Which medical devices require approval before being allowed within secured facilities?

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The requirement for approval of medical devices within secured facilities often centers around their capabilities and the potential risks they pose. Medical devices with a two-way capability can both send and receive information, which opens up avenues for wireless communication and data exchange. This two-way interaction can expose the facility's systems to security vulnerabilities, especially if those devices could connect to broader networks or access sensitive data. Therefore, stringent scrutiny and pre-approval are crucial to mitigate risks associated with data breaches or unauthorized access.

On the other hand, other types of devices may not necessarily present the same level of risk. For example, while devices with loadable data storage may require oversight, their risk is not always as immediate or significant as that presented by devices capable of two-way communication. Similarly, while emergency medical equipment is critical, it usually has specific protocols to ensure that it can be used without jeopardizing facility security. The necessity for approval typically emphasizes the implications of the technology's functionality, thereby making approval essential for devices that can engage in two-way communication.

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