• Boston Scientific Recalls 955 Guidewires after Patient Death

    Boston Scientific is overseeing a Class I recall of the RotaWire Elite guidewire after being granted a PMA Supplement from FDA to change the contract manufacturer and the branding of the device. The device was sold to 30 hospitals as part of a “limited release.” Nancy CrottiThe RotaWire Boston Scientific has recalled 955 RotaWire Elite guidewires used to clear severe arterial blockages because the wires may break and cause patient injury or death. There were a total of three reports of the...
  • How a Sunscreen Ingredient Could Thwart Superbugs

    Zinc oxide nanopyramids could protect pacemakers, replacement joints and other implantables from MRSA and other pathogens, according to University of Michigan researchers.Chris NewmarkerThis illustration shows a pacemaker lead coated with nanoscale zinc oxide pyramids. The pyramids hinder MRSA from colonizing the coated surface. (Image courtesy of Steve Alvey, Michigan Engineering Communications and Marketing)University of Michigan researchers are reporting some success when it comes...
  • FDA Commissioner Nominee Grilled Over Adverse Events

    Robert Califf, MD, faced some tough questions during a Senate committee confirmation hearing about how he would handle medical device and drug regulation as FDA chief. Brian BuntzWhile Califf stated he would work to streamline medical product approvals, some Senators raisedquestions about his industry ties. Image from C-Span. Robert Califf, President Obama’s pick to head the FDA, received mostly warm support from the Senate panel during his Tuesday confirmation hearing, until he was asked about...
  • FDA Orders Recall for Endoscope Reprocessors

    FDA has instructed Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), and recommended that health care providers find alternative processing methods “as soon as possible.”Nancy CrottiFDA has found that the company Custom Ultrasonics (Ivyland, PA) has continually violated federal law and a consent decree entered with the company in 2007. According to the terms of a consent decree cited in the recall, FDA in 2012 ordered Custom Ultrasonics to stop manufacturing and...
  • How to Power Bioelectronics with Light

    Scientists out of China propose the use of a light-driven device that can power bioelectronic implants through the use of near-infrared rays and flashing light pulses.An illustration from the Chinese researchers' paperKristopher SturgisNanotechnologies have burst onto the medtech scene in recent years, with many different implants and devices benefitting from the miniaturization of advanced nanotechnological breakthroughs. Unfortunately harvesting a reliable and efficient power source for these...
  • Is the U.S. or Europe the True King of Medtech?

    While the United States has traditionally been a global leader in the medical device field, Europe appears to be gaining ground—at least in terms of the major medical device companies based there. Brian BuntzImage from EucomedConventional wisdom has it that the United States is still the strongest global player in the medical device industry. But a casual look at the five largest medical device companies reveals that only Johnson & Johnson has a U.S. domicile. Among the top 10, half...
  • Google's $25 Million Bet to Cure Heart Disease

    With the American Heart Association matching the money, the goal is to spend $50 million over five years on a single, to-be-determined research effort.Slideshow: The Year High Tech Got Serious about MedtechChris NewmarkerCall it another example of Google’s “moonshot” approach to tackling technological problems. This time, it involves cardiovascular diseases—which account for 17 million deaths around the world annually, making it the No. 1 cause of death.Alphabet’s Google Life Sciences business...
  • Is There a Disconnect over Medical Device Indications?

    If it looks like a duck, swims like a duck, and quacks like a duck, then it’s probably a duck. While that “duck test” may be true for fowl, determining how medical devices are used in patients is a trickier subject.Qmed StaffWhile medical devices are granted clearance or approval by FDA for a prescribed indication, off-label use is legal in many circumstances and is up to a doctor’s discretion. The fact that it is legal, means that off-label promotion of medical products is commonplace, says...
  • 3 Medical Device Trends to Know

    The impact of the Internet of Things and digital health disruption—those are but some of the things Qmed senior editor Chris Newmarker discussed in a recent online interview.Qmed StaffQmed senior editor Chris Newmarker spoke of everything from reporting to compliance to the Affordable Care Act to employee self-service usage during a recently freewheeling online interview on the TechnologyAdvice Expert Interview Series.The series, hosted by TechnologyAdvice’s Josh Bland, explores business and...
  • Move Over Wearables: Here Come Holograms and Cardiac Photosharing Apps

