Do New EU Rules On Electronic Instructions For Use Go Far Enough?

In short

The European Commission has issued new regulations governing the use of electronic instructions for use(IFU) for medical devices. The regulations come into force on March 1st 2013 and are clearly intended to bring the rather archaic practice, providing paper instructions, into the 21st century. It doesn’t go quite as far as it might have done though.

Background to the new regulations

The full blurb says this regulation, which applies from 1 March 2013, establishes the conditions under which the instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC on active implantable medical devices and in point 13 of Annex I to Directive 93/42/EEC concerning medical devices may be provided in electronic form instead of in paper form.

From the regulations, which can be found here (regulation in italics), we’ve extracted some key points for discussion:

Electronic IFUs instead of paper IFUs are sometimes a good idea

It is recognised that, for some medical devices, the provision of instructions for use in electronic instead of in paper form can be beneficial for professional users. It can reduce the environmental burden and improve the competitiveness of the medical devices industry by reducing costs, while maintaining or improving the level of safety.

But only some products

Such a possibility should however be limited to certain medical devices and accessories intended to be used in specific conditions. 

The list includes

  • Active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;
  • Implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;
  • Fixed installed medical devices covered by Directive 93/42/EEC;
  • Medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use;
  • Stand-alone software covered by Directive 93/42/EEC.

And paper version needs to be available on request

In any case, for reasons of safety and efficiency users should always have the possibility to obtain those instructions for use in paper form on request.

And always on a website

In any case the provision of instructions for use in electronic form should be available through a website and be subject to a specific risk assessment by the manufacturer.

To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates and of product alerts, the instructions for use in electronic form should also be available through a website.

We say

It would be churlish not to applaud the introduction of this directive, but we’re a little worried about a few things and may even suggest it’s an opportunity missed in some areas, mainly because it seems so focused on electronic goods themselves. For example, looking at the tightly defined list of product types for which this will be allowed, there is a clear intention to focus primarily on devices where electronics are implicit in the device, no doubt because changes to software will frequently render paper IFUs out of date, where electronic versions can be maintained as current. Also, it makes total sense that if a device has a screen, there’s no point in having a folded up piece of paper explaining everything that could be provided on that screen.

So far so good, but what about re-usable devices which fall outwith the definitions supplied? At the present time, if a hospital acquires a new instrument that is designed to be reprocessed, it is accompanied by a paper IFU. We’re guessing this “hits the round file” almost instantaneously in many cases, almost certainly as frequently as it does with a consumable such as a screw. Assuming the IFU had some purpose in the first place (eg guidance on cleaning and sterilisation, resharpening, lubrication etc), would it not be better to have rather longer term access to those instructions?

There are two ways of looking at provision of instructions and my jaded view is somewhat informed by the fact that I’ve never seen anyone read them… in the same way that I’ve never read the ones that came with my car, Sky box, phone to name a few. What’s important is not provision of instructions, but access to instructions. Rather than the somewhat fearful language that suggests electronic IFUs may somehow reduce access to vital information, surely knowing where they are stored (ie on a website somewhere) is always going to be better than having a giant sheet of paper with thirteen languages thrown in the bin when the product is opened.

That would save me from having to turn my house upside down in the vain quest for some guidance every time I can’t start the chainsaw, and I’m not sure medical devices are fundamentally that different.

Source: European Commission, medlatest staff