With the anticipated completion of a device connectivity standard and the rapid growth of home healthcare, AAMI aims to enable medical device OEMs adjust to the requirements of a new standard. IEC 80001, “Application of Risk Management for IT—Networks
Incorporating Medical Devices,” deals with risk management and connectivity challenges that require coordination between clinical engineers in hospitals and OEMs.
“I think a major question for device manufacturers is how to get the standard on the radar screen of hospitals. The second question is how to get hospitals to buy into it, which is probably the biggest challenge, because it’s a new idea to have a standard apply and put responsibilities on hospitals,” says Mary Logan, president of AAMI.
The standard is anticipated to be out during Q4 2010, after which, AAMI plans to provide guidance documents, educational workshops, and training materials to help OEMs implement the standard.
Another area of focus for AAMI in 2010 is home healthcare. “The push on decreasing the cost of healthcare and making healthcare efficient and patient centric—all of those efforts are going to lead to more care being provided outside of the traditional hospital setting,” says Logan. Moving healthcare into the home, an uncontrolled environment, could pose new challenges. AAMI plans to support firms that have a presence in home healthcare, especially because there are no regulatory aspects to this sector in the healthcare reform legislation, according to Logan.