Instrument Grade Selection and Choices for Maintaining the Sterile Barrier

Procuring surgical instrumentation and sterilization packaging for your OR and SPD can be a challenge.  Because both optimal patient care and cost containment are top of mind, it is important to understand exactly what you are purchasing and how to maintain your instrument fleet for the best return on investment.

There are a number of reasons why instrument grade and quality are important:

·        Instruments crafted with high quality steel under strict tolerances are designed to perform consistently, resist corrosion and last longer to maximize investment

·        Reliably consistent instruments can lead to better performance in the OR and greater efficiency for the SPD during set building, which ultimately impacts patient care and resource utilization

Following are some of the critical factors in selecting the appropriate grade of instrument for your surgical teams:

1.      Defining the Grade

a.      Steel quality/ grade (type 300 or 400 steel) and properties of hardness, flexibility and malleability can be different depending on the instrument type and how it will be used

b.      Steel type is determined by Iron, Carbon and Chromium content (among other components) that impact hardness and corrosion resistance of the final instrument


2.      Understanding How the Instrument is Manufactured

a.      From creation of master drawings through forging, crafting and finishing may require 15 steps or more to produce high quality instruments

b.      Tight manufacturing  tolerances can enhance pattern consistency and performance for the surgical staff


3.      Knowing the Country of Origin

a.      Many instruments may be forged in one location/ country and the manufacturing completed in another country

b.      US Customs Law defines country of origin for surgical instruments as the country where the major transformation occurs, which is commonly where the instrument is forged

Once you purchase your instruments, how do you determine the best process for maintaining sterile sets for your facility? Each sterile packaging method has benefits and challenges.

Key considerations in choosing sterile packaging and maintaining the sterile barrier include:

1.      Packaging Material Selection

a.      Assess the 3 basic types of sterile packaging

                                                    i.     Pouches

                                                   ii.     Sterilization wrap

                                                  iii.     Rigid sterilization Containers

b.      Determine if the selection fits the key needs of your facility

                                                    i.     Does it effectively protect your valuable instruments during processing, transportation, storage and aseptic presentation?

                                                   ii.     Is it compatible with transportation trays and other sterile protection methods?

                                                  iii.     Is it available in the sizes needed?

                                                  iv.     Can it be stacked?

                                                   v.     Will it be easily damaged?

c.      Analyze the Impact on annual operating costs and environmental footprint


 2.      Manufacturer Validation Testing and Pre-purchase Evaluation

a.      Assure the selected packaging and processes have been validated by the manufacturer and are FDA cleared for your specific sterilization methods

b.      Evaluate and verify any new sterile packaging for optimal performance using the policies and procedures of your facility


 3.      Preparation for a Smooth Transition

a.      Prepare the facility and train the OR and SPD staff members to aid in smooth transition to any new procedures

b.      Provide your team with access to the most current version of the IFU and assure these instructions are followed carefully with periodic reviews


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