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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Experts recommend that older women have regular bone density tests to screen for osteoporosis. But it’s been unclear how often to repeat the tests.

A study of nearly 5,000 women now reports that patients with healthy bone density on their first test might safely wait 15 years before getting rescreened.

Osteoporosis is a disorder marked by weakened bones and an increased risk of fractures. More than 40 million people nationwide either have osteoporosis or are at increased risk for broken bones because of low bone mineral density (osteopenia).

Osteoporosis is often called a “silent disease” because it usually progresses slowly and without symptoms until a fracture occurs.

When low bone density is identified early through screening, lifestyle changes and therapies can help protect bone health and reduce the risk of fractures.

That’s why the U.S. Preventive Services Task Force recommends routine screening of bone mineral density for women ages 65 and older.

To help doctors decide how often to repeat bone density tests in women who don’t have osteoporosis at their initial screening, a research team led by Dr. Margaret Gourlay of the University of North Carolina at Chapel Hill analyzed data on nearly 5,000 women, age 67 or older.

The women were participants in the Study of Osteoporotic Fractures, a long-term nationwide study supported by NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Aging (NIA) and National Center for Research Resources (NCRR).

Researchers divided the women divided into 4 groups based on initial bone density tests that were either normal or showed mild, moderate or advanced osteopenia. They were given 2 to 5 bone density tests at varying intervals during the 15-year study period.

As reported in the January 19, 2012, issue of the New England Journal of Medicine, the scientists found that less than 1% of women who initially had normal bone mineral density went on to develop osteoporosis during the study.

Only 5% of those with mildly low bone density at the start made the transition to osteoporosis. Overall, the data suggest that women in these 2 categories might safely wait about 15 years before being rescreened for osteoporosis.

The scientists also found that about 1 in 10 women with moderate osteopenia at baseline developed osteoporosis within 5 years. For those with advanced osteopenia at the start, about 10% had developed osteoporosis within a year, suggesting that 1-year screening intervals might be advisable for this group.

“If a woman’s bone density at age 67 is very good, then she doesn’t need to be rescreened in 2 years or 3 years, because we’re not likely to see much change,” Gourlay says. “Our study found it would take about 15 years for 10% of women in the highest bone density ranges to develop osteoporosis. That was longer than we expected, and it’s great news for this group of women.”

These findings can help guide doctors in their bone screening recommendations. Other risk factors, such age, medications or specific diseases, would also influence screening frequency.

This article first appeared in NIH Research Matters.

To learn more about osteoporosis:

• Health Info: Osteoporosis

• Osteoporosis: The Bone Thief

• Bone Mass Measurement: What the Numbers Mean

• Article: Keeping Bones Strong and Healthy

Credit: Wikipedia - Creative Commons License

By Carolyn M. Clancy, M.D.

January 3, 2012

Whether it’s music, lifestyles, or a refuse-to-age outlook, Baby Boomers think of themselves as trailblazers.

Now, that generation born between 1946 and 1964 can claim credit for another “first”—a dramatic increase in knee replacement surgeries.

Women and men between the ages of 45 and 64 were more than twice as likely to have had knee replacement surgery in 2009 than in 1997, recent data from the Agency for Healthcare Research and Quality (AHRQ) show. The rates among women were even higher.

Knee replacement surgery is most common in people whose knees have been damaged by osteoarthritis (OA), rheumatoid arthritis, or injury.

Due to their age and fondness for sports, Baby Boomers fit neatly into each category.

The percentage of people who have osteoarthritis, the most common type of arthritis, grows with age. About 27 million Americans have this condition, and, after age 45, it is more common in women. Osteoarthritis occurs when the cartilage that coats the end of each bone breaks down. This can cause the bones to rub against each other, causing pain and stiffness.

Knee pain may also be caused by rheumatoid arthritis, a less common form of arthritis that occurs when the membrane surrounding the joint becomes inflamed. Over time, inflammation damages cartilage, resulting in pain and stiffness. Rheumatoid arthritis affects about 1.3 million people—more women than men. It often begins in middle age, but can occur in children and young adults.

Arthritis after a serious knee injury or repeated stress is another reason for knee replacement surgery. Pain caused by ligament tears or bone fractures caused by sports injuries, for example, may be managed non-surgically for years. Over time, however, pain and limited knee function causes some patients to consider knee replacement surgery.

If you have knee pain from one of these causes, you’ve probably heard about treatments that are intended to relieve pain and even postpone the need for surgery. Some, but not all, of these options work, a review of 86 research reports funded by AHRQ has found.

What has been shown to work?

• Exercise. Becoming more active—whether through walking, swimming, or water aerobics—can reduce pain and make movement easier. Physical therapy may also help, so ask your doctor if you would benefit.

• Maintain a healthy weight. A 10 percent weight loss combined with a moderate exercise program reduced knee pain in patients with knee osteoarthritis by 50 percent, a recent study  by Wake Forest University researchers has found.

