalent in quality when steel are scissors, osteotomes, chisels in this category are made from forgings
new; however, there are differences and rongeurs. of lower-grade metals and have a
in the quality of stainless steel and The 300 series stainless steel is not as wide pattern variation. As a result, the
the manufacturing process. These hard as 400 series; it is more malleable. precision of the instruments’ key features
differences determine the “grade” of the Examples of instruments made of 300 is less exact than those of a higher
surgical instrument. Three commonly series stainless steel include retractors, quality. New floor-grade instruments
seen grades are: cannulas and rib spreaders. should be examined for nicks or burrs
1. Premium OR-grade instruments The “recipe” or combination of or tips or jaws that do not meet (if any of
2. Mid-grade OR instruments materials is determined by the attributes these issues are found during inspection,
3. Floor-grade instruments needed for the instrument type. the instrument should not be used).
Floor-grade instruments may bend or
The overall quality of any surgical Instrument Grades break easily and are at increased risk for
instrument is determined based Premium OR-grade instruments differ staining and corrosion. Using floor-grade
upon a combination of the quality from other grades of instruments in the instruments to perform delicate surgical
of craftsmanship used during the following ways: procedures may result in unintended
manufacturing process and the type • Less pattern variation (e.g., jaw width, tissue damage that may require repair
and quality of metal composition, tip length) and increase the risk for impaired
particularly the grade of stainless steel. • Greater quality control (QC) of raw healing, infection or other negative
materials patient outcomes.
Grades of Stainless Steel • QC inspections performed at several Floor-grade instruments should not
Approximately 85% of all surgical points during the manufacturing be mixed with premium OR-grade
instruments are made from stainless process instruments and should not be placed in
steel. The physical properties of the steel an ultrasonic cleaner. When instruments
vary in: This classification results in more of different grades are processed together,
• Quality uniformity by instrument type and is instrument corrosion can spread to other
• Flexibility less prone to failure after repeated use. instruments. Instruments with corrosion
• Temper With proper care, handling, cleaning, present should never be used for surgical
• Hardness and sterilization, premium OR-grade procedures.
• Malleability instruments can provide years of Key attributes for all three surgical
• Corrosion resistance useful life. instrument grades include performance
Mid-grade instruments (e.g., towel expectations, price points and useful
For example, sharp instruments require clamps, basins and blade handles) are life. There are no nationwide or
more hardness (higher carbon content), comprised of lower-quality stainless international standards to clearly define
while other instruments (such as steel than premium OR-grade the grades of surgical instruments, so it
clamps) require less hardness. Stainless instruments and were developed to may be challenging for those using and/
steel is an alloy of iron, chromium meet hospitals’ needs for less expensive, or purchasing surgical instruments to

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 CIS SELF-STUDY LESSON PLAN

Figure 1. Grades of Surgical Instruments: Common Market Understanding

Figure 2. Examples of Country of Origin

understand the difference that surgical in Germany” if the forging is done Three principal prerequisites
instrument grades have on patient care in Germany, even if the remaining for producing premium OR-grade
(see Figure 1). production steps are done outside instruments are:
Surgical instruments are labeled with of Germany. Figure 2 lists several • Use of high-quality stainless steel
a country of origin, which is defined examples of country of origin labeling. • Following or exceeding DIN standards
by U.S. customs law as “the country of for pattern consistency
manufacture, production or growth of Objective 2. Understand how surgical • Incorporating defined QC testing
any article of foreign origin entering the instruments are made/manufactured during manufacturing
United States.” Further work or material Quality processes for manufacturing
added to an article in another country surgical instruments are provided Like surgical instruments, stainless
must effect a substantial transformation by Deutsches Institut für Normung steel is manufactured in many parts
in order to render such other country (DIN), which is the German Institute of the world. Quality is determined by
the “country of origin.” Based on this for Standardization. Master craftsmen the manufacturing process and end
definition, the country of origin for generally follow DIN standards when product rather than the part of the world
surgical instruments is where forging producing surgical instruments. where it is produced. Stainless steel is
takes place (this is the second step in the Manufacturers of premium OR- the raw material used for most surgical
manufacturing process). For example, grade instruments may exceed the instruments, and the raw materials are the
an instrument can be stamped “Made requirements of DIN. first step in the production of premium

