PROCESSING NON-STERILE IMPLANTS

This document provides recommendations for cleaning and sterilizing non-sterile Biotek implants. The information provided applies to unused and non-contaminated Biotek implants only.  Explanted Biotek implants must never be reprocessed and should be handled according to hospital protocol upon removal. It must be noted that most implants provided sterile but rendered un-sterile (package opened but unused) can be processed via these recommendations.  To determine which sterile implants can be resterilized, refer to the package insert included with the sterile implant. Any implants that has not been used, but has become soiled, should be handled according to hospital protocol. Biotek does not recommend the processing of soiled implants. These recommendations are to be followed unless otherwise noted on specific product insets.

Cautions 

 • Any Implant that has not been used, but has become soiled should be handled according to hospital protocol. Biotek does not recommend the reprocessing of soiled implants.
• Biotek implants should not be lubricated.
• Do not use a Biotek implant if the surface has been damaged.
• Do not use steel wool or abrasive cleaners on Biotek implants.
• Biotek implants should not be processed or transported with any type of soiled or contaminated materials.
• In accordance with the CDC, AORN, and AAMI guidelines, Biotek does not recommend or support the flash sterilization of implants.
• Biotek implants are critical devices and must be terminally sterilized prior to use.
• The sterilization parameters are only valid for devices that are adequately cleaned.
• The following parameters are only valid for properly installed, maintained, compliant reprocessing equipment.

Limits on reprocessing 

• Repeated processing cycles that include ultrasonic, mechanical washing and sterilization have minimal effects on Biotek implants.
• Biotek Implants should be inspected for corrosion, damage such as scratches and notches, debris, discoloration of residue.
• Damaged implants should be discarded.

PROCESSING INSTRUCTIONS

Point of Use Care 

• Implants should remain covered until needed to avoid becoming soiled or contaminated. Only those to be implanted should be handled.
• Minimal handling of implants is necessary to prevent damage to the surface.

Containment and Transportation 

• Implants should not come in contact with soiled devices and / or equipment.
• To avoid contamination, implants should be transported from soiled devices.

Preparation for Processing 

Any implant contaminated with blood, tissue and/or bodily fluids/matter should be processed according to hospital protocol, Biotek does not recommend the reprocessing of soiled implants.

Processing –Manual Method 

Equipment:- Soft-bristled brush, lint-free cloth, neutral enzymatic cleaner detergent with a pH≤8.5.

1. Prepare a fresh solution using warm deionized  (DI) of purified (PUWR) water and detergent or cleaner. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for the correct exposure time, temperature, water quality(i.e. pH, hardness) and concentration. Note: a fresh solution is a newly-made, clean solution.
2. Carefully wash implant manually.
3. Rinse implant thoroughly with deionized (DI) or Purified (PURW) water. Use DI or PURW for final rinse.
4. Dry implant using a clean soft, lint-free cloth to avoid scratching the surface.

Processing – Ultrasonic Method 

Equipment:- Ultrasonic cleaner, neutral enzymatic cleaner or natural detergent with a pH≤8.5. Note: Ultrasonic cleaning may cause further damage to implants that have prior surface damage.

Prepare a fresh detergent solution using a neutral pH enzymatic cleaner or detergent. Follow the enzymatic cleaner or detergent manufacturer’s instructions for use for the correct dilution, temperature, water quality (i.e. pH hardness) and exposure time. Note: a fresh solution is a newly-made, clean solution.
Clean Biotek Implant ultrasonically for a minimum 15 minutes.
Rinse implant thoroughly with deionized (DI) or Purified (PURW) water. Use DI or PURW for final rinse.
Dry implant using a clean soft, lint-free cloth to avoid scratching the surface.

Processing – Mechanical Method

Equipment:- Water/disinfector, neutral enzymatic cleaner and/or  natural detergent with a pH≤8.5.
Use the following cycle parameters:

Thermal disinfection 

For automated cleaning, thermal disinfect at 93*c for minimum of 5 minutes.

Inspection

• Biotek implants should be inspected after processing , prior to sterilization.
• Any Implant with corrosion , discoloration, scratches ,flaws, residue or debris should be Discarded.

Sterilization 

• The following are the recommendations for the sterilization of Biotek implants:

*  When applying dry times to Biotek cases and their accessories, dry times outside the standard healthcare prevacuum parameters may be required. This is especially important for polymer-based (plastic) case/trays used in conjunction with heavy duty nonwoven sterilization wraps. The current recommended dry times for Biotek cases can range from a standard 20 minutes to an extended time of 20 minutes. The dry time is most often influenced  by the presence of polymer based (plastic) materials; therefore, changes such as reduced weight, elimination of silicone mats, and/or change in sterile barrier system (i.e. heavy grade to light grade wrap or a sterilization container) cab reduce the necessary dry time. Dry times may be highly variable due to differences in packaging materials (e.g. nonwoven wraps), environmental conditions, stem quality, implant material, total mass, sterilizer performance and varying cool down time. The user should employ verifiable methods (e.g. visual inspections) to confirm adequate drying .

• the autoclave manufacturer’s operating instructions and recommended guidelines for maximum sterilization load should be followed. The autoclave must be properly installed, maintained, and calibrated. Only legally marketed, FDA cleared sterilization wrap/pouches should be used by the end-user for packaging terminally sterilized devices.
• For product sold sterile, refer to devices specific insert for limitations regarding resterilisation.

Additional Information

• Sterile product that has exceeded the labeled expiration date and intact original packaging, may be sterilized using the above sterilization parameters unless product is coated, i.e. HA, plasma, etc. or resterilization is not permitted. Refer to device specific insert for limitations regarding resterilization.
• The cleaning and sterilization information is provided in accordance with ANSI/AAMI ST81, ISO 17664, AAMITIR 12 and AAMI ST77.
• The recommendations provided above have been validated by the medical device manufacturer as being capable of preparing a non-sterile Biotek medical implant. It remains the responsibility of the processor to ensure that the processing is actually performed, using equipment, materials and personnel in the reprocessing facility, and achieves the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the recommendation provided should be properly evaluated for effectiveness and potential adverse consequences.
• All users should be qualified personnel with documented expertise, competency and training. Users should be trained on hospital policies and procedures along with current applicable guidelines and standards.
• Users should don appropriate personal protective equipment (PPE) when processing implants.

Manufacturer Contact

For further information, contact Biotek Customer Service Department.