Archive for the ‘CT Scan’ Category

Radiation Overdoses from CT Scans (December 2009)

Monday, December 21st, 2009

Video originally created by FDA -- posted by Lawsuit.com on December 14, 2009

FDA is investigating a situation in which more than 200 patients undergoing CT brain perfusion scans at a single hospital received overdoses of radiation. In some cases the radiation doses were high enough to produce erythema and hair loss.

While these events involved one type of procedure at one facility, FDA is concerned that they could reflect more widespread problems with CT quality assurance programs. If patient doses from CT procedures were higher than the expected level but not high enough to produce obvious signs of radiation injury, the problem could go undetected and unreported. This could put patients at increased risk for long-term radiation effects, including certain types of cancer.

To help prevent overexposures, FDA is encouraging facilities that perform CT procedures to be aware of the dose indices displayed on the control panel. These indices include the volume CT dose index, expressed “milligray” (mGy), and the dose-length product, expressed in “milligray-centimeter” (mGy-cm). Before a patient is scanned, the operator should make sure that the values displayed for these indices correspond reasonably to those normally associated with the procedure being performed. These indices should be checked again after the patient is scanned.

FDA is working to obtain more information on reports of CT overdoses and encourage healthcare professionals to report these when they occur.

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CT Scanning May Cause Malfunction of Electronic Medical Devices

Friday, February 27th, 2009

Video originally created by FDA -- posted by Lawsuit.com on October 13, 2008

FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and magnetic fields.

Most patients with electronic medical devices do not experience problems with CT scans, but FDA has received a small number of reports in which the scans may have caused unintended shocks from neurostimulators, malfunctions of insulin pumps, and transient changes in pacemaker output. Theoretically, defibrillators, cochlear implants and retinal implants could also be affected.

Here is what FDA recommends to help reduce any possible risk:

•Before beginning a CT scan, use scout views to check whether the patient has an electronic medical device and where it is. If the device is in or very near the area to be scanned, there are several steps to take.

•Determine the device type. If it is an externally worn device, try to move it out of the scan range, if possible. If it is a neurostimulator, ask the patient to temporarily shut it off.

•During the scan, minimize x-ray exposure to the device by using the lowest x-ray tube current that will allow you to get the required image, and by making sure that the x-ray beam does not dwell over the device for more than a few seconds. If the procedure requires continuous scanning over the device for longer than that, as with CT perfusion or interventional exams, be ready to take emergency measures to treat adverse reactions if they occur.

•After the scan, remind the patient to turn the device back on if it was turned off beforehand. Even if the device was turned off during the scan, ask the patient to be sure that it is working properly. If not, tell the patient to contact their healthcare provider as soon as possible.

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Shoulder Pain Pump Lawsuits

Monday, February 16th, 2009

Due to the high number of lawsuits involving shoulder pain pumps across the U.S., motions have been filed to bring all cases forward in one court. Personal injury attorneys are still accepting legal cases relating to shoulder pain pumps that may cause Post arthroscopic Glenohumeral Chondrolysis or PALG.

PAGCL is characterized by cartilage loss and debilitating shoulder pain. PAGCL is a progressive condition that may not be evident for 12 months following the use of the pain pump. As Laura B Kalur, Attorney at Law, of Portland, Oregon explains, “The pain pump was not approved by the FDA for use intra-articularly (inside the shoulder space). In fact, it was denied approval by the FDA for that specific use through the 510(k) process as early as 1998. However, orthopedic surgeons using the pain pumps were not informed by the pain pump manufacturers of the FDA’s specific denial. Failure to warn the doctors and ultimately the patients exposed to the pain pump has resulted in crippling severe arthritic disease called ‘chondrolysis’ for many shoulder surgery patients.”

The Pain Pump Personal Injury

Pain pumps are often used in many types of surgery today. Pain pumps deliver medication directly to the location of surgery to relieve pain. As Angel Reyes of Dallas, Texas explains, “The pain pump appeared to be attractive with the advantage of no gastric indigestion or mental acuity issues when compared to post operative pain medication. However, the pre and post operative photos are clear. Pre-operative photos demonstrate cartilage presence. Many post operative photos show no cartilage. The only recourse many victims have is to proceed with shoulder replacement surgery which lasts for ten or more years.”

Manufacturer Outlook

A number of manufacturers sold shoulder pain pumps to doctors with the alleged impression that they are suitable for intra-articular use following arthroscopic shoulder surgery. However, a study published in the July 2007 issue of The American Journal of Sports Medicine (AJSM) demonstrated a link between shoulder pain pump use and PAGCL. PAGCL may create a host of disabilities and the physical disabilities may be far greater than the disability that the patient had contended with prior to surgery. PAGCL symptoms include: at rest shoulder pain, motion shoulder pain, compromised range of motion as well as shoulder clicking, popping, grinding, stiffness, weakness and arthritic conditions of crippling severity.

Partial List of Pain Pumps with Associated Problems

• Stryker®
• Stryker® PainPump 1®
• Stryker® PainPump 2®
• PainPump® Blockaid®
• I-Flow®
• On-Q® Painbuster®
• Donjoy®
• Donjoy® Pain Control Device
• Accufuser® Plus Pain Pump

Evaluating Shoulder Pain Pump Disability

As Meryl Viener, Attorney at Law suggests, “If the recuperation process from shoulder surgery is not going as expected, it is important to obtain a second opinion from another doctor. Also, be aware that your surgeon may be unfamiliar with the issues surrounding the pain pump.” Personal injury attorneys dedicate an extensive amount of time to research about the effects of shoulder pain pump injuries. They also investigate the circumstances surrounding victims that have Post arthroscopic Glenohumeral Chondrolysis or PAGCL as a result of shoulder surgery. Shoulder pain pump injury disabilities are evaluated through many methods. Compensation for injury from shoulder pain pumps may consider many factors, including: a rating of permanent disability that coverts into a financial compensation amount, the possible requirement of vocational assistance for job replacement, the effect of the disability on daily life activities and the effect of the disability on other family members.

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