Technical requirements for UV decontamination devices: Notice to manufacturers
Date published: November 6, 2020
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- About this notice
- About UVC and UVGI
- Reprocessed single-use devices and soft surfaces
- Regulatory considerations and claims
- Safety and effectiveness requirements
- International activity
- Contact us
About this notice
This notice outlines the safety and effectiveness requirements for closed system devices that decontaminate medical devices using ultraviolet (UV) radiation. The notice is for manufacturers using an interim order (IO) authorization or medical device licence application.
The notice doesn’t cover UV decontamination products used on household items (for example, wallets and keys) or for low-level disinfection of surfaces.
About UVC and UVGI
The COVID-19 pandemic has created interest in using UV-based decontamination systems to decontaminate reusable medical devices and/or reprocess single-use medical devices.
There are 3 main types of UV rays: UVA, UVB and UVC. UVA rays have the longest wavelengths, followed by UVB and UVC rays.
UVC radiation has the shortest wavelengths but the highest energy. UVB and UVA aren’t effective for decontamination purposes.
The effectiveness of ultraviolet germicidal irradiation (UVGI) using UVC devices depends on a number of factors, including:
- exposure time
- the wavelength of UV radiation
Decontamination using UVGI has challenges. For example:
- other devices may block the UVC light, causing an insufficient and thus ineffective UVC dose (known as shadowing)
- the design of the device being decontaminated may prevent penetration
- irradiance levels may not be consistent or sufficient to achieve sporicidal reduction of the deepest layer of the device being decontaminated
- it may be impossible to achieve effective UV dosage levels without damaging the device
UVGI is connected most often with water or air decontamination methods. The circulation of water and air help to expose the device completely to the UVGI rays. How effective this method is depends on line-of-sight exposure.
UVGI can achieve a low level of disinfection on non-porous device materials. This may be sufficient to decontaminate certain non-porous medical devices, such as dental instruments. UVGI must be contained in a closed system as prolonged exposure can cause damage to the skin and eyes.
Reprocessed single-use devices and soft surfaces
For UV devices intended to decontaminate single-use personal protective equipment (PPE) with porous surfaces, please see Health Canada’s notice on reprocessing single-use filtering face-piece respirators (FFRs). This notice sets out the requirements for sporicidal and viral inactivation and labelling.
Also, please see our 2016 notice on the commercial reprocessing of single-use devices regulated under the Medical Devices Regulations.
Regulatory considerations and claims
In Canada, medical devices are grouped into 4 risk classes, from Class I to Class IV. Class I devices represent the lowest risk and Class IV the highest. Commercial products for low-level disinfection (less than or equal to a 3 log or 99.9% reduction in microorganisms) of non-medical devices are not regulated as medical devices.
UV-emitting devices intended to decontaminate other medical devices are Class II devices. When used in relation to the COVID-19 pandemic, such devices must be authorized through the IO pathway or the Class II medical device licence application process. For help on applying, please see Health Canada’s:
- guidance on how to apply for an IO authorization
- guidance on how to complete the medical device licence application form
We have received applications under the IO for UVC devices that are intended to decontaminate previously used, single-use FFRs. So far, we haven’t issued any authorizations.
Safety and effectiveness requirements
Devices that use UV radiation to decontaminate other medical devices, including PPE, should meet the safety and effectiveness requirements described below. These requirements are aligned with the US Food and Drug Administration (FDA)’s premarket requirements.
Note: Based on the potential for contamination from clinical use and criticality of FFRs, low-level disinfection is an insufficient decontamination level for previously used, single-use FFRs.
Submit the following information with your IO application:
- Performance testing should demonstrate:
- the irradiation dose throughout the UV chamber is enough to decontaminate all PPE surfaces (through microbial challenge validation testing)
- the irradiation dose throughout the chamber is enough to irradiate both the inner and outer sides of each medical device within the UVGI chamber set-up
- includes a minimization of shadowing or dark spaces where objects can block UVC light from reaching others within the device, thereby affecting their ability to decontaminate effectively
- medical devices being decontaminated are compatible with the energy delivered by the UV decontamination device and that the device still meets all safety and performance criteria
- appropriate analyses and/or testing have been conducted to validate electrical safety, mechanical safety and electromagnetic compatibility of the device being decontaminated in its intended use environment after decontamination
- ozone emitted from the device is less than 0.05 parts per million through test data (if the UV decontamination device also generates ozone)
- Labelling must:
- include warning statements for users about the hazards of exposure to UV radiation
- include device operating procedures
- describe the preparation required for medical devices that will undergo decontamination in the UV device
- identify the specific validation microbes used in successful decontamination validation testing of the device as well as the level of decontamination achieved, such as log reduction
- validate instructions for decontamination of the target medical devices
The decontamination of PPE is outlined by the FDA in guidance published in May 2020. This guidance provides Emergency Use Authorization (EUA) recommendations for decontamination and bioburden reduction systems for surgical masks and respirators during COVID-19. As of October 9, 2020, the FDA hasn’t issued any EUAs for UV decontamination units.
For more information about UV radiation and disinfection related to COVID-19, please see the FDA’s fact sheet.
You may send your questions or comments about this notice to the Medical Devices Directorate at email@example.com.
- Removal of microbiological and organic contamination from an item to the extent necessary for further processing or for the intended use. Removal is normally done using water with detergents or enzymatic products.
- Removal of microorganisms to leave an item safe for further handling. There are 3 levels of decontamination: cleaning, disinfection and sterilization.
- A physical and/or chemical process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects
Note: Disinfection processes do not ensure the margin of safety associated with sterilization processes.
- Low-level disinfectant:
- Kills most vegetative bacteria and some fungi as well as enveloped (lipid) viruses (for example, hepatitis B and C, hantavirus and HIV). Low-level disinfectants do not kill mycobacteria or bacterial spores. They are generally used to clean environmental surfaces.
- Entity of microscopic size encompassing bacteria, fungi, protozoa and viruses (Association for the Advancement of Medical Instrumentation (AAMI) TIR30:2011)).
- To make ready for reuse a device, instrument or piece of equipment by any or a combination of cleaning, decontamination or disinfection, repackaging and sterilization (AAMI TIR30:2011).
- A physical and/or chemical process that destroys or eliminates all forms of microbial life (AAMI TIR30:2011).
- Interim order respecting the importation and sale of medical devices for use in relation to COVID-19
- Applications for medical devices under the interim order for use in relation to COVID-19 - Guidance
- Notice: Expedited review of health product submissions and applications to address COVID-19
- Disinfectants (guidance documents)
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