Feedback PLC announces that, in compliance with the Medical Device Directive (MDD) and having met the stringent criteria associated with the manufacture of a medical device, it has affixed a CE Mark to Bleepa. Bleepa is Feedback’s flagship imaging-based communication platform for clinicians to access medical grade images through smartphones, tablets and desktops.
All clinical communication platforms that display digital images of patients for the purpose of diagnosis are classed as medical devices under the MDD guidelines and require a CE mark. Feedback believes that Bleepa is the only communication platform to address the UK market that has met MDD certification requirements.
We also believe that having a CE mark is a major step forward for the Bleepa product since the use of a non-CE marked product inappropriately may put individual clinicians and trusts at risk of civil claims for damages arising from misuse of that product. For this reason the Medicines & Healthcare products Regulatory Agency (MHRA) advise that all providers only use appropriately CE marked devices.
Dr Tom Oakley, CEO of Feedback, commented:
“We believe that Bleepa is the future for communicating about patient care and is already changing the way in which clinicians discuss cases and process patients through the hospital system. The CE mark is an important milestone in its commercialisation and sets Feedback apart from other providers.
“Pennine Acute Hospitals NHS Trust is already demonstrating the value of using Bleepa across the hospital setting. This important regulatory milestone offers healthcare providers confidence in our product over other unregulated providers as we continue the roll-out of Bleepa in support of the NHS, both to support the fight against COVID-19 as well in day-to-day patient management.”
Under MDD guidelines MedDev 2.1/6, any product that acts as an image viewer with functionality for diagnosis based on digital images may be classified as a medical device. Any communication platform being used by clinicians to display digital patient images as part of case discussion meets this stipulation and are classified as a medical device under the MDD. Under EU and UK law, CE marking is mandatory and manufacturers must ensure the product bears CE marking if such product comes under the scope of a directive requiring CE marking.
Clinicians and hospitals are advised by the MHRA to use medical devices with a CE mark, as this shows the device has met the legal requirements for safety, quality and performance when it is used as the manufacturer instructs. The MHRA further advises that off-label use of a device, such as use of a device that does not carry an appropriate CE mark will be at such user’s own risk and such person or their employer could become liable for civil claims for damages from injured patients or their families if something goes wrong with the device.
Feedback believes that Bleepa is the only communication platform combining imaging and instant messaging to address the UK market that has certified its compliance with the MDD and is therefore legally able to market itself as having image display capabilities. The CE mark technical file defines the use case for Bleepa and provides protection not only for the hospital trust but also for the individual clinician using the app, which Feedback believes will make Bleepa the clinical communications tool of choice.
Dr Oakley added: “We believe that many NHS sites are unknowingly using uncertified tools and are therefore exposed to civil claims arising from use of those tools. Bleepa will enable trusts to engage the digital communication revolution safely and securely within a regulated environment. Ensuring the roll out of a regulated communication platform should be a key priority for the NHS in its efforts to combat COVID-19 and beyond. Bleepa is now uniquely positioned to deliver against this need.”
Real-world feedback forms an essential component of CE accreditation and the deployment at Pennine Hospitals NHS Trust not only generated the required clinical feedback but additionally led to improvements in the product that have been incorporated into the CE marked version of Bleepa. The CE marked version of Bleepa will now be deployed at Royal Papworth Hospital as Feedback’s second NHS site.