Two new resources are now available to provide additional guidance to AAMI members on information technology (IT) integration issues.

The first is a questionnaire that provides guidance to hospitals on integration issues; and the second is a comprehensive document listing IT standards and guidance documents. Both resources are available to all AAMI members through the CE-IT Community at www.ceitcollaboration.org.

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	These two resources, created by the CE-IT Community, are available for free download at www.ceitcollaboration.org.

The questionnaire — called the Medical Device Integration Matrix — contains dozens of specific questions that healthcare facilities could consider asking vendors with respect to medical device integration.

The matrix is divided into 10 sections including topic areas such as vendor information; a decision chart; and issues affecting security, network, hardware, software and interface, human factors, service support, training, and documentation.

Within the matrix, each section includes a number of specific questions that a healthcare facility could ask a vendor. For example, in the system support category, questions pertain to whether the vendor provides loaner equipment, the type of onsite and remote support that is offered, and the onsite response time provided.

The matrix — which was developed by the CE-IT Community’s Integration Working Group — serves as a reminder to hospitals to ask questions about certain components in a system, says Linda Chan, information services manager for New Jersey-based Virtua Health Information Services, and a member of the Integration Working Group.

“Each hospital will have its own standards on what the answer should be,” Chan says. Vendors also can use an accompanying decision tree to submit responses to the questions.

One-Stop Reference

The second new resource developed by the CE-IT Community is a 26-page document that provides a comprehensive listing of applicable IT references, resources, and standards.

The document — titled “Medical Device Integration: Reference, Resources, and Standards” — includes seven chapters listing general IT references, key interoperability organizations, reference documents, Food and Drug Administration (FDA) documents, FDA recognized standards, informative standards, and relevant journals.

The document — which is intended for clinical engineers, system integrators,
and IT professionals — provides a glimpse into an engineer’s point of
view, says Rick Schrenker, systems Engineering manager for Boston-based Massachusetts General Hospital and a member of the Requirements Working Group which developed the document.

The resource can help in the development of requirements for systems and vendors. “We couldn’t write requirements because they are often organization specific,” Schrenker says. “Those of us who were familiar with doing requirements came up with the idea of providing people with references that would help them develop requirements for systems that must remain highly dependable and safe in high-intensity clinical areas.”

References to IEEE standards also are useful. “People in our field don’t think of them, but a lot of standards like ANSI/AAMI/ISO 14971:2007, Medical devices—Application of risk management to medical devices, reference or build on IEEE standards work,” Schrenker notes.

The document also focuses on aspects of both clinical engineering and IT. “Many in IT aren’t familiar with the breadth of history with technology that clinical engineers deal with,” Schrenker says. “A lot of people still think of us as mainly focused on electrical safety and keeping things maintained. There is a lot more to the field than that.”

The document will be updated periodically. Both resources were developed by the CE-IT Community — a collaboration among members of AAMI, the American College of Clinical Engineering (ACCE), and the Healthcare Information and Management Systems Society (HIMSS). The CE-IT Community was created in 2008 to develop resources, best practices, and network opportunities to advance CE-IT interests.

SOURCE: AAMI News: January 2010, Vol. 45, No. 1