ISO/IEEE 11073-20xxx: Medical Device Application Profile, IEEE 1073.4.1 Physical Layer; Bluetooth operates in frequencies ranging from 2402 to 2480MHz with channel bandwidth of 1MHz in US. Coming along with the urgent development of wireless technology, wireless devices have invaded the medical area with a wide range of capability. Some standards are discussed in this section. The Medical Devices Bureau of Health Canada recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. The standards can be used for designing, integrating, evaluating and coordinating telecommunications resources in order to guarantee providing needed functions of EMSS systems. On a large scale, WiMAX networks can be established and operated by a regional health authority to provide telemedicine services among regional clinics, hospitals and drugstores. CIMIT is a center conducting research in order to improve patient care [CIMIT]. For more information on recognized standards, go to the FDA Recognized Consensus Standards database. Operation assisting is very new application of wireless network [CIMIT]. 2.5 Other technologies What are mobile medical apps and how are they regulated? Wireless technology could be the best solution for mass emergency situations like natural or human-included disasters and military conflict where patients’ records such as previous medication history, identification and other vital information are necessary. Thus guaranteeing information security can be an issue and challenge for system developers. Medical emergencies can be detected sooner and proper treatment can be applied timely. It all started with German physicist Heinrich Hertz (1857-1894) when he discovered electromagnetic waves. The system collects periodic and continuous data and then transmits it to the centralized server. Upon connection establishment, a slave synchronizes frequency hopping and its timer to the master’s and then waits for the polling from master to transmit. Figure 5: Future clinical system [CIMIT]. Medical devices that incorporate wireless technology introduce some unique risks that should be addressed. Patient’s data is easily transferred around the hospital. In addition, these hops are sometime located in very critical conditions, such as magnetic field or areas bearing interference of radio waves. Cable-Connected Mode (Withdrawn). CIMIT: Center for Integration of Medicine and Innovative Technology http://webs.cs.berkeley.edu/retreat-1-04/slides/mattwelsh-vitaldust-poster.pdf, [BOHM] B.O.H.M. Health care facilities should also consider the following: The following FDA recognized standards can provide useful information: In addition, the FDA recommends that health care facilities periodically consult the FCC website for new specifications and updated information that may affect their wireless infrastructure. Although wireless medical applications have been successfully implemented not only in research but in practice as well, there are still many challenges for developers and researchers. Specifically, the new system should be low cost and not interfere with existing infrastructure. - ISO/TR 21730:2007 - Health informatics -- Use of mobile wireless communication and computing technology in healthcare facilities Portable devices such as heart rate monitors, pulse oximeters, spirometers and blood pressure monitors are essential in… Traditionally, the sensors for these instruments are attached to the patient by wires; and the patient sequentially becomes bed-bound. Copyright @ 2017 | Cardiac Devices | All rights reserved. What is an MDDS (medical device data system)? http://www.instromedix.com/pdf/products/HealtheKit/LifeStarPDA_m070009_Lite.pdf, [Airborne] “Quatech Launches 802.11b/G Wireless Networking Products for “OEMs Wireless medical devices are for the most part designed and tested in the simulated environments of test labs. Your email address will not be published. Paper presented at: 2nd Joint EMBS-BMES Conference, 2002; Houston, TX. Wireless Medical Telemetry System-1 -Wireless Medical Telemetry System (WMTS) communicates data (except voice and video) for remote monitoring of a patient's health. How are Medical Devices Regulated in the United States? 4.4 ASTM standards For example, in a given hospital wireless medical devices from multiple manufacturers will be found, yet rarely are these other vendor’s products included in product testing during the product development process. 