WHITE PAPER SAFER MEDICAL DEVICE INTEGRATION IN HEALTHCARE ENVIRONMENTS
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The challenge A growing range of bedside medical technologies, such as patient monitors, electrocardiographs, intravenous pumps and ventilators, are being deployed that deliver safer medical care with a high degree of automation. These medical devices generate an increasing number of notifications and alerts that need to be handled within short time limits. This situation is producing a mounting challenge for hospitals as they must respond efficiently to these alerts and preserve quality of care without creating alarm fatigue among healthcare personnel. To manage the flow of alerts, hospitals integrate medical devices with general purpose communication systems so that relevant notifications are displayed directly on each staff member’s wireless handset. When such systems filter, add information or assign destination information to medical device alerts, they are classified as distributed alarm systems and must comply with medical device regulations. Often, existing communication systems are not designed for medical device integration. When connecting medical devices to these systems, the full responsibility falls upon the hospital to secure that the system complies with the regulations. In such cases, the hospital technology department must execute an onerous amount of tasks including risk management, verification, validation and documentation of the installation as a custom-built solution. This usually involves a significant administrative effort that can delay the deployment of technology. The Ascom solution Ascom Wireless Solutions has a strong track record of enabling mission critical communication within healthcare. Building on its vast experience of integrating many different technologies for wireless communication and display of critical alerts, Ascom can offer1 software and hardware solutions that are specifically intended for use with medical devices, which provide a reliable flow of alerts and notifications. Using a solution for medical device integration certified by Ascom Wireless Solutions, hospitals can significantly reduce their compliance burdens and simplify the deployment of distributed alarm systems. Distributed by: Ascom Wireless Solutions Enterprise Drive, Aldridge Road Grimbodalen 2, SE-417 49 Göteborg, Sweden

Safer to purchase All Ascom Wireless Solutions medical device products come with clear labeling and instructions that identify the types of medical devices that can be connected and the types of alerts and notifications the system can handle. These make it easier for the customer to understand what can be expected from the product. Likewise, documented procedures for delivery include meticulous testing and verification, which ensure a clear handover of responsibilities from Ascom to the customer. Knowing that every product is designed for use with medical devices and suitable for conveying...

Safer to own Ascom Wireless Solutions provides traceability and safety related follow-up of all its installations. This includes usage reports that indicate potential issues throughout the product’s lifecycle. Should an issue be detected, Ascom promptly evaluates it according to vigilance procedures. If a new unacceptable risk is detected, Ascom Wireless Solutions reports it to the competent appropriate authorities, such as the FDA3 in the US and relevant Competent Authorities in Europe, and mitigates the issue in a timely way. Additionally, Ascom issues field safety information...