Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic’s Carmeda BioActive surface, which includes heparin. No injuries have been reported in relation to the Medtronic devices, but the recall underscores the enormous scope of the problems involving contaminated heparin.

Tainted heparin first garnered attention earlier this year, when Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. There have been similar recalls by other manufacturers of Chinese-sourced heparin in 11 other countries, including Denmark, Italy, France Germany and Japan. In the US, heparin has been associated with the deaths of more than 100 people since early 2007, according to the Food & Drug Administration (FDA). Of those, the vast majority - 81 to be exact - were associated with contaminated batches of heparin. (more…)

Still struggling in the wake of last year’s Sprint Fidelis Defibrillator Lead recall, medical device maker Medtronic Inc. says it plans to cut 1,100 jobs worldwide as part of a restructuring plan.  Medtronic’s business has been hurt, not just by the Sprint Fidelis recall, but by the declining worldwide demand for implantable defibrillators, which has been shrinking since Medtronic and competitors recalled faulty products in 2005.

Medtronic suspended sales of the Sprint Fidelis Leads in October 2007 after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture. (more…)

Mentors ObTape Vaginal Sling is a medical device meant to stop the uncontrollable flow of urine as a result of urinary stress incontinence, a medical condition affecting about two million American women. Patients with urinary stress incontinence are no longer able to control or stop urine flow, which often happens in the years following childbirth. Approximately 35,000 women were implanted with Mentor Corporation’s ObTape and, now, women are reporting that the tape has deteriorated in their bodies and is making them ill and causing severe pain and other complications.

ObTape is a piece of mesh that is inserted as a type of sling that tapes up the bladder to prevent leaking. The Mentor ObTape Vaginal Sling is designed to replace eroded or weakened muscles in the urethra and is essentially a hammock for the vaginal wall. The vaginal sling technique has been around for about 100 years and is considered the “gold standard” in stress urinary incontinence treatment. Generally, the minimally invasive treatment can be done on an outpatient basis. (more…)

A review by the US Food and Drug Administration (FDA) just revealed that insulin pumps can be risky and have been linked to injuries and deaths.  Insulin pumps are generally used by teenagers with Type I diabetes and the FDA, while not suggesting parents find alternate treatments, suggest they exercise increased vigilance.  The FDA is also calling for additional studies to review and respond to safety issues in teenagers and children using insulin pumps.

Type 1—juvenile—diabetes comprises between five and 10 percent of all diabetes cases, affecting 12 to 24 million people globally and involves the body attacking insulin-producing cells in the pancreas.   Type 2 diabetes is far more common, usually affects adults, and is generally linked to obesity.  Insulin regulates blood sugar levels and if blood sugar levels go too high, heart disease, blindness, and kidney damage can result. (more…)

Stryker Corp. has been hit with another Food & Drug Administration (FDA) warning letter, the medical device maker’s second since last November, and the third in a little over a year.  This time, the FDA took Stryker’s biotech division to task for quality systems and compliance issues at its Hopkinton, Massachusetts, location.  One of the issues cited by the FDA warning letter involves falsification of hospital-approval documents used under an FDA rule that allows device sales on a very limited basis.

The past year or so has been a rough one for Stryker.  In January, Stryker recalled some of its hip implant components made under the popular Trident line because of possible contamination issues.  The Stryker Hip Implant component recall involved two hip replacement cups – the Trident Acetabular PSL Cup and the Trident Hemispherical Cups – made at the Stryker facility in Cork, Ireland.  Acetabular Cups are used in the socket portion of replacement hip components.  The PSL version is the most commonly used Stryker cup in the U.S. (more…)

An agreement has been reached by a unit of Medtronic Inc. on a consent decree with the U.S. Food and Drug Administration (FDA) over quality system improvements for its external defibrillators.  The agreement—which is subject to court approval—addresses concerns raised by the FDA during inspections and outlines actions Medtronic’s Physio-Control subsidiary must take to resume unrestricted distribution of the portable electronic devices. Physio-control is a maker of external defibrillators,

Automated external defibrillators, or AEDs, are becoming more and more available in office buildings, schools, and other public venues for use by bystanders to help a person suffering from sudden cardiac arrest.  Physio-Control stopped U.S. shipments in January 2007 due to quality problems.  Medtronic said shipments to meet critical customer requirements and certain specified public health needs will continue; however, in September, Medtronic announced plans to eliminate about 200 jobs in the Physio-Control unit.  The consent decree agreement requires court approval. (more…)

The new Xience heart stent out-performed the more popular Taxus heart stent in a one-year trial; however, experts disagree on whether stent science is moving too fast and doctors are concerned over the recent discovery that blood clots can form at the site of drug-coated stents long after implantation.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following balloon angioplasty procedures.  Bare-metal stents tend to re-clog more often than drug-coated stents, so physicians are quick use drug-coated stents, even in those patients with complex heart disease, not the patients in whom the devices were tested. (more…)

More and more, physicians are realizing that children should not be fitted for adult-sized medical devices.  According to Dr. David Staffenberg, a metal plate improperly lodged in a young boy’s skull showed him how very dangerous traditional devices—generally made to fit adults—can be when implanted in children.  In the case of Staffenberg’s patient, the plate was implanted to help stabilize the boy’s skull but ended up resting on his brain.  Staffenberg safely removed the titanium plate; however, that did not resolve the overarching issue that the vast majority of medical devices are made for adults.  Apparently, doctors work around the problem by “jury-rigging” devices to suit their patients’ needs; however, this practice has limits and patient risk can be high.  Also, problems exist not because children are smaller, but because they are also growing and their metabolism is quicker.

Now, lawmakers and doctors are pushing the medical device industry to design a new class of “kid-friendly” equipment and President Bush signed a law in September offering financial incentives to those companies that design child-sized devices.  The law also provides regulators with additional power to both analyze the use of adult-sized devices in children and requires device makers to swallow the cost of such tracking. (more…)

Philips Medical Systems Inc. has been warned by U.S. health regulators about a wide variety of problems with its manufacturing procedures at an Ohio plant.  According to a letter released by the U.S. Food and Drug Administration (FDA), one of the problems cited includes Philips Medical’s failure to oversee proper medical device design.  Philips Medical System is a unit of Philips Electronics NV.

FDA inspectors visited Philips’ Cleveland, Ohio plant this past September and October 2007 and found more than one dozen production problems at the facility.  Philips Medical manufactures computed tomography (CT) and nuclear medicine devices.  Among the production problems cited were an inadequate system to manage production changes as well as problems with software to check device and also said Philips Medical Systems did not properly maintain certain investigative records and failed to set up proper procedures to handle complaints.  The FDA cited these issues in an April 1 letter to Philips Medical Systems, which is also quoted as saying, “Your procedure does not require systematic evaluation to determine if an event is … reportable.” (more…)

There is a small group of prominent academic scientists who no longer accept payments from food, drug, and medical device companies. In this unprecedented trend, some physicians no longer accept payment for speaking at meetings or for sitting on advisory boards. Although they may still work with these companies—because they feel it is important for scientists to assist these companies in their work with these studies—they work for free. The scientists involved say their decisions were private and difficult. For instance, one scientist will experience significant financial sacrifice. Regardless, the group feels that they are now able to provide decisions based on science and with no connection to money.

This group is acting in response to accusations of ethical conflicts. According to Dr. Jerome P. Kassirer, a professor at the Tufts School of Medicine and who wrote a book on conflicts of interest, this group’s actions renounce decades of industry influence. Five years ago, “nobody paid any attention to taking money from industry. They just took it. In some instances, I think people thought they were suckers if they didn’t.” (more…)