Each prescription drug you take has a unique code that the government can use to track problems. But artificial hips and pacemakers? They are implanted without identification, along with many other medical devices.

In fact, the FDA doesn’t know how many devices are implanted into patients each year – it simply doesn’t track that data.

The past decade has seen numerous high profile cases of malfunctioning medical devices, which have led to injury or even death. Critics say the FDA’s minimal monitoring of devices contributes to these problems.

“If you’re lucky, you might find a sticker on the operating room note that was left over from the product,” said Richard Platt, who runs the Harvard Pilgrim Health Care Institute. Otherwise, there is little way of knowing what device was used.

Right now, the FDA depends mostly on voluntary reports from doctors, patients, manufacturers and hospitals to notify them of problems with devices already on the market.

The agency does have some power to require manufacturers to conduct further studies or track a particular device once it is sold. But many devices don’t get that level of surveillance.

“It’s much like a patchwork of streams of information getting to the FDA,” said cardiologist Frederic Resnic of Brigham and Women’s Hospital, who has worked with the FDA on medical device safety monitoring. “The FDA is relying on anecdotal and very variable information about the safety of medical devices.”

If manufacturers get word from a doctor or hospital about a death or injury that occurred as a result of their product, they are legally obligated to investigate the event and report it to the FDA.

But the process isn’t straightforward, as has become clear in the recent controversy over the malfunctioning St. Jude’s Riata defibrillator leadsb(wires that connect a defibrillator to the heart). The FDA said an individual doctor’s report helped alert them to the problem, but it was months before the device was recalled.

And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere, said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families.

For example, if someone dies from complications in a surgery to remove an implant, the manufacturer may argue that it was the surgery – not the implant – that killed the patient.

The FDA responds to the criticism by pointing out that while every medical device carries a potential risk, the vast majority of devices perform well and improve patient health.

An FDA spokeswoman emphasized that the agency must evaluate thousands of medical devices each year, and is constantly looking for ways to better and more quickly identify problems.

While the FDA makes the adverse event reports publically available in a searchable database, it doesn’t have a standardized system for reviewing reports once they are sent in, said Vodra, the attorney.

A disclaimer on the site specifically states that the data is “not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices.”

“What you would normally consider the simplest kind of data analysis is not done,” said Zuckerman. Often, doctors catch a malfunctioning device before the FDA ever notices.

In one case, a group of Pennsylvania doctors noticed that several patients were showing severe complications a few years after getting an IVC filter – a device designed to capture blood clots.

Bits of the filter were breaking off, causing chest pain and a dangerous build-up of fluid and pressure around the heart.

In 2010 the doctors conducted their own study and found that the filter broke in a quarter of all patients who used it.

On the day that study was published, the FDA issued a warning saying it had received over 900 reports of problems with IVC filters since 2006, and that the device was meant to be removed after a few months, not left in permanently.

There have been numerous attempts at reform. Five years ago Congress ordered the FDA to set up a post-market surveillance system to track the safety of all medical projects, but a system hasn’t yet been set up for medical devices.

A year later the FDA announced the Sentinel Initiative, which would combine existing data from electronic health records and medical claims to track drugs, vaccines, and devices.

Some groups of hospitals or other organizations have voluntarily set up registries to collect information about the make and model of devices.

While the FDA has made significant progress on tracking drugs, it’s not yet in a position to do the same thing for devices, according to Harvard’s Platt, who is the principal investigator of Mini-Sentinel, the FDA’s pilot program for the national system. The data isn’t there.

The FDA has long acknowledged the need for a unique device identifier system, and got permission from Congress to set one up five years ago.

No such system of ID-tags exists yet, but after several recent high profile medical device failures, the issue getting some attention from Congress.

A proposed Senate bill, which cleared the Health, Education, Labor and Pensions Committee last week, sets a timeframe for implementing a unique identification system, among other reforms.

“If UDI’s were used in a consistent way, we could use the same kinds of techniques we’ve developed for drugs for devices,” said Platt. “It would be a huge breakthrough.”

