4D cardiac imaging, which generates a three-dimensional motion picture of a beating’ heart, offers cardiologists a revolutionary new tool. Indeed, the ability to acquire images across all phases of a heartbeat cycle is the only way to meaningfully visualizing morphological anomalies and make an authentic assessment of cardiac function.
Traditionally, ultrasound has been a preferred modality for 4D cardiac imaging. However, 4D cardiac MRI (known formally as cardiovascular’ MRI) has been gaining ground. Coupled with MRA (magnetic resonance angiography), it enables cardiologists to view images of the heart, major blood vessels and blood flow.

The novelty of 4D
4D cardiac imaging is a recent technique. Its novelty is best illustrated by an editorial in The Journal of the American College of Cardiology’. The editorial, published as recently as 2009, observed the role of ‘2- and 3-dimensional coronary mapping’ in high-resolution digital imaging.
Major imaging vendors now offer real-time 3D/4D imaging products – across all modalities, PET/CT, MRI and ultrasound. However, the bulk of 4D applications so far have involved ultrasound – especially for cardiac imaging. This may be changing, with increased attention, above all, to MRI.

Ultrasound’s longer legacy
One reason for ultrasound’s pole position in 4D consists of a longer legacy. In the early 1980s, researchers from Duke University in the US reported that though MRI was faster, ultrasound offered the closest achievement of ‘3D real-time acquisition,’ or what is now called 4D.
Technical standardization bodies also moved quickly to endorse and drive the take-up of 4D ultrasound. In 2008, the DICOM (Digital Imaging and Communications in Medicine) initiative approved Supplement 43 which addressed the exchange of real time 3D ultrasound datasets between different vendors. In 2011, IHE (Integrating the Health Enterprise) published a White Paper on 3D/4D imaging workflow.

Early adoption of 4D ultrasound by cardiologists
On their part, cardiologists were enthusiastic early adopters of 3D (and later 4D) ultrasound. The IHE’s White Paper mentioned above was written by its Cardiology Technical Committee. Another factor strongly favouring ultrasound was mobility, since small ultrasound devices could be transported to the patient.
During this period, competing imaging modalities seemed to stand little chance as far as cardiology was concerned.
Computerized tomography (CT) was dismissed since it required cardiologists to use complex post-processing techniques in order to visualize the bearing heart. Cardiac magnetic resonance imaging (MRI) was considered relatively expensive, with limited availability and requiring specialized training.

GE’s cSound: industry seizes the ultrasound opportunity
Industry was quick to seize the ultrasound opportunity. In 2015, healthcare technology giant GE released new software for its ultrasound machines called cSound. cSound-equipped machines intelligently process data being returned by an ultrasound signal, analysing almost 5 gigabytes of data every second, and then filtering it on a pixel-by-pixel basis via algorithms which produced real-time 4D views. This allowed cardiologists to observe how blood swirls around clots in arteries, measure blood leakage around the valves and assess damage. cSound reinforced GE’s presence at the cutting edge of ultrasound, reinforcing a technique patented by the company in the early 2000s and known as Spatial Temporal Image Correlation (STIC). STIC allowed for the quick capture of a full fetal heart cycle beating in real-time.

4D PET/CT and MRI turn to diagnostic oncology
Proponents of 4D PET (positron emission tomography)/CT and MRI were however not sitting by idly. Rather than cardiology, they turned their attention to other specialities, above all oncology where 4D offered huge potential in diagnostics.
4D PET, for example, seemed unmatched in characterizing solitary pulmonary nodules, while 4D CT offered a revolutionary approach in oncology – such as gating tumours and determining treatment margins. On its part, 4D MRI demonstrated a superiority to CT in soft-tissue imaging and in cases where radiation exposure was a concern.

From 4D to 5D imaging
As of now, the focus in diagnostics is to combine the anatomical with functional or molecular imaging, in order to make precise assessments of biological and metabolic pathways. Key modalities include PET with radio-labelled tracers for molecular imaging, and MRI using molecular markers for functional imaging. The molecular/functional enhancement is often referred to as 5D, and to its proponents, offers hope in increasing the specificity and sensibility of diagnostics.
At some stage in the future, it is inevitable that cardiologists will see the virtues of 5D imaging for diagnostics.

