The June 2017 issue of the American Journal of Infection Control included a report from the Children’s Hospital of Philadelphia (CHOP) which described 23 infants in their intensive care unit (ICU) who contracted eye infections after eye examinations. In the report, CHOP attributed the cause of the outbreak to some medical staff not wearing gloves, and a “lack of standard cleaning practices” of equipment used in the exams.

This outbreak occurred in August 2016, and a recent lawsuit has been filed on behalf of a family who alleges their premature baby died as a result of her contracted infection at CHOP in September 2016. The premature infant had been transferred to CHOP in July, and by mid-August had tested positive for infection with an adenovirus and was suffering from respiratory symptoms. She eventually developed a bacterial infection on top of the viral illness, and died on September 11, 2016.


Continue Reading 23 Infants Contracted Infections at CHOP

Telemedicine” or “Telehealth” are the terms most often used when referring to clinical diagnosis and monitoring that is delivered by technology. Telemedicine encompasses healthcare provided via real time two-way video conferencing; file sharing, including transmission of health history, x-rays, films, or photos; remote patient monitoring; and consumer mobile health apps on smart phones, tablets, and devices that collect data and transmit it to a healthcare provider. Telemedicine is increasingly being used for everything from diagnosing common viruses to monitoring patients with serious long-term health issues.

The American Telemedicine Association reports that majority of hospitals now use some form of telemedicine. Two years ago, there were approximately 20 million telemedicine video consultations; that number is expected to increase to about 160 million by 2020. An estimated one-third of employer group plans already cover some type of telehealth.


Continue Reading Telemedicine – Are There Increased Risks With Virtual Doctor Visits?

In the 1980s, journalists used the Freedom of Information Act to obtain data on individual cardiac surgeons’ surgical outcomes from the New York State Department of Health. A recent JAMA article discusses that type of data and takes the position that despite its limitations, the data should be publicly reported.

Debate Surrounding Reporting of Individual Surgeons’ Outcomes

The debate centers on whether data should be reported on the hospital level only or also reported as to individual surgeons.

According to the article, several objections to reporting data relating to individual surgeons have been raised.

First, an individual surgeon may perform a low number of procedures, possibly leading to an unreliable measure of performance. However, the author notes that performance can be aggregated across multiple years or a surgeon’s performance across a range of procedures can be used. Also, the data can be presented in a way that highlights the statistical limitations.


Continue Reading Should Surgical Outcomes for Individual Surgeons Be Available to the Public?

After the sudden deaths of five people following the placement of inflated silicone balloons in their stomachs to treat obesity, the Food and Drug Administration sent a letter to health care providers on August 10, 2017, warning of potential risks associated with the intragastric balloons. All five reported deaths happened within one month of the procedure, with three of the five people dying one to three days after the procedure. The agency said two more death reports happened within the same time frame and may be related to complications from the balloon treatment. The agency has not yet determined whether any of the deaths were directly related to either the devices or the insertion procedures.

Potential Risks of Intragastric Balloons

One risk is over-inflation. Overinflation may occur when the intragastric balloon inflates with more fluid or with air after placement in the patient’s stomach. Overinflation symptoms include abdominal swelling, severe abdominal pain, breathing problems, and vomiting. Acute pancreatitis is a separate type of risk, caused when the balloons compress other gastrointestinal structures. Symptoms include back and abdominal pain.

Both types of complications can happen within days of the procedure and may require doctors to remove the devices.


Continue Reading FDA Issues Warning Letter Concerning Stomach Balloons Used to Treat Obesity

A recent New Jersey case addressed a statute of limitations issue pertaining to claims arising from a physician’s disclosure of a patient’s HIV-positive status to a third party without his consent.

Plaintiff was a patient of the defendant physician, a board-certified nephrologist. He was being treated for acute kidney failure. During an emergency consultation in plaintiff’s private hospital room, defendant discussed his medical condition and disclosed plaintiff’s HIV-positive status in the presence of a third party without plaintiff’s consent.