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By Glenda Fauntleroy, Contributing Writer

As more and more soldiers return from recent conflicts overseas, new research reveals that female veterans experience poorer health than other women.

In 2010, women made up 8 percent of the U.S. veteran population, according to the U.S. Department of Veterans Affairs (VA).The study, appearing in the American Journal of Preventive Medicine, is the first to demonstrate how female veterans’ health status differs from their civilian and active duty counterparts, even when controlling for access to health care.

KEY POINTS

• Female veterans are more likely to smoke, be overweight or obese and have heart disease compared to civilian women and women in the National Guard or Reserves, even when controlling for access to health care, according to a new study.

• Women serving in active duty have better access to health care, report better physical health and engage in fewer risky health behaviors than civilian or veteran women.

“While we found that women veterans were more highly educated, had higher incomes and were more likely to have health insurance, they reported worse health compared to active duty, National Guard or Reserves and civilian women across a host of outcomes,” said lead author Keren Lehavot, Ph.D., of the VA Puget Sound Health Care System in Seattle.

The study used data from the 2010 Behavior Risk Factor Surveillance Survey, a national phone survey that included 274,399 civilian women, 4,221 veterans, 661 active duty military and 995 women in the National Guard or Reserves. Researchers asked each person about her access to health care and health status.

Women veterans were more apt to smoke, be overweight or obese and have heart disease compared to civilian and National Guard or Reserve women. Veterans also reported more instances of depression and anxiety.

Yet, it was not all bad news for women in the military. Women who were serving on active duty had better access to health care, better physical health and were less prone to engage in risky health behaviors.

The researchers did not determine potential reasons for these disparities, but Lehavot said previous studies suggest that women veterans’ increased exposure to violence as well as inadequate social support might be associated with poorer health.

“We need additional research to determine if these, and other factors, help explain the differences we found,” she said.

Lehavot added that there have been changes in the Veterans Health Administration in recent years to reach out to women veterans and facilitate their access to care.

So why aren’t women currently using the health services available to them within VA medical system?

Chloe Bird, Ph.D., a senior sociologist at the RAND Corporation and expert on women’s health issues, said many factors, including geography, could determine whether women utilize the VA.

“For example, not all veterans live within easy access to a VA medical center, and the VA is far better recognized for their men’s health care than for women’s health care,” she explained. “Many women veterans may associate the VA with images of a place that serves a population of older men.”

Bird agreed that specialized outreach and other targeted interventions could improve the health and well being of the women veteran population.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

Local events are sponsored by Seattle Parks and Recreation and the American Heart Association.

Start Walking events will be held at 17 area locations:

Start Walking Locations:

• Parks Administration, 100 Dexter Avenue North , Seattle WA 98109 – 12 noon, 30 minutes to Lake Union Park and back.

• Alki Community Center at Alki Bathhouse, 2701 Alki Ave. SW, Seattle WA 98116- 5:30 p.m., walk along the beach sidewalk

• Ballard Community Center , 6020 28th Ave NW, Seattle WA 98107 – 10 a.m., 30 minute walk around the neighborhood

• Bitter Lake Community Center, 13035 Linden Ave N, Seattle WA 98133 – 12 Noon, 30 minute walk around the neighborhood

• Green Lake Community Center, 7201 E Green Lake Dr N, Seattle WA 98115 – 12 Noon, 45 minute walk around Green Lake

• Loyal Heights Community Center, 2101 NW 77th St, Seattle WA 98117 – 12 Noon, 30 minute walk around the neighborhood

• Helene Madison Pool, 13401 Meridian Ave N, Seattle WA 98133 – 2:30 p.m., “Walking in Water”, admission required

• Magnolia Community Center, 2550 34th Ave W, Seattle WA 98199 – 9:30 a.m., 30 minute walk around the neighborhood

• Magnuson Community Center & Life Long Recreation , 6344 NE 74th Street, Seattle WA 98115 – leaving from the Magnuson Brig – 12 Noon, walk through the wetlands

