Pulse Oximeter Cleaner

European patent number: 11738272.1

The problem

The pulse oximeter is another common piece of medical measuring equipment, designed to measure pulse rate and oxygen saturations by pegging onto a patient's finger. They are used on almost every hospital patient at least daily, and so are highly prone to transmitting HCAI.

A contaminated finger will naturally find its way to the mouth, meaning that contaminated pulse oximeters can easily spread highly contagious orally-ingested pathogens such as Norovirus (vomiting and diarrhoea) and C. difficile.

The shape of the pulse oximeter probe presents a cleaning challenge. Existing methods include manual cleaning with alcohol-soaked swabs, but this is not only inconvenient and prone to non-compliance but also ineffective against C. difficile and its spores.

The solution

The Mantra Medical Pulse oximeter Cleaner will conveniently, rapidly and effectively clean pulse oximeters at the bedside.

It is designed to attach to the 'obs trolleys' that accommodate pulse oximeters and other measuring equipment in hospitals, and may co- mount with the blood pressure cuff cleaner to provide a complete cleaning solution. after using the pulse oximeter probe as normal, the healthcare worker will simply clip it to the device, ostensibly as somewhere to store it and keep it safe.

Cleaning then takes place 'in the background' without needing any further input, thereby avoiding the behavioural change that provides a barrier to adoption of other cleaning methods.

Chemical & mechanical cleaning

The design incorporates a replaceable cartridge with a number of cleaning elements providing a mixture of chemical and mechanical cleaning. The unique design ensures that a fresh cleaning surface is provided each time.

The chemical to be used within the device is effective against all significant pathogens including C. difficile spores and is safe to use at the bedside. The cartridge is designed to be replaceable after a number of uses, providing an ongoing revenue stream, but optimisation for environmentally friendly disposal is a priority within the development plan.

Patent searches have revealed very limited prior art and Mantra Medical's design is the only one that provides a fresh cleaning surface for each time. It is therefore the only one that will not itself become a source of infection.

Market size

The market size for this device is as large as that for the blood pressure cuff cleaner – pulse oximeters and blood pressure cuffs are often mounted together on the same 'obs trolley', and both require cleaning between every patient.

A conservative estimate suggests that 150,000 pulse oximeters are in daily use in the UK, with similar comparative numbers worldwide. To protect this market, we have a robust international patent application with virtually no identifiable prior art.

If 100% penetration is defined as one device per pulse oximeter, we would target 10% penetration in the UK after 5 years. With extrapolation internationally, this clearly demonstrates that the potential market is considerable.

Competition

Manual cleaning is the only realistic existing option for cleaning adult pulse oximeter probes. They are far too expensive to be disposable, and a physical barrier between probe and skin is very likely to interfere with the functional accuracy of the device. Such a barrier solution would need to be safe enough to withstand the many demands of the clinical environment, including (for example) needing 'breathable' characteristics to prevent danger in the case of inhalation by a child; a requirement which would of course negate any real usefulness as a barrier to infection.

Market research

Market research so far has indicated that finding a solution to the problem of contaminated pulse oximeter probes is an area of focus for many infection control departments. Again working with Medipex NHS Innovation hub we have approached infection control departments across Yorkshire and beyond, and the need for a solution to this problem has translated into significant interest in our design. This interest provides a route into testing and ultimately a route to market once the design is ready.