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.

Microbotics (or micro-robotics) is a term that describes the emerging field of intelligent, miniaturized robotics. Biomedical microbotics offers a glimpse of a future where tiny, untethered devices (smaller than 1 mm in size) are inserted into patients via natural orifices or through extremely small incisions. Thereafter, they navigate autonomously through the bloodstream or inside fluids such as the vitreous humour in the eye cavity, targeting areas of interest with extreme precision.
Microbots aid medical professionals in earlier diagnosis and more effective treatment of diseases, delivering drugs to targets in the body, removing plaque deposits in the arteries or excising and repairing tissue at cellular levels – which are too small for direct manipulation.
One of the most exciting possibilities offered by medical microbotics is to enable wholly new therapies which have yet to be conceived, simply because of the lack of small, precision-access equipment.

MEMS and MST
Biomedical microbotics seeks to combine established techniques of robotics such as motion control, path planning, remote operation and sensor fusion with new tools enabled by miniaturized MEMS (Micro-Electro-Mechanical-Systems) technology, as it was known in the US; the European equivalent was micro-systems technology (MST).
Microbots are one outcome of the rapid growth in microcontroller capabilities in the 1990s, alongside the appearance of MEMS and development of high-efficiency Wi-Fi connections. MEMS, used for example in airbag sensors, opened the way for low-cost, low power consumption applications, while Wi-Fi allowed microbots to communicate and coordinate with other microbots.
Apart from coping with challenges on power and stretching the limits of material science, considerable research has also recently been focused on microbot communication. A good example of this is a 1,024 microbot swarm’ at Harvard University which spontaneously’ assembles itself into various shapes.

First endoscopic capsules date to mid-1990s
One of the first medical applications of microbotic technology was in the gastro-intestinal (GI) tract. The microbotic intervention in the mid-1990s, by an Italian team, was published in the book Sensors and Microsystems’ (World Scientific Publishing Co, Singapore, 1996) and consisted of endoscopic capsules which were simply swallowed by the patient. They captured video images as they moved naturally through the GI tract using in-built imaging and illumination systems.
In 2012, the U.S Food and Drug Administration (FDA) authorized a much smaller swallowable technology, namely a single-square-millimeter silicon circuit embedded inside a pharmaceutical pill, and produced by Proteus Digital Health.
Other researchers have proposed robotic systems with autonomous locomotion and biopsy capabilities. Some are tested, with models already on the market.

Sequel to MIS
In many senses, medical microbotics is a natural sequel to minimally invasive surgery (MIS), which has, since the 1980s, represented one of the key developments in medical technology. MIS resulted in a leap in patient recovery time and a sharp reduction in trauma.
Microbotics is expected to go even further, into what seems eerily close to the realms of science fiction.

From microgrippers to artificial bacteria
For example, researchers at Johns Hopkins University in Baltimore have developed microgrippers, The arms’ of these star-shaped devices, less than a millimeter in size from one tip to another, are temperature-sensitive grippers and react when exposed to body heat.
In sufficient numbers, they provide a less-invasive way to screen for colon cancer than a colonoscopy – which currently requires taking dozens of samples with forceps.
Moreover, when required, the arms can be closed around tissue, thereby performing what is effectively an automated biopsy.
One of the most dramatic demonstrations of microbotic miniaturization is at the Swiss Federal Institute of Technology in Zurich (ETH Zurich), where artificial bacterial flagella (ABF), about half as long as the thickness of a human hair, have been developed (See also page 23).
In initial experiments, ETH Zurich researchers have already made the ABFs transport polystyrene micro-spheres.

3D printing converges with miniaturization
New 3D printing technologies are now converging with miniaturization to open other frontiers for microbotics.
For example, the Nanoengineering Department at the University of California, San Diego (UCSD) have created 3D printed microbots in the form of a small fish (microfish), for sensing and detoxifying toxins. The microfish, with dimensions of just 120 x 30 microns, are designed for testing in applications such as directed drug delivery and microbot-assisted surgery.
UCSD researchers added a polymer nanoparticle (polydiacetylene) to capture pore-forming toxins, such as those found in the venoms of sea anemones, honeybees and spiders, in order to establish that the microfish could be both detoxification systems and toxin sensors. When the nanoparticles bound with toxin molecules, they became fluorescent and emitted red-coloured light, whose intensity correlated to their detoxification abilities.

Key design and engineering challenges
Technologically, key challenges faced by microbotics include design issues for in-vivo applications. The microbots need to be small and reliable, and equipped with all necessary tools and sub-systems on board. They must be inserted into, steered and removed from the target area of a patient’s body, non-invasively.
All this means a high degree of integration. MEMS devices were traditionally designed as components for insertion into larger electro-mechanical systems, along with physical interfacing for power supply and data input-output. In contrast, sub-millimetre sized medical microrobots must be manufactured in their final, operational and deployable form.