Continue Reading Is Doctor’s Disclosure of Patient’s HIV-Positive Status Medical Malpractice?

According to the Centers for Disease Control and Prevention (CDC), 83.6 percent of adults and 93 percent of children had contact with a health care professional in 2015. Hospital visits numbered 125.7 million while physician office visits numbered 922.6 million.

While the vast majority of medical procedures go smoothly, errors do occur and cause injury to patients. Surgery errors are the most common basis for an inpatient medical malpractice claim. As for outpatients, errors in diagnosis are the most common basis for a claim.

If a person suspects medical malpractice due to an adverse outcome from a medical diagnosis or procedure, he or she may decide to reach out to the physician, medical care provider, or hospital for some explanation or recourse. As a recent case illustrates, that may NOT be the best course of action to take.


Continue Reading What You Should and Shouldn’t Do if You Suspect Medical Malpractice

Heart surgery patients failed to prove that they were injured after Intuitive Surgical Inc.’s da Vinci surgical robot left metal fragments in their brains, said the Eleventh Circuit in upholding a District Court decision dismissing their case. The plaintiffs alleged that MRIs showed that metal fragments discharged from the robot’s surgical instruments, entered their bloodstreams and ended up in their brains. The complaint in Gabriel Fernando Nassar Cure v. Intuitive Surgical Inc. asserted that Intuitive designed, manufactured, marketed, and sold defective medical instruments that were used during surgeries at hospitals across the country.

In dismissing the case, the district court cited to Boyd v. Orkin Exterminating Co. The district court found that the injuries allegedly caused when Intuitive’s da Vinci surgical robot inadvertently sent bits of metal debris into the brains of patients were speculative, similar to injuries claimed due to toxic chemical exposure. The patients, however, argued the injury is similar to foreign object claims where objects left in the body constitute an injury. The plaintiffs asserted that their injuries are not speculative and that Intuitive designed and manufactured a defective instrument or instruments which caused them injury by improperly shedding metal fragments into their bodies during surgery. The patients alleged they have suffered physical, neurological, and mental impairments as a result of the metal shavings left in their brains following surgery.


Continue Reading Surgical Robots Left Behind Metal Fragments in Heart Patients’ Brains

Many people are taking advantage of technology to monitor their health and vital signs. But should you monitor your heart with a smartphone? Is this technology approved or regulated by the U.S. Food & Drug Administration? Entering the market in increasing numbers are heart-monitoring apps that are intended to be used as medical devices, which – unlike fitness trackers – must be approved by the FDA. Some are designed for home use, while others are for health care providers.

Digital health technology has revolutionized health care, empowering consumers to make better-informed decisions about their health. The U.S. Food & Drug Administration (FDA) is reevaluating its oversight of digital health technology. The FDA seeks to ensure patients’ timely access to high-quality, safe, and effective digital health products.


Continue Reading Should You Check Your Heart Rate With Your Smartphone?

In 2015, prompted by outbreaks of antibiotic-resistant infections linked to duodenoscopes, the FDA issued a Safety Communication, indicating that the complex design of duodenoscopes may impede effective reprocessing. From January 2013 through December 2014, the FDA received 75 Medical Device Reports (MDRs) involving approximately 135 patients relating to possible microbial transmission from reprocessed duodenoscopes. Duodenoscopes are used to visualize the duodenum and upper digestive tract, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Reprocessing involves a detailed, multistep process to clean and disinfect or sterilize the reusable devices.

The FDA reports that more than 500,000 Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures using duodenoscopes are performed in the United States each year. The procedure is the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The complex design of duodenoscopes improves the efficiency and effectiveness of ERCP. However, that design creates challenges for cleaning and disinfection because some parts of the scopes may be difficult to access. Residual body fluids and organic debris may remain in crevices after cleaning and disinfection. If these fluids contain microbial contamination, subsequent patients may be exposed to serious infections.


Continue Reading Voluntary Recall of Duodenoscope Issued Due to Infection Risk