• Meadowbrook Pool & Center, 10517 35th Ave NE, Seattle WA 98125 – Walking in Water” event – 12 Noon at Meadowbrook Pool (People not wanting to get wet will be able to walk the pool deck while cheering on those in the water). Admission required

• Medgar Evers Pool, 500 23rd Ave, Seattle WA 98122 – water walking on Wednesday, April 4th from 1:30 – 2:00 P.M. in the shallow end Admission required

• Miller Community Center, 330 19th Ave E, Seattle WA 98112 2:30 p.m., Teens walk with NOVA and One World Schools

• Rainier Community Center , 4600 38th Ave S, Seattle WA 98118 – meet at 11:45 a.m., start walking at 12 Noon, community center to Mt. Baker Rowing & Sailing and back

• Sound Steps : Rainier Indoor Walkers, Rainier Community Center 4600 38th Ave S, Seattle WA 98118 (group meets every Wednesday) at Rainier CC at 10 a.m.

• Southwest Teen Life Center, 2600 SW Thistle St, Seattle WA 98106: for teens “Walk and Mile, Talk a Mile” – starting at 4 p.m.

• West Seattle Life Long Recreation – Alki Beach, approximately 2726 Alki Ave. SW, Seattle WA 98116 10 a.m. meet at the Statue of Liberty

• South Park Community Center, 8319 8th Ave S, Seattle WA 98108 4 p.m., teens and adults at the playfield

Photo by Brainloc

By Randy Dotinga, Contributing Writer
Health Behavior News Service 

Single, middle-aged people who live alone spend more time sitting.  A new study, published in the American Journal of Preventive Medicine discovered that men tended to sit for longer periods watching TV on the weekends while women sat for longer periods doing activities such as reading or dining out.

Unemployed people tended to spend more time sitting than employed people.

Sitting habits, which lead to risks of poor health, were found to vary by gender, age, health status and during weekdays versus weekends.

“Sitting is not the same for everyone,” said study lead author Nicola Burton, Ph.D., a senior research fellow at The University of Queensland. “If we want to identify who does prolonged sitting, we need to think about the context of sitting and take into account group differences.”

Key Points:

• Single people who live alone or have health restrictions spend the most time sitting on a daily basis.

• Men spend more time sitting while watching TV or using the home computer, while women spend more seated time doing other leisure activities, like reading or eating out.

• People without jobs spend more time sitting than people who are employed full-time.

It’s important to study sitting habits because research has begun to link them to health problems, Burton said. “While people may associate prolonged sitting with muscular problems such as back and neck pain, research evidence is emerging to suggest that prolonged sitting a total of more than 6-8 hours a day or watching television more than 4 hours a day is in itself also potentially harmful for cardiovascular and metabolic health.”

Among other things, she said, researchers have linked lots of sitting to high blood pressure, heart problems, diabetes and higher death rates. Studies suggest that sitting causes problems even in people who exercise, she said.

The study authors analyzed survey responses from 7,719 people aged 40 to 65 in Australia who were asked about their daily activities. The researchers found that people sit longer on weekends than on weekdays, and sitting habits among groups differed depending on what they did while sitting. The findings would probably be similar in other Western countries like the United States, Burton said.

“The next step is to develop and evaluate strategies to reduce sitting time, and see what works for whom, and in what context,” she said. “This is different from strategies to increase exercise, as sitting time can be exchanged for things other than exercise.”

Is it really possible to neither sit nor exercise? Yes, Burton said. “Some research is suggesting that interrupting sitting time is important, so people could think about how to break up sitting for light activity that is not exercise, like doing things around the house during TV commercial breaks or taking standing or walking breaks during the working day.”

Susan B. Sisson, an assistant professor who studies diet and exercise at the University of Oklahoma said the findings are important because they can be used to figure out how best to coax people to not sit so much. “For example, this study found that individuals that are single and living alone sit more… A media campaign telling people to do on a walk with their spouse would likely not be as effective in this group.”