One emerging technology which seeks to address such challenges is known as Hybrid MEMS. It seeks to combine individual MEMS components through a robotic micro-assembly process, which brings together different manufacturing technologies such as lithography, nanosystems LIGA, Micro-Opto-Electro-Mechanical Systems (MOEMS) and 3D printing.

Materials and power
Apart from these kind of structural and miniaturization issues, other challenges of a robotic operation at microscopic scale consists of biocompatibility and power. The former has sought to be addressed with new generation MIS and implantable systems. However, few could underestimate the constraints of working in the human body – not only in terms of tracking precisely where a microbot is (especially in the vicinity of vital organs), but also making sure that it is neither toxic nor poses a threat of injuring tissue, while ensuring that it degrades safely or exits the body after completing its mission.
A key condition for effectiveness, therefore, is that microbots must have similar softness’ as biological tissues. This is where the difference with traditional robots is most stark. Rather than cogwheels and cranes, pistons and levers, designers of microbots are inspired by the tentacles of an octopus.
The provision of power for moving the microbot, gathering/transferring useful information and taking interventional action when necessary, is even more challenging. Microbots can use a small lightweight battery source or scavenge power from the surrounding environment in the form of vibration or light energy.
The Proteus ingestible pill authorized by the FDA in 2012 contains two electrode materials which become electrically connected when the circuitry comes into contact with the stomach’s gastric juice. For 5 or 10 minutes, the chip has enough power to modulate a current, transmitting a unique identifier code that can be picked up by an external skin patch.

An alternative to an on-board battery is to power the robots using externally induced power. Examples include the use of ex-vivo electromagnetic fields, ultrasound and light to activate and control micro robots. Researchers are now also focusing efforts on wireless power transfer, such as using radio waves from outside the body to generate electricity. However, this approach too faces limitations at small scales. To be effective, a microbot would need an antenna, which needs to be large enough to collect a meaningful amount of energy and also stay fairly close to the source.

Magnetic actuation
Magnetic actuation technology has been applied in biological systems for several years, in areas such as targeted drug delivery where magnetized carrier particles coated with chemical agents are concentrated on specific target regions of the body using external magnetic fields. Magnetic beads of a few microns diameter have also been successfully steered inside cells to manipulate individual DNA molecules.
At the UC San Diego 3D printed microbots project referred to above, the microfish are powered by nanoparticles with hydrogen peroxide being the power source, while magnets provide steering.

Molecular motors
Some experiments have focused on using molecular motors for microbots. These molecular motors are the sensing and actuation systems ubiquitous in biological systems. They have been adapted over millions of years and play vital roles in processes such as cell motility, organelle movement, virus transport.
From a practical viewpoint, interest in such molecular machines for the next generation of hybrid biomotor sensing and actuation systems will be driven by biomedicine as well as related applications such as microfluidics (e.g for nano-propellors) and chemical sensing.
Nevertheless, despite some signs of progress, the use of molecular motors in hybrid living-synthetic engineered systems remains several years away.

Artificial bacterial flagella (ABF)
The bulk of research into biological motors as power sources are focused on F1-ATPase and artificial bacterial flagella (ABF).
ABFs are manufactured through a Hybrid MEMS process by vapour-depositing several ultra-thin layers of indium, gallium, arsenic and chromium onto a substrate, followed by ribbon patterning using lithography and etching. The ribbons curl into a spiral once they are detached from the substrate, due to differences in the molecular lattice structures of the various layers.
The size of the spiral, and the scrolling direction of the ribbon, can be determined in advance. The latter is due to the presence of nickel in the head’ of the microbot. Nickel is soft-magnetic, in contrast to the other (non-magnetic) materials used, and enables the spiral-shaped ABF to move forward/backward as well as upward/downward within a rotating magnetic field generated by several coils, towards which the head constantly tries to orientate itself and in whose direction it moves. Steering the ABF to a specific target is achieved by adjusting the strength and direction of the rotating magnetic field.

Nevertheless, the precise placement of microbots is crucial in order to avoid a clinician’s nightmare – to place something solid in the blood, and trigger clots. Even ultra-sophisticated microbots which can follow a change in temperature, may not be able to fight the powerful currents in the bloodstream.

Europe is playing a major role in microbotics, with ETH Zurich considered a world leader in the field. One of its first biomedical microbots aims at ophthalmic operations on the retina. Drugs to treat the retina can now be injected into the eye, where they diffuse. However, only a fraction of the dose reaches its target. Microbots could potentially deliver drugs in a more targeted manner, reducing doses as well as side effects.