Adverse events and recalls aren’t always proof of a mechanical error. Some devices are difficult to use. Human error and patient harm can stem from unclear electronic interfaces or complicated procedures for use.
Interoperability is an increasingly important component of med tech, due to the need for communication and data exchange within a networked system of other devices, electronic health records and clinicians. Poor interoperability is blamed for problems like “alarm fatigue” whereby poorly networked devices produce an excessive number of loud warnings out of an abundance of caution, leading to the risk that a necessary alarm will be ignored.
With superbug infections proliferating at U.S. healthcare facilities, hospitals are looking for new ways to eliminate potentially deadly bacteria. Mayo Clinic is jumping on the bandwagon, rolling out bacteria-fighting robots that use UV light to kill C. difficile.
Columbia engineering researchers have found that electrical stimulation of human heart muscle cells, or cardiomyocytes, engineered from human stem cells can beat with electrical stimulation. For the first time, they found that this activity actually encouraged the nascent cardiomyocytes to beat autonomously and to transfer that to surrounding cardiomyocytes.
The National Institutes of Health has launched a program to explore the role of genomics in common diseases such as heart disease, diabetes, stroke and autism. This program, along with the continuation of another program dedicated to the study of genomics underlying rare diseases like cystic fibrosis and muscular dystrophy, has gained a commitment for $313 million in NIH funding from various agencies over the next four years.
The FDA’s device arm (CDRH) aims to increase use of “real-world” data in decision-making, further engage patients, and strengthen product and manufacturing quality, according to an outline of its strategic priorities for 2016.
With medical testing on the rise, companies are eager to jump on the bandwagon with products geared toward consumers. However, more testing does not always translate into better outcomes for patients, some experts say, and the latest recommendations on breast cancer screening provide a case in point.
Lumos Labs is shelling out $2 million to settle claims from the FTC that it duped consumers about its “brain training” program and apps by convincing them that its games could help stave off serious health conditions or cognitive impairments.
Back in 2013, nonprofit hospital accreditor the Joint Commission set alarm safety for patient monitoring as its safety goal, giving hospitals until January 2016 to set up new policies and procedures for related devices. With the first of the year come and gone, healthcare centers are rolling out new solutions to reduce unnecessary alarms and improve monitoring.
The U.S. National Institutes of Health (NIH) is financing what is expected to be the largest long-term clinical study for an artificial pancreas to regulate the blood sugar levels in Type 1 diabetics to the tune of $12.7 million. This is the biggest chunk it’s yet doled out as part of a program the Agency started in 2014 to promote testing of artificial pancreas systems that’s already backed at least three other research efforts.