BI&T Editorial Board Awards Top Honors
An airline pilot (who also is a healthcare consultant), a clinical technology and biomedical engineering team at Stanford, and a cadre of nurses and one physician at Johns Hopkins Hospital have been recognized for their outstanding contributions to BI&T. The winners will be recognized during a ceremony on Saturday, June 4, during the AAMI 2016 Conference & Expo (June 3–6 in Tampa, FL).
Best Article. This honor was awarded to a clinical technology team at Stanford Medicine in California for its article published in the July/August 2015 issue: “Operabtionalizing Medical Device Cybersecurity at a Tertiary Care Medical Center.” The article provides a detailed and clear “how to” case study that described the steps and processes the team took to ensure medical device cybersecurity at a 400-bed facility. Priyanka Upendra, CCMS, SSLP, Purna Prasad, PhD, CCE, Glenn Jones, and Harvey Fortune, CBET, also shared their “lessons learned,” providing a handy tip sheet to the many other facilities that face the same challenge.
Best Research Paper. This award went to a clinical team at Johns Hopkins Hospital in Baltimore for the article, “Effect of Altering Alarm Settings: A Randomized Controlled Study,” which was included in the May/June 2015 issue of the journal. Maria Cvach, DNP, RN, assistant director of nursing, clinical standards; Kathleen Rothwell, RN, nurse manager; Ann Marie Cullen, RN, CCNS, CCRN, clinical nurse specialist; Mary Grace Nayden, RN, NCIII nurse clinician; Saint Joseph's University undergraduate student Nicholas Cvach; and Julius Cuong Pham, MD, PhD, emergency department and anesthesia critical care physician, looked at the relationship between the number of alarm signals and staff responsiveness. The study demonstrated how a hospital could develop a controlled study to obtain outcome data related to altering patient monitoring alarm settings, providing a roadmap to assess a formidable patient safety problem (alarm fatigue) and offering a potential solution (altering alarm parameters).
Best Commentary. Best Commentary was awarded to “Adverse Events Do Not Happen by Accident” by Joseph Brown, a commercial airline pilot who also runs a consulting firm that specializes in applying the lessons learned in aviation to improve healthcare. “Healthcare can no longer afford to approach safety reactively,” Brown wrote in the May/June 2015 issue of BI&T. “Determining healthcare quality based solely on outcomes is neither optimal nor affordable. Outcomes are nothing more than ‘box scores,’ and box scores don't tell us how the game was played.”
In another award category voted on by AAMI's Technology Management Council, the ABM clinical engineering (CE) team at the Women & Infants Hospital of Rhode Island was selected to receive the 2016 Bright Ideas Award. The ABM CE team was chosen for its collaborative, silo-breaking process to streamline temperature control monitoring. According to the article profiling the team (March/April 2015 BI&T): “The efforts of the ABM CE team to rally the multidisciplinary team, improve its understanding of the temperature control system, and set out clear roles and responsibilities highlight the invaluable role that CE plays in improving patient care.”
Paralyzed Man Performs Movements with Brain Implant, Electrode Sleeve
Using NeuroLife—a neural bypass technology from the Columbus, OH–based company Battelle—a young man with quadriplegia was able to move his fingers and hand for the first time in six years.
Ian Burkhart, age 24, who injured his spine in 2010 during a diving accident, had a microchip sensor implanted in the motor cortex of his brain (the part where nerve impulses dictating movement originate). The implant sends signals to an electrode sleeve worn on the arm, which translates the impulses and stimulates muscles in the forearm to move the hand and fingers. During a demonstration at Ohio State University Wexner Medical Center, Burkhart was able move his fingers and hand with his own thoughts, allowing him to perform movements such as swiping a credit card and playing a video game.
“It's much like a heart bypass, but instead of bypassing blood, we're actually bypassing electrical signals,” said Chad Bouton, a research leader at Battelle, in a news release. “We're taking those signals from the brain, going around the injury, and actually going directly to the muscles.”
The findings were published online on April 13 in Nature.
