Reviews and News on Medical Equipment

The Food and Drug Administration announced last week that they will begin to address inherent safety issues with external infusion pumps used to deliver medications and nutrients to patients during hospitalization. Until now, medical equipment manufacturers making infusion pumps had not been subjected to strict pre-market guidelines.

Because these pumps are used to provide high-risk patients with critical life-saving fluids, any failure in the equipment could have serious implications. As a result, more comprehensive safety guidelines became a necessity. A new FDA web page will help medical equipment suppliers adhere to the new safety regulations for improved pump design.

Infusion pumps are used in various clinical settings to help doctors control drug delivery and reduce errors in medication dosage. However, in the past five years the FDA received over 50,000 reports citing adverse affects because of problems with this medical equipment. Some of the more serious incidents resulted in the death of over 500 patients. Some of the most common defects involved the failure of software and dosage safety alarms, ambiguous interface issues that led to dosage errors, and mechanical failure under routine use.

According to the FDA, 87 different infusion pumps were recalled to address these concerns in the past five years. Because most of the defects uncovered were related to medical equipment manufacturing and engineering, the FDA has ordered manufacturers to conduct additional testing and risk assessment on new or modified infusion pumps before they are brought to market. In addition, manufacturers have the option of submitting the software codes for these pumps for pre-market analysis by the FDA. Using static analysis, the agency can help detect problems related to software while the device is still in the development phase. A public workshop will be held on May 25 and 26 where participants can work to improve infusion pump design and the risk of equipment malfunction.

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When patients are awaiting a heart transplant, a mechanical circulatory support system is an excellent way to improve outcomes, lower costs and increase their chance for survival. Recent research shows that continuous flow Ventricle Assist Devices (VADs) are among many new advances in medical equipment that will saves improve clinical outcomes for patients with severe heart disease.

According to the International Society for Heart and Lung Transplantation, heart pumps (also known as VADs) can be used to either partially or fully replace heart functions. They do this by restoring a healthy flow of blood throughout the body in a patient whose heart has been seriously weakened.

How are these new pumps different than previous VADs?

First of all, this revolutionary medical equipment device is designed to provide a continuous flow of blood instead of a flow that is administered in pulses. While earlier VADs mimicked the pulse of a beating heart, they were often associated with complications during implant surgery, these newer continuous flow VADs have not shown to increase complications after a heart transplant.

Recent research from the University Medical center in Salt Lake City showed a marked improvement in patients tested between 2004 and 2008. The report illustrates improvements in post-transplant survival rates when patients were given a continuous flow VAD instead of a pulsatile device. According to the study, when a continuous flow pump was used, patients’ overall improvement rate after surgery was 30% higher than those who used pulsatile flow technology.

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Long the domain of engineers and manufacturing professionals, flow meters have traditional been used to measure the volumetric flow rate of gases and liquids. They are typically found within machinery that falls outside of the medical profession, but a few companies have found ways to use these devices in circulatory support systems, particularly while patients recover from heart surgery.

The industrial community uses flow meters for a number of different applications, including power plants, water treatment facilities, and chemical centers. They are typically a measurement device for water, corrosives, coolants, compressed air, hydrogen, carbon dioxide and many other fluids and gases. When treating acute heart failure, medical professionals are now able to use flow meters to function as a way to detect the flow of blood through the heart while a patient recovers.

Universal Flow Monitors creates custom-designed flow stream devices for use in the machines made by many well-known medical equipment manufacturers. These unique flow meters are used to drive air pulses to the ventricular assist devices used in cardiac recovery units. By controlling the pumping action of the machine, flow meters analyze the state of the pump to ensure that it is using the correct timing and pressure while it empties and fills corresponding ventricular pumps.

By working closely with medical equipment manufacturers who specialize in ventricular assist devices (VADs), these very unique flow meters are designed to measure relationships between pressure drop and flow within the human heart. The meters also use a temperature sensor and an absolute pressure sensor to compensate for variances in density. Additionally, these flow meters use a bidirectional feature to measure air flow both to and from the blood pumps.

As a supplier to the medical equipment industry, Universal Flow Meters has worked with manufacturers to successfully align their products with the stringent demands of heart recovery systems.

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Surgeons are constantly being presented with new technologies that enhance their ability to treat patients, but one of the most important elements of a surgical unit is often overlooked. Maintaining a well-lit surgical suite throughout procedures is a crucial to both the medical team and the patient. Until recently, the Xenon bulb has been used by most health care facilities, but this type of lighting brings a number of legitimate concerns.

