AAMI News January 2018

News in Brief

Apple Heart Study AppThe Apple Heart Study app, paired with an Apple Watch, alerts wearers if it detects an irregular heartbeat.

Apple’s First Medical Study Signals Broader Health Ambitions

Electronics giant Apple has partnered with Stanford Healthcare to launch a mobile application to collect health data on a large scale. The partnership uses the Apple Watch’s LED-based heart rate sensor, a newly launched Apple Heart Study app, and advanced algorithms to determine whether the wearer is experiencing the irregular heart rhythm that characterizes a condition known as atrial fibrillation (AFib).

If the watch detects AFib, it alerts the wearer and offers a free consultation with a study physician who can provide additional monitoring options.

“Through the Apple Heart Study, Stanford Medicine faculty will explore how technology like Apple Watch’s heart rate sensor can help usher in a new era of proactive healthcare central to our precision health approach,” said Lloyd Minor, dean of the Stanford University School of Medicine in a statement.

AFib, which often goes undiagnosed, affects an estimated 33.5 million people worldwide, according to a 2013 study published in the journal Circulation. It is a leading risk factor for stroke.

Individuals who are 22 years old or older can download the app and participate in the study.

FDA Approves Digital Pill with an Ingestible Sensor

The Food and Drug Administration (FDA) has approved the first drug in the U.S. that contains a digital ingestion tracking system. The FDA approved Abilify MyCite, which contains a sensor that records when the patient took the medication, for the treatment of schizophrenia, some bipolar disorder scenarios, and as an additional treatment for adult depression.

The sensor in the pill, when paired with a wearable patch, allows patients and approved caregivers to track when the medication was taken.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in statement. “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.”

Abilify MyCite prescribing information cautions that the drug “is not for use as real-time or emergency monitoring” and that its ability to improve patient compliance “has not been established.”

AAMI Foundation, REMEDI Launch Ventilator Alarm Database

The AAMI Foundation, in partnership with the Regenstrief National Center for Medical Device Informatics (REMEDI) at Purdue University and the American Association for Respiratory Care, has developed a national database to collect and study ventilator alarm settings on a national scale.

The free online database allows stakeholders to enter alarm settings for different types of ventilators, patient conditions, and modes. After entering their own ventilator alarm data, respiratory therapists can then examine variations in default settings from around the country. The interactive tool also includes filters based on hospital characteristics and allows users to ask questions of others in the community.

“We are all very excited about the launch of this tool that permits hospitals to share their ventilator alarm default settings,” said Marilyn Neder Flack, executive director of the AAMI Foundation. “Our hope is that sharing this knowledge will help hospitals make decisions that will reduce nonactionable ventilator alarms and improve patient safety.”

To participate in the benchmarking program, respiratory therapists can enter data via catalyzecare.org/remedi.

Soft Robotic Sleeve Gives Hearts a Squeeze

Researchers at Harvard University and Boston Children’s Hospital announced in early 2017 that they developed a soft, silicone-based robotic sleeve to improve treatment options for people experiencing heart failure. Now, those researchers have taken a next, “half-hearted” step.

“We set out to develop new technology that would help one diseased ventricle when the patient is in isolated left or right heart failure, pull blood into the chamber, and then effectively pump it into the circulatory system,” said Nikolay Vasilyev, a cardiac surgery researcher at Boston Children’s, in a press release.

Device, which Vasilyev and other team members have demonstrated on pigs, uses a combination of rigid bracing, soft robotic actuators, and anchors to the heart’s septum to provide external pressure on the ventricle. The device is designed to help the heart pump blood, and unlike external ventricular assist devices, does not come into contact with the blood.

The study describing the soft robotic sleeve was published in the November 2017 issue of Science Robotics.

ACI to Offer Two Certification Testing Windows in 2018

The AAMI Credentials Institute (ACI) has scheduled two testing windows for 2018, running May 1–15 and Nov. 1–15. During this time, interested professionals will be able to take exams to become a Certified Biomedical Equipment Technician (CBET), Certified Laboratory Equipment Specialist (CLES), Certified Radiology Equipment Specialist (CRES), Certified Healthcare Technology Manager (CHTM), Certified Industrial Sterilization Specialist (CISS), or Certified Quality System Manager (CQSM).

“Congratulations to all of the test takers who passed an ACI certification exam in 2017, especially the industrial sterilization specialists who sat for the first-ever Certified Industrial Sterilization Specialist exam in December!” said Sherrie Schulte, AAMI’s senior director of certification and annual conference. “If you haven’t earned your certification yet, make the commitment now. There is plenty of time to prepare before the next testing window opens.”

Earning a certification is one way for healthcare technology professionals to demonstrate and showcase their accomplishments, mastery of skills, and experience in core competencies. Certification also helps highlight a professional’s ability to provide quality and trustworthy service.

For more information about ACI certification or to register for an upcoming exam, please visit www.aami.org/aci.