For more photos by Brainloc go here.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

FDA Consumer Update:

If you’re one of the millions of Americans who take statins to prevent heart disease, the Food and Drug Administration (FDA) has important new safety information on these cholesterol-lowering medications.

FDA is advising consumers and health care professionals that:

• Routine monitoring of liver enzymes in the blood, once considered standard procedure for statin users, is no longer needed.

  Such monitoring has not been found to be effective in predicting or preventing the rare occurrences of serious liver injury associated with statin use.

• Cognitive (brain-related) impairment, such as memory loss, forgetfulness and confusion, has been reported by some statin users.

• People being treated with statins may have an increased risk of raised blood sugar levels and the development of Type 2 diabetes.

• Some medications interact with lovastatin (brand names include Mevacor) and can increase the risk of muscle damage.

This new information should not scare people off statins, says Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP).

“The value of statins in preventing heart disease has been clearly established,” she says. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

FDA will be changing the drug labels of popular statin products to reflect these new concerns. (These labels are not the sticker attached to a prescription drug bottle, but the package insert with details about a prescription medication, including side effects.)

The statins affected include:

• Altoprev (lovastatin extended-release)
• Crestor (rosuvastatin)
• Lescol (fluvastatin)
• Lipitor (atorvastatin)
• Livalo (pitavastatin)
• Mevacor (lovastatin)
• Pravachol (pravastatin)
• Zocor (simvastatin).

Products containing statins in combination with other drugs include:

• Advicor (lovastatin/niacin extended-release)
• Simcor (simvastatin/niacin extended-release)
• Vytorin (simvastatin/ezetimibe).

Liver Injury Called Rare

FDA has found that liver injury associated with statin use is rare but can occur. Patients are advised to consult their health care professional if they have symptoms that include unusual fatigue, loss of appetite, right upper abdominal discomfort, dark urine or yellowing of the skin or whites of the eyes.

Statins work in the liver to reduce the production of cholesterol, a waxy substance that can form plaque on the walls of the arteries and keep the heart from getting the blood it needs.

Egan explains that there had been signals in early clinical trials of possible liver damage tied to statin use, so health care professionals were advised to regularly test their patients’ liver enzyme levels. However, she says, such damage is rare, and the tests are not effective at predicting or preventing who will develop this rare side effect.

So FDA is now recommending that liver enzyme tests be performed before statin treatment begins and then as needed if there are symptoms of liver damage.

Reports of Memory Loss

FDA has been investigating reports of cognitive impairment from statin use for several years. The agency has reviewed databases that record reports of bad reactions to drugs and statin clinical trials that included assessments of cognitive function.

The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking.

In general, the symptoms were not serious and were reversible within a few weeks after the patient stopped using the statin. Some people affected in this way had been taking the medicine for a day; others had been taking it for years.

What should patients do if they fear that statin use could be clouding their thinking? “Talk to your health care professional,” Egan says. “Don’t stop taking the medication; the consequences to your heart could be far greater.”

The Risk of Diabetes

Diabetes occurs because of defects in the body’s ability to produce or use insulin—a hormone needed to convert food into energy. If the pancreas doesn’t make enough insulin or if cells do not respond appropriately to insulin, blood sugar levels in the blood get too high, which can lead to serious health problems.

A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins.

“Clearly we think that the heart benefit of statins outweighs this small increased risk,” says Egan. But what this means for patients taking statins and the health care professionals prescribing them is that blood-sugar levels may need to be assessed after instituting statin therapy,” she says.

The Potential for Muscle Damage

Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. Egan explains that some new drugs are broken down (metabolized) through the same pathways in the body that statins follow. This increases both the amount of statin in the blood and the risk of muscle injury.

FDA is revising the drug label for Lovastatin to clarify the risk of myopathy. The label will reflect what drugs should not be taken at the same time, and the maximum lovastatin dose if it is not possible to avoid use of those other drugs.

Patients and health care professionals should report negative side effects from statin use to FDA’s MedWatch Adverse Event Reporting Program.

This article appears on FDA’s Consumer Update page, which features the latest on all FDA-regulated products.

February 27, 2011