As many hospitals deploy initiatives to reduce preventable harm, the key goal is to strive to minimize errors and improve patient safety.
While medical devices such hip, knee and cardiovascular implants are essential to the treatment and well-being of patients—they extend life and improve quality of life—they sometimes don’t work as intended and those incidents may result in harm to the patient.
New research from TGHRI Scientist Dr. Anna R Gagliardi reveals that hospitals may need to improve the systems by which physicians, the health care professionals who implant medical devices, identify and report medical device incidents.
Previous work by Dr. Gagliardi and colleagues analyzed data from Health Canada on medical device recalls over a ten-year period (2005 to 2014) and found that 5% of over 7,200 medical devices recalled were due to problems with the device that could cause harm to patients. Thus, while medical device incidents might be rare events, it is crucial to quickly identify and report such problems.
To further explore the underlying reasons for this underreporting of medical device incidences, Dr. Gagliardi, along with collaborators at UHN, the University of Toronto and across Canada, conducted a qualitative study—one in which detailed information is gathered from a small group of individuals who represent the views and experiences of a larger group. In this case, detailed interviews were conducted with a diverse group of 22 physicians from across Canada.
During the 30 minute interviews, physicians were asked to describe a recent event in which a medical device malfunctioned, the implications, and how they reported it, including any factors that influenced reporting.
The findings showed that there are two factors that could be addressed at the health system level: physician beliefs and health care system capacity. Reporting may be limited by physicians’ understanding of what is and is not a medical device incident. It is further limited by a lack of administrative tools at hospitals to capture the information or bypass purchasing agreements with medical device manufacturers in order to purchase alternative devices.
“Taken together, the results of our study suggest that effective solutions to the underreporting problem must be multifaceted. Rather than simply educating physicians on how and when to report incidents, we need to create the right environment for reporting. This includes the right policies at hospitals, including information systems and incentives to encourage reporting. It may also include establishment of national and international systems to broadly capture and publicly share information about medical device incidents,” says Dr. Gagliardi.
This work was supported by the Canadian Institutes of Health Research and the Toronto General & Western Hospital Foundation.
Gagliardi AR, Takata J, Ducey A, Lehoux P, Ross S, Trbovich PL, Easty A, Bell CM, Urbach DR. Medical Device Recalls in Canada from 2005 to 2015. Int J Technol Assess Health Care. 2017 Sep 18. doi: 10.1017/S0266462317000824.
Gagliardi AR, Ducey A, Lehoux P, Turgeon T, Ross S, Trbovich P, Easty A, Bell C, Urbach D. Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices. BMJ Qual Saf. 2017 Aug 2. doi: 10.1136/bmjqs-2017-006481.
The American College of Rheumatology (ACR) named Krembil Emeritus Scientist Dr. Murray Urowitz recipient of the 2017 Distinguished Clinical Investigator Award. This highly prestigious award is presented annually to a clinical investigator that has made exceptional contributions to the field of rheumatology.
Dr. Urowitz’s research is focused on the study of the autoimmune disease known as systemic lupus erythematosus, which is commonly referred to as lupus. He is responsible for establishing a key resource for clinicians and researchers—a database containing one of the largest stores of clinical data on lupus, with data from over 1200 patients. This resource has led to the creation of the Centre for Prognosis Studies in The Rheumatic Diseases, for which Dr. Urowitz serves as Co-Director along with Dr. Dafna Gladman.
His research program has enabled the establishment of new standardized approaches for measuring lupus outcomes, which are now used worldwide; and has helped shed light on aspects of the disease, including disease flares, the effects on pregnancy and hormone replacement therapy, as well as diseases that are linked to lupus, such as cancer, renal disease and atherosclerosis.
Dr. Urowitz will receive this award of distinction at the ACR Annual Meeting in San Diego on November 4, 2017. To see the other awardees, visit the ACR website.
Congratulations to Dr. Urowitz!
On October 12, 2017, researchers from the iDAPT labs at University Health Network’s Toronto Rehabilitation Institute launched DriverLab. This state-of-the-art virtual reality research simulator will enable researchers to study the impact of our health on driving performance, with an aim to increase driver safety in healthy older adults and people living with injury or illness.
DriverLab is the most advanced driving simulator in Canada and is unique in the world, in terms of the realistic experience it offers drivers. Using a mounted Audi A3, a 360-degree projector system, and a 7-degrees-of-freedom hydraulic motion platform, DriverLab immerses drivers in a high-resolution virtual environment, complete with surround sound. One-of-a-kind features include a weather simulator (to produce real rain droplets on the windshield) and a glare simulator (to recreate the harsh glare of oncoming headlights). Virtual scenery takes drivers into the city, country, and highway, during the day and at night.