The challenge from multi-detector ultrasound scanners
Meanwhile, cardiac ultrasound faces competition in certain applications from other imaging modalities.
In recent years, multi-detector CT scanners seem to offer considerable promise, particularly for non-invasive detection of coronary artery disease and higher flexibility for analysis and visualization of individual vessels. These images, nevertheless, continue to require special processing and rendering tools for assessment of segmental narrowing or occlusions.

The growing promise of 4D cardiac MRI
Rather than CT, cardiac (or cardiovascular) MRI in 4D seems to have rapidly become the principal technology paradigm challenger to ultrasound.
Cardiac MRI scanners do not use open’ magnets which face serious limitations in the case of moving objects – such as a beating heart. The magnet strengths most widely used for cardiac MRI are 1.5T and 3T – although the latter, in some conditions, require software to cancel artifacts. Higher strength magnets are, however, the technology of choice in studying conditions such as aortic construction.
What is also a key advantage of cardiac MRI compared to CT is its lack of ionizing radiation, high spatial resolution and the ability to provide a functional cardiac assessment in one scan.

The technique of 4D cardiac MRI is closely based on traditional MRI. However, it is optimized for use in the cardiovascular system in real time, principally via ECG gating and rapid imaging sequences. This results in acquisition of images at each stage of a sequence of cardiac cycles, and functional assessment of the heart. Blood, in such sequences (technically known as balanced steady state free precession or bSSFP), appears bright due to contrast with blood flow. As a result, 4D cardiac MRI makes it possible to discriminate in a relatively easy fashion between the myocardium and blood.

With and without contrast agents
Cardiac MRI typically uses several approaches to make a comprehensive assessment of the heart and cardiovascular system. Some of the most promising applications include the ability to visualize heart muscle fat or scar in high resolution without the need for a contrast agent. This is based on a technique called spin echo’, which shows blood as black, and identifies myocardium abnormalities through differences in intrinsic contrast.

On the other hand, contrast agents like gadolinium-DTPA can be used for applications such as infarct imaging – where healthy heart muscle appears dark, and infarction areas show in bright white. Contrast agents in cardiac MRI have also proven their worth for treatment of coronary artery narrowing, which starves the heart muscle of oxygen. The contrast agent reveals any transient perfusion defects from artery constriction. Knowing about the presence of such a defect assists in guiding interventional procedures.

Image quality, superior access to anatomical structures
Cardiac MRI provides images of superior quality, accuracy and versatility, alongside access to anatomical structures which are tough to achieve with ultrasound. Examples of these include congenital heart anomalies as well as anatomical changes after surgical interventions.
The latest generation of MRI scanners allow for acquiring high-resolution isotropic data with detailed anatomical information and identical resolution in all three dimensions. Frontier areas of research for 4D MRI include qualitative and quantitative flow pattern analysis in mice with aortic constriction.

Detecting hemodynamic alterations with 4D MRI
At present, one of the most promising cardiac applications for 4D MRI consists of the detection of haemodynamic alterations. The incorporation of pharmacological stress procedures allows for enhanced detection of alterations in heart function during stress-induced ischemia.
In April 2014, a team at Northwestern University reported that 4D flow MRI would help better understand altered hemodynamics in patients with cardiovascular diseases and improve patient management and monitoring of therapeutic response. Their study, published in Cardiovascular Diagnosis and Therapy’, noted that these hemodynamic insights could also lead to new risk stratification metrics in patients and impact upon individualized treatment decisions in order to optimize patient outcomes.

Diagnostics and prognosis of heart events
Cardiac MRI is also being seen as a diagnostic tool to predict heart events. In May 2016, a study led by John P. Greenwood from the University of Leeds in Britain noted that it was ‘a better prognosticator of risk for serious cardiovascular events than SPECT, regardless of a person’s risk factors, angiography results, or initial treatment, and that it would be a powerful tool for ‘the diagnosis and management of patients with suspected coronary heart disease.’ The serious events, assessed over a 5-year period, included death, myocardial infarction/acute coronary syndrome, unscheduled coronary revascularization, or hospitalization for stroke, transient ischemic attack, heart failure, or arrhythmia.
The study was based on a multi-parametric cardiovascular MRI protocol, and performed on a 1.5T MRI scanner and published in the Annals of Internal Medicine’. It was formally known as the Clinical Evaluation of Magnetic Resonance Imaging in Coronary Heart Disease (CE-MARC), and billed as ‘the largest prospective comparison of cardiovascular MRI and nuclear myocardial perfusion imaging (MPI) with SPECT’ with X-ray angiography used as the reference standard.

