As executive director of the Continua Health Alliance, Chuck Parker is tasked with helping the nonprofit industry organization achieve its goal of end-to-end plug-and-play connectivity for personal health devices. MED caught up with him to get his thoughts on everything from what progress Continua is making in accomplishing that mission to what wireless technologies are coming to the fore in...
GE Healthcare and Philips Healthcare praised a recent FCC decision to allocate spectrum for wireless networks made of body-worn medical sensors, saying it will allow them to create technology that will reduce the spaghetti of wires connected to patients. But some experts worry that a lack of rules governing interoperability in the bands could hold back progress. MBANs are made up of low-power...
Editor’s note: This is a two-part article. Part 1 focused on the software development. IEC 62304 focuses on the software development process, defining the majority of the software development and verification activities. This standard outlines requirements at each stage of the development lifecycle and defines the minimum activities and tasks to be performed to provide confidence that the...
Last month, a government group tasked with identifying threats to information security and privacy sent to the U.S. Office of Managment and Budget (OMB) a list of recommendations to ensure the safety of Internet-connected medical devices. The Information Security and Privacy Advisory Board (ISPAB), a subgroup of the National Institutute for Standards and Technology, discussed the matter of device...
A recent Forbes article on the threat of medical device hacking is the latest in a steady drumbeat of calls for more attention to be paid to medical device security. Contributor Marc Weber Tobias, a security expert and investigative attorney, paints a frightening picture for readers: Just think of the possibilities: a spouse or business partner decides it is time for a change. She (or he) obtains...
Recently, the FDA reported that “of the 56,000 medical device reports relating to the use of infusion pumps received by the FDA over a five-year period, approximately 1% (560) were related to deaths, 34% (19,040) to serious injuries, and the remainder to system malfunctions.” As a result, the FDA issued a guidance directed specifically toward infusion pumps. It states that when paired...
Grant Ramaley has long been opposed to the latest edition of IEC 60601-1 because "concerns over credibility of certification to continue to emerge," he says. The standard is intended to be applied to all electronic medical devices traded internationally. In a new opinion piece, Ramaley claims that 60601-1 3rd edition could be the most expensive and burdensome standard ever developed....
People often think of a battery as an energy-storage device that’s similar to a fuel tank dispensing liquid fuel. For simplicity reasons, this is somewhat accurate. However, measuring stored energy from an electrochemical device is far more complex. The battery fuel gauge is generally poorly understood, particularly in the medical field. While an ordinary fuel gauge measures liquid flow...
FDA today released draft guidance for artificial pancreas device systems for treatment of type 1 diabetes, an event one advocacy group is hailing as a “huge opportunity for patients.” A press release issued by FDA says the draft guidance provides “flexible recommendations for design and testing” of the systems—including leeway in the choice of clinical study length...
Insulin pump with infusion set. Photo by Mbbradford at en.wikipedia [Public domain], from Wikimedia Commons. FDA today received a petition urging the administration to issue “clear and reasonable” gui dance for development of an artificial pancreas. More than 100,000 people throughout the United States signed the petition, which was launched by the Juvenile Diabetes...
When the third edition of IEC60601-1 was published, it marked the beginning of a new era. The standard now incorporates the concept and application of risk management in the design and production of devices. Implementation of risk management has implications for not only the end-product manufacturer but component providers as well, and further cascades through the entire supply chain. All parties...
Last week, we brought you a feature on new reliability tests in line with RoHS. Little did we know how timely it would be. India recently became the latest country to enact such legislation, as our sister site EBN reports. RoHS legislation has also been enacted in the EU, Japan, China, Korea, and California. Ken Manchen, of Newark/element14, wonders which country will be next: Will it be...
The first Restriction of Hazardous Substance (RoHS) legislation out of Europe, in 2006, provided an exemption for medical electronics. However, a second version that modifies this exemption has been released. Medical devices will be covered as of 2014, in vitro diagnostic equipment as of 2016, and industrial monitoring and control instruments as of 2017. The importance of planning for lead-free...
Wind River is the next major operating system (OS) vendor to understand the value of having an enriched medical offering. The company recently introduced a platform for medical devices, which is part of a comprehensive software portfolio designed for medical device development, including those devices requiring premarket notification, FDA 510(k), or the more stringent Premarket Approval. The...
The newly upgraded intrinsically safe Earth-Rite TELLUS II from Newson Gale offers effective, constantly verified static ground monitoring for drums, IBCs, and other mobile or portable equipment during hazardous area operations. It’s suitable for use in the handling, transporting, or mixing of combustible products. The TELLUS II provides the operator with a bright green flashing LED to...
Medical devices have to be reliable—people's lives depend on them. But current reliability testing standards don't cover all of the specific stresses faced by implantable medical electronics products, including implantable subcutaneous glucose monitors and retinal implants. Now, one industry organization is trying to change that.    The International Electronics Manufacturing...
Bluetooth low energy is an important wireless medium for the medical space. We’ve covered it lately and readers have told us how critical it is. Texas Instruments (TI), one of the innovators in wireless technologies, recently launched ten Bluetooth low energy technology (Bluetooth v4.0) profiles with associated sample applications for compliant sensor devices. The Bluetooth low energy...
Medical developers must think differently The biggest difference between a mainstream embedded application and a medical application is that the medical device usually has to work right all the time, every time. For the majority of embedded applications, it a product has an infrequent error or needs a reboot, it’s a nuisance, but not much more than that. For medical applications, product...
Anytime FDA starts proposing new regulations for medical devices, designers understandably get wary. But according to experts, the administration’s proposed regulations for medical mobile apps might result in more clarity than confusion.   According to the draft guidance issued last week, FDA is proposing to regulate apps that “are used as an accessory to a medical device already...
As promised, FDA has issued draft guidance laying out plans for the oversight of mobile applications used for medical or healthcare purposes. In a press release dated July 19, the administration explained that the proposed guidelines will only impact applications that “are used as an accessory to a medical device already regulated by the FDA” or “transform a mobile...
Boston Scientific CEO Ray Elliott celebrated the Fourth of July by exercising his right to freedom of speech. Three days after an attempt to repeal the medical device excise tax stalled out, Elliott wrote an opinion piece in the Minneapolis StarTribune calling for Congress to “immediately repeal the medical device tax included in the year-old national health care law.” Elliott’s...
The Advanced Medical Technology Association on Monday laid out a set of policy recommendations it says should be implemented in order to maintain the United States' position as the world leader in medical technology innovation. "We know medical technology has a bright future. The question is: will that future be made in America—or somewhere else?" AdvaMed President and CEO ...
What a wild week it was at the Embedded Systems Conference (ESC). I spent Tuesday and Wednesday last week in San Jose with the world’s leading embedded developers and came back with some great ideas. The highlight of the trip was a meeting with Steve Wozniak (co-founder of Apple). It was an impromptu meeting, but one I’ll surely remember. Steve was the event’s keynote...
The healthcare industry has been trying to cut the electric cord since the 1950s when Earl Bakken and Palmer Hermundslie invented the first transistorized cardiac pacemaker with an internal battery. Over the ensuing decades, manufacturers have continued to introduce devices—hearing aids, digital thermometers, defibrillators, nerve stimulators, suction pumps, ultrasound equipment, all manner...
Emergo says mobile medical apps should soon see some guidance. "Manufacturers have thus far received little official guidance from FDA regarding how  CDRH would handle mobile medical applications. Although some medical devices incorporating mobile applications have already been cleared by the FDA—GE’s Pocket Viewer, Airstrip Technologies’ Airstrip, Mobisante’...