Started with Symbol in 1999 as their Senior Systems Analyst in the WLAN space helping to design OEM WLAN based products as well as an evangelist for the enterprise space. Symbol was one of the founding members of the WIFI Alliance.
As 802.11b got approved in 1999...the rest is history. The same will more than likely be with all the unique physiological sensors that are being incorporated in wearable consumer devices that will eventually find their way into the medical device space. The value add is driving down costs..while providing more and more useful real value add application models.
Will not rehash all the articles and buzz around the known, however will give my perspective. This perspective is based upon experience selling/training clinicans/ and providing system reviews in the patient monitoring, holter, EKG, cardiac monitoring space since 1982…a long time.
Not touching on infusion therapy or ventilator alarms, because in this blog I felt that focusing on alarms contributing to fatigue generating by patient monitoring is critical.
Measuring the electrical activity of the heart via the Einthoven triangle 3 lead and 5 lead, and also the 12 lead for interpretive cardiographs has been around for decades. However obtaining a quality signal depends upon several variables. Other than the patient medical conditions, having a quality signal will ensure the fidelity processed by the algorithms for identifying violation of set rate and rhythms values.
It starts out with proper site selection and skin preparations adequate skin preparation, and there are numerous articles surrounding this and why this is absolutely important. It continues with quality electrodes that ensure the conductive interface is optimal and reliable. In my experience there are variability in electrodes manufactures and storage conditions at the point- of-care. For example, electrodes that are left open while stored on shelf somewhere for months where they could be exposed to heat or other factors. Finally, how often are these electrodes changed?
Lead wires and connectors. What about lead wires, they can act as an antenna. Are they quality lead wires, or low cost/quality disposables? Are they short and affixed to the patient? Are they shielded from interferences? Do their connectors mate properly?
The next stage is the quality of the algorithms for arrhythmia processing. Here again, each patient monitoring company has their own that were validated and verified by different databases. Now, enteres the monitor level of processing and how smart the alarm detection is. Can the alarm detect system’s issues (loose lead, electrode off, etc) and physiological issues and prioritize them accordingly? Again, enters into another variability.
But, perhaps highly critical issue is the ability to set and compliance with setting of the alarms limits to match the medical conditions of the individual patient.
So these are the basics behind just setting the stage for obtaining the best signal possible. Not going down this path…well you will more than likely get artifact, lead off alarms, and your arrhythmia processing algorithms will have a hard time to give a quality analysis and interpretation.
Once the aforementioned has been addressed and evaluated…then you can start looking at tailoring alarm profiles for your specific patients. Defaults are defaults. For example if the patient is in chronic atrial fibrillation, how the alarms are adjusted just should be looked at.
While all of the proceeding may not address the entire nature of alarm fatigue, looking at these factors and the ability to educate care givers about it will go a long way to reduce the potential of false alarms from patient monitoring. These will factor into the overall metrics of reducing alarm fatigue.
Thanks goes out to Yadin B. David Ed.D for his professional review and edits.
Yadin B. David
Ed.D., P.E., C.C.E., F.A.I.M.B.E., F.A.C.C.E. Biomedical Engineering Consultants L.L.C. 1111 Hermann Drive, Suite 12B Houston, Texas 77004
Voice: (713) 522-6666 Fax: (713) 522-6686
E-mail: david@BiomedEng.com URL: www.BiomedEng.com
We will be visiting www.epfl.ch and having meetings with a medical device start up incubated by EPFL. Integra Systems, Inc., has provided our expertise to EPFL on the behalf of this company.
During an eight hour shift it is understood that a clinician may need to log into the EMR up to sometimes 68 times with his/her password? What if all you had to do was carry your BluStor card to eliminate the “manual log in”? Simply by biometric authentication, a random key generation, and wireless communications, you could dramatically improve work flow, improve security, and lower the hassle factor. It is possible now.
Integra Systems, Inc. and Motorola Solutions will be conducting a web event in September. As the WLAN has evolved over the past decade plus, there are new requirements such as how the client device needs to perform in a mobile environment, the adoption of 802.11ac, and the convergence of Bluetooth 4.0 with the WLAN.
See the following link to the event:
This blog will not delve into the ins and outs of the different ways of how to manage alarm fatigue as in accordance with the JCAHO NPSG announcement on June 25, 2013.
Much has been written about this and the awareness is front and center. It (JCAHO NPSG) is broken into the respective two phases, that is Phase I (beginning in June 2014) and Phase II, (beginning in January 2016). Education of those in the organization about alarm system management will also be required in January 2016.
Several patient monitoring companies are addressing this by collecting alarm information from patients from different physiological parameters and thus being able to create custom profiles for different types of patient populations. I commend these efforts as a great start and from what I have seen this has had excellent results…a significant reduction of false alarms. Actually it is creating the right predictive tools to understand perhaps what is going on before you have an alarm. That is what is ideal.
We envision that every medical device will have Bluetooth LE embedded in it. Follows the same process as WIFI over 14 years ago, but for different reasons.
