Making the transition from printed to electronic information for users
05 September 2013
Author: Gabriel Naughton, general manager, KPW Print
Printed leaflets, booklets and manuals for medical devices may soon, like lots of other printed materials, be a thing of the past. Until recently, European Union legislation required that all medical devices be accompanied with printed instructions for use (IFUs). But, this has changed and new legislation that came into force in March 2013 (Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices) allows for certain medical devices to use electronic instructions for use (eIFUs).
In the USA, the Food and Drug Administration (FDA) regulations governing electronic IFUs are broadly similar to the EU regulation but they pre-date it, with the result that the use of electronic IFUs is well established in that market. The introduction of the well-flagged regulations follows industry pressure to move to electronic IFUs. The regulation notes that the electronic provision of these can be beneficial for professional users, in the following ways:
- Reduce the environmental burden;
- Improve the competitiveness of the medical devices industry by reducing costs; and
- Maintain or improve the level of safety.
There is no doubt that medical device companies will see the new regulation as presenting an opportunity to reduce input costs by eliminating the need to have user information printed, stored and transported around the world. Some of the larger US-based OEM (original equipment manufacturer) medical device manufacturers have already developed online capability to provide IFUs electronically.
It is important to note at the outset that the regulation does not apply to all devices. The medical devices applicable for electronic IFUs must fall within the following categories: (a) 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; (b) 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; (c) fixed installed medical devices covered by Directive 93/42/EEC; (d) medical devices and their accessories covered by Directive 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use; (e) standalone software covered by Directive 93/42/EEC.
Furthermore, medical device manufacturers must demonstrate that the devices and accessories are intended for exclusive use by professional users, and the use by other persons is not reasonably foreseeable. If manufacturers have confirmed that their products are within the scope of the regulation and wish to make the transition to electronic IFUs , they must undertake a documented risk assessment that shall cover a number of elements, including:
- Knowledge and experience of the intended users, in particular regarding the use of the device and user needs;
- Characteristics of the environment in which the device will be used;
- Knowledge and experience of the intended user of the hardware and software needed to display the IFU in electronic form; and
- Access of the user to electronic resources needed at the time of use.
They must also assess the performance of safeguards to ensure that the electronic data and content are protected from tampering; and examine safety and back-up mechanisms in the event of a hardware or software fault, particularly if the IFU in electronic form are integrated within the device.
The manufacturers must also consider foreseeable medical emergency situations requiring the provision of information in paper form and plan for the impact that might be caused by the temporary unavailability of the specific website or of the internet in general, or of their access in the healthcare facility as well as the safety measures available to cope with such a situation. Finally, an evaluation of the time period within the instructions for use should be provided for at the user’s request.
Having completed the risk assessment, the medical device manufacturer must further demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instruction in paper form. They must also provide instruction for use in electronic form in all Member States where there product is made available or put into service, unless otherwise justified in the risk assessment.
A system must be put in place to provide the IFUs in printed form at no additional cost for the user, within the time period set out in the risk assessment, or at least within seven calendar days of receiving a request from the user. In addition, the manufacturer must provide on the device or on a leaflet information on foreseeable medical emergency situations and, for devices fitted with a build-in system visually displaying the IFU, information on how to start the device:
- Ensure the proper design and functioning of the IFU in electronic form and provide verification and validation evidence to this effect;
- For medical devices fitted with a build in system visually displaying the IFU, they shall ensure that displaying the visual IFU does not impede the safe use of the device, in particular life monitoring or life-supporting functions;
- Provide, in their catalogue or in other appropriate device information support, information on software and hardware requirements needed to display the IFU;
- Have a system in place to clearly indicate when the IFU has been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;
- For devices with a defined expiry date, except implantable devices, they shall keep the IFU available for the users in electronic form for at least two years after the end of the expiry date of the last produced device;
- For devices without a defined expiry date and for implantable devices, they shall keep the IFU available for the users in electronic form for a period of 15 years after the last device has been manufactured.
Companies that move to electronic IFU will have to communicate that user information is available electronically – it is a requirement that the information be provided on the actual product packaging or on the sales packaging. Details on how to access the information will also need to be provided.
It is likely that, over the next five years, many medical-device manufacturing companies will move to the electronic provision of user information. Cost reduction, through lean initiatives, will move companies in this direction – traditional logistics is expensive due to the rising cost of fuel and paper prices have risen steadily in the last three years.
When the decision is made to move to electronic IFUs, companies will then need to decide if they want to develop this capability in-house or invest in an already developed, functioning system.
For further information on the Commission Regulation on electronic IFUs, contact Gabriel Naughton at 0872317475 or email firstname.lastname@example.org://www.engineersjournal.ie/2013/09/05/making-the-transition-from-printed-to-electronic-information-for-users/http://www.engineersjournal.ie/wp-content/uploads/2013/09/eIFU-Surgeon-on-Computer-1024x834.jpeghttp://www.engineersjournal.ie/wp-content/uploads/2013/09/eIFU-Surgeon-on-Computer-300x300.jpegBioelectronics,European Union,medical devices