April 2010 Archives

April 29, 2010

Medical Errors Are Costly and On the Rise

Research has shown that medical errors may result most frequently from system errors. One out of 25 patients in hospitals are injured due to medical errors, and an estimated 48,000 to 98,000 patients die from these errors a year. Even if you consider the lower estimate of 48,000 errors a year, it is still higher than the annual mortality from motor vehicle accidents (43,458), breast cancer (42,297), or even AIDS (16,516), thus making medical errors the eighth leading cause of death in the United States. These errors, besides causing death, have also cost the economy from $17 to $29 billion each year and cost more that $5 million a year in large teaching hospitals, according to the Agency for Healthcare Research and Quality (AHRQ).

For Patients at Risk, Medical errors may result in the following:

- A patient being given the wrong medicine
- A clinician misreading the results of a test
- An elderly person that shows up to an emergency room with ambiguous systems, such as: shortness of breath, abdominal pain and dizziness, whose heat attack is not diagnosed by the medical staff

How Errors Occur:
- Medication Errors:
These are preventable mistakes in the prescribing and delivering of medications to a patient, these errors include: prescribing two or more drugs whose interaction is known to produce side effects or prescribing a drug to which the patient is allergic to.
- Surgical Errors
- Diagnostic Inaccuracies:
This leads to ineffective treatment and/or unnecessary testing, which is costly and can be invasive to the patient.
- System Failures:
This is the way health care is delivered and the way that resources are provided to the delivery system.

Medical Mistakes are also made by distracted nurses. It is believed that if medical facilities had more nursing staff that could focus their attention on fewer tasks at a time that medical mistakes would decrease, patient safety increase and it would reduce the risk of medical malpractice. When nurses are interrupted, it increases the chance of a procedural failure by 12.1%, and the chances of a clinical error by 12.7%, as indicated by the Archives of Internal Medicine study published in Australia in 2008.

April 23, 2010

Virginia Enforces Stricter Traffic Laws for Motorcyclists

In Virginia, motorcycles make up about two percent of all registered vehicles, yet in 2009, they accounted for nine percent of total fatalities, ten percent of all occupant fatalities, and three percent of all occupants injured, according to Richard Holcomb, the Governor's Highway Safety Representative.

For every mile traveled by motorcyclists there chances of dying in a traffic crash is 37 times more likely that passenger car occupants. This is because there is no protection on a motorcycle, which increases the likelihood of being seriously injured or even killed in a crash.

In 2009, there were 71 motorcycle fatalities and 1,938 reported injuries in Virginia alone. The Virginia Department of Motor Vehicles (DMV) Highway Safety Office announced last week that law enforcement agencies across Virginia will focus more on the safety of motorcycle riders by enforcing stricter traffic laws. The traffic laws that will be enforced are speeding, improper licensure and drinking and riding.

April 20, 2010

Hospital Acquired Infections on the Rise

The Centers for Disease Control and Prevention (CDC), reports that there are over 2 million hospital infections acquired each year, resulting in almost 90,000 deaths annually. This number is much higher when dealing with nursing home infections.

It is because of this huge number of yearly deaths that Medical Malpractice lawsuits have increased in the United States. Experts believe that these potentially life threatening infections can be prevented if steps are taken by hospitals and their staff. The steps that need to be taken should include: improving the methods of handling catheters during insertion, leaving them in for shorter periods of time and improving hygiene. Also hospital staff should was their hands more frequently and make sure to keep areas more sterile and catheters clean.

The hospital acquired infections include Postoperative sepsis, catheter-associated urinary tract infections and other preventable infections. Hospital stays are prolonged because of these avoidable infections and patients are also more likely to die from these infections, according to the U.S. Department of Health and Human Services (DHHS) 2009 National Healthcare Quality Report released earlier this year.

The biggest increase of hospital acquired infections occurred in sepsis infections. Sepsis is when a full body inflammation occurs as a reaction to an infection. Symptoms of sepsis include high heart rate, high respiratory rate, high and/or low body temperature and elevated white blood cell count. All of these symptoms can cause organ damage and in some cases organ failure, which lead to death in about 20 to 35% of cases.

Hospitals in the Washington Metropolitan Area, such as Washington Hospital Center (WHC), George Washington University Hospital (GWUH), Sibley Memorial Hospital (SMH) and Georgetown University Hospital (GUH), are making much needed changes to try and reduce these infections and deaths in order to avoid Medical Malpractice Lawsuits. These medical facilities are devoting more attention to patient safety in order to ensure that health care does not result in patient harm.

