Regulatory Consideration for Aereus Shield Coated Medical Devices

Between July 2014 and February 2015 Aereus Technologies engaged regulatory consultants to undertake a Regulatory Review of Aereus Shield Copper Alloy Coating for Class I & II Medical Devices in Canada.

A rationale and body of supporting information to demonstrate Aereus Shield copper alloy coating is safe and effective for use on contact surfaces in the medical environment has been prepared. The coating has been shown to confer antimicrobial properties to the surfaces to which it has been applied, and can be a benefit for touch surfaces of some Class I and Class II medical devices in Canada. While a device’s intended use or primary mechanism of action is not typically altered by the coating, the ancillary (e.g. secondary) properties conferred by Aereus Shield do not change the device’s compliance with safety and effectiveness provisions of the Canadian Medical Devices Regulations. Further, the company has evidence to show that Aereus Shield reduces bacteria on contact, is durable, resists wear and degradation when subject to standard institutional cleaning/disinfecting protocols, and is not irritating upon skin contact.

There are many examples of Class I and II devices for which the antimicrobial properties of Aereus Shield would add value. Items which are handled frequently or repeatedly by multiple individuals are particularly noted as sources of microbes which may transmit infection. The follow ng points address our review of the company’s position on the Aereus Shield coating’s properties in the context of its safe and effective use in Class I and II medical devices, and considerations of regulatory compliance in Canada.

Regulatory Considerations

The Food and Drugs Act and the Medical Devices Regulations (MDR) provide authority to Health Canada to regulate the manufacture of medical devices, with Medical Device Establishment Licensing (MDEL) for companies producing Class I products, and by the issuance of Medical Device Licenses (MDL) for Class II medical devices. Application processes to the agency with attestations, fees and annual renewals apply. Manufacturers are responsible to hold evidence that their products are safe and effective when used for their intended purposes (MDR sections 10-20), and that their labelling is in compliance (MDR sections
21-23). Aereus has analyzed these provisions of the regulations and documented how properties, testing, and claims for Aereus Shield applied to devices can be cited as in compliance; supporting references are noted and are available.

The addition of the Aereus Shield coating to a medical device would be considered at the design stage for a new device or when planning a change to an existing device. Risk analysis is a key element of design input; a manufacturer should document risks and their mitigation in accordance with ISO 14971.

The addition of Aereus Shield coating to add ancillary properties to an already licensed Class II medical device may or may not require an amendment to the license. If the manufacturer makes a change to the product’s name, catalogue number or intended use as a result, an amendment would be needed. For Class I devices, the addition of the coating to an existing marketed device would not require any regulatory action.

Biocompatibility

Materials selected in the design of Class I and II medical devices should be compatible with human contact according to a product’s intended use, in other words, biocompatible with the parts of the body contacted for the duration of exposure anticipated with normal use. The international standard ISO 10993-1:2009 provides guidance in the selection of appropriate tests, and Aereus has conducted those appropriate for surface devices with limited skin contact, since human skin will be exposed to devices coated with Aereus Shield. Testing showed no skin sensitization or intracutaneous reactivity.

Reduction of Microbes

Aereus has conducted or arranged efficacy and durability testing of the applied Aereus Shield coating to support reduction of bacteria and durability that are described in their supporting references. Aereus is committed to ongoing, supplemental testing.

Data anticipated in regard to reduction in viable bacterial count, and continuous reduction of bacterial contaminants over various inoculation cycles, will complement the data Aereus has already generated and support further claims. Manufacturers of Class I and II medical devices who choose to coat their devices with Aereus Shield, in order to add these ancillary properties, will have access to this supporting evidence.

Device Labeling and Claims

Labeling includes all written and graphic information provided by a manufacturer with a medical device including product label, instructions for use, promotional and advertising material (including print and electronic media). Labeling claims for Class I and II medical devices could include statements that are supported in the Aereus references for efficacy in reduction of microbes and durability. Aereus recommends that a statement be included to the effect that devices should undergo any ongoing standard practices of cleaning and disinfection be included to the effect that devices should undergo any ongoing standard practices of cleaning and disinfection be included as established for the product type with their intended use and environment. ¬†Claims such as “significant bacterial reduction”, and “antimicrobial” are supported.