When designing a device, one of the most important things to remember is to “treat the patient, not the medical device,” according to Rick Hampton, wireless communications manager at Partners HealthCare Information Systems (Charlestown, MA). Hampton spoke about the standard and its potential effect on manufacturers at an AAMI conference in March. The clinician shouldn’t be distracted from this mission with a complicated device. Although devices are created with new features and capabilities to accomplish more tasks, the goal of designers should be to make devices that solve problems, not create them.
IEC 80001 recognizes that hospitals, medical device vendors, and network infrastructure vendors play a role in how networked medical devices operate. However, the largest burden is placed on the hospital in terms of responsibility and ensuring that risks are managed. The standard also places responsibility on the manufacturer by requiring documentation of a device’s intended use with an IT network as well as how the network must be configured to work with a device.
Better communication with clinicians during the design phase of an IT project should help create point-of-care devices that interact more efficiently and effectively. This will help designers understand work flow efficiencies and how wireless technology can be used to support both new and existing processes at the point of care, said Hampton. Device manufacturers should form partnerships with IT vendors and create a cross-functional risk management team during the design phase.
As security becomes a critical issue, companies should also conduct security risk assessments. This includes implementing realistic and scalable encryption and authentication mechanisms, advised Hampton. For more information about securing wireless connections, visit the U.S. Computer Emergency Readiness Team’s Web site at www.us-cert.gov/control_systems/csstandards.html#secure