Moving Instructions For Use (IFUs) Online: A Path to Improved Care

Last year, the Pharmaceutical and Biomedical Device industries generated a combined total of $850 billion in revenue. Our partnerships in the industry have revealed that companies consistently spend one one-thousandth of their revenues on printing. This means that the two industries allocated an estimated $850 million to printing IFUs in one year alone. Imagine what could be done with a sum like this across the industry: price cuts on existing products, additional job creation, more attention to quality control, or any number of measures that would help accomplish the end goal of healthcare efforts—improving quality of life and saving life-years of patients.

How can we cut these costs and enable companies to reallocate resources to more critical areas? The answer is simple: we can allow them to replace printed IFUs with electronic ones (eIFUs). The European Union has already issued a regulation (207-2012), effective since March of 2013, permitting the use of eIFUs for certain devices.

Unfortunately, regulation 207-2012 only allows eIFUs to replace printed instructions for very specific use cases: the eIFU must be intended exclusively for a healthcare provider and the device to which it refers must be implantable, contain a built-in system that visually displays instructions for use, or be stand-alone software.

Though the regulation affects a limited number of products, this legislation is setting precedent for digital distribution of information that was previously required in print. In addition to reducing costs, the move towards digital distribution has numerous benefits to biomedical manufacturing companies and the end users of their products. These benefits include:

-Increasing the speed at which devices get to market.
-Reducing the risk of lost IFUs, which can result in improper use of devices.
-Reducing carbon emissions associated with the preparation and distribution of products.

We applaud companies like Medcomp, Abbot Vascular, and Medtronic that have already made their IFUs available online. Not only are they ensuring that patients and their healthcare providers have constant access to the most updated information about their medications or devices, but they are positioning themselves to eliminate paper instructions when the FDA inevitably follows the EU Commission’s lead and permits a full replacement. 

RossPPD offers a cloud-based eIFU management system. If you are looking to move your IFUs online, find out more at http://www.rossppd.com/products/ifutrack.