Medical equipment designers are moving away from less efficient sources of light and using LEDs for an increasing number of medical applications. The implementation of LED technology in surgical settings eliminates the disadvantages of Xenon lighting. This is because Xenon bulbs reach temperatures up to 260°C, generate a distracting noise, and consume up to 400 watts of power, which can present electrical hazards such as overheating. In addition, Xenon bulbs are powered with bulky fiber optic cables that can restrict movement around the operating table. Any entanglement of the cable during surgery could cause it to unplug, resulting in light failure in a critical procedure.

Here are some of the advantages of using LED lighting in medical equipment:

* LED lighting uses a lighter-weight headlamp, which is more comfortable for surgeons
* The units are engineered with a rechargeable battery that allows them to operate continuously during surgery
* LED surgical lighting replicates the white lighting found naturally in sunlight, which is optimal during surgical procedures
* LED bulbs last between 8,000 and 50,000 hours, which is a vast improvement over Xenon’s life expectancy of 600 to 1,000 hours
* LED uses less power, making it a more energy efficient alternative

Overall, LED lighting is proven to be a more effective and energy-efficient source of light during surgery. Due to high customer demand, medical equipment manufacturers are expected to implement new LED lighting within surgical equipment.

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Advancements in home-based medical equipment and Internet technology have had a positive impact on the both patients and clinicians around the world.

Electronic medical records are expected to revolutionize the way medical offices manage the flow of patient information, and allow patients to easily access their medical charts from home. While detractors may worry about the privacy issues inherent to any online database, the benefits of electronic health management far outweigh the costs.

A good example of how electronic medical records will be of value in patient care is the increase in available home-based medical equipment for patients with chronic illnesses. Instead of traveling to and from the doctors’ office for frequent testing, many patients will opt to take advantage of miniature Bluetooth-enabled medical devices that perform the same type of monitoring from home. Using a miniature handheld pulse oximeter or glucose monitor, for example, a patient’s test results can be instantaneously transferred to a web-based medical record at their doctor’s office.

Some of the challenges to this type of monitoring include the graphically detailed nature of data that is transmitted. Some of the more complex tests, such as ECGs, involve the transmission of a waveform, which can present challenges if the data arrives in an incomplete form. However, by using some new products like USB isolators, a more reliable connection can be established between the patient monitor and the clinician’s office.

As medical equipment and home monitoring systems become more advanced, it is expected that more and more patients will take advantage of the ease and convenience of Bluetooth-enabled devices for many diagnostic tests.

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In keeping with the trend toward miniaturization in durable medical equipment, new strides have been made recently in creating tiny versions of pulse oximeters. A pulse oximeter monitors the blood-oxygen level in a patient by displaying the percentage of hemoglobin in the bloodstream. Normal acceptable ranges are between 95 and 100 percent, but values that fall as low as 90% are still common.

As a noninvasive measurement tool, the pulse oximeter typically uses a pair of LEDs (light-emitting diodes) that face a photodiode, usually through a translucent portion of the anatomy like an earlobe or fingertip. Using both red and infrared wavelengths, a measurement of hemoglobin absorption is calculated based on the ratio of light absorption between the two. Because the signal of a pulse oximeter bounces in conjunction with the heartbeat, the detection of a pulse is essential for the monitor to function.

The miniature versions of these devices have been greatly enhanced by the availability of miniature LEDs that will function within the required wavelengths. These devices also utilize an analog microcontroller to perform all of the required measurement and electronic control within a single microchip. Miniature pulse oximeters will be useful in any situation outside of a hospital where a patient’s blood oxygenation may become unstable. They can be used in settings as diverse as mobile emergency units and pressurized aircraft’s. Essentially, no vital sign is more important than the body’s ability to absorb oxygen.

So important is the implementation of compact pulse oximeters that over half of the major international medical equipment manufacturers in China were exporting producers of these devices. One of the world’s foremost manufacturers of home-based monitors is Nonin Medical. Last year they introduced the first Bluetooth-enabled handheld device to measure pulse oximetry through the fingertips. This device, and others like it, enables doctors to remotely monitor their patient’s oxygen saturation levels through the use of a computerized home telemedicine system.

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Recently, there has been a scientific breakthrough by a research team in the Netherlands to test MRI-guided radiation therapy in a clinical atmosphere. The main goal is to accurately target tumors using “real-time image guidance” with radiotherapy. This particular design of medical equipment can be beneficial when used in conjunction with an MRI because it integrates a linear accelerator with an MR scanner. The researchers were able to prove that MR imaging did not corrupt the MR scanner or the linac performance. In addition, they discovered that they can avoid critical structures and reduce side effects.

Both the accelerator and the MRI were modified to enhance operation so it was simultaneous and unrestricted. This was important to prove that quality diagnostic MR imaging and irradiation were attainable. In addition, the redesign of the MR magnet allowed the radiation to beam through and vertically maximize the irradiation field. Most of the external field was canceled, because the magnet was actively shielded and side effects were reduced.

