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Medical device interoperability has been identified as a key way of decreasing healthcare costs while improving patient care. 1 This has led to a shift toward placing more medical devices onto information technology (IT) networks. However, placing medical devices onto an IT network may lead to additional risks to safety, effectiveness and security of the devices, the network, and the data. ANSI/AAMI/IEC 80001-1 addresses the roles, responsibilities, and activities that need to be carried out when managing these risks. In this article, we describe an exercise undertaken to assess the medical IT network risk management practice implemented within a hospital to control risk associated with a clinical information system (CIS). The level of compliance with the 80001-1 standard was determined using an assessment framework developed by the Regulated Software Research Centre. The purpose of this exercise was to test and inform the development of an assessment method that is part of the assessment framework for this standard. The exercise also sought to identify how the management of such an existing CIS project meets the requirements of 80001-1.

In an AAMI survey last year of the top medical device-related challenges, 42% of respondents cited medical device incident reporting and investigations as an issue. All HTM professionals should make sure that they and their team understand their role in investing and reporting of APEs that involve medical devices. In general, all healthcare organizations have room for improvement in how they deal with APEs and NMEs. The discussion about how to do a better job of investigating and reporting these incidents should be going on in your organization. If the HTM team is not already participating in that discussion, it's time to start.

While the practice of ethical pondering has a formal academic history more than several thousand years old, and its pedigree within the human heart is undoubtedly much older, the somewhat specialized field of bioethics goes back approximately only 50 years in the United States. And while practitioners in the field-known as much for their painstaking pondering as for their acrimonious tendency to disagree-rarely achieve quick consensus on the pressing issues of the day, it would appear that in the United States we have reached some consensus on the best way of teaching biomedical ethics to undergraduate students.