FDA will publish shortly a guidance document on how the agency will use ISO 13485 audit reports voluntarily submitted by device manufacturers. The idea is that these manufacturers can be classified as a “low priority inspection” need because they will have shown the FDA that they have already been audited. This way FDA can focus on manufacturers which do not have a ISO audited system.

Original nrews from the website site FDANews.com - FDA Plans to Release ISO Audit Guidance Shortly.

I was warned at the Elsmar Cove Forum - thanks Dustyn!

- IEC 62366 Ed. 1.0 - Medical devices - Application of usability engineering to medical devices

This standard is the best example of the regulatory trend to require the use of usability engineering (also know as human factors engineering) to demonstrante conformance to the Essential Principles of Safety and Performance of Medical Devices (to understand what i´m saying about the regulatory trend, take a look at the FDA Human Factors Program at the CDRH website, where you can download human factors guidance documents such as Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, Write It Right: Recommendations for Developing User Instruction Manuals for Medical Devices used in Home Health Care. Also take a look at Do It By Design - An Introduction to Human Factors in Medical Devices).

Standard IEC 60601-1-6, on medical electrical equipment usability was the basis for this new standard, which expands the scope to all medical devices.

This standard specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use.

The standard is totally based on risk management and, therefore, is best used integrated in a risk management process and system based on ISO 14971.

More information on the IEC Webstore.

- IEC 60601-2-39 Ed. 2.0 - Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

The new version of the standard for peritoneal dialysis equipment is already aligned with the third edition of IEC 60601-1 . The technical change made was the addition of a list of essential performance requirements contained in the standard - this list will be a feature of all the new particular standards; this was added to facilitate the understanding of the concept of essential performance of medical electrical equipment.

More info on the IEC Webstore.

- IEC 60601-1-3 Ed. 2.0 - Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment

The new version of colateral standard IEC 60601-1-3 is also aligned with the new edition of the general standard, and also has some technical modifications (which i won´t detail here because x-ray equipment are not my business….yet :-))

More info about the standard on the link da IEC Webstore.

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.

For those interested, the American Society for Quality (ASQ) has made available in its website, free of charge, the commitee Drafts (CDs) of future standards ISO 9001 (Quality Management Systems - Requirements) and ISO 9004 (Managing for Sustentability - A Quality management Approach), qhich will probrably be published in 2009. The document can be downloaded (just for registered users) from: http://www.asq.org/quality-press/display-item/index.html?item=T843E&author=ANSI/ISO%20CD1%209001:2009%20|%20ANSI/ISO%20CD1%209004:2009