Please refer to our official manual for a complete guide on sterilization of RUMEX instruments: General Instructions for Care, Cleaning and Sterilization of Reusable Instruments for Ophthalmic Applications.
What is the step-by-step protocol for sterilizing ophthalmic instruments?
It starts with immediate pre-cleaning at the point of use, followed by manual or ultrasonic cleaning with specialized detergents, thorough rinsing, drying, packaging (or placement in sterilization trays), and validated sterilization - typically steam autoclaving.
A robust sterilization process rests on one non-negotiable principle: an instrument cannot be sterilized if it isn't first thoroughly cleaned. Bioburden, blood, and ophthalmic viscoelastic devices (OVDs) like sodium hyaluronate shield microbes from the sterilant, dooming the process to failure. Research from the Joint Commission shows that uncleaned proteins reduce steam efficacy by 50-70%, allowing spore survival. In ophthalmic contexts, where instruments contact avascular tissues, this failure amplifies TASS risks exponentially.
The lifecycle of an ophthalmic instrument follows this strict sequence of steps, ideally completed within 1-2 hours post-use to prevent drying:
Step 1: Point-of-Use Pre-Cleaning (Immediate Action)
- Immediately after surgery, wipe away gross debris and flush instrument lumens with sterile distilled or deionized water using a syringe or dedicated flush device. This prevents organic material - blood, vitreous humor, or OVDs - from drying on surfaces, which hardens into barriers resistant to later cleaning. For example, in cataract surgery, OVD residue in phaco tips can calcify within minutes.
- Then, place the instrument in a covered, leak-proof container with a pre-soak solution (e.g., water plus enzymatic starter) and transport it to the dedicated decontamination area, following OSHA bloodborne pathogen protocols to avoid staff exposure.
Step 2: Manual or Mechanical Cleaning
- Most modern ophthalmic instruments demand manual cleaning to protect delicate tips from damage - ultrasonics alone risk pitting on titanium forceps.
- Fully submerge them in a low-sudsing, pH-neutral, noncorrosive detergent solution, adhering strictly to the manufacturer's recommended concentration (typically 0.5-2%) and water quality - tap water risks introducing endotoxins from pipes, as seen in a 2020 TASS outbreak linked to municipal supply minerals.
- Enzymatic detergents spark debate: they excel at breaking down proteins and fats via proteases/amylases but leave microscopic residues that are hard to remove from intraocular instruments and are linked to TASS in ASCRS task force reports. If used, follow with copious, repeated rinsing (3-5 cycles) using 1-2 liters per load.
WARNING! RUMEX does not recommend enzymatic detergents. Only detergents specially designed for surgical stainless steel or titanium instruments should be used, with pH level between 6-9. Always follow the instrument manufacturer's Instructions for Use (IFU).
- Ultrasonic cleaning can dislodge debris from microscopic crevices in select instruments - but never as the sole method, per AORN recommendations. Run a 5–10 minute cycle at 40-50 kHz with instruments secured on a silicone mat to avoid cavitation damage; daily degas the bath and change solution per cycle to prevent biofilm buildup, a common TASS culprit.
WARNING! According to RUMEX manufacturer instructions, ultrasonic cleaning must NOT be applied to diamond knives, vitreoretinal instruments, or microincisional instruments (e.g., scissors, forceps with delicate tips, choppers, hooks, manipulators). Use only manual cleaning for these devices.
Step 3: Rinsing and Drying
- Perform final rinses with sterile distilled or deionized water (conductivity <10 µS/cm) to prevent recontamination - discard it after each use, as rinsing baths accumulate residues. Flush instruments with lumens thoroughly using air-water adapters for 30 seconds per lumen.
Fully demineralized water for rinsing and correct loading must be used to prevent staining. Tap water may cause an increase in ion concentrations on the surface of stainless steel instruments.
- Then, dry instruments completely to avoid moisture hindering sterilization (e.g., impeding steam penetration) or causing water spots and mineral deposits that etch titanium. Use:
o Pressurized air (30-50 psi) via compressed air guns for delicate lumens, or
o Lint-free wipes/microfiber cloths for surfaces;
o Forced-air ovens at 40-50°C for 15-30 minutes ensure bone-dry results without heat stress.
Step 4: Inspection and Lubrication
- At the end of each surgical day, inspect every microsurgical instrument under microscope (10-40x) or magnification for debris, damage, or wear - log findings in a quality tracker.
- Lubricate moving parts - like scissors or forceps joints - with medical-grade, thermoresistant instrument milk (e.g., water-soluble silicone emulsions) to ensure smooth operation; apply sparingly, wipe excess, and rinse pre-sterilization to avoid residue.
WARNING! Do not use silicone oil-based lubricants on RUMEX instruments. Only paraffin/white oil based lubricants that are biocompatible, suitable for steam sterilization, and vapor-permeable are permitted.
Step 5: Sterilization
- Once cleaned and dried, arrange instruments in a sterilization tray; wrap or containerize as needed per IFU.
- Process the tray in a sterilizer - such as a steam autoclave - using a validated cycle with exact parameters for time, temperature, and pressure (e.g., 132°C/30 min/30 psi).
- Biological indicators (e.g., Geobacillus stearothermophilus spores) and chemical integrators verify efficacy quarterly.
Important Tips
- Only clean, disinfected, and dry products can be sterilized. For lumen instruments (e.g., tips, cannulas, handpieces) the gravity procedure is not suitable.
- The sterilization steam must not contain any impurities. Do not apply steam sterilization temperatures exceeding 137°C (280°F). The autoclave drying cycle should be used to avoid oxidation. Gas plasma sterilization is not recommended as delicate instruments might be physically damaged when exposed to low pressure.
- Follow the guidelines of the processing times. The rapid sterilization (flash) process should be reserved for emergency processing only and should not be used for routine instrument sterilization. Longer sterilization periods and higher temperatures can lead to premature aging of instruments.
Please refer to our official manual for a complete guide on sterilization of RUMEX instruments: General Instructions for Care, Cleaning and Sterilization of Reusable Instruments for Ophthalmic Applications.