Injuryboard Commentary - Medical Devices & Implants

Rapid CT Heart Scan Better at Diagnosing Blocked Arteries

David Mittleman — Fri, 20 Nov 2009 10:00:00 GMT

According to a recent study, a rapid CT heart scan is better able to provide doctors with a more efficient method of diagnosing blocked arteries after a patient complains of chest pain. In the past, doctors have routinely used electrocardiograms, treadmill, and resting stress tests along with nuclear imaging, to diagnose blocked arteries. However, these tests are often longer and don’t always provide a clear diagnosis.

The author of the study, Kavitha Chinnaiyan of William Beaumont Hospital in Royal Oak, MI, discovered that the rapid CT heart scan cuts the diagnosis time in half, and also saves 40% of the cost of the previous diagnostic methods. However, there is one drawback to the test: patients increase their exposure to medical radiation. Some doctors are concerned about the effects of such exposure on patients who routinely and frequently go to the hospital for chest pains.

Nevertheless, approximately 6 million people per year travel to the hospital complaining of chest pains, 60% of which are told that their symptoms are not serious and are sent home. Subsequently, 4 to 13% of those patients that are sent home suffer “missed” heart attacks, which can be fatal 10 to 25% of the time. Thus, the rapid CT heart scan could help reduce the incidence of “missed” diagnoses, ultimately saving lives.

Originally posted at InjuryBoard by David Mittleman

Synthes Components Recalled

Jamie Sheller — Wed, 18 Nov 2009 21:17:38 GMT

Recently, Synthes, a Swiss medical device company, voluntarily recalled its Synex II Central Body components. According to the company, all surgeons and hospitals with the recalled devices were to immediately stop implanting them. The FDA has classified the recall as a Class I, which means that they could pose an imminent health hazard. The Synthes devices are used to replace damaged or unstable vertebral body in the T1-L5 portion of the spine. The recall was issued after reports of device failure causing loss of vertebral body replacement height. Those problems could lead to neural injury, increased pain and possible need for further surgery.

Originally posted at InjuryBoard by Jamie Sheller

Cardiovascular Systems ViperSheath Sheath Introducer Recalled Due to Fracturing

Rick Patterson — Wed, 18 Nov 2009 15:02:49 GMT

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use.

In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

Lot range: S28117 through S29174
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

Originally posted at InjuryBoard by Rick Patterson

“Wiihab” Proving to be a Powerful Rehabilitation Tool

Rick Shapiro — Tue, 27 Oct 2009 20:19:35 GMT

Hospitals routinely struggle to keep their patients motivated and active in the traditional rehabilitation routine. Why? Because most routines are repetitive, cause pain, and are not very exciting.

Enter the Nintendo Wii.

This popular video game system is no longer the exclusive domain of teenagers. People who were seriously injured in car, motorcycle, and truck accidents, people who suffered a stroke, and even our brave military men and women with combat wounds have discovered “Wiihab.”

Using the game console's motion-sensitive controller, Nintendo Wii games require actual body movements which mimic therapy exercises. However, since the games are entertaining and mentally engrossing, patients usually ignore or don’t even notice the rigor making Wiihab an effective form of steady rehabilitation, according to CBS News.

Our injury law firm is a big proponent of Wiihab, which is why we donated a Wii gaming system to the Lake Taylor Transitional Care Hospital in Virginia (VA). We witnessed the positive results of Wiihab. Within minutes of our donation, patients were playing, or watching and waiting to play, the Wii.

Studies are currently under way to quantify the effectiveness of Wiihab, but from what we’ve seen up to this point, it has great potential to help a lot of injured people.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and our attorneys have handled thousands of car and truck accident cases. Check out our case results to see for yourself. In addition, check out our FREE special reports on distracted driving and The Best Guide to Car Accident injuries in Virginia. Our primary office in based in Virginia Beach, Virginia (VA) although our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

Originally posted at InjuryBoard by Rick Shapiro

X-Ray Risks: Steps You Need To Take to Reduce Radiation Exposure

Rick Shapiro — Thu, 22 Oct 2009 08:59:00 GMT

X-rays, by in large, are a great medical tool which assist doctors in making diagnoses and provide an internal view of the human body without making surgical incisions. However, this technology is not 100 percent safe. There are inherent risks due to the fact that X-rays rely on radiation (as the name implies). As an injury lawyer who represents people adversely effected by radiation exposure, this issue is important to me.

