Risk management medical products

US Department of Health and Human Services - Food and Drug Administration (1999), Managing the Risks from Medical Product Use, May. 

The Important Role of Pharmacists in a Complex Risk-Management System Managing the Risks from Medical Product Use by Focusing... 

As one of her first initiatives after being sworn in as FDA Commissioner, Dr. Jane Henney established a Task Force to evaluate the system for managing risks of FDA-approved medical products. The Task Force assessed risk-management practices within the overall healthcare-delivery system, focusing on the roles and responsibilities of each participant. The Task Force s report Managing the Risks from Medical Product Use Creating a Risk Management Framework found that a systems framework for medical product risk... 

Complex system for managing the risks of medical products. 

FDA, Report to the FDA Commissioner From the Task Force on Risk Management. Managing the Risks From Medical Product Use Creating a Risk Management Framework, Food and Dmg Administration, Rockville, MD, May 1999 (http //www.fda.gov/oc/tfrm/riskmangement.pdf). Hepler, C.D. and Strand, L.M., Opportunities and responsibilities in pharmaceutical care. Am. J. Pharm. Educ., 53,15S, 1989. 

FDA, Mana in the Risks from Medical Product Use Creating a Risk Management Framework. Washington, DC FDA, 1999. 

FIGURE 9-1. System for managing the risks of prescription drugs. [From U.S. Food and Drug Administration. Managing the risks from medical product use creating a risk management framework http //www.fda.gov/oc/tfrm/executivesummary.htmi accessed May 10, 2004.)... 

This presentation addresses tissue engineering and how it relates to biomaterials and medical devices. Consideration is given to risk analysis and risk management in tissue engineering, and current proposals are discussed for an approach to the regulation of tissue engineering products and regulatory processes in the European Union. EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... 

To accelerate the introduction of more effective medical countermeasures, there needs to be an overhaul of the DOD drug and vaccine management structure. The new structure and processes should mimic best commercial practices and allow for risk tolerance in product development. To ensure that this issue receives the attention needed, the Chief of Naval Operations needs to champion an effort through the Secretary of the Navy to accelerate those efforts that are of the highest interest to naval forces. 

In the past decade there has been increased emphasis on drug safety, and more public visibility of safety problems. The volume of reports now exceeds 250 000 spontaneous reports per year, and adverse events have been highlighted in the medical sector and also in the media. In parallel, the FDA has focused more intently on this area in both NDA reviews and in the postmarketing period. This has accompanied withdrawals of a number of products, such as cisapride, phenylpropanolamine and terfenadine, and special scrutiny of products associated with particular adverse events, such as cardiac arrhythmias (torsades de Pointes ) and hepatic necrosis. The result has been an emphasis on the concept of risk management of a product. This concept, which is due to be described in forthcoming FDA recommendations, stresses the need to identify potential... 

ISO 14971 has been adopted by the European Committee for Standardization as EN ISO 14971 2012 [6]. Importantly it is one of the harmonised standards which manufacturers are obliged to comply with if they wish to certify their product as a CE Marked medical device (including in vitro diagnostic devices). Similarly in the US, the 21 code of federal regulations requires risk management to be undertaken as part of design validation (820.30 (g)). ISO 14971 is a Recognised Consensus Standard which the FDA expects manufacturers to comply with to meet this requirement. 

The standard applies not only to physical medical devices but also to software products which meet the criteria. And to this ends an additional publication lEC/TR 80002-1 2009 [13] describes in detail how the requirements can be appUed to medical device software. The standard requires that risk management activities are carried out throughout the lifecycle of the product, i.e. from vision through go-live and until decommissioning. 

ISO 62366 2007 Medical devices - Application of usability engineering to medical devices [12] is a design and development standard which is harmonised with medical device compliance requirements in many territories. It is closely aligned to risk management standard ISO 14971 2012, essentially ISO 62366 explores in greater depth those hazards which arise from a product s usabifity characteristics. Whilst intended as a standard to support the manufacture of medical devices it contains a useful framework that could be utilised by manufacturers of general HIT products where the user interface is associated with a number of important safety related hazards. 

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