Posted on July 16, 2013 in Defective Medical Devices

The latest concern to rip though the field of medical devices is regarding the security placed within those devices. Recent pranks have demonstrated that it's extremely easy to hack into these devices and alter the controls, presenting a safety risk to the patients depending on these defective medical devices. The Center For Internet Security is a nonprofit group that provides advice to government agencies and private companies, and the group has announced the development of guidelines for medical device manufacturers to consider in the development and refinement of their products.

The goal of the report is to help manufacturers reduce malfunctions coming from computer viruses and to protect the confidentiality and integrity of the data connected to these devices. With some simple protection tips, individuals using critical machines can feel safer about the devices they use every day. The organization has requested information and cooperation from hospitals and medical professionals around the country in the development of these guidelines.

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 Posted on July 12, 2013 in Defective Medical Devices

Pain medication is given to patients to relieve pain and to make patient care better. At times, medical devices are implanted in a patient's body that administers pain medication and can be regulated by the physician if necessary. This is beneficial to the person because it removes the concern of missing the time to take the medication or the possibility of taking the wrong dosage. But, when these implanted medical devices don't work properly, a patient's health becomes compromised.

The FDA recently recalled two such pumps: Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps. The reported reason was for a potential short in the electrical wiring of the device. This short in the electrical currency could cause the devices to stall which could lead to a drop in the administration of medications. If this were to happen, a patient's could also experience withdrawal symptoms and or their symptoms of the underlying condition could return. This reduction in pain therapy could adversely affect the patient's health, which could lead to death.

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 Posted on July 06, 2013 in Defective Medical Devices

Respironics, a subsidiary of Phillips, has recently received the FDA's highest-risk label for a recall that has affected over 19,000 V60 ventilators. These ventilators were pulled due to potentially dangerous power management software.

These V60 ventilators are used to aid with breathing in the hospital or at home for those patients who face “respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea.” The devices got the Class 1 status recall due to a “situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

California-based Respironics originally recalled its V60 ventilators when they discovered a major issue with their power management software. The devices were often shutting down suddenly, which ends the flow of ventilator support to a patient, without sounding any sort of alarm.

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 Posted on July 02, 2013 in Birth Injuries

Recently, the FDA has approved the return of a prescription medicine used to treat morning sickness during pregnancy that was taken off the market about 30 years ago after leading to hundreds of lawsuits that claimed it led to birth defects.

The pill that has been brought back from the dead was called Bendectin in the past, but will now be sold as Diclegis. The FDA never actually stated that the pill was unsafe, but the pharmaceutical company who distributed the pill decided to pull it once the litigation costs outweighed profit.

During the time Bendectin was on the market, over 300 lawsuits were filed against Merrell Dow, the company behind it. These various lawsuits claimed that the drug led to babies being born with deformities. However, no direct link was made between Bendectin and the birth defects it supposedly caused. There was no scientific evidence.

When Bendectin was pulled off the market, The New York Times had something to say about the ordeal:

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 Posted on June 30, 2013 in Defective Medical Devices

More often now than ever before, high school students are graduating and entering into colleges and universities without any idea of what they would like to study or what they want to do with the rest of their lives. As time seeds out those who are not meant for college-life, there are very few students left in comparison when it is time to enter graduate school .

Not only did Andrew Murtha make it through undergraduate school and continue on for a graduate degree from Saint Louis University, but he has also already become the winner of the 48th annual Alpha Omega Alpha Medical Student Research Forum at SLU before completing his second year of medical school.

Murtha plans to specialize in orthopedic medicine and was given an opportunity at SLU to develop an artificial hip that should reduce complications after operations, which won him the prestigious award.

Riya Anandwala from SLU reported on the project, writing that in his research, Murtha discovered “that using a thinner plastic liner to accommodate larger femoral head, which replaces the highest part of the bone in the thigh, did not increase the risk of fracturing the liner.” That research was the answer for previous issues that arose after surgery due to larger femoral heads.