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 CIS SELF-STUDY LESSON PLAN

OR-grade surgical instruments. therefore, the forged parts must undergo Step 9: Worker Self-Testing. Quality
Surgical instrument pattern an annealing process for machining. instrument manufacturers require
consistency begins with master drawings intermediate tests of all required
and a master pattern for each individual Step 5: Drilling. The joint bore is then instrument manufacturing steps.
instrument (e.g., catalog number or drilled into the annealed part. Shape
ID) that is cataloged and stored. Master and dimensional checks monitor the Step 10: Cleaning. Cleaning in quality
craftsmen use both drawings and pattern proper completion of this and all other instrument manufacturing is done with
samples to ensure pattern consistency processing steps. two cleaning units. Cleaning Unit I is
when working on fine specialty used before hardening and washes out
instruments. Today’s technology is oil, grease and foreign matter. Cleaning
computer-supported for mass production Unit II performs the final cleaning, which
of general instruments; however, master takes place after instrument production is
craftsmen are still needed. Combining Step 6: Jaw Tooth Milling. The annealed completed.
modern manufacturing technology parts are then milled based on the
with the expertise of master craftsmen requirements of the final instrument Step 11: Vacuum Hardening. Vacuum
supports the quality demanded by today’s design. The individual parts comprising hardening improves an instrument’s
surgical procedures. a two-part instrument are inseparably hardness, toughness and wear
The numerous steps of the quality connected at the joint by pressing them characteristics, increasing corrosion
instrument manufacturing process together and then riveting. resistance.
are outlined below. For example, a
hemostat requires 15 major steps in the Step 12: Surface Treatment. This step
manufacturing process. consists of processes such as grinding
and polishing.
Step 1: Splitting. This step results in an
unmatched part cut from the steel by a Step 13: Passivation. Passivation is the
splitting machine. process of chemically treating or coating
stainless steel to construct a corrosion-
Step 2: Forging. The forge uses a die to protective layer (a chemical reaction
“stamp” the shape of the instrument part. between the chromium in the stainless
Step 7: Profile Grinding. After the forged steel and oxygen). During this process,
parts are milled, they are ground on a organic acids react with iron through
rough stone grinding wheel. This step oxidation to create iron oxide (FeO)
removes any excess material that may be and chromium oxide (CrO). Iron oxide
remaining after the forging process. is dissolved from the surface, while the
chromium oxide remains and builds
Step 3: Deburring and Dulling. Deburring a “passive” protective layer of iron/
is the removal of excess material to chromium oxide. The layer is usually 2nm
round off sharp edges following the to 5nm thick. The surface finish (e.g.,
forging step. high gloss to matte) does not impact the
effectiveness of this passive layer.

Step 4: Annealing. Due to the extremely Step 8: Bending. The bending step
high temperatures in the forging involves the use of specialized tools to
process, the steel becomes hardened. bend an instrument (i.e., the jaw of an
The next steps of drilling, milling, atraumatic clamp) to ensure the correct
etc. are only possible with soft steel; shape is consistently achieved.

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 CIS SELF-STUDY LESSON PLAN

Objective 3: Determine how to optimize their instruments and incorporates QC

instrument selection for one’s facility mechanisms throughout all stages of the
When selecting surgical instruments manufacturing process.
to be used in surgical sets, numerous
considerations will impact those RESOURCES
decisions. Among the most critical are: “The History and Evolution of Surgical
Instruments.” Annals of The Royal College
• Quality and longevity of the of Surgeons of England 63, no. 4 (August
instrument 1981): 279–85. https://www.researchgate.
• Surgeon preference net/publication/16181396_The_history_
• Price and_evolution_of_surgical_instruments_I_
Introduction.
• Ease of care and cleaning
• Consistency and reliability of Specialty Steel Industry of North America.
Stainless Steel Primer. Available at https://
instrument performance www.ssina.com/wp-content/uploads/2019/06/
• Reputation of the supplier for quality, primerupdatebroc.pdf.
service, support and education Title 19: Customs duties–Part 134–Country of
• Patient safety and comfort origin marking. https://www.gpo.gov/fdsys/pkg/
CFR-2012-title19-vol1/pdf/CFR-2012-title19-
When examining options for an vol1-chapI.pdf.
instrument within a set, consider asking U.S. Customs Ruling. https://www.
these questions: customsmobile.com/rulings/docview?doc_
id=561189&highlight=561189.
• Will the instrument be similar or
“cross” to existing patterns in the set? Deutsches Institut für Normung (German
Institute for Standardization) https://www.din.
• How easy or difficult is the instrument de/en/about-standards/din-standards.
to clean? Can it be taken apart and
Association of periOperative Registered Nurses.
easily reassembled? “Guideline for Care and Cleaning of Surgical
• Does the instrument design provide Instruments.”Guidelines for Perioperative
a universal feel and ease of use for the Practice, 2020 ed.
surgeon?
• Will the instrument be easy to repair,
so it will last longer?
• Does the supplier provide original
equipment manufacturer (OEM) parts
for repair/replacement?