The most disturbing risk is the development of cancer. High frequency and exposure to radiation has been shown to cause genetic damage which leads to cancer, according to the American Cancer Society. Studies show that young people are at a higher risk due to the fact that they accumulate more radiation exposure over the years. Surprisingly, women are more susceptible to cancer development from X-ray exposure than men, even with the same level of exposure.

Here’s a video discussing the risks associated with X-rays:

http://www.youtube.com/watch?v=NWqfAjpr1iQ

There’s also a chance of developing cataracts and skin burns from X-rays. Once again, this usually occurs when you’re exposed to high levels of radiation and with fluoroscopy (i.e. continuous x-ray imaging) procedures, according to the FDA.

These risks do not mean you should avoid X-rays. Here are some simple steps you should follow when it comes to handling X-ray exposure:

Ask if you can use a lead apron or shield can be used
Don’t always ask for an X-ray
Ask your dentist if they use E or F speed film for X-rays since these films are much more efficient and reduce exposure
Remain aware of your X-ray history

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and our attorneys have experience handling medical malpractice cases. Check out our case results to see for yourself. In addition, check out our FREE special reports on the Top 10 Tips from a Medical Malpractice Insider and the top 5 surgical errors you must know about. Our primary office in based in Virginia Beach, Virginia (VA) and we also have a North Carolina (NC) law office. Our lawyers hold licenses in NC, SC, WV, KY and DC. We are ready to talk to you by phone right now—we provide free initial confidential injury case consultations, so call us toll free at 1-800-752-0042. Our injury attorneys also host an extensive injury law video library on Youtube . Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

Originally posted at InjuryBoard by Rick Shapiro

206 Stroke Patients Given Overdose of Radiation During CT Scans at Cedars-Sinai

David Mittleman — Tue, 13 Oct 2009 16:50:33 GMT

Cedars-Sinai Medical Center recently made a startling discovery: because of a setting error, hospital staff realized that at least 200 potential stroke patients were given CT scans at radiation doses 8 times the normal level.

On Monday, doctors admitted that the error occurred in February 2008, the same time that the hospital started a new protocol for scanning for potential strokes in patients. Specifically, doctors thought that the new procedures would help them to gather more useful data in analyzing the flow of blood to brain tissue.

Apparently, when a hospital employee set the scanner, they did not fully understand the set of directions that came with the machinery. Instead, they set the scanner at 8 times the normal radiation levels, which remained the default setting for the next 18 months. Doctors weren’t aware of the problem until a patient contacted the hospital to report that his hair had started falling out after receiving a CT scan. In response, hospital staff reviewed their records and found that 206 patients had received the higher dosages of radiation from the CT machine. When contacted, most of those patients also reported patchy hair loss as well as reddening of their skin. Fortunately, the incident prompted the Food and Drug Administration to issue a warning to all hospitals to check their CT scanners to make sure they are properly set.

Originally posted at InjuryBoard by David Mittleman

Portable Headphones Can Cause Interference With Cardiac Devices

Jamie Sheller — Sat, 10 Oct 2009 17:11:24 GMT

According to a recent study published in the journal Heart Rhythm, the magnets in portable headphones may cause temporary malfunction of some cardiac devices. Therefore, the researchers suggest that patients with implantable cardioverter-defibrillators or pacemakers should not place headphones from MP3 players too close to their chests. The interference that can be caused by the headphones includes inhibition of tachyarrhythmia detection in ICDs and asynchronous pacing in pacemakers. Patients with these devices don't need to avoid portable headphones, they should just keep them at least 3 centimeters (1.2 inches) from their chests. Cardiac arrhythmia specialists have long told patients not to place electronic equipment directly over their devices.