DriverLab’s innovative technology comes at a time when vehicle collisions represent the number one cause of accidental death in Canada, and cost Canadians $62.7 billion per year. Global numbers are equally staggering: Every year, 1.24 million people around the world die in motor vehicle collisions and up to 50 million people suffer from disabling injuries due to motor vehicle collisions.
Key research goals that will be enabled by DriverLab include:
● Support independent aging by enabling the creation of customized driver licenses. Too many older adults are involved in collisions. DriverLab will help researchers to identify the most dangerous driving conditions, which could be used to inform the creation of customized licenses that would enable older adults to continue driving as long as safely possible.
● Study the effects of medication on driving performance. DriverLab will be used to determine the effect of various drugs, such as opioids, on driving performance. Watch a video of Dr. Andrea Furlan, Senior Scientist and pain specialist, explain how DriverLab will help us to understand how opioids affect a person’s ability to drive safely.
● Research the implications of drowsy driving. DriverLab will help address the associations between major sleep disorders (such as sleep apnea) and driving performance, and develop methods for preventing, detecting and diverting drowsy driving.
● Determine the full effects of automated driving systems. DriverLab will evaluate the impact of modern car safety systems, semi-autonomous vehicle features and driverless cars. Watch a video of Dr. Alex Mihailidis, Scientific Director of the AGE-WELL Network of Centres of Excellence (NCE), explain how DriverLab will support the research goals of AGE-WELL as it relates to transportation and new technologies for seniors.
● Reduce driving simulator sickness. DriverLab will help develop optimized driving simulation technologies, for testing centres to use for driver training and testing purposes.
To see DriverLab in action, and to learn about the above research goals, watch this video.
DriverLab was made possible through support from the Canadian Institutes of Health Research, the Canada Foundation for Innovation, the Government of Ontario, and Toronto Rehab Foundation. DriverLab was developed with the assistance of International Development of Technology B.V. (based in the Netherlands).
The Honourable Kirsty Duncan, Minister of Science, announced that the Canada Foundation for Innovation (CFI) will be investing $554 million to provide cutting edge research equipment to researchers across Canada.
Of these funds, UHN will be awarded $18.3 million for two projects: one to advance precision medicine for cancer and another to develop new therapeutics for neurological disorders.
"This funding will enable UHN to build upon our reputation for world-class research, enhance research capacity and strengthen partnerships across sectors,” says Dr. Bradly Wouters, Executive Vice President, Science and Research at UHN, and Senior Scientist at PM Cancer Centre. “This state-of-the-art equipment will propel our research projects to the next level, so that we can ultimately deliver the best possible care.”
The two UHN-led projects that received funding are as follows:
● The Princess Margaret Cancer Centre Precision Medicine Program
This project, led by Dr. Bradly Wouters, will enable researchers to profile tumours like never before: tumour cells from patients will be analyzed using a variety of advanced readouts (eg, genomics, transcriptomics, proteomics, single cell analysis, imaging, tumour biology and drug response). These readouts will be cross analyzed and linked to patient outcomes, enabling PM researchers to peer into the molecular makeup of cancer cells with unprecedented detail. With an investment of $11.8 million from CFI—the second largest award given to a single project in this competition—this project will ultimately enable the development of more effective cancer therapies that are better tailored to individual patients.
● The CenteR for Advancing Neurotechnological Innovation to Application (CRANIA)
This project, led by TRI Senior Scientist Dr. Milos Popovic, will receive $6.5 million to create advanced ‘neuromodulation’ therapies. These therapies work by stimulating specific brain regions involved in neurological diseases and conditions, such as epilepsy, depression, Alzheimer disease, Parkinson disease and spinal cord injury. CRANIA’s researchers—including those at the University of Toronto and at UHN’s Krembil Research Institute—will use the cutting-edge equipment to identify brain regions involved in disease, and develop and customize new ‘smart’ implantable devices to target these specific regions for therapeutic purposes.
UHN was involved in two additional projects: one was led by The Hospital for Sick Children’s Dr. John Rubinstein, to establish a joint electron cryomicroscopy facility with Toronto-area institutions; and a second, led by the University of Toronto’s Dr. Milica Radisic (who is also a TGHRI Affiliate Scientist), will develop novel ‘organ-on-a-chip’ models that will accelerate drug discovery efforts for a variety of diseases.
Congratulations to all UHN researchers and staff involved in these exciting projects.
More than one billion people around the world use the web mapping service Google Maps. Among its most popular features is the trip planner, which suggests the most optimal route to travel from one destination to another.