AAMI Announces 2016 Award Recipients
The following lineup of healthcare technology experts and innovators, along with patient safety champions, standards volunteers, young professionals, and students, will be recognized during AAMI 2016:
The AAMI Foundation's Laufman-Greatbatch Award. Ary L. Goldberger, MD; Roger G. Mark, MD, PhD; and George Moody, founders of PhysioNet
The AAMI Foundation & ACCE's Robert L. Morris Humanitarian Award. Roy G. Morris, CBET, director of biomedical engineering for the International Children's Heart Foundation in Memphis, TN
The AAMI Foundation & Institute for Technology in Health Care's Clinical Solution Award. James Piepenbrink, director of clinical engineering and Clinical Alarm Task Force at Boston Medical Center in Boston, MA
AAMI & Becton Dickinson's Patient Safety Award. Maria Cvach, DNP, RN, FAAN, director of policy management and integration for Johns Hopkins Health System and a clinical safety specialist for the Armstrong Institute for Patient Safety and Quality in Baltimore, MD
AAMI's HTM Leadership Award. Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, managing partner and principal consultant for Strategic Healthcare Technology Associates, LLC
AAMI & GE Healthcare's BMET of the Year Award. Carlos Villafañe, CBET, CET, a biomedical equipment technician III at St. Joseph's Hospital in Tampa, FL
AAMI's Young Professional Award. Jennifer DeFrancesco, chief biomedical engineer for the Indianapolis VA Medical Center and VISN 10
The Spirit of AAMI Award. Larry Hertzler, MBA, CCE, vice president of technical operations at Aramark Healthcare Technologies in Charlotte, NC
Standards Developer Award. Charles (Phil) Cogdill, senior director of sterilization and microbiology at Medtronic, for his work on AAMI's sterilization committees; John Hedley-Whyte, MD, David S. Sheridan Professor of anesthesia and respiratory therapy at Harvard University in Cambridge, MA, for his contributions to anesthesia and respiratory standards; Byron Lambert, PhD, MAR, senior associate fellow, sterilization science at Abbott Vascular in Temecula, CA, for his work on AAMI's sterilization committees; Harold (Hal) Yeager, MS, RAC, global device safety officer at Eli Lilly & Company in Indianapolis, IN, for his contributions as chair of ISO TC 84; Michael Schmidt (posthumous), principal consultant and owner of Strategic Device Compliance Services in Cincinnati, OH, for his long-standing commitment to the IEC TC62D program
AAMI Technical Committee Award. This award recognizes outstanding committee efforts to advance standards and will be presented to the Combination Products Committee. This committee exemplifies the capacity of AAMI to guide and thereby advance efficient and effective industry practice in an area that previously did not have established regulatory procedures.
AAMI Foundation Scholarship Winners
Each year, the AAMI Foundation awards scholarships to students aspiring to become HTM professionals who demonstrate a record of academic excellence, technical aptitude, and a commitment to the field. This year's winners are:
Sarah Brockway, who is working toward a master's of science in biomedical engineering at the University of Connecticut in Storrs, CT
Victor Makwinja, who is studying for a postgraduate diploma in healthcare technology management at the University of Cape Town in South Africa
Jay McKinney, who is working toward a bachelor's degree in healthcare engineering technology management at Indiana University–Purdue University Indianapolis in Indiana
Conrad Robinson, who is working toward an associate of applied science degree in biomedical equipment technology and medical imaging certificate at Texas State Technical College in Waco, TX
Google Patents Drone Delivery of Medical Devices
In early April, Google was awarded a patent for a dispatch system that would fly life-saving medical equipment to where it was needed on demand. According to the company, this could be especially useful in remote or rural locations.
The patent describes a device akin to an emergency intercom that would allow people to press a button to indicate their specific medical emergency or request. The system would then deploy a drone to deliver the necessary equipment, such as a defibrillator in the case of a heart attack.
Google isn't the only organization looking to utilize drones to deliver medical care. A startup company called Zipline plans to deliver medicine, blood, and other medical supplies to remote clinics throughout Rwanda starting in July. These plane-like drones will make up to 150 flights per day and will be paid for by the Rwandan government.
