Articles Posted in Medical Devices

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URGENT/11: Medical Products Are Vulnerable to Cybersecurity Threats

Healthcare organizations, IT professionals, device manufacturers and patients are being warned of cybersecurity vulnerabilities. The U.S. Food and Drug Administration issued a safety communication alert on October 1 explaining the serious safety and security risks due to URGENT/11 and a third-party software system called IPnet.

“Security researchers, manufacturers and the FDA are aware that the following operating systems are affected, but the vulnerability may not be included in all versions of these operating systems,” said FDA officials in a released statement which included a warning involving six different operating systems.

breathing tubes

Breathing Tube Removal Mistakes Can Be Deadly for Hospital Patients 

During sedation or illness, many hospital patients may require breathing assistance through intubation. The device used in this procedure is called an endotracheal tube (ET) which is placed through a patient’s mouth and then into the airway so that a breath can be delivered when used with a ventilator. The sensitive intervention can be especially necessary for patients with respiratory failure in both hospital intensive care units (ICU) and pediatric intensive care units (PICU).

Unplanned extubation (UE) is the uncontrolled and dangerous removal of this life-sustaining breathing tube. Sometimes the removal is self-induced by a patient, but healthcare providers also make deadly mistakes during the repair of a tube, suctioning, weighing, or replacing a ventilator circuit. Sadly, UE is a complication that occurs in more than 121,000 adult patients every year in the U.S. and kills 33,000 American adults, as noted in a recent article published in MedPage Today, authored by Art Kanowitz, MD, FACEP.

When we are sick we often require treatments and procedures that assist in the diagnosis of our medical problem. In one recent case, a woman died after a medical testing procedure was allegedly administered improperly. The woman’s estate administrator filed a lawsuit stating that the hospital and doctors were negligent by failing to provide proper care to the woman and thereby causing or contributing to her death.

Endoscopic Procedures

Endoscopies are generally safe procedures that are completed to view and diagnose internal medical problems throughout the digestive tract. In this case, the woman underwent an esophagogastroduodenoscopy, EGD. The procedure is exploratory and is performed using a scope with a camera which is used to view the inside of the esophagus and stomach. The procedure is not supposed to be invasive. The procedure may be completed as outpatient surgery or can be completed in the ICU or emergency room using special portable equipment.
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A woman has filed a medical malpractice lawsuit in Cook County against a hospital, medical group, and two doctors alleging negligence during surgery caused serious injuries. The woman was a patient at St. Alexius Medical Center where she underwent a surgical procedure. The procedure was not performed properly, according to the woman, and she was injured as a result. The lawsuit seeks damages of more than $50,000.

Failure to Properly Perform Procedure

The lawsuit indicates that the woman underwent a surgical procedure through Suburban Surgical Care Specialists, S.C. although the exact operation was not disclosed. After the procedure, the woman complained of extreme physical pain and also suffered from vomiting. The woman claims that the doctors did not perform the procedure properly and that caused her to suffer injuries along with pain.

Negligence

Negligence occurs when a responsible party fails to provide proper care or take proper precautions to keep someone safe. Particularly, in the case of a doctor, negligence may happen due to a mistake or the failure to do something that should have been done to prevent injuries. Negligence by a doctor is often the same as medical malpractice. Doctors and other medical professionals must provide a high standard of care. Failure to do so could result in medical malpractice if the patient suffers a serious injury or dies as a result.

Surgical Procedures
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A malpractice lawsuit filed in Cook County alleges that negligent care at a Chicago hospital caused the death of a man in 2013. According to the lawsuit, the man underwent triple bypass surgery at the University of Chicago Medical Center. After surgery, the man was utilizing an extracorporeal membrane oxygenation machine (EMCO) which supplies oxygen directly into the femoral artery. In order to prevent bedsores, the man required regular turning which was performed by hospital staff. The EMCO became dislodged due to turning the man, causing him to suffer massive blood loss and ultimately death.