According to the study's researchers, the FDA has already concluded that digital music players are unlikely to interfere with implanted devices, but not much was known about potential interference from portable headphones. In the recent study, electromagnetic levels from portable headphones exceeded levels sufficient to disable sensing in an implanted device, when the headphones were less than 2 centimeters from the chest. Most of the devices returned to normal functioning once the headphones were moved away. Patients with ICDs were more likely to have an interaction, than patients with pacemakers. The headphones' magnetic fields were the same whether the MP3 player was turned on, or the headphones were plugged in.

Originally posted at InjuryBoard by Jamie Sheller

Recall of Defibrillators

Jamie Sheller — Sat, 10 Oct 2009 15:55:21 GMT

Certain models of the HeartStart FR2+ brand of automated external defibrillator (AED), manufactured by Phillips, have been recalled. Recently, the voluntary recall was announced by the FDA. According to the FDA, the AEDs have a memory chip failure that can cause the device not to work. The AED is supposed to alert the defibrillator user when the patient needs a life saving shock. The AED determines when a shock is necessary by automatically analyzing the patient's heart rhythm. Between mid-2007 and early 2008, the memory chip failed some self-tests done by Phillips. There are no reported injuries from failed memory chips. Phillips will provide replacements for the recalled AEDs. The recalled AED models are the M3860A and M3861A, distributed by Phillips, and models M3840A and M3841A distributed by Laerdal Medical.

Originally posted at InjuryBoard by Jamie Sheller

CPSC Urges Parents Not To Use "My Baby Soother" Pacifiers

Chrissie Cole — Fri, 09 Oct 2009 13:17:00 GMT

Parents and caregivers should stop using the “My Baby Soother” pacifier, according to a recent safety alert by The U.S. Consumer Product Safety Commission (CPSC).

The pacifiers, distributed by T & L Trading Corp, fail to meet federal safety standards because the nipples can easily separate from the base, posing a choking hazard to infants and toddlers.

The agency announced a safety alert after the company refused to recall these pacifiers.

The recalled pacifiers have a ring-shaped handle and a blue, pink, red, white or yellow heart-shaped mouth guard. The packaging displays the words "My Baby Soother."

The agency urges parents to take the pacifiers from infants and toddlers and discard them.

Originally posted at InjuryBoard by Chrissie Cole

Controversial Medical Device - Menaflex - Approved By FDA

Greg Webb — Wed, 07 Oct 2009 17:11:15 GMT

In a bid to get a controversial knee-surgery device known as Menaflex approved by the Food and Drug Administration (FDA), ReGen Biologics relied too heavily on two consultants with strong ties to Congress and the FDA. One consultant previously worked as the FDA’s associate chief counsel for medical devices and had regular contact with the agency about the device; the device was approved last December despite staff objections. Another top ReGen consultant is the former chief of staff to Senator Robert Menendez, who was among four lawmakers that signed a letter urging the FDA to review the case. Campaign finance records also show that one of these consultants contributed about $40,000 to Menendez and the other three New Jersey politicians that signed the letter.

The two consultants were part of an aggressive campaign by ReGen to obtain approval for Menaflex, which is a surgical mesh used to aid in repairing torn knee tissue. FDA staff scientists rejected Menaflex three times, citing concerns that patients may experience adverse effects and that the manufacturer had not provided enough evidence that the device was more effective than routine surgery. However, in late 2008, ReGen appealed to Andrew von Eschenbach, the FDA Commissioner, who ordered an expedited review by a panel of independent advisers, allowed ReGen input regarding the composition of the panel and refused to permit FDA staff scientists who had been reviewing the Menaflex applications to address the panel. An internal probe found ReGen had remarkable access to von Eschenbach and approval came after he met with the New Jersey legislators who asked von Eschenbach to handle the matter personally. According to the Center for Responsive Politics, ReGen has spent $500,000 lobbying in Washington since 2007. Three of the company’s executives also gave substantial sums of money to the campaigns of the lawmakers that signed the letter to the FDA, though the congressmen’s aides claim the contributions played no role in their decision to approach the FDA.

The exposure from this ReGen case and how the FDA is now considering approving the Menaflex has alarmed not only public interest groups seeking FDA reforms, but also the $200 billion medical device industry, which is also seeking changes to health-care reform legislation making its way through Congress.

Originally posted at InjuryBoard by Greg Webb