    USC has unveiled a photo-sharing app that tracks heart metrics and a virtual clinic that make use of hologram-based doctors.Qmed StaffWhile perhaps no other digital health technology has gotten as much attention as wearables, there are countless possibilities to leverage the technology to better monitor our health, says Leslie Saxon, cardiologist and executive director of the University of Southern California’s (USC) Center for Body Computing (CBC). Saxon showed off two such technologies at at...
  • Qmed Reader Survey

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  • Gamma Camera Defects Can Be Deadly

    ECRI Institute and FDA have received multiple reports of mechanical failures linked to gamma cameras, which can threaten patients and hospital staff members. In the past two years, there have been more than 40 recalls linked to the devices, which are used in nuclear medication applications. The cameras are typically very heavy, which has resulted in some patients being crushed. Many of the problems were linked to mechanical problems and sensor failures in the devices.The devices, which are...
  • Intensive Care Ventilator Problems

    As the ECRI report explains, inappropriate patient ventilation can cause lung injury in intensive care patients, possibly proving fatal in some cases. While ventilators include modes and features designed to address this problem, ventilator-induced lung injury (VILI) continues to be a problem. One contributing factor is that complex ventilator functionality included in some devices can be difficult for some clinicians to understand. In addition, there is a lack of standards among manufacturers...
  • USB Port Glitches in Medical Devices Trigger Recalls

    Many medical devices have USB ports. Plugging unauthorized devices into those ports can cause an array of problems, triggering, for instance, some physiologic monitors to reboot according to the ECRI Institute report. Last year, ArsTechnica reported that merely plugging a phone into an anesthesia device could potentially have fatal results for patients.A recall noticed from the manufacturer, Spacelabs Healthcare, acknowledges that a software defect could cause its ARKON Anesthesia System (shown...
  • Alarm Problems Can Contribute to Deaths and Injuries

    Creating an effective medical alarm may sound straightforward on the surface, but it is anything but. Up to 72–99% of alarms that go off in hospital settings are false, according to a 2013 article in the American Association of Critical-Care Nurses (AACCN) journal. The cacophony of alarms sounding in busy hospitals contributes to alarm fatigue—clinicians hear so many alarms that they begin to tune them out. John Hopkins Hospital reported in a study that, in its facility, 59,000 alarms sounded...
  • Improper Cleaning of Flexible Endoscopes Can Spread Superbug Infections

    Few other medical device problems received as much attention in the press in 2015 as a duodenoscope’s potential to spread pathogens. The devices were associated with outbreaks in hospitals in Seattle, Los Angeles, and outside Chicago, ultimately prompting FDA to release warnings related to the device and convene an FDA advisory panel to discuss the subject.In May, the FDA advisory panel recommended overhauling the cleaning protocols for the instruments and called for the use of ethylene...
  • Top 5 Medical Device Dangers to Avoid in 2016

    While faulty alarms continue to be a perennial risk, several of the other top medical device technology risks cited in ECRI’s annual roundup of health technology hazards have gotten relatively little recognition. Qmed Staff 1. Improper Cleaning of Flexible Endoscopes Can Spread Superbug InfectionsThe failure to adequately reprocess contaminated instruments—that is, to clean and disinfect or sterilize them—before using them on subsequent patients can lead to the spread of deadly pathogens....
  • Safeway May Be Cutting Ties with Theranos

    Theranos continues to get hammered by negative press from the Wall Street Journal. This time, the paper says Safeway executives are severing ties. Theranos claims the report is defamatory. Qmed StaffA Theranos Timeline2003 Elizabeth Holmes founds Theranos at the age of 19. In the coming decade, she secures hundreds of millions in funding for the firm.February 2014 Theranos CEO Elizabeth Holmes breaks her customary silence to grant a softball interview to Wired.November 2014 Walgreens announces...
  • Apple Hints at Its Medical Device Plans

    Before the Apple Watch debuted, the product was rumored to have medical device functionality. Now, Apple chief Tim Cook is saying that future iterations of the Apple Watch won’t have medical functionality either, but stated that it may produce “adjacent” products that go through FDA testing.  Qmed StaffApple WatchIn a recent public appearance in England and an interview with Telegraph, Tim Cook declared that the end is near for PCs and that the company is mulling launching some sort of...
  • Humanizing Implantables: The 'Invisible' User Experience

    Today’s implanted medical devices hold the potential to support wellbeing and proactively address preventable diseases in a more meaningful way than wearables ever could. But there are some glaring problems—including the “creepy factor” of implanting electronics into one’s body—that must be overcome.Stuart KartenWe are coming to a crossroads in the human-machine interface. Advances in battery technology, microsensors, and mobile technology networks have brought about a new category of...