Genotoxicity poses calls for caution
There have, nevertheless, been some calls for caution due to the chance of genotoxic effects of cardiac MRI scanning.
In October 2011, a study by researchers at Seoul National University in South Korea, assessed high-field intensity 3T clinical MRI scans in cultured human lymphocytes in vitro and ‘observed a significant increase in the frequency of single-strand DNA breaks following exposure to a 3T MRI.’
In June 2013, another study on cardiac MRI in European Heart Journal’ reported similar conclusions, this time in vivo. The study, by researchers from University Hospital Zurich, prospectively enrolled 20 patients, and found a ‘significant increase in median numbers of DNA DSBs in lymphocytes induced by routine 1.5T’ MR scanners. The study also made a recommendation, urging cardiac MRI to ‘be used with caution and that similar restrictions may apply as for X-ray-based and nuclear imaging techniques in order to avoid unnecessary damage of DNA integrity with potential carcinogenic effect.’

Finns call for further studies
Nevertheless, there has been no study so far on the genotoxic effects of MRI compared with those of CT scans. In addition, cardiac MRI risk research has been based entirely on cell level experiments with no conclusive and definitive evidence of actual cancer risk. This is in direct contrast to the link between ionizing radiation and cancer risk.
MRI is therefore still considered by its proponents as the safest alternative.
Indeed, weeks after the University Hospital Zurich study, Finnish researchers published a riposte, again in the European Heart Journal”, arguing that the ‘cellular mechanism’ of how cardiac MRI induced DNA damage was unknown ‘and may be different from that of radiation.’ They concluded that it was ‘obvious that further larger studies are warranted before any restrictions’ were imposed on the use of cardiac MRI.

CardioConfirm is Mortara Instrument’s latest tool for connectivity and IT. CardioConfirm has been launched almost a decade after Mortara Instrument started a successful path leading to the adoption of the DICOM standard in all its ELI^TM series cardiographs, Stress Testing, Holter and Monitoring equipment.

The DICOM standard allows users to seamlessly integrate reports from Mortara devices with existing information systems available in hospitals. CardioConfirm takes connectivity a step further: in addition to traditional viewing options, its user-friendly interface is designed to provide full editing capabilities for all DICOM-enabled systems. Besides opening, editing and storing resting ECGs, physicians may now use dedicated tools for zooming in or measuring ECG waveforms, and may take advantage of a library of statements that conveniently appear with just a few key-strokes, on the basis of those normally used for reports.

CardioConfirm also offers the possibility of editing final reports of stress and Holter tests. Preliminary exports generated by DICOM-friendly systems can be edited by physicians from the main system workstation, a feature that makes the workflow smoother and reduces the time needed to review and edit these types of reports. This new OEM software allows any hospital or clinic to leverage their existing system by simply embedding CardioConfirm into it, thus eliminating the need to spend significant capital investment on an entirely new operation system.

CardioConfirm allows medical professionals to concentrate on patient care with its unique ability to integrate high quality diagnostic display of tests together with all patient information – including test results, vitals, and personal and family history – in one convenient location so that cardiologists do not need to look for additional test results that a technician may have recorded elsewhere.

As the health care landscape continues to grow and change, Mortara’s CardioConfirm is making a big impact on the continued transformation. Hospitals and health care professionals will have a more streamlined workflow, increased efficiency and the ability to focus more attention on patient care.

Mortara Instrument supplies CardioConfirm to all PACS and EMR providers and hospitals that want to expand or complete their PACS/EMR systems to include diagnostic cardiology workflow. It is available in a variety of versions that meet your need for a seamless integration with third party systems.

For further information, click here

DICOM is the registered trademark of the National Electrical Manufacturers Association for its standard publications relating to digital communications of medical information.

The safe use of health technology-from basic infusion pumps to large, complex imaging systems-requires identifying possible sources of danger or difficulty with those technologies and taking steps to minimize the likelihood that adverse events will occur. This list will help healthcare facilities do that.