Shifting Clinical Evidence for Medical Devices toward Postmarket
Advances in technology and data collection can help regulators and other parties keep better track of the safety and performance of medical devices once they are on the market, opening the door to potentially faster product development. This was the message delivered at a recent conference hosted by the University of Maryland's Center of Excellence in Regulatory Science and Innovation (M-CERSI), titled Building the National Evaluation System for Medical Devices: Using Real World Evidence to Improve Device Safety and Effectiveness.
A number of systems, such as the Medical Device Epidemiology Network Initiative (MDEpiNet), Sentinel, and the National Patient-Centered Clinical Research Network (PCOR-net), provide this information on a smaller scale. However, this has created a “disparate, uncoordinated system of data,” according to Gregory Daniel, PhD, deputy director of the Duke-Margolis Center for Health Policy. A national evaluation system would build a coordinated approach and structure to integrate these data, he added.
At the moment, clinical trials and clinical practice are “parallel worlds,” said Jeffrey Shuren, MD, director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health. But with the data available in electronic health records (EHRs), insurance claims forms, patient registries, and other databases, the FDA believes that creating a system to collect, aggregate, and analyze this valuable information could bring postmarket data into the realm of clinical evidence.
Although clinical trials are considered the gold standard for ensuring the safety and effectiveness of medical devices on the market, high costs, inefficient data generation, and other burdens associated with the regulatory process have created disincentives for companies to study their devices in the United States and are driving away innovation, as reported by a number of conference presenters.
The FDA's goal is to gain access to 25 million patient records from national and international clinical registries, claims data, and EHRs by the end of 2016. It also is aiming to increase the number of pre- and postmarket decisions that leverage real-world evidence by 40% during that time frame.
1,400+ Software Vulnerabilities Found in Medical Supply System
Cybersecurity researchers uncovered 1,418 third-party software vulnerabilities in an outdated, but still utilized, automated supply cabinet used to dispense medical supplies and keep track of stock, according to a federal cybersecurity advisory.
Independent researchers Billy Rios, who spoke at last year's AAMI Annual Conference & Expo, and Mike Ahmadi, an AAMI member, in collaboration with CareFusion, identified the vulnerabilities in older versions of the Pyxis SupplyStation system, specifically versions 8.0 through 9.3, which run on Microsoft Server 2003/XP. The issues were linked to seven different third-party vendor software packages bundled into the system, including MS Windows XP, Symantec Antivirus 9, and Symantec pcAnywhere 10.5.
According to the advisory, a low-skill attacker would be able to exploit many of these vulnerabilities and do so remotely.
CareFusion has started contacting healthcare facilities that are still using these systems about the vulnerabilities and is encouraging them to upgrade or at least apply specific compensating measures. Patches will not be provided, as the affected versions are at end-of-life and are no longer supported.
More Patients than Previously Thought Affected by Superbug-Contaminated Scopes
The number of patients affected by endoscopes carrying carbapenem-resistant Enterobacteriaceae between 2010 and 2015 is much higher than the Food and Drug Administration previously reported, according to the results of a Congressional investigation cited by Kaiser Health News.
The investigators reported 350 patient cases at 41 provider sites worldwide. The House Committee on Oversight and Government Reform stated it had evidence that contaminated duodenoscopes were responsible for up to 404 patient infections and 44 four additional patient exposures to contaminated devices, Kaiser Health News also reported. The full report was set to be unveiled in late April.
Sterigenics Boosts Sterilization Offerings with Nelson Laboratories Acquisition
Sterigenics International LLC announced in early April that its acquisition of Nelson Laboratories. With the deal, Sterigenics—which was acquired in 2015 by private equity firms Warburg Pincus and GTCR—culminates in the largest fully integrated global sterilization and lab services firm in the world. The acquisition is expected to put the new company in a prime position to address a pressing issue facing the industry: medical device contamination, particularly that related to duoendoscopes.