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 Posted on June 28, 2013 in Defective Medical Devices

Defective medical equipment can serious injury those who need the products, especially in the case of diabetic monitoring devices. Diabetes is when the body does not process the food properly – glucose (sugar) cannot be converted to energy for the body to use. Some conditions can go unnoticed if not tested by a blood sugar meter. If untreated, it can cause short term problems such as hypoglycemia, hyperglycemia, or diabetic ketoacidosis. However, long terms issues affecting blood vessels and organs can cause the body to shut down – possibly leading to blindness, amputation of limbs, or organ failure. To help a diabetes patient monitor and keep track of their blood sugar level, a blood glucose meter is a daily instrument for survival.

FreeStyle InsuLinx Blood Glucose Meters sold or distributed between the dates of April 18, 2012 and April 1, 2013 are being recalled, according to the FDA. These meters prick blood from the fingertip to then be placed on the monitor to test blood sugar levels. These machines are being recalled because they are not giving users correct results.

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 Posted on June 25, 2013 in Defective Medical Devices

Every year, the FDA recalls medical devices that are deemed unsafe or that don't function properly. In 2012, 50 medical devices were recalled throughout the year, and 2013 is no different. Early in May, five medical devices were recalled.

On May 1^st, two different medical devices were recalled. The first was from Hospira Inc. The GemStar Infusion System was recalled. It is used in intravenous, arterial, subcutaneous, short-term epidural infusion and parental administration of general IV fluids, medications, nutritional foods and blood products, according to the FDA. It can be used in the home or hospital. It was recalled because of battery leakage.

The second medical device that was recalled was from Newport Medical Instruments, Inc. The HT70 and HT70 Plus Ventilators were recalled because it went into internal backup battery sooner than expected. They are used to provide positive pressure mechanical ventilator support.

Three medical devices were recalled on May 7^th.

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 Posted on June 19, 2013 in Defective Medical Devices

Though medical devices are meant to help those who need them to live healthy and productive lives, there are risks involved in the use of a medical device. If the device does not work properly, is not used properly, or begins to break down, it can cause more problems for the person using it. The following will help you understand what makes a medical product defective, and what to do if you encounter a defective device.

In order to bring up the issue of a defective medical device in a court of law, it must be defective in one of the two following ways:

1. The design is defective. This means that if the device is in proper condition and is used according to the directions, it will be harmful to the user.
2. The product is defective. This means that the device was designed in a way that would help the user, however it was poorly constructed, and does not work properly.

Understanding these two definitions of a defective device can help you determine whether or not you have a case. Contact an Illinois defective medical devices lawyer today with questions.

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 Posted on June 12, 2013 in Defective Medical Devices

When purchasing a medical product, it is expected that the product will be safe, functioning, and helpful. The Food and Drug Administration exists to regulate the safety of these products. However, when a product is found to be unsafe after it has been used by the public, the FDA can post product recalls.

A multi-state recall of drug products that were supposed to be guaranteed sterile by the Nora Apothecary & Alternative Therapies pharmacy has been announced. These products are not yet expired, but since they were compounded and delivered on or before Friday, April 19, 2013, the pharmacy cannot guarantee they are safe. Quality control process is to blame, as well as the fact they were not able to keep the sterility assurance during a recent FDA inspection.

Though there have been no reports of injury or illness, they chose to announce a voluntary recall as a precaution in order to insure no issues do arise. According to the press release that announced the recall, “Patients are at increased risk for serious infections in the event a sterile product is compromised.”

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 Posted on May 30, 2013 in Defective Medical Devices

So many people put their lives in the hands of medical professionals. In turn, medical professionals rely on medical devices to assist in the care of patients. Without these devices, care would be limited. Having equipment that works properly is critical, as it can be used in a life and death situation.

Recently, the Maquet SERVO-I ventilator battery module was recalled by the FDA. These battery types are important because they allow healthcare professionals and patients to be mobile as opposed to being near an electricity source. Ventilator units are used to monitor and treat people with respiratory issues. If for any reason this medical equipment should fail to operate, it could cost a patient's life.

The FDA reports that the reason for the recall is due to reports that some battery packs distributed after the first of the year had shorter a battery life than expected. This can cause the ventilator to shut down which is something the hospital cannot afford to happen. If this were to happen, it could cause serious health complications, which could include death and that, could lead to a malpractice suit.

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