Produced each year by ECRI Institute’s Health Devices Group, the Top 10 Health Technology Hazards list identifies the potential sources of danger that it believes warrant the greatest attention for the coming year. The list does not enumerate the most frequently reported problems or the ones associated with the most severe consequences-although such information is certainly considered in the analysis. Rather, the list reflects the Health Devices Group’s judgment about which risks should receive priority now.

All the items on the list represent problems that can be avoided or risks that can be minimized through the careful management of technologies. Additional content provided with the full article, which is available separately to members of certain ECRI Institute programmes, provides guidance to help manage the risks. In this way, the list serves as a tool that healthcare facilities can use to prioritize their patient safety efforts.

International Hospital presents here the abridged version of ECRI Institute’s 2017 Top 10 list of health technology hazards which is available as a free public service to inform healthcare facilities about important safety issues involving the use of medical devices and systems.

1. Infusion errors can be deadly if simple safety steps are overlooked
Most large-volume infusion pumps incorporate safety mechanisms for reducing the risks of potentially deadly intravenous (IV) infusion errors. These mechanisms have greatly improved infusion safety, but can’t eliminate all potential errors. And the mechanisms themselves have been known to fail.
ECRI Institute continues to learn about and investigate incidents of infusion errors involving pump or administration set failures, staff unknowingly defeating a safety mechanism, or incorrect infusion programming. Such errors- particularly those that result in the uncontrolled flow of medication to the patient, known as ‘IV free flow’-can lead to patient harm and even death.

In many of these incidents, harm could have been averted if staff had:

• Noticed signs of physical damage to infusion pump components
• Made appropriate use of the roller clamp on the IV tubing
• Checked the drip chamber beneath the medication reservoir for unexpected flow

Once commonplace, these simple practices are now often overlooked-perhaps because staff implicitly trust the pump’s advanced safety features.

2. Inadequate cleaning of complex reusable instruments can lead to infections
The use of contaminated medical instruments can lead to disabling or deadly patient infections or instrument malfunctions.
Outbreaks associated with the use of contaminated duodenoscopes-such as those that caused headlines in recent years-illustrate the severity of this issue. But duodenoscopes are not the only devices that warrant attention. ECRI Institute has received reports involving a variety of contaminated medical instruments that have been used, or almost used, on patients.
Complex, reusable instruments-such as endoscopes, cannulated drills, and arthroscopic shavers-are of particular concern. They can be difficult to clean and then disinfect or sterilize (i.e., reprocess) between uses, and the presence of any lingering contamination on, or in, the instrument can be difficult to detect.
Often, we find that inattention to the cleaning steps within the reprocessing protocol is a contributing factor. Healthcare facilities should verify that comprehensive reprocessing instructions are available to staff and that all steps are consistently followed, including precleaning of the device at the point of use.

3. Missed ventilator alarms can lead to patient harm
Ventilator alarm management challenges complicate efforts to prevent patient harm resulting from missed alarms. Ventilators deliver life-sustaining therapy, and a missed alarm could be deadly. Concerns include:

• Alarm fatigue-in which staff become overwhelmed by, distracted by, or desensitized to the number of alarms that activate.
• Alarm notification failures-in which alarms are not effectively communicated to staff.

These concerns, and the ways to manage them, are similar to those that exist with physiologic monitoring systems, which we have addressed in previous Top 10 Health Technology Hazards lists. Ventilators, however, pose some unique challenges. For example: Collecting and analysing ventilator alarm data can be difficult, making it harder for hospitals to identify where their vulnerabilities lie. And the options for supplementing a ventilator’s alarms-so that the alarm can be noticed outside the patient’s room, for example-are limited.
As a result, ventilators will require different methods for studying the problem and different strategies for addressing it.

4. Undetected opioid-induced respiratory depression
Patients receiving opioids-such as morphine, hydromorphone, or fentanyl-are at risk for drug-induced respiratory depression. If not detected, this condition can quickly lead to anoxic brain injury or death. Thus, spot checks every few hours of a patient’s oxygenation and ventilation are inadequate.
Drug-induced respiratory depression is of particular concern for patients receiving parenteral and neuraxial opioids in medical-surgical and general care areas. However, it is also of concern for hospital or ambulatory surgery/endoscopy facility patients receiving opioids during procedural sedation and while in the postanesthesia care unit (PACU).