4.3 Bluetooth SIG standard In addition, whenever patient needs to be moved, all monitoring device has to be disconnected and then reconnected later. Wireless sensor network can be applied to medical applications to build up databases for long-term clinical uses [McLoughlin06]. Some ASTM standards used in wireless medical system: Many other standards are currently being developed in the research community. As mentioned above, the other application of WiMAX-based network is prehospital management service. Reliability is one of the most important factors in a successful healthcare system. The data rate is defined at 720 kbps per user. The profile is developed by the Medical Devices Working Group to ensure that devices used in medical, health and fitness applications can transfer data between devices in a secure and well defined way via Bluetooth wireless technology. The Radio Frequency Wireless Technology in Medical Devices provides recommendations to develop and support safe and effective wireless medical devices. Many challenges for wireless medical system designers and developers are discussed in this section. The demand of up-to-dated standards is inevitable with the rapid development of wireless medical care. Figures 12 illustrates architecture of Wireless B.O.H.M system. That year, a new law for the first time classified medical devices into three risk categories, with clinical data required only for devices in the highest-risk category, Class III. Quatech Airborne and AirborneDirect support 802.11b/g are: Airborne(TM) 802.11b/g embedded Wireless Device Server Module, Airborne(TM) 802.11b/g embedded Wireless Ethernet Bridge Module, AirborneDirect(TM) 802.11b/g external Wireless Device Server, and AirborneDirect(TM) 802.11b/g external Wireless Ethernet Bridge. The FDA recommends that manufacturers periodically consult the FCC website for new specifications and updated information. The developers have to consider the longevity of the devices and extend it by using such scheduling algorithms and power management schemes that energy consumption should be shared over the whole network, rather than having a few devices or nodes carrying the whole network’s load. Many extensions of 802.11 were released, including 802.11g, added in 2003 with capacities of 54Mbps transmission working on 2.4GHz band at range of 350ft outdoors and 150 feet indoors; 802.11n with higher throughput of up to 200Mbps; 802.11i, added in 2004 with enhanced security; and 802.11s added for Mesh Network. Wireless inside-body monitoring is a hot application of wireless network in patients’ monitoring. Table 1 illustrates the mapping between IEEE11073 sub-standards and the OSI reference model. The interface modules allow the old machines last longer[Airbone]. Examples of functions that can utilize wireless technology include controlling and programming a medical device, monitoring patients remotely, or transferring patient data from the medical device to another platform such as a cell phone. Figure 8: UVa/AID-N wireless blood pressure cuff [CodeBlue] http://springerlink.com/content/q648q72743085875/, [Cooper02]Cooper T, ISO/IEEE 11073 Standards for Medical Device 10 hot new home medical devices that are lifesavers Published Fri, Jan 29 2016 10:00 AM EST Updated Fri, Jan 29 2016 10:02 AM EST Chris Morris, special to CNBC.com Many products of the project have great potential to apply to practice such as: Intel SHIMMER motes (figure 6), UVa/AID-N "eTag" wireless triage tags (figure 7), UVa/AID-N wireless blood pressure cuff (figure 8), Limb movement in stroke patient rehabilitation monitoring system (figure 9)[CodeBlue]. http://www.ieee802.org/19/pub/archive/2002/02004r0P802-19_EMI-EMC-Issues-in-POC-Medical-Device-Communications.ppt, [CIMIT] Center for Integration of Medicine and Innovative Technology We have also identified standards being used in wireless medical applications and location of wireless network in a healthcare system. The wearable … When manufacturers submit pre-market notification to the FDA for device clearance or approval, declarations of conformity to these standards may eliminate the need for certain safety and effectiveness data. 7. 5.3 Capsule endoscope Rapid developments in wireless technologies have ushered in a new era of medical devices that are improving patient quality-of-life and lowering costs for both healthcare providers and owners. In this section of the paper, we will highlight current uses of various wireless communications in healthcare domain. A. Stankovic et al., “Wireless Sensor Networks for In-Home Healthcare: The FDA recommends that you periodically consult the FCC website for new specifications and updated information. The base technologies of medical applications CIMIT teams have been designing and constructing “Operating Room of the Future, a fully functioning operating room in which novel, integrated technologies and new processes are introduced, evaluated, and improved, and through which patients move with far greater comfort, speed and safety”[ORF]. We have also investigated standards being used in wireless medical applications and location of wireless network in a healthcare system. “Demo Abstract: Continuous Medical Monitoring Using Wireless Microsensors”, SenSys’04, November 3–5, 2004, Baltimore, Maryland http://www.cimit.org/orfuture.html, [CodeBlue] CodeBlue project From patient’s aspect, one of the most important issues is how comfortable they feel when using these new applications. Remote monitoring can also help special populations such as seniors, through home monitoring of chronic diseases so that changes can be detected earlier before more serious consequences occur. Reporting Adverse Events (Medical Devices). In this part of the survey, we will discuss about industrial products used in medical care domain. ECG: electrocardiogram http://www.cimit.org/about_ov.html, [ORF] Operating