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Save paper thanks to digital instructions for use
A survey by MedicalMountains and SPECTARIS, the results of which were published in July, confirms this: Electronic instructions for use for medical technology products could save tonnes of paper in every company every year. However, the sole use of digital instructions for use for medical devices is limited to a few product groups and is subject to conditions. Three quarters of the companies surveyed would like to see the legal framework expanded.
03/08/2023
A little more than half of medtech companies (53%) recognise the explicit customer request for electronic instructions for use (eIFUs), but only a fraction (around 18%) are allowed to provide them exclusively: This is the result of the latest industry survey conducted by MedicalMountains GmbH in collaboration with SPECTARIS. The joint appeal is therefore to expand the existing legal framework in terms of product safety and sustainability. This is what 76% of the companies surveyed are calling for. Digital instructions for use should be the rule, and the supplement in paper form should only be provided at the customer's request.
„You can't push digitalisation and demand sustainability, but at the same time put the brakes on instructions for use to such an extent“, emphasises Julia Steckeler, Managing Director of MedicalMountains GmbH, and calls for a paradigm shift: „The eIFU should be the rule in future and the printed version a supplement on customer request.“ The advantages are quite literally „obvious“: Hardly any user today can imagine searching for information on a sheet of paper in a high-tech operating theatre. This would not mean a loss of security, on the contrary. „The use of eIFUs is recognised, as is their added value“, recalls Dr Martin Leonhard, Chairman of Medical Technology at the industry association SPECTARIS. „The information is updated immediately and provided with instructional videos or multilingual content. The added flexibility and user-friendliness ultimately benefits those who are at the centre of everything: the patients.There are many arguments in favour of expanding the current legal framework: Firstly, there is the customer request, with around 53 percent of manufacturers reporting an explicit customer request for digital instructions for use. These are available quickly and up-to-date in the right place, are easier to search, archive and find and can be flexibly provided with additional information - points that are relevant both inside and outside the EU. However, the top answer is „environmental aspects“. A complete switch to digital instructions for use could save around 500 tonnes of paper per year and company in Germany, according to reports from the industry: an average of 482 tonnes for documents for professional use and an average of 522 tonnes for all products.
The survey results form the basis for further dialogue with political decision-makers at national and European level. We are keeping the topic of eIFU high on the agenda because it makes things easier for both manufacturers and users," emphasise Julia Steckeler and Dr Martin Leonhard. They are convinced that a further liberalisation of the EU regulations is not only desirable, but also necessary in order to make a valuable contribution to resource protection. „The will of the industry is there. The will of users and clinics is also there, as the 2021 user survey of 400 users, also conducted by MedicalMountains GmbH and SPECTARIS, showed. All that is needed now is the will of politicians.“
The survey can be accessed free of charge on the MedicalMountains GmbH website.
The above texts, or parts thereof, were automatically translated from the original language text using a translation system (DeepL API).
Despite careful machine processing, translation errors cannot be ruled out.