Similarly, the healthy brain depends on many networks of optimally connected routes to efficiently send and receive information. A new study by Krembil Senior Scientist Dr. Antonio Strafella reveals that the disruption of these networks may result in Parkinson disease—a neurodegenerative disorder causing changes in movement, behaviour and cognitive ability.
In the study, Dr. Strafella and his research team used a highly sophisticated imaging analysis technique called dynamic functional connectivity to visualize the brains of people with or without Parkinson disease. They found that brains switch back and forth between two states: in the first state, the brain has sparse connections, but these connections function very efficiently in transmitting information; however, in the second state, the connections are unstable despite the fact that they are highly connected.
In comparing the brain states of those with or without Parkinson disease, the researchers found that people with Parkinson disease were more likely to be in the second state. A shift in brain states from the first to the second was associated with the severity of Parkinson disease symptoms, such as tremor, slowness of movement and impaired speech.
“We are the first to identify this second brain state,” says Dr. Strafella. “Our results indicate that the brain of a patient with Parkinson disease is not very efficient and is not taking the fastest and shortest route between two points to perform a task. Our next step is to figure out what role this process plays in the evolution of the disease and how treatments to influence this brain state might help improve patients’ quality of life.”
This work was supported by the Canadian Institutes of Health Research and the Toronto General & Western Hospital Foundation. A Strafella is a Tier 2 Canada Research Chair in Movement Disorders and Neuroimaging.
Kim J, Criaud M, Cho SS, Dı´ez-Cirarda M, Mihaescu A, Coakeley S, Ghadery C, Valli M, Jacobs MF, Houle S, Strafella AP. Abnormal intrinsic brain functional network dynamics in Parkinson’s disease. Brain. 2017 Oct 5. doi: 10.1093/brain/awx233.
Adopting a Canadian policy of determining death by the absence of circulation has increased donation by 57 per cent in Ontario in 12 years, says a new study led by TGHRI Senior Scientist Dr. Vivek Rao.
Dr. Rao, who is also Chief of Cardiovascular Surgery at the Peter Munk Cardiac Centre and a heart transplant surgeon at UHN’s MultiOrgan Transplant Program, compared transplant activity in three distinct eras, from 2002 to 2014, spanning the time before the donation after cardiac death (DCD) policy to after the policy was adopted in Ontario in 2006.
In study, which was recently published in the Canadian Medical Association Journal (CMAJ), found that the total number of organ donors increased from 132 to 233 per year, with a cumulative total of 2,258 deceased donors and 6,763 deceased-donor transplants. Over the three successive eras, the proportion of DCD donors also increased, with DCD accounting for 21 per cent of overall donor activity in the most recent era, ending in March 2014.
"Ontario now enjoys one of the highest rates of DCD in North America", writes Dr. Rao, adding that DCD has been the most important development in efforts to expand the donor pool.
In DCD, death is declared on the basis of cardiopulmonary criteria (irreversible cessation of circulatory and respiratory function) rather than the neurologic criteria used to declare "brain death" (irreversible loss of all functions of the entire brain, including the brain stem). Such donations usually involve patients who are on a ventilator as the result of irreversible brain or spinal cord injuries or end-stage musculoskeletal disease.
DCD is practiced in the U.S. and Europe, including the United Kingdom, where DCD donors comprise about 40 per cent of all deceased donations. This approach was followed until about 1968, when a brain-based definition of death was adopted.
In an accompanying commentary, Dr. Sam Shemie, a critical care physician at the Montreal Children's Hospital, adds that donation after neurological determination of death does not appear to have been adversely affected by DCD.
Both types of donations have increased, he writes, pointing out that donation-focused personnel, such as physicians and nurse coordinators, have also improved the organ donation system.
"This DCD resource has always been there," notes Dr. Les Lilly, Medical Director, Gastrointestinal Transplantation. "But for years and years the organs of these patients have been buried with them, and although there is minimal activity in their brain stem, you can't live with just a brain stem. These are patients who don't wake up."
The impact on increasing donation is huge, says Dr. Lilly, noting that brain death accounts for about 1.5 per cent of hospital deaths. For most patients, death occurs due to cardiac death after life support is removed.
In Ontario, at any point in time, there are 1,500 patients waiting for an organ transplant, and someone dies every three days while waiting. Currently, about 30 per cent of Ontarians have registered consent to donate.
You can register online at www.BeADonor.ca, the provincial site administered by Trillium Gift of Life network.
Rao V, Dhanani S, MacLean J, Payne C, Paltser E, Humar A, Zaltzman J. Effect of organ donation after circulatory determination of death on number of organ transplants from donors with neurologic determination of death. CMAJ. 2017 Sep 25. doi: 10.1503/cmaj.161043.