Standard IEC 62366, “Medical Devices – Application of Usability Engineering to Medical Devices,” has a scheduled release date in october or november 2007. But the new blog , Medical Devices Today, has an inside scoop on the standard with views from FDA personal. A must read (even thought it´s no a full article): New Usability Standard Aims To Help Firms Institute Human Factors Programs

From the Medical Connectivity Consulting Website

ISO just published standard ISO/TR 21730:2007 - Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices. Abstract from the ISO website (i don´t have access to the standard so i could only copy it):

ISO/TR 21730:2007 provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities in a way that promotes effective electromagnetic compatibility (EMC) among the wireless technology and active medical devices through mitigation of potential hazards due to electromagnetic interference (EMI). The recommendations given recognize the different resources, needs, concerns and environments of healthcare organizations around the world, and provide detailed management guidelines for healthcare organizations that desire full deployment of mobile wireless communication and computing technology throughout their facilities. In addition, suggestions are included for selective restrictions in cases where healthcare organizations have decided that comprehensive management procedures are not feasible, practical or desirable at the present time. The recommendations herein distinguish between wireless technology controlled by the facility and used by doctors and staff for healthcare-specific communication and health informatics transport versus non-controlled (personal) mobile wireless equipment randomly brought into the facility by visitors, patients or the healthcare organization workforce.

Seems like a good reading to clinical engineers worldwide!

Read more at the Medical Connectivity Consulting Website: http://medicalconnectivity.com/2007/04/11.html#a979

The International Organization for Standardization (ISO) published last month the new verison of the risk management standard for medical devices, ISO 14971:2007 - Medical devices - Application of risk management to medical devices. From the site:

ISO 14971:2006 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2006 are applicable to all stages of the life-cycle of a medical device.

The development of this second edition used the experience gained from the application of the previous edition. One of the main problems identified, for example, was that users of the standard failed to understando the principles of risk management applied to the safety of medical devices. This has been dealt with in an extensive annex. Another annex provide real-life examples of hazard and hazardous situations.

This standard is the most important one in the field of medical device safety, simply because the majority of the certification and conformity assessment systems in the world are based on risk management. Even safety standards (for example, the new IEC 60601-1:2005) are being developed inside a risk management framework.

IEC published last week the new edition of the electromagnetic compatibility standard for medical devices, IEC 60601-1-2 - Ed. 3.0 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. This new edition has some technical cnaghes. mainly in subclause 4; these changes are related to the risk management requirement (ISO 14971) of the general standard, IEC 60601-1:2005. Apart from that, the changes are editorial, aligining the standard to the new edition of the general standard.

This will be the last edition of 1-2 using the name Electromagnetic Compatibility; the IEC committe responsible for the standard decided to remove this concecpt from the 60601 series because EMC is not safety (and the series is about safety). The next edition will be named 60601-1-2 Ed4: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic phenomena - Requirements and tests and will feature revised / modified tests.

Series IEC 60601-1-X is now aligned with the new edition of the general standard, consisting of IEC 60601-1-2, IEC 60601-1-6 (usability) e IEC 60601-1-8 (alarms), and some more standard are on the way (IEC 60601-1-9 ed 1 - environmentally conscious design, IEC 60601-1-10 ed 1 – development of physiologic closed-loop controllers and IEC 60601-1-11 – home-care aplications)