SmartDevices
Contents
Medical Devices, Computerized -- SmartDevices
Overview
What is a "smart" medical device?
Machines and devices used in medicine to monitor and treat patients are being developed with integrated computers and communication capabilities.
There is no known standard definition of what it means for a device to be considered "smart". As a class, devices like infusion pumps that once were simply mechanical and later, mechanical devices with electronic controls, are said to have become "smart" when they include integrated computers with on-board databases, data storage and networking capabilities.
Some existing non-computerized devices, such as some vital signs monitors, can be augmented with external add-ons and made to communicate over networks.
Other devices, such as automated dispensing machines, have developed over time into networked, dispensing systems offering also clinical decision support which provides dispensing alerts, dose conversion information, cumulative dose dispensed alerts and administration process reminders.
"Smart" Device Integration
A major topic of interest for informaticians is smart device integration with Electronic Health Record (EHR) and Electronic Medical Record (EMR) systems. Smart device integration has been discussed by Rausch and Judd in 2006 (Conf Proc IEEE Eng Med Biol Soc. 2006;Suppl:6740-3). These authors mention that "interoperability between medical devices and electronic medical records (EMR) is one key to developing a system of higher quality , safer, and efficient healthcare delivery."
Device integration can be one-way (from device to EMR) or two-way communication. There are use cases for both. For example, in the case of a pulse-oximeter, one way posting of data to the EMR from the device may be all that is necessary to automate the documentation and monitoring functions provided by the device itself. On the other hand, two-way communication via wireless networks between the EMR and smart infusion pumps has been proposed and successfully implemented, albeit in very few locations to date.
The adoption of managing chronic illness utilizing mobile phone technology may ultimately lead to a reduction in hospital admissions and subsequently a reduction in healthcare dollars being spent. For complex management of chronic disease usability and user-interface design are of prime importance. New touch interfaces, such as the iPhone, are a considerable improvement in terms of usability. As mobile phone technology improves the ‘average phone’ will be equipped with optimal device features such as SMS/MMS, glucometer, air sensor, and GPS. Smith, Joshua C., and Bruce R. Schatz. "Feasibility of Mobile Phone-Based Management of Chronic Illness." Proc. of AMIA 2010 Symposium, Washington, D.C. Web. 20 Jan. 2011. <http://tizra.com/amia/AMIA-1431-A2009.PDF>. ''Link title''
Regulation of Medical Devices, including "Smart" Medical Devices
In the United States, the Food and Drug Administration provides regulatory oversight for medical devices, including some "smart" devices such as smart infusion pumps (see www.fda.gov/CDRH/510khome.html#download).
The FDA program governing these devices takes its name from section 510(k) of the Food, Drug and Cosmetic Act which requires manufacturers to register and notify FDA before marketing a medical device. 510(k) is known also as Premarket Notification (PMN).