Even if they are otherwise healthy, such patients can be at risk if, for example:

• They are receiving another drug that also has a sedating effect
• They have diagnosed or undiagnosed sleep apnea or other conditions that predispose them to respiratory compromise
• They receive more medication than intended-for example, because of a medication error

ECRI Institute recommends that healthcare facilities implement measures to continuously monitor the adequacy of ventilation of these patients and has recently tested and rated monitoring devices for this application.

5. Infection risks with heater-cooler devices used in cardiothoracic surgery
Heater-cooler systems have been identified as a potential source of nontuberculous mycobacteria (NTM) infections in heart surgery. The likelihood of infection during surgery is not fully understood. However, these infections can be life-threatening and have resulted in patient deaths.
Heater-cooler systems are used in cardiothoracic surgeries to warm or cool the patient by extracorporeal heat exchange with the patient’s blood during heart-lung bypass procedures. These devices circulate warm or cold water through a closed circuit. Water in the circuit is not intended to come into direct contact with the patient or the patient’s circulating blood. However, aerosolized water carried by air from the exhaust vents of contaminated heater-coolers has been suggested as a cause of NTM infections.
Initial reports focused on one specific model of heater-cooler, but models from other suppliers could likewise become contaminated under certain circumstances and if appropriate precautions are not taken.
The U.S. Food and Drug Administration has issued recommendations for all heater-cooler devices; they are intended to help prevent and manage device contamination risks and to minimize patient exposure to heater-cooler exhaust air, which may contain aerosolized contaminated water.

6. Software management gaps put patients, and patient data, at risk
Inadequate medical device software management can delay a facility’s responses to safety alerts, allow cybersecurity vulnerabilities to be exploited, and impact patient safety.
Maintaining a central repository of up-to-date and easily retrievable information about the software versions used in a healthcare facility’s medical devices is challenging. But failure to do so leaves the facility ill-prepared to effectively manage software updates and alerts.

Mismanagement of software updates and alerts can adversely affect patient care or impact patient/staff safety- for example, by:

• Causing downtime or otherwise affecting the performance of medical devices or interconnected systems
• Delaying identification and implementation of key software updates, including those that address safety concerns
• Allowing cybersecurity vulnerabilities to persist, possibly leading to lost, stolen, or inaccessible data

To address the hazard, a healthcare facility should verify that its computerized maintenance management system (CMMS) provides the capabilities needed to effectively track software versions for its medical devices and systems. In addition, the facility should establish practices for keeping the software version information in the CMMS current and complete.

7. Occupational radiation hazards in hybrid ORs
Clinicians working in hybrid ORs-operating suites that include built-in x-ray imaging systems-are at risk of unnecessary occupational exposures to ionizing radiation if appropriate precautions are not consistently followed.
Particular concern exists in this environment because hybrid OR staff may be less knowledgeable than radiology and interventional radiology staff about the risks of radiation exposure, and they may be less experienced at taking appropriate precautions.
In addition, with the increasing reliance on X-ray imaging systems during complex OR procedures, an increasing number of specialists and staff members who previously would have had little exposure to ionizing radiation during surgeries are now participating in these procedures.
Because long-term exposure to radiation increases the risk of cancer, it is imperative that hybrid OR staff obtain OR-specific radiation protection training, that they put this training into action, and that available tools and methods be used to minimize radiation exposures.

8. Automated dispensing cabinet setup and use errors may cause medication mishaps
Poor choices made when setting up automated dispensing cabinets (ADCs), as well as mistakes made during use, can lead to harmful medication errors.
Medication errors and near misses associated with ADCs have been traced to insufficient planning when setting up medication drawers, as well as errors made when stocking them. Incidents reported to ECRI Institute include: the presence of the wrong drug or dose in an ADC pocket, the availability of high-alert drugs in unsecured areas of the cabinet, and the unavailability of needed drugs.
Problems such as these have resulted in delays in patient care and the administration of incorrect drugs or drug concentrations, leading in some cases to severe patient injury.

