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Medical devices are a critical component of the global health care infrastructure, accounting for about $350 billion spent annually. The U.S. Department of Health and Human Services estimates that there are more than one billion patient encounters (visits to physician offices, hospital and outpatient emergency departments) annually in the United States alone, which all likely involve the use of medical devices. These devices include a wide range of products, from tongue depressors and bandages through life-sustaining products such as pacemakers, and more recently, associated software systems. Given the number of encounters and range of devices, medical device safety is of significant importance to the health care industry.
The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for ensuring that medical devices sold in the United States are safe and effective. However, the increased complexity and connectivity of medical devices has made this task exponentially complex for both medical device manufacturers and the FDA. Recent legislation from the FDA has been aimed at guaranteeing the safety of medical devices, prior to making them available commercially, by requiring cybersecurity documentation as part of the pre-market approval process.
In August 2015, the FDA issued an alert, warning of security flaws identified in a commercially available infusion pump, which resulted in the removal of those pumps from the market. This unprecedented action by the FDA has given effective notice to medical device manufacturers that products must be secured and maintained over their entire life cycle, from deployment to retirement. The challenge facing medical device manufacturers today is clear — reliably produce safe and secure medical devices, maintain the safety and security of those fielded devices and respond appropriately to continued changing regulations. Investment in products and services that support compliance is not optional. Medical device manufacturers, in order to remain viable, must adapt traditional processes and policies in addition to adopting new processes and policies.
Driving factors Health care organizations, including medical device manufacturers, are being driven to adopt a cybersecurity strategy...
• To ensure patient safety.
• To respond to legislation.
• To remain competitive.
• To respond to customer inquiries.
