Up to 6.900tons of paper could be saved at large manufacturers if it would be possible to switch to digital IFUs completely. A survey by SPECTARIS and MedicalMountains GmbH regarding #eifu showed the potential of #eIFU, if the laws would be adapted to allow its full potential. 👉 80% of professional users reported that they would prefer an #eIFU over a paper IFU. Thanks for those insights, Sarah Haake-Schäfer, Karim Djamshidi and Maximilian Reuter. #eumdr #sustainability #medxd #eIFU
Itamar Urmann
11mo
Markus, thank you for sharing. I would also expand the 2021/2226 scope for specific cases to lay users of AIMD and their accessories. For example, why do Cochlear Implant patients need to receive the same old IFU for external accessories such as batteries, cables and others that they are been using for the past 20+ years? These IFUs do not bring much-added value to the patients, as they are already familiar with the content. Instead, they could simply scan a QR code with a URL to the manufacturer's website, where IFU is always made available and customer service details are also shared, which is much more important than IFU in the case of AIMDs, in my opinion.
Thank you for pointing towards this issue. Sadly the current Regulation 2226/2021 still stuck in the 90s with their requirements. I am still unsure why this happened since this implementation clearly undermines the EU Green Deal to reduce waste. And ironically the regulation already pointed out the correct solution for more reasonable use of paper and digital soulutions for IFUs: Risk Management. The form and structure of an IFU and the way of distribution should always be evaluated by risk management. An IFU for a professional user for a commonly known article can easily use digital instructions where as mobile equipment in an ambulance might need a paper version. Sadly the focus on a risk based approach was only limited for devices in scope of the regulation. Increasing this focus might be a quick and direct solution to bring this regulation to the present and prepare it for the future.
Robert Radloff
11mo
I'm 100% for digitalization as an efficiency boost and as an AI enabler. However, when talking about paperless documentation we should also take into acount the energy / CO2 footprint of cloud and AI services. "A Carnegie Mellon University study concluded that the energy cost of data transfer and storage is about 7 kWh per gigabyte." https://medium.com/stanford-magazine/carbon-and-the-cloud-d6f481b79dfe
Fabiola Hartung-Linz
11mo
SPECTARIS & MedicalMountains GmbH Thanks for the great overview 💪🏻
thanks for sharing this key data! This is very much aligned with the survey MedTech Europe ran last year among healthcare professionals in the EU: 88% reported they would prefer eIFU over paper. In addition, internet access is not an issue as over 99% of healthcare professionals do have internet access. More details in our position paper: https://www.medtecheurope.org/resource-library/electronic-instructions-for-use-for-all-professional-use-medical-devices-medtech-europe-calls-for-scope-expansion-of-eu-2021-2226-position-paper/
Ralf Labugger
11mo
Thanks Markus for pointing out this important topic. Totally agree but how would you envision this to work for implants and the requirements laid out in Art. 18 of the MDR (i.e. information for the patient in lay persons' language and implant card)?
Director, Global PMS - Reimagining PMS - Think data, not documents!
11moJust to add: the 6.900 tons are annually…and even smaller manufacturers could save up to 1.000 tons/year.