Careful planning is required to determine:

• Which medications should be available in a particular care area
• Where in the drawer a medication should be placed (e.g., to reduce the chances that one drug will be mistaken for another)
• Whether locked pockets or other control mechanisms should be used to further restrict access to certain medications

9. Surgical stapler misuse and malfunctions
Problems associated with the use and functioning of surgical staplers can lead to intraoperative hemorrhaging, tissue damage, unexpected postoperative bleeding, failed anastomoses, and other forms of patient harm.
Surgical staplers require meticulous technique to operate, and problems during use are not uncommon. The U.S. Food and Drug Administration receives thousands of adverse event reports related to surgical staplers each year, and ECRI Institute likewise consistently receives reports of surgical stapler problems. Although severe injuries are infrequent, they do occur: We have investigated fatalities and other cases of serious patient harm.
Commonly reported problems include: misfiring or difficulty in firing, misapplied staples, unusual sounds during firing (which can indicate a damaged or malfunctioning mechanism), and tissue becoming ‘jammed’ in the mechanism.
To prevent patient harm, users must be familiar with device operation, they must carefully select the appropriate staple size for the patient and tissue type, and they must be alert to the signs that the stapler may not be functioning as intended.

10. Device failures caused by cleaning products and practices
The use of cleaning agents or cleaning practices that are incompatible with the materials used in a medical device’s construction, or that are otherwise inappropriate for the device’s design, can cause the device to malfunction or to fail prematurely, possibly affecting patient care. Specifically:

• Repeated use of incompatible cleaning agents can damage equipment surfaces and degrade plastics, often resulting in device breakage-possibly with no visible warning signs.
• The use of improper cleaning practices can damage seals, degrade lubricants, and cause fluid intrusion. This can result in damage to electronics, power supplies, and motors.

Because there is no single cleaner or cleaning process that will work with all devices, hospitals must stock and use multiple cleaning products and familiarize staff with device-specific cleaning methods-tasks that pose a significant burden. Nevertheless, failure to do so can lead to ineffective cleaning (a potentially deadly circumstance), as well as excessive component breakage and premature equipment failures (which can affect patient care and be a significant financial burden).

www.ecri.org.uk www.ecri.org

Based in Milwaukee (Wisconsin, USA), Mortara Instrument, Inc. recently opened its new manufacturing and distribution facility.

The 64,000-square-foot, air conditioned, high tech facility consolidate and expand Mortara’s manufacturing and distribution operations which were previously split between the company’s headquarters building and its warehousing operation on Sleske Drive in Milwaukee.

‘I am proud of our continued growth and our increasing prominence in the market and in our community,’ said Justin Mortara, the company’s Chief Executive Officer, on the occasion of the ground-breaking ceremony in August 2015. ‘We’re excited to further invest in our community and truly live out our promise that all Mortara products are – Built with Pride in Milwaukee.”

The facility will allow Mortara to continue its growth in Milwaukee, where the company is committed to growing. Since May 2013, Mortara has added approximately 150 jobs, bringing its total global workforce to over 420. The expansion is part of a larger growth plan that will allow for the creation of more than 150 additional jobs over the next five years.

Mortara’s entire portfolio of products is ‘Built with Pride in Milwaukee.’ Mortara is committed to delivering the highest quality products to healthcare providers and their patients. In order to consistently deliver such quality, Mortara remains dedicated to manufacturing its entire portfolio of products in the United States, and more specifically in Milwaukee.

The company is also committed to keep the supply chain as physically close as possible, with 30 per cent of components being produced within 100 miles of its facility. This allows Mortara to ship most orders within 72 hours even if 80 per cent of the orders require custom configurations, whereas many are shipped within 24 hours, if not the same day.

Local sourcing is strategic both to reduce production times, and to invest in the community. As Mayor Tom Barrett said during the ceremony, ‘Mortara’s investment in Milwaukee pays dividends for our entire community. Mortara’s success means more jobs and more economic activity in our city.’

A flourishing community is also beneficial the company’s commitment to innovation. ‘We try to innovate on a timeline of one to three years, whereas the typical rhythm in medical devices is five to seven years,’ Mortara said. The company invests about 8 percent of its revenue into research and development, especially devoted to enhance diagnostic capability and connectivity. This commitment requires recruiting top talent, which can be attracted from the main universities only if the region is thriving.

The new facility was built with aim to reduce the environmental footprint. Among the main features, porous asphalt, LED lighting, heating and cooling powered by a geothermal system, and a blue roof that retains water and releases it slowly, so as to work as a retention pond.