The Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning the 525/1025 Oxygen Concentrators, manufactured by Drive DeVilbiss.
According to the manufacturer, the recent outbreak of the COVID-19 human coronavirus has generated some questions regarding safe and appropriate cleaning and disinfection guidelines for oxygen concentrators that are being used/re-deployed between patients.
There is limited published scientific data on the COVID-19 virus. However, there are published data on other strains of human coronaviruses, such as the strains that caused SARS and the MERS. To date, there is no evidence of coronavirus transmission from inanimate objects, the CDC states that while it may be possible, it is an unlikely cause. The evidence does demonstrate coronavirus to have limited survival on inanimate surfaces, and that it can be deactivated with simple cleaning materials and process. Studies validate the use of diluted bleach solutions are highly effective and efficient surface disinfectants for human coronavirus.
The cleaning and disinfection protocol that is outlined can be found in all 525 and 1025 series oxygen concentrator user manuals. It can be located in the section titled "Provider Notes-Cleaning and Disinfecting When There is a Patient Change". In addition to this protocol, the manufacturer recommends providers follow their infection control and universal precaution policies, as well as any other federal, state or local infection control policy.
According to the manufacturer, users are advised to do the following actions:
- Use disinfectants safely. Always read the label and product information before use.
- Always wear personal protection equipment when performing this procedure. Use suitable gloves and safety glasses. Cover exposed skin on arms to prevent accidental contact with bleach solution that has been applied to the Concentrator.
- Dispose of accessories that are not suitable for reuse. This may include but not be limited to the oxygen tubing, tubing connectors, nasal cannula and/or mask, oxygen outlet connector, and humidifier bottle.
- Clean the exterior of the Concentrator with a clean lint free cloth. Heavy soil should be removed with a clean lint free cloth dampened with water. A soft bristled brush dampened with water can be used to remove stubborn soil. Dry the Concentrator using a clean lint free cloth if water was used to remove soil.
- Use 5.25% chlorine bleach (Clorox Regular Liquid Bleach or equivalent). Mix one (1) part bleach with four (4) parts of water in an appropriate clean container. This ratio produces a one (1) part bleach to five (5) total parts solution (1:5). This produces a 1% or 10,000 ppm bleach solution. The total volume (amount) of solution required is determined by the number of concentrators in need of disinfection.
- Apply the bleach solution to all exterior surfaces of the Concentrator using a clean lint free cloth in an even manner. The cloth should be dampened only and not dripping of solution. Do not use a spray bottle to apply the solution. Do not saturate the device with the solution. Take care that no solution enters the vent areas on the Concentrator Base or the Auxiliary O2 fitting area on the back of the unit. Avoid over-saturating the Cabinet seams so that no solution residue builds up in these areas. Avoid the Caster wells located on the bottom of the unit.
- Exposure time of the disinfectant solution should be 10 minutes minimum to 15 minutes maximum.
- After the recommended exposure time, all exterior surfaces of the Concentrator should be wiped with a clean lint free cloth dampened with drinking quality water no warmer than room temperature. Dry the unit with a dry, clean lint free cloth. This is to remove residue that may stain or leave a film on the unit, especially after repeated disinfections.
- Although not required as part of preventive maintenance and in an abundance of caution in the current environment, in addition to following the cleaning and disinfection instructions, providers consider changing both the gross particle and inlet HEPA filters between patient use.
According to the local supplier, the affected products are distributed in Hong Kong.
For details, please refer to the following website:
https://mhra-gov.filecamp.com/s/jc17pvZQS3IWE11J/d
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 24 March 2020