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Guidelines for Reprocessing 3M Curing Lights This document contains information from our parent company 3M US in regards to the US-based Centers for Disease Control (CDC) recommendations1 in dental settings for medical devices that come in contact with mucous membranes or non-intact skin, which include all orthodontic curing light guides. You should always follow your provincial guidelines. The 3M™ Ortholux™ Luminous Curing Light meets the CDC recommendations in the US for sterilization, high-level disinfection or barrier with intermediate-level disinfection as outlined below.
3M Curing Lights+
Non-removable Light Guide++
Criticality/Reprocessing
Validated
All semi-critical items should be sterilized using heat, including curing light guides.
Validated
If a semi-critical item is heat-sensitive, replace with a heat-tolerant alternative. If none available, process using high-level disinfection.
Validated
Feasible
If the item cannot tolerate heat or high-level disinfection, at a minimum, protect with an appropriate barrier. Disinfect with a hard surface disinfectant with intermediate-level activity between patients.
+ Example: 3M™ Ortholux™ Luminous Curing Light. ++ Example: Valo Grand Cordless.
Instructions for Cleaning and Disinfection of a 3M Curing Light Shield and Curing Light Handpiece
Disinfection or Sterilization Options for 3M Removable Curing Light Guides
Cleaning: Wipe thoroughly with CaviWipes™, or equivalent wipe, for 30 seconds or until visibly clean, according to manufacturer instructions.
Intermediate-Level Disinfection (only when using a sleeve) 1. Select cleaning option A or B. 2. Disinfect with an alcohol-quaternary ammonium wipe, such as CaviWipes™ and wipe for the contact time on the disinfectant label.
Disinfection: Disinfect with an alcohol-quaternary ammonium wipe, such as CaviWipes™ for the contact time on the disinfectant label.
Cleaning Options for 3M Curing Light Guides 30 sec.
Option A: Wipe thoroughly with CaviWipes™, or equivalent wipe, for 30 seconds or until visibly clean, according to manufacturer instructions. Option B: Manually clean by submerging in an enzymatic detergent for five minutes and scrubbing with a soft plastic brush until visibly clean. Rinse in purified water according to detergent instructions. Option C: Washer-disinfector with an enzymatic detergent and a minimum of five minutes at 95°C thermal rinse cycle.
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High-Level Disinfection 1. Select cleaning option C with thermal rinse for five minutes at 95°C. Sterilization 1. Select cleaning option A, B or C. 2. Package light guide in a single sterilization pouch. 3. Sterilize the curing light guide according to the instructions (below). Sterilization Pre-vacuum Gravity
Temp. (°C)
Time
Dry Time
132
4 minutes
134
3 minutes
121
20 minutes
30 minutes, or until dry in the autoclave being used
Centers for Disease Control and Prevention. Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; October 2016. Page 12.
June 2020
Frequently Asked Questions What is the origin of these guidelines? Based on CDC guidelines, 3M has compiled the US validated options for reprocessing its curing lights in order to support and assist our customers in helping to protect staff and patients from the risk of infection. Always follow your provincial guidelines.
How to Define your Curing Light Device (semi-critical vs. non-critical)
What is a semi-critical device? A device that contacts intact mucous membranes or non-intact skin.
If the light guide can be removed from the handpiece, light guide is semi-critical.
What is a non-critical device? A device that contacts only intact skin or does not directly contact the patient but may become contaminated with microorganisms and organic soil during patient care. What is cleaning? Removal of contamination (usually organic or inorganic soil) from an item to the extent necessary for further processing. What is intermediate-level disinfection? A process that kills viruses, mycobacteria, fungi, and vegetative bacteria, but not necessarily bacterial spores.
The handpiece of the curing light and the light shield are considered non-critical.
What is high-level disinfection? A process that kills all microbial organisms but not necessarily large numbers of bacterial spores. What is sterilization? A validated process used to render a product free from all viable microorganisms. What is gravity sterilization? Type of sterilization cycle in which incoming steam displaces residual air through a port or drain usually in or near the bottom of the sterilization chamber. What is dynamic air removal sterilization? Type of sterilization cycles in which air is removed from the chamber and the load by means of a series of pressure and vacuum excursions (pre-vacuum cycle) or by means of a series of steam flushes and pressure pulses above atmospheric pressure (steam flush pressure pulse (SFPP) cycle). What happens if the sleeve is damaged during use? If the sleeve is damaged or has a hole, the curing light guide should be high-level disinfected or sterilized. Can the sleeve impact the power or irradiance of a curing light? Yes, the sleeve can impact power and irradiance of a curing light. It is critical to ensure the sleeve is powder free and the seam is not over the tip of the light guide and that the sleeve fits well. Finger cots should never be used for a barrier sleeve. We have tested the following sleeves: Sleeve
If light guide is non-removable, the device is considered semi-critical.
Impacts Power or Irradiance of 3M Curing Lights
Cure Sleeve® Tip Covers (short) – Kerr
No
Complete Curing Light Sleeves-Demi – Kerr
No
TIDIShield™ Custom Fit Curing Light Sleeves – TIDI Products
No
SmartLite® Max Lens Cover Sleeve – Dentsply
No
Curelastic Cure-Light Sleeve (Steri-Shield)
Yes
™
June 2020
Customer Care Centre: 1-888-363-3685 | 3M.ca/Dental Available in Canada from
3M Canada 3M Oral Care 300 Tartan Drive London, ON N5V 4M9 Canada 1-888-363-3685
3M ESPE Dental Products 2510 Conway Avenue St. Paul, MN 55144 USA 1-800-634-2249
3M, 3M Science. Applied to Life., Ortholux and ESPE are trademarks of 3M or 3M Deutschland GmbH. Used under license in Canada. © 2020, 3M. All rights reserved. All other trade names referenced are the service marks, trademarks or registered trademarks of their respective companies. 2006-17693 E