Negligent Care at Hospitals
Negligent care by a doctor or medical professional is also called medical malpractice. Proper care is expected when someone is a patient at a hospital. In this case, the care providers were negligent because they did not use proper care when turning the man and did not ensure that the EMCO device was still in place after moving him. Further, the lawsuit in this case indicates that the providers did not observe the man’s vital signs, and they were not notated on the man’s chart. Had the caregivers noticed that the man was bleeding medical action could have prevented his death. The man’s death in this instance was clearly caused directly by the substantial blood loss.
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When we go under the knife we trust that our surgeon and medical team will provide the best possible care during the procedures. That wasn’t the case for a Vernon Hills woman. The woman underwent a surgical procedure at Hoffman Estates Surgery Center in 2014. According to the lawsuit, during the surgery a Bovie cautery pad was placed onto the woman’s leg causing a third-degree burn on her thigh. The burn was serious and purportedly left her with a scar and permanent disfigurement. The lawsuit was filed in Cook County court, alleging medical negligence.

Surgical Procedures

Many tools and various types of equipment and implements are utilized during surgery. These must be properly accounted for and taken care of throughout the procedure. Many incidents involving misuse of surgical implements have resulted in injuries or death to patients. Common problems include leaving sponges and other items inside the patient, improper sterilization of implements, and general mistakes made during the procedure. These issues are preventable and are generally considered medical malpractice.
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Medical malpractice is a common occurrence in today’s world. Doctors and other medical professionals often make mistakes that cause harm to their patients. Of course, not every error results in a medical malpractice lawsuit. The laws regarding malpractice are complex and require the expertise of a skilled malpractice attorney. When a doctor or nurse has provided inappropriate treatment, the patient likely suffers both physically and emotionally. The result can range from minor medical problems that are quickly resolved, to long-term physical problems, and even could cause death.

Standard of Care
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Power morcellators are essentially small power tools that can be used to remove fibroids in the uterus by cutting uterine tissue during surgery. They are manufactured by several companies, including Olympus, Karl Storz, Blue Endo, and Ethicon (a subsidiary of Johnson & Johnson).

However, there is a concern that, in the process of cutting the tissue, they could end up spreading tumor parts to other areas of the body if that tissue contains cancerous cells, resulting in leiomyosarcoma, myelosarcoma, and uterine sarcoma.
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Usually when one thinks of medical malpractice, he or she thinks of an error by a doctor or nurse that leads to a serious medical complication. Sometimes, however, the problem is not with the medical staff. Instead it is with the medical device. One such medical device has been making news ever since the FDA warned the public about it last year. This device is used for a treatment called laparoscopic power morcellation and the problem with it is that it appears to be causing cancer to spread throughout the body. Called a ¨power morcellator,” this device has been made by companies like Johnson & Johnson. The FDA warned doctors about the dangers of the device last year, but the FBI is investigating whether Johnson & Johnson knew about the problem long before that warning.

FDA Warned Doctors About the Device Last Year

Over a year ago, in April 2014, the Food and Drug Administration (FDA) issued a warning about laparoscopic power morcellation. The procedure involves using a power tool to chop up the tissue of fibroids or, in the case of a hysterectomy, to chop up the uterus itself. Tissue fragments are then removed from the body using tiny incisions. The problem is that roughly one out of every 350 women undergoing fibroid removal or a hysterectomy has a type of cancer called uterine sarcoma.
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Again and again in the news we have heard that Ebola is only transmittable through contact with the bodily fluids of an infected person, and that if proper safety protocols are handled it is an extremely difficult illness to transmit from person to person. And experts all seem to agree that this is true. But when the makers of equipment designed to protect medical professionals from disease exposure fails, the story changes. Just like medical device failures, these failures could be deadly.

Lawsuit Alleges Kleenex-Maker Falsely Claimed its Surgical Gowns Protect Against Ebola
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