Room of the Future This chapter focuses on miniature implantable devices for electrical cardiac stimulation (pacing) and two types of sensing modalities (pressure and electrocardiogram). As with any medical device, if you have problems or questions, please consult the information provided by the manufacturer or contact your health care provider. Many monitoring and diagnostic processes can be executed simultaneously with the present of large network capability. Brian Carmody. WiFi: Wireless Fidelity Reference Based on this model, a set of sub-standards were developed to map to the full seven-layer ISO/OSI model. Unlike prior medical devices that were once standalone instruments, today’s wireless infusion pumps connect to a variety of healthcare systems, networks, and other devices. Nowadays, all of these time-consuming jobs could be terminated and patients could be liberated from instrumentation and bed by wireless technology. This paper is organized as follows: We will briefly discuss the base wireless technologies which current applications are using. 2.2 WLAN As the mater of fact, most wireless network based devices are battery operated; therefore, the design of a system must not require devices to expend excessive energy. 3. Connecting medical devices including IV pumps and vital sign monitors to a hospital's network also will lead to greater productivity and improved care. The Internet of Things (IoT) has opened up a world of possibilities in medicine: when connected to the internet, ordinary medical devices can collect invaluable additional data, give extra insight into symptoms and trends, enable remote care, and generally give patients more control over their lives and treatment. Coming along with a rapid increase of wireless systems for medical applications, significant academic and corporate resources are being directed towards development of standards. To ensure this factor, system designers have to care about adaptation of nodes when its location, connection and link quality is changed [Soomro07]. In most of the life, the devices are in sleep mode to save device’s power. It also can be used for emergency medical care [VitalDust] and many other applications. - ISO 17090-3:2008 - Health informatics -- Public key infrastructure -- Part 3: Policy management of certification authority WPANs using Zigbee or Bluetooth standards are gaining in popularity, with wireless motes available from industry. [ASTM F1220] Standard Guide for Emergency Medical Services System (EMSS) Telecommunications The doctors can monitor several patients simultaneously which is can not be done by traditional monitoring, in which the patients are monitored directly by the doctors. • Clarifies use of non-DoD WLAN systems. In this section, we will identify some standards that have been developed or are currently being developed in the research community for the wireless medical care. http://ddmg.csail.mit.edu/publications/medical-monitoring-abstract-sensys2004.pdf, [Sarikaya06] Behcet Sarikaya, M. Abdul Alim, and Siamak Rezaei; WBAN: Wireless Body Area Network Figure10: Between wearable WBAN and implanted WBAN[Takizawa08]. Although the technology has found ways into various fields, medical domain has very strict quality and assurance requirements, which causes many challenges that are faced when implementing and operating the systems. Communication. Finally, we identify innovative medical applications of wireless networks developed or being developed in research, projects and research groups on wireless medical application, and commercial products. Cardiac-Devices.com is intended to inventory of all devices used in Cardiology, in order to ease the cardiologist’s task of choosing which device is pertinent to which disease. The tablet mates with a variety of wireless devices available from the firm—a scale, pulse oximeter, glucometer, blood pressure cuff, thermometer, motion sensors, contact sensors (for doors … http://bestohm.com/index.php?option=com_frontpage&Itemid=1, [ISO] International organization for standardization. We identified innovative medical applications of wireless networks developed or being developed in research, projects and research groups on wireless medical application, and commercial products. Quality of wireless service: With wireless technology, a medical device might experience a delay in administering or terminating therapy. The Association for the Advancement of Medical Instrumentation (AAMI) TIR 69 – Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systemsand American National Standards Institute (ANSI) C63.27: Standard for Evaluation of Wireless Coexistencediscuss testing and risk management for wireless medical device coexistence. The first and oldest wireless technology used in medical application is wireless local area network (WLAN). The FDA’s policies on wireless medical devices are coordinated with the FCC and provide medical device manufacturers with more predictability and a better understanding of regulatory requirements for medical devices that utilize these technologies. A good example of a product that Bluetooth makes possible is a wireless electrocardiogram.