AAMI Journal Features Effective Management of Medical Device RecallsDecember 12, 2014
The Association for the Advancement of Medical Instrumentation (AAMI) recently featured a cover story on effective management of medical device recalls in its bimonthly journal, Biomedical Instrumentation and Technology (BI&T). The current issue examined the reasons behind the staggering increase of risk-based recalls between the fiscal year 2003 to 2012.
A recall is a course of action that involves removal of commercially distributed products that are in violation of laws administered by the Food and Drug Administration (FDA). Most often, this method is usually conducted voluntarily by the manufacturer to protect consumers and the product from public health risks and gross deception.
The article entitled “Clearing the Shelves: How Do Hospitals and Manufacturer Handle Recalls,” highlighted the significant role of Healthcare Technology Management (HTM) professionals in developing an effective process in managing the massive amount of product recalls in diverse healthcare facilities. To further attain this, the Food and Drug Administration (FDA) devised a new unique device identification (UDI) system, which is ideal for tracking the use and distribution of medical devices as well as the essential factors required in ensuring fast and effective recalls.
The article also featured a list of nine best practices provided by various industry experts, which covers all information relevant to documentation and disposal of recalled products. In conclusion, this cover story stressed on the necessary efforts needed in the part of the HTM professionals, manufacturers and regulators.
With this BI&T new journal entry, healthcare facilities and manufacturers can now anticipate solutions concerning recall counts for medical devices. AIV is committed to providing support to all national, state, and local groups in the biomedical and clinical engineering field through the delivery of high-quality resources. Browse through the list of biomedical and healthcare technology management associations that we support at www.aiv-inc.com/biomed-associations.html.
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