In addition to redesigning the medical equipment, researchers modified the arrangement of the treatment room. This enabled researchers to shield the accelerator and the remaining portion of the treatment room. Also, with the magnet actively shielded, most of the external field generated by the inner coils is canceled, which provides enhanced imaging performance and a steroidal low-field zone around the magnet.

More research must be explored before this type of medical equipment can be used in radiotherapy clinics. However, research has proven that having an active shield enhanced the MRI performance while the radiation beam was on. This was achieved because the active shield can achieve both magnetic and RF decoupling.

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Anyone who pays attention to innovations in the medical equipment industry is aware of the shrinking size of medical devices. This relatively new push for miniature medical devices has affected all areas of the industry, from EKG machines to pulse oximeters and ultrasound technology. An increasing number of hand held devices are allowing for a more mobile approach to patient care for both clinicians and patients.

In the world of medical equipment, miniature-sized lab equipment, patient monitors and imaging machines are being promoted not only for their compact profiles; in many cases they are also far more advanced in terms of technology. Some machines, such as portable hand held glucose monitors, can be used by the patient at home without the need to travel to and from a medical facility.

Other portable monitors include the release of a personal blood monitor that can be used for coagulation testing. These machines are used at home by patients who are on anti-coagulation therapies, such as Coumadin, without necessitating frequent trips to a lab or clinic. Patients simply draw a single drop of blood, which is place on a temperature-sensitive strip that produces on-the-spot results.

For medical equipment manufacturers, these revolutionary portable devices represent a new stream of revenue as more and more patients opt for miniaturized testing equipment. Patients are able to save the money and time it takes to be monitored in a clinical setting.

While greatly improving the accessibility and convenience of health care, the trend toward miniaturization has its own set of challenges, including the skill level of the person conducting the test. This is why medical equipment manufacturers are working to ensure their diagnostic devices are very simple to use, even by an elderly patient with limited dexterity and poor vision. It is also critically important that these devices need little or no user-performed calibration. This way, the results will be consistently accurate and reliable.

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Thanks to their use of Wi-Fi on the campus of Ohio State University Medical Center, medical professionals can now use software to track medical equipment. Using this new technology, OSU plans to tag up to 15,000 pieces of equipment, including patient monitors, EKG machines and IV pumps, as well as 200 hospital beds. This is being done by attaching a small box on each item that will emit a signal that can be tracked on the hospital’s Wi-Fi network.

This type of medical equipment tracking isn’t necessary everywhere, but in high-risk emergency departments and units with psychiatric patients, the system will come in handy. The same tracking devices can be used to track patients with dementia or other neurological issues.

But this is just the beginning. In the future, the medical center expects to use the same equipment to assess how long it takes for patients to be treated, and how these delays are affecting the operations and effectiveness of the hospital.

In addition, the system will eventually alert staffers whenever medical equipment is taken into a trash area or whether sensitive items are receiving proper refrigeration.

Because the OSU Medical Center covers an area of over five million square feet, it is easy for a piece of equipment to become lost. Sometimes, a monitor or IV pump is accidentally moved into a remote area of the unit, which can cause medical staff to spend a lot of time searching for it. Missing equipment can increase expenses and reduce productivity.

The system includes a software program and thousands of matchbook-sized electronic tags that can be tracked on the center’s Wi-Fi network. Signals associated with each tag will be visible on a floor plan map, allowing staff members to easily track every item – or person – they wish.

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Drug-releasing stents are used to prevent heart tissues from growing within an artery after angioplasty, and they are used in more than a million U.S. patients every year. They release drugs like paclitaxel and rapamycin, which can successfully impede tissue growth, but despite their seemingly helpful mission, some stents have been shown to cause very dangerous side effects.

For years, medical researchers have puzzled over their observations about drug-releasing stents. These are the tubes used to hold a patient’s coronary arteries open after surgery, but sometimes they can increase the likelihood of heart attacks from blood clots.

Medical equipment developers from MIT have recently developed a mathematical model to predict which types of stents are most likely to have these life-threatening side effects.

The MIT Model helps explain why certain types of stents are better than others, using a model which is based upon the size and shape of the stent itself. According to their study, certain stents impact the dynamics of the fluid, or blood that is flowing past them, which can cause drugs to accumulate in certain areas. When this occurs, the drugs they release can build-up, causing clots to form.

This groundbreaking research represents the first time a mathematical model has examined changes in arterial blood flow to predict stent performance. Until now, a stents impact on the distribution of drugs had not been considered.

Thanks to this conclusive research, medical equipment manufacturers are expected to design stents that allow for a more even distribution of drugs throughout the area.

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