April 12, 2010

Prescription Drug Poisoning Has Surpassed Automobile Accidents As the Leading Cause of Unintentional Injury Deaths

Rx bottle.jpgIn a report by the American Journal of Preventative Medicine, prescription drug poisoning now surpasses automobile accidents as the leading cause of unintentional injury death among people of ages 35 to 54.

Currently the number of people that are hospitalized due to overdoses from prescription drugs is 65% higher than they were between 1999 and 2006. Such drugs are OxyContin, Fentanyl and Morphine. The use of these drugs, whether illegally or as a suicide attempt rose 130% and accidental overdoses rose by 37%. No other prescription drug causes such a high occurrence of hospitalizations in the United States, according to Researchers from the West Virginia University School of Medicine.

Overdoses from drugs such as tranquilizers, sedatives and painkillers, has also risen by 65% in the last couple of years, making drug poisoning the second leading cause of unintentional injury death in the U.S.

In 2009, an average of 71,000 people, were hospitalized for painkiller overdoses. This is a huge increase from the 43,000 people that were hospitalized in 2008. Methadone is the drug that saw the largest increase in poisoning hospitalizations. Among other drugs that saw an increase in hospitalization is Valium, which saw a 39% increase. Barbiturates and antidepressants actually saw a decrease.

It is due to these huge increases in drug overdoses that caused the Food and Drug Administration (FDA) to approve a new tamper-resistant version of OxyContin. This new version of the drug is supposed to resist the efforts to cut, chew, or crush the pills in order to defeat the slow medication release design of the pills.

April 7, 2010

Human Factors Experts Testimony in Product Liability Cases Is On the Rise

The Food and Drug Administration (FDA) has regulations, guidance documents and industry standards in relation to the use of human factors experts, which allow for more effective cross-examination and a strong defense in Product Liability Cases. With these regulations, human factors not only base their expert opinion on speculation, but also on facts.

You may be asking yourself, what are Human Factors, well it is the study of the relationships between humans, the tools they use, and the environment in which they live and work.

It is with these tools that human factors experts are allowed to testify in cases to provide opinions regarding the adequacy and efficacy of warnings and/or the impact of human factors in the design of products. The Expert must be able to identify a reliable scientific basis for his/her opinion to be used as testimony. It is the goal of the human factors professional to eliminate user error through proper product design and labeling.

Medical devices that are designed by the FDA are designed with the human factor principles in mind. According to the FDA manufacturers must use the following three device classes/guidelines when manufacturing a device for human use:

- The Manufacturer must consider human factors in the development of the device. Such things as what the user sees, feels and hears;
- The Manufacturer must test all devices for the potential in error use by the user;
- The Manufacturer, when conducting risk analysis of the device, must consider user error.

These three device classes must all be subject to good manufacturing practices (GMPs) and these can be found in its Quality System Regulations. It is imperative that the medical device withstand the actions and inactions of its intended user, in order to design an error-tolerant medical device. It is important that the developer consider the characteristics of the worst case user. It is this underlying philosophy that human factor experts are used for.

These Human Factors Principles are also embraced by the Association for the Advancement of Medical Instruments (AAMI), the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO)

April 1, 2010

The Food and Drug Administration Ignored CT Scan Radiation Warnings

CT scan.jpgIn Gaithersburg, Maryland today there will be a two day public hearing to discuss allegations that the FDA ignored some Scientists warnings on the risks of radiation exposure from CT scans that have lead to unnecessary and unexpected health problems and dangers to some patients.

The public hearing will focus on reducing the risks of unnecessary radiation exposure. The concerns about radiation exposure risks came about late last year in Los Angeles, California, when over 200 patients were subjected to radiation overexposure at Cedars-Sinai Medical Center. It was uncovered by the FDA that various cases at other area hospitals were discovered. These discoveries by the FDA lead to a new radiation exposure reduction initiative that was announced in February of this year.

This new initiative seeks to reduce the risk of radiation exposure from medical procedures by promoting the safer use of all medical devices that use radiation, and by providing support to patients in order to better inform them on the risks and side effects to radiation exposure. With this knowledge, patients will be able to make better decisions in regards to their medical procedures and be aware of their total radiation exposure.

The FDA issued a statement in December 2009 that better describes the side effects of radiation and the proper use of medical devices to health care professionals and radiologists. This guidance advised health care providers to review procedures and CT scan settings, and to thoroughly inspect the amount of dosage prescribed for each CT scan patient.