Conclusion
It is important for perioperative
personnel to understand that the
quality of today’s premium OR-grade
surgical instruments is directly related
to the quality of the steel used and
the quality of the manufacturing
process. Manufacturing of surgical
instruments is a complex process,
and there is no agency in the U.S. that
sets standards for instrument quality;
therefore, it is imperative that surgical
instruments are obtained from a
reputable manufacturer or supplier
that uses high-quality stainless steel for

www.iahcsmm.org NOVEMBER / DECEMBER 2021 PROCESS 39

 CIS Self-Study Lesson Plan Quiz
Why Surgical Instrument Grade Is Important
Lesson No. CIS 288 (Instrument Continuing Education - ICE) • Lesson expires November 2024

1. One reason stainless steel is used for 6. Which of the following instruments are 11. Floor-grade instruments should be
surgical instruments is to allow for made of 300 series steel? reprocessed with premium OR-grade
repeated cleaning and sterilization. a. Retractors and rib spreaders instruments in the ultrasonic cleaner.
a. True b. Osteotomes a. True
b. False c. Chisels and gouges b. False
d. Scissors
2. Quality control (QC) should be performed 12. A surgical instrument’s country of origin
during which of the following surgical 7. Approximately which percentage of is established by:
instrument manufacturing steps? surgical instruments today are made of a. The Association of periOperative
a. When the raw material is received stainless steel? Registered Nurses
b. During all steps in the a. 99% b. The Manufacturer’s Association
manufacturing process b. 85% c. The U.S. Food and Drug
c. When the manufacturing process is c. 50% Administration
completed d. 15% d. U.S. customs law
d. All the above
8. Which of the following properties of 13. An instrument’s country of origin
3. Which of the following statements stainless steel can vary? indicates the location where the
is true? a. Hardness and flexibility instrument was:
a. In the U.S., there are universally b. Titanium content and malleability a. Finished
accepted guidelines for defining c. Quality and acidity b. Labeled
instrument quality d. All the above c. Forged
b. There are three grades of surgical d. Purchased
instruments available 9. How do premium Operating Room
c. Grades of steel used in the (OR)-grade instruments differ from 14. Passivation of a surgical instrument
manufacturing of surgical other grades of instruments? involves:
instruments are also defined as a. Premium OR-grade instruments a. Etching the stainless steel
premium-grade and floor-grade require more stringent quality b. Building a passive protective layer of
d. None of the above control for their raw material iron/chromium oxide about 1nm to
b. Premium OR-grade instruments 6nm thick
4. Stainless steel is an alloy of: generally have more pattern c. Chemically treating or coating
a. Iron and carbon variation stainless steel to construct a
b. Carbon and chromium c. Premium OR-grade instruments corrosion-protective layer
c. Iron, chromium and carbon require less quality control d. None of the above
d. Iron and chromium throughout their manufacturing
process 15. When looking at options for purchasing
5. Which of the following instruments are d. None of the above instruments for sets, which of the
made of 400 series stainless steel? following should be considered?
a. Retractors 10. Which of the following are the a. How easy or difficult the instrument
b. Probes most commonly used mid-grade is to clean (e.g., can the instrument
c. Rongeurs instruments? be taken apart and easily
d. Towel clamps a. Mayo scissors reassembled, if applicable?)
b. Towel clamps b. Whether the instrument design
c. Mosquito clamps provides ease of use for the surgeon
d. Handheld retractors c. Whether the instrument will be easy
to repair
d. All the above

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