What if you can have all your different patient profiles for all different type of unit settings loaded in a secure pass word smart card vault? Then when setting up your patient for monitoring this profile could be easily and by authentication to the user be loaded into the medical device. Would potentially decrease errors, improve productivity and work flow as well as create an audit trail.
Smart cards have significant benefits versus magnetic stripe (“mag stripe”) cards for healthcare applications.
First, smart cards are highly secure and are used worldwide in applications where the security and privacy of information are critical requirements.
▪ Smart cards embedded with microprocessors can encrypt and securely store information, protecting the patient’s personal health information.
▪ Smart cards can allow access to stored information only to authorized users. For example, all or portions of the patient’s personal health information can be protected so that only authorized doctors, hospitals and medical staff can access it. The rules for accessing medical information can be enforced by the smart card, even when used offline.
▪ Smart cards support strong authentication for accessing personal health information. Patients and providers can use smart health ID cards as a second factor when logging in to access information. In addition, smart cards support personal identification numbers and biometrics (e.g., a fingerprint) to further protect access.
▪ Smart cards support digital signatures, which can be used to determine that the card was issued by a valid organization and that the data on the card has not been fraudulently altered since issuance.
▪ Smart cards use secure chip technology and are designed and manufactured with features that help to deter counterfeiting and thwart tampering.
▪ Smart cards can help to reduce healthcare fraud by providing strong identity authentication of patients and providers.
The use of secure smart chip technology, encryption and other cryptography measures makes it extremely difficult for unauthorized users to access or use information on a smart card or to create duplicate cards. These capabilities help to protect patients from identity theft, protect healthcare institutions from medical fraud, and help healthcare providers meet HIPAA privacy and security requirements.
Second, smart cards provide the capacity to store healthcare information on the card and the flexibility for securely adding information to a patient healthcare card after issuance.
For healthcare applications, this can deliver several benefits.
▪ Patient healthcare information and prescriptions can be stored on the card and updated after issuance, providing up-to-date information when a patient is receiving medical care from multiple providers or in an emergency situation.
▪ Multiple patient identification or patient record identification numbers can be written to the smart card, facilitating record exchange and assisting with coordination of care among multiple healthcare providers.
▪ Patient healthcare information can be written to and updated on the card by authorized healthcare providers, with updated information then available for both the patient and other healthcare providers (if authorized) to access.
Third, smart cards can support a wide variety of functions to improve healthcare provider and insurer processes, including:
▪ Quickly and accurately identifying patients, reducing medical identity theft and improving quality of care.
▪ Streamlining patient registration and patient information access at any points of care, reducing routine paperwork and eliminating errors.
▪ Supporting audit logging and remote access accountability.
▪ Enabling secure access to healthcare websites.
▪ Storing all necessary applications and information on the card, enabling offline access to critical healthcare information using portable readers.
Magnetic stripe cards, by contrast, have significant disadvantages for healthcare and other identity and payment applications.
▪ Magnetic stripe cards have minimal security. Because data is very easily read from and written to a magnetic stripe card, information can be easily stolen and a duplicate magnetic stripe card can be created. It is straightforward for a thief to “swipe” a magnetic stripe card and to collect all of the information from the card; the thief simply needs a magnetic stripe reader that has the ability to capture the information from the card (which all readers do). The thief can then either use that information directly or create a duplicate magnetic stripe card.
▪ Magnetic stripe cards store only a limited amount of data (less than 2 Kbytes) and are not updated after issuance, providing no ability to securely store or update healthcare information.
▪ Magnetic stripe cards support minimal functionality and require an online infrastructure to access healthcare applications and information.
Magnetic stripe cards have had a well-established position in the marketplace for over 30 years. However, many industries and government organizations recognize the limitations of magnetic stripe technology and are replacing magnetic stripe ID cards with smart cards.
For example, the global payments industry is migrating from magnetic stripe bank cards and infrastructure to smart payment cards based on the Europay MasterCard Visa (EMV) specification. Over 1.2 billion smart card-based credit and debit cards are now issued globally and 18.7 million point-of-sale terminals accept EMV cards. Eighty countries globally are in various stages of EMV chip migration, including Canada and countries in Europe, Latin America and Asia, with migration to EMV smart payment cards now starting in the U.S.
For legacy applications that are accessed with magnetic stripe cards, a smart healthcare card can incorporate a magnetic stripe to support legacy applications.
Table 1 summarizes the key differences between smart cards and magnetic stripe cards for healthcare applications.
As the costs for smart cards and smart card readers have dropped dramatically, and as the reader infrastructure is replaced or upgraded, smart card technology is poised to capture market share in financial services, personal identification and healthcare markets–where security, privacy and information portability are crucial.
BluStor www.blustor.co is the “smart card, smart storage, smart connectivity system”…the only technology platform in the industry that has the storage, capacity, and eliminates proprietary readers, while providing a multi-layered security strategy. Integra Systems, Inc. is partnering with BlueStor to develop leap frog next generation solutions in this space.
