Blood Pressure Cuff Cleaner

European patent number: 2629805

The problem

Studies have shown that blood pressure cuffs provide an ideal surface for growth of harmful bacteria and viruses, and readily act as a vector in HCAI spread. Healthcare staff are already expected to clean blood pressure cuffs between patients, but because existing methods are too time consuming and inefficient cleaning is in reality sporadic, ineffectual, or not done at all.

This simple piece of medical equipment therefore continues to be a significant contributor to HCAI transmission in the UK and around the world. Our market research supports that this is an area of concern to infection control departments across the UK, and is in real need of a solution.

The solution

The Mantra Medical Blood Pressure Cuff Cleaning Device will rapidly, effectively and safely clean blood pressure cuffs at the bedside before and after use on every patient.

It is designed around minimising required behavioural change for staff, therefore reducing barriers to implementation and promoting consistent use.

UVC light

By using UVC light at 254nm this device employs a cleaning method of known and trusted germicidal effectiveness that, unlike other solutions, generates no direct material waste. UV light is the optimal solution for rapidly and effectively cleaning objects such as blood pressure cuffs that are flat with a large surface area.

The innovation is in taking this technology and packaging and supporting it in a way that makes it suitable for bedside use, with a focus on absolute safety, effectiveness and ease of use.

Additionally, the device will provide a storage solution for blood pressure cuffs while they are not in use. Cuffs are presently stored in metal baskets attached to the 'obs trolleys' normally used to mount blood pressure taking equipment, and are therefore exposed to airborne pathogens between uses. In contrast, while being stored inside the Mantra Medical device the cuff can be exposed to 'pulsed' UV light to ensure it remains absolutely free of pathogens, and can be removed at any time as required.

Automatic auditing

Furthermore, through use of RF chip technology the device will provide an automatic auditing function. By using an RF chip on the cuff and a receiver inside the device, it will automatically record how often the cuff has been cleaned. This information can be pushed to a secure server, collated, and presented as part of a larger body of data to form an overall picture of compliance with infection control standards.

Patent protection

An international patent application has been filed for this device, and the European Patent Office search has revealed that the Mantra Medical design is unique worldwide with no competing designs or relevant prior art at all. We have the market to ourselves.

We presently have an advanced concept, incorporating design features to meet the following challenges:

  1. Making UV completely safe to use at the bedside while maintaining useability
  2. Allowing passage of cuffs into and out of an opening on the device while preventing escape of any UV light
  3. Preventing inadvertent inflation of a cuff while inside the device, since this could damage both the cuff and the device
  4. Preventing the cuff from folding as it moves through the device, which would limit UV exposure
  5. Permitting use of the cuff at any time by a healthcare professional – the device will never interfere with clinical need.

Market size

The market for this device is potentially very large. With no direct competition this is the only solution that combines an effective waste-free cleaning method with useability, a storage function, and an auditing capability. Ultimately international marketing is intended, but initial focus will be on the UK.

Using figures for England alone 4, blood pressure measuring equipment is needed for:

  • 150,182 general ward beds
  • 538 A&E/injury units
  • 3747 Critical Care beds
  • 8230 GP Surgeries
  • Out-patient clinics, chemotherapy units, nursing homes and private hospitals.

Therefore, a conservative estimate is that there must be at least 150,000 blood pressure monitors in daily use in the UK, and the Mantra Medical device is designed to co-mount with them on a 1:1 basis. By extrapolating these figures internationally it can be clearly seen that the addressable market is very substantial.

Competition

Patent searches have revealed that this concept is unique. Competing methods of preventing blood pressure cuffs spreading HCAIs include manual cleaning, disposable or single use cuffs, and barrier solutions.

Research shows 5 that manual cleaning is too time-consuming and prone to non-compliance to be considered a reliable means of cleaning, and is of questionable effectiveness even if done well. Disposable cuffs and barrier solutions including disposable cuff covers are effective in use but highly unsatisfactory due to very considerable and ongoing cost. They are also environmentally unsound since they must be burned as clinical waste after use. Cuff covers are also cumbersome and unattractive to use.

By contrast the Mantra Medical device is a 'once only' cost, generates no material waste, and provides an easy and quick method of cleaning that doubles as a place to store the cuff. It requires little behavioural change. The goal of consistent bedside cleaning can be achieved with this device.

Market research and feedback

We have approached a number of infection control departments around Yorkshire and beyond with the assistance of Medipex NHS Innovation hub. Thus far, responses to our concept have been extremely positive and Liverpool, Leeds, Harrogate, Bradford and Doncaster have all expressed an interest in piloting the device once ready.

These links not only provide a route for feedback on the design as it develops, but also provide a clear route to market. Having such expressions of interest at this stage also considerably lessens the risk for the investor.

Current practice: cleaning of blood pressure cuffs 5
Cuff cleaning method Percentage usage
Nothing 22%
Clinell wipes inconsistently 44%
Clinell wipes every time 10%
Disposable: High-risk patients only 14%
Disposable Consistently 2%
Unknown 8%

Summary

With a unique design, a large addressable market already expressing interest, significant international potential, and an overall cost less than that of disposable solutions, we confidently expect a positive return.

We also anticipate that the device will make a return for healthcare providers who purchase it – the 'do nothing' approach has a very real and ongoing cost. We are providing a cheaper, simpler and more elegant solution to something that is already needed, and firmly believe that this product will become the standard solution to cleaning blood pressure cuffs.

  1. 4 Source: DoH figures, 2012
  2. 5 Source: Telephone survey conducted by Mantra Medical Ltd of UK hospitals in 2012