• Pain medicines. Medicines can relieve osteoarthritis pain, AHRQ’s research review concluded. Your doctor or nurse may prescribe an over-the-counter or prescription medicine. Learn more about choosing pain medications for osteoarthritis in this guide developed by AHRQ.

What has been shown not to work?

• Glucosamine and chondroitin. Some people take nutritional supplements to help build new cartilage. Studies have found that people who take these supplements report less pain, but people who don’t take the supplements report the same result.

• Joint lubrication shots. This treatment is a gel-like substance given by a shot into the knee. Studies have found that most people who get the shots do not improve very much.

• Arthroscopic knee surgery. In this procedure, a flexible tool is inserted into the knee, which is used to rinse the joint. It can be helpful for other types of knee problems, but not for knee osteoarthritis.

If conservative treatments don’t provide relief from pain, it may be time to consider knee replacement surgery. The good news is that this procedure has been shown to give a better quality of life that makes it worth the cost, a Government-funded study has found.

The benefits of this procedure are even better if the surgery is done at a hospital that does a large number of knee replacement procedures.

Before you have surgery, prepare yourself for the best possible outcome by asking questions of your surgeon. You will feel more in control of your health if you have a good idea of what to expect before, during, and after surgery.

I’m Dr. Carolyn Clancy, and that’s my advice on how to navigate the health care system.

Resources

Agency for Healthcare Research and Quality
Healthcare Cost and Utilization Project

Statistics on Hospital-Based Care in the U.S., 2009
http://www.hcup-us.ahrq.gov/reports/factsandfigures/2009/TOC_2009.jsp

Effective Health Care Program

Osteoarthritis of the Knee: A Guide for Adults
http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=132

Choosing Pain Medicine for Osteoarthritis
http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageAction=displayProduct&productID=4

Having Surgery? What You Need to Know
http://www.ahrq.gov/consumer/surgery/surgery.htm

National Institute of Arthritis and Musculoskeletal and Skin Disease

Handout on Health: Osteoarthritis
http://www.niams.nih.gov/Health_Info/Osteoarthritis/default.asp

Handout on Health: Rheumatoid Arthritis
http://www.niams.nih.gov/Health_Info/Rheumatic_Disease/default.asp

Total Knee Replacement Found Cost-Effective for End-Stage Knee OA
http://www.niams.nih.gov/News_and_Events/Spotlight_on_Research/2009/knee_OA_replacement.asp

American College of Rheumatology

Weight Loss Best Medicine for People with Knee Osteoarthritis
http://www.rheumatology.org/about/newsroom/2011/2011_ASM_21_weightloss.asp

Current as of January 2012

Internet Citation:

Baby Boomers Trigger Major Increase in Knee Replacement Surgeries. Navigating the Health Care System: Advice Columns from Dr. Carolyn Clancy, January 3, 2012. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/consumer/cc/cc010312.htm

In a smaller, earlier trial, lead author Dr. Karen Sherman, Ph.D. and colleagues found that yoga was slightly more effective than a program of aerobic, strengthening, and stretching exercises, so they decided to do a larger trial in which patients with back pain were randomly assigned to participate in a yoga program, a stretching program or to self-care.

The yoga and stretching programs consisted of 12 weekly, 75 minute classes at Group Health facilities. In addition, participants were asked to practice for 20 minutes a day on non-class days.

To supplement class instruction, the participants received handouts and instructional yoga CDs or stretching DVDs.

The yoga program included seven simple postures adopted from a style of yoga called viniyoga. Each class included breathing exercises, 45-50 minutes of yoga, and ended with a session of “guided deep relaxation,” the researchers write.

The self-care group received The Back Pain Helpbook, which provides information about the causes of back pain, advice on exercising, lifestyle modifications and the management of flare ups.

At the end of 12 weeks, back-related symptoms and function had improved in all three groups, but those in the stretching and yoga programs saw significantly more improvement than those in the self-care group.

“We expected back pain to ease more with yoga than with stretching, so our findings surprised us,” said Dr. Sherman.

“The most straightforward interpretation of our findings would be that yoga’s benefits on back function and symptoms were largely physical, due to the stretching and strengthening of muscles,” Dr. Sherman said.

Dr. Sherman speculated that because the stretching classes included more stretching than many programs and because the stretches were held for a relatively long time, the stretching classes may have “been a bit more like yoga than a more typical exercise program would be.”

“Our results suggest that both yoga and stretching can be good, safe options for people who are willing to try physical activity to relieve their moderate low back pain,” Dr. Sherman said. “But it’s important for the classes to be therapeutically oriented, geared for beginners, and taught by instructors who can modify postures for participants’ individual physical limitations.”

Learn about care and recovery from complicated spinal cord injuries, with case studies and in-depth research. From vertebroplasty to disc replacement, this series delivers the most recent developments in spine treatment from national experts as well as doctors at with UW Medicine.

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