AeroPod 15 – Real World Evaluation

Real World Evaluations of the newly developed patient transport device, the AeroPod 15.

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Project Dates

Project Start 01/02/2022
Project End 30/06/2022

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AeroPod was developed from the issues that arose during the Covid pandemic for the movement of infectious patients by various transport and within the hospital environment. The Company reviewed what was available and developed a concept which was then discussed with healthcare professionals.

Key parameters se includedt:  Weight, Ease of Use, Stretcher attachment, Patient safety, Access to the patient and in transportation care. These issues were enveloped by the need to protect healthcare staff and others, as well as the immediate environment.

The parameters were tested on an air ambulance – Britten Norman Islander.  These parameters have been maintained throughout the development and design of the device.

Prior to the development of the AeroPod there were no aviation approved devices for the transport of hazardous patients (biological or chemical) within small aircraft or helicopters.

The features and design of the AeroPod 15 required testing with the end users to ensure it was fit for purpose and met clinical and NHS requirements.

 

AeroPod is a device designed to transport patients with biological or chemical hazards via land or air. https://www.bblprotect.com/product/aeropod/

They are fully gas tight devices for the transportation of hazardous patients.  AeroPod 10 is Aviation specific and has gained aviation compliance as well as Medical Compliance.

The products are the lightest, most compact and portable of all isolation devices on the market.

The Company is planning on creating a bariatric and paediatric version.

Two Real World Evaluations of the newly developed patient transport device, the AeroPod 15 were completed in February and May 2022. Participants gave verbal and written feedback, in the form of a survey, on the attributes and functionality of the product to assess its fit for purpose for the end user.

An industry/NHS partnership was created with the assistance of funding from the AHSN NENC, for an End User Design and evaluation collaboration to evaluate a new product for the transport of patients with hazardous conditions such as high consequence infectious diseases (HCID) or chemical contamination. The findings of the evaluations were directly inputted into the design of the device and have continued through into the manufacture of the product, due for market launch in January 2023.

The partnership was between B-B-L Protect Limited (BBL) and clinical experts from the Infection Prevention and Control Team (IPC), Infectious Diseases (ID) department and Internal Medicine Directorate from the Royal Victoria Infirmary, part of The Newcastle upon Tyne Hospitals NHS Foundation Trust, and the Hazard Area Response Team (HART) from the North East Ambulance Service (NEAS).

An End user design and Real-World Evaluation was undertaken during two evaluations sessions.

Staff involved in the evaluations were representatives from Newcastle Hospitals (Infectious Diseases, Infection Prevention and Control and Internal Medicine), NEAS HART, GAMA Aviation (a guest of BBL) and BBL.

Participants gave verbal and written feedback, in the form of a survey, on the attributes and functionality of the product to assess its fit for purpose for the end user.

Comments, suggestions and information from testing the Device with equipment used by the various medical teams informed the design of components on AeroPod.  Changes were made to the product as a direct result of the first collaboration and were assessed further in the second evaluation.

The result was a much improved device. Following the second evaluation additional comments were made and additional changes have been implemented on the device accordingly and in the user manual and device handbook.

The evaluation process significantly informed the refinement and design of the product. The product has achieved CE Marking and aviation compliance and is being registered with MHRA.  The Company is now also making final preparation for ISO 13485.

Following the RWE BBL have been able to progress the AeroPod as follows:

  1. BBL have redesigned elements of the device in line with Comments from the collaboration and are currently preparing for manufacture with injection molding tools currently being manufactured .
  2. Completed CE Marking processes and preparing to register with MHRA, gained aviation approval and preparing for ISO 13485
  3. AeroPod is on trial with Channel Islands Air Ambulance who have already placed an order with the Company
  4. Have just returned from exhibiting at Medica 2022 and have picked up world wide interest including the German airforce and Belgian Army.
  5. They have re-designed some elements of the device and are currently in the process of progressing to start manufacturing the product. This includes tooling for the injection molded parts.  The Company
  6. A test device is currently being trailed by the Channel Islands Air Ambulance who have already ordered a device.
  7. They are working with the Manufacturing Technology Centre to improve the unit and improve the design for recycling.
  8. They are developing a digital logging device to produce an auditable record of the patient’s journey in the unit to aid handover of the patient at the receiving centre.

Once the device is available, it will enable the safe transport of patients with biological and chemical hazards via road or air nationally and internationally. AeroPod 15 is a device which can also offer a cost benefit to the NHS as an alternative in some instances, against the current product in use, as well a more portable alternative which could be held on ambulances for emergency use.

Having a device which can be used in an air ambulance should facilitate quicker transport of patients to their end point treatment centres, which may improve patient outcomes. This will also release HART staff who can currently be involved in lengthy patient transfers.

Sustainability

To date the project has not resulted in any environmental savings.  However, the company has developed AeroPod with the aim of minimising the environmental impact as much as possible through work with the Royce Institute in Manchester.

The device is manufactured predominantly from recyclable materials and has identified the companies and processes through which to recycle as much of the product as possible. It is estimated that approximately 90% of the device will be recyclable. Where possible the product can be reclaimed and radiated before being recycled.  One potential use for the recycled material is soles of footwear.

The device has been developed from materials which give it a longer usability lifespan than others in the market.

AeroPod is the lightest device in the market and reduces the use of fuel on vehicles particularly aircraft which in turn reduces CO2 emissions.

The Company is also exploring the use of Ozone gas which can decontaminate and then is deconstructed and returned to normal air within a 30-minute time period reducing use of energy, water and contaminants.  As an alternative the Company is promoting the use of a H2O2 fumigation device which returns the liquid to a harmless water and like the Ozone device reduces the use of energy water and harmful contaminants.

AHSN NENC provided the funding to enable the Real-World Evaluations to be completed through payment of staff time for consultancy, product evaluation sessions, and administration.

BBL has also had support from the Research and Innovation Accelerator Springboard Programme in Manchester, Health Innovation Manchester and is currently planning another RWE in the North West.

BBL Protect Ltd continue to expand their network including being part of the Research and Innovation Accelerator Springboard in Manchester, working with them to prepare the Company to be able to supply into the NHS and other healthcare services through the UK. The Company is also in discussion with the MoD.

The company has also received interest from International NGO’s and has just returned from Medica 2022 where it has received global interest including; Ukraine, Germany, Switzerland, Malaysia, Peru, US and Australia.

The Company is also part of a European Standards Agency which is setting new worldwide standards for the movement of infectious patients within the aviation medevac sector working alongside representatives of the UN, WHO and NATO.

The product has completed development and is ready for launch in January 2023.