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MANUAL CLEANING
DRYING
MAINTENANCE INSPECTION AND
TESTING
PACKAGING
TRANSPORT
STERILIZATION
STORAGE
CONTACT INFORMATION
The instructions provided above have been validated by DJO Surgical as being capable of preparing a medical device for re-use. It remains the responsibility of the user to ensure that the reprocessing
is performed using appropriate equipment and materials, and that personnel in the reprocessing facility have been adequately trained to achieve the desired result. This normally requires validation and routine
monitoring of the process.
An electronic version of this IFU can be located at:
http://www.djosurgical.com//IFU
Some DJO Surgical products use SurgiBit® technology. The SurgiBit® technology is protected by the following patents: Drill Point protected under U.S. Design Patents D523313 & D523398.
U.S. Utility Patents Pending.
1.
Pre-Cleaning: Remove gross contaminants by immersing the devices in room temperature neutral pH enzymatic cleaner* (e.g. MetriZyme) and
disassemble/loosen instruments, if suitable. The majority of the surgical instruments and trial devices are simply constructed and will not require
disassembly. However, some of the more complex instruments are made of several components and these should be disassembled into their
individual parts prior to decontamination. Scrub with the appropriate soft bristle brush until visibly clean.
2.
Washing: Immerse devices in the ultrasonic washer/cleaner with room temperature neutral pH enzymatic cleaner* (e.g. MetriZyme) and sonicate for
10 minutes. Ultrasonic cleaners can be used with hot water per the manufacturers' recommended temperature; however, room temperature was
qualified. Be aware that loading patterns, water temperature, and other external factors may change the effectiveness of the equipment.
3.
Rinsing: Thoroughly rinse the devices with deionized or distilled water. For example, a minimum of 2 minutes three (3) times.
* Do not use high acidic (pH <4) or high alkaline (pH >10) products for disinfection or cleaning, since these can corrode metal, cause discoloration or stress
fractures. DJO Surgical has qualified the above cleaning method with the provided solution examples, for a 3 Spore Log Reduction (SLR). Other
cleaning/disinfection methods may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any
alternate method using appropriate laboratory techniques.
Allow devices to air dry a minimum of 20 minutes prior to inspection and sterilization preparation. Instruments must be thoroughly dried to remove residual
moisture before they are stored.
After cleaning/disinfection, the disassembled instruments should be visually inspected. Check for misalignment, burrs, bent, or fractured tips. Mechanically
test the working parts (e.g. hinges) to verify that each instrument functions throughout its intended range of motion. Place instruments into appropriate
configuration within instrument case and wrap with protective sterilization wrap according to AAMI / AORN guidelines.
Surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling. Care must be taken to
avoid compromising their performance. To minimize damage, conduct the following:
1.
Inspect instrument cases and instruments for damage when received and after each use and cleaning. Incompletely cleaned instruments should be
re-cleaned, and those that need repair returned for servicing.
2.
Only use an instrument for its intended purpose.
3.
When handling sharp instruments use extreme caution to avoid injury. Consult with an infection control practitioner to develop safety procedures
appropriate for all levels of direct instrument contact.
4.
If instruments appear to be damaged in such a way that may compromise the performance of the instrument, contact your DJO Surgical
representative for a replacement.
Health care personnel are ultimately responsible for ensuring that any packaging method or material, including a reusable rigid container system, is suitable
for use in sterilization processing and sterility maintenance in their particular health care facility.
Compliance with the general precautionary measures for handling contaminated/biologically hazardous materials is required.
Loaner instrument sets supplied by DJO Surgical have been thoroughly cleaned, inspected and tested for proper function prior to shipment. Unless
otherwise indicated, these sets are NOT STERILE and must be sterilized prior to use. NOTE: DJO Surgical does not recommend Flash Sterilization
within instrument cases or Chemical Sterilization.
The following is a recommended minimum cycle for steam sterilization that has been validated by DJO Surgical under laboratory conditions to achieve a
SAL of 10
with components loosened. DJO Surgical has data on file. Other sterilization cycles may also be suitable; however individuals or hospitals not
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using the recommended method are advised to validate any alternate method using appropriate laboratory techniques. Proper validation of the autoclave is
essential to ensure proper sterilization temperatures and cycle times.
Sterilization with a Pre-Vacuum Sterilizer (HI-VAC):
270° F (132° C), 5-minute exposure time, with 4 pulses and a 30-minute dry time.
Sterilization with a Gravity Displacement Sterilizer:
270° F (132° C), 30-minute exposure time, with a 30-minute dry time.
Instruments must be thoroughly dried to remove residual moisture before they are stored. Instrument cases that have been processed and wrapped to
maintain sterility should be stored in a manner to avoid extremes in temperature and moisture. Care must be taken in handling wrapped cases to prevent
damage to the barrier. The health care facility should establish a shelf life for wrapped instrument cases, based upon the type of sterile wrap used and the
recommendations of the sterile wrap manufacturer. The user must be aware that maintenance of sterility is event-related and that the probability of
occurrence of a contaminating event increases over time and with handling.
DJO Surgical
ATTN: Customer Service
9800 Metric Boulevard
Austin TX, 78758 USA
1-800-456-8696
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