See attached a great article about BlueTooth LE. (June 2014)
Bluetooth LE or 4.0 is disruptive technology that will re-shape the medical device landscape. I really do not like the term of 4.0, because it tends to describe this as another evolution of BT. It is not a evolution, but in my opinion a revolution. It is my prediction that every medical device will eventually have this incorporated. The reason I am so bold to say this is that I was a senior systems analyst at the company that was the founding member of the WIFI Alliance in 1999. So I remember exactly when 802.11b came out. The rest what we say is history! I also as a research project with an infusion pump company that got bought out demonstrated for the first time the ability to control an infusion pump by a wireless fashion…long time ago, year 2001. This was "before the smart infusion pump...entered into the market"!
Bluetooth 4.0 just makes sense for a variety of connectivity reasons. Technology disruption becomes available in the enterprise, as is first enters into the consumer space. Bluetooth LE or 4.0 has been adopted by the IOS and Android platforms as well as being incorporated in virtual every smart phone and tablet device. Those companies that quickly embrace the technology as the path to competitive differentiation will be the winners.
For a small incremental cost Bluetooth 4.0 can be incorporated and while WIFI does have it’s specific niche, the ability of having the medical device adapt to different wireless application modalities has a use merit. Just think of the Smart Phone Use model.
Most of the WLAN players have or will be now incorporating Bluetooth 4.0 into their access points. So in essences what we now are creating is a real “personal area Bluetooth network” that can use the WLAN as the backhaul. With the potential of using the location capabilities of BTLE, we could have a very cost affordable and adaptable RTLS solution.
Business Insider magazine estimates that there are over 200 million iPhones and iPads currently deployed that are capable of acting as or receiving signals from iBeacons. Of course, once Android and other devices are added to the mix, the market potential grows even bigger; Analyst ABI Research puts the space at $5 billion today, but predicts a rather modest Bluetooth Smart beacon deployment figure of 20,000 by 2015. By 2018 however, ABI predict that over 800 million smartphones will be actively using indoor location for applications, making the technology as widespread in smartphones as GPS is today.
As for what this market will look like, ABI speculate that the development of technologies like sensor fusion for handsets will enable a whole new set of consumer applications. These potential applications will span ambient intelligence, social networking, corporate and enterprise, fitness and health, mobile advertising, and gaming.
Nordic Semiconductor has released a reference design for Bluetooth Smart beacons based on its nrF51822 System-on-Chip (SoC). The reference design allows beacons developed to Apple’s iBeaconTM standards, and proprietary smart beacon hardware for iOS and Android mobiles, to be developed quickly and easily.
Bluetooth Smart beacons are low-cost, low- power wireless transmitters that can advertise their location to Bluetooth Smart ready smartphones in close proximity.
Adding low power wireless connectivity to a product has become less of a challenge as chipmakers serve up proven silicon, reference designs, and development kits. But designing an RF link from scratch is still far from a trivial exercise. Quick to spot an opportunity, commercial vendors now offer pre- engineered wireless solutions in the form of modules. Such devices have been optimized by the manufacturer to provide maximum range and bandwidth while meeting the regulatory requirements for operation in the Industrial, Scientific, Medical (ISM) 2.4-GHz band. Some are even delivered with certification proving they comply with a particular wireless standard.
The market is rapidly expanding: According to analyst IHS, worldwide revenue for the low-power wireless modules market will reach $1.40 billion this year, up a robust 14 percent from $1.23 billion in 2013. The company says this is the third consecutive year of double digit expansion for the market.
IHS forecasts that the fastest- growing market for low-power wireless modules in the immediate future will be sports and fitness monitoring, with a compound annual growth rate (CAGR) of 49 percent.
The underlying growth in the application of wireless technologies in these markets will be the primary reason for the increase in module shipments. However, a secondary reason for expansion is the high rate of adoption of Bluetooth Smart, ANT+, EnOcean, RF4CE, and Z-Wave wireless technologies.
While these multivendor solutions are enjoying growth, low-power wireless technology is moving away from proprietary protocols, according to the company. Proprietary protocols made up 88 percent of module shipments in 2011, but will only account for about 50 percent by 2018. Key drivers for this trend are that customers are looking for interoperable communications across diverse systems, and want devices to communicate with mobile platforms like smartphones, tablet computers and laptops, without requiring dongles.
The ‘BlueTEG’ wristband sensor uses the temperature difference between the wearer’s skin and surrounding air to harvest enough energy to power the sensor’s systems. The device can measure parameters such as acceleration or ambient temperature and transmit the data to any Bluetooth Smart Ready smartphone, tablet, or computer.
Developed by the Fraunhofer Institute for Integrated Circuits IIS in Germany, the BlueTEG does not require a battery eliminating the need for it to be recharged or changed.
The BlueTEG is said to employ little more than a conventional thermogenerator and a special voltage converter developed by the Fraunhofer ISS, while being compatible with all types of body-worn wireless sensor systems and could even be integrated into multifunction GPS watches, for example.
The CSPo1 developed by German startup Cosinuss is a sophisticated optical heart rate monitor that can transmit recorded data via either Bluetooth or ANT+. It also eliminates the need for a chest belt. Future versions will be able to measure core body temperature and with an addition of another LED and photodiode the the sensor pack blood oxygen saturation levels as well. Available Q4 of 2014 at around $208.00