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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The company issued the recall after receiving complaints from consumers who reported difficulty using the Infants’ Tylenol  SimpleMeasure dosing system.

SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose.

In some cases, the flow restrictor was pushed into the bottle when inserting the syringe, the company said.

Consumers can continue to use Infants’ TYLENOL provided the flow restrictor at the top of the bottle remains in place, the company said.

If, however, the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product, the company said.

The company has made a video on how to use the new dosing system - click on image to view.

No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote, the company said.

Consumers can request a refund by visiting www.tylenol.com or contacting McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time; Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).

Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information

Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund.

The recall includes:

• Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well.

• Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products, company officials said.

Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive reimbursement.

• For more detailed information, consumers should visit the Novartis website at www.novartisOTC.com.

• Additional information may also be found on the FDA website at www.fda.gov.

Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

• Online: www.fda.gov/medwatch/report.htm

• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm – and the completed form mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD  20852-9787

• Fax: 1-800-FDA-0178

Photo by Debsch

An FDA Consumer Update

The best thing you can do to lower the chance of Sudden Infant Death Syndrome (SIDS) is to place your baby on his or her back to sleep, with nothing else in the crib or bassinet.

That’s the recommendation of the Food and Drug Administration (FDA), which is working to prevent manufacturers of over-the-counter sleep products for babies from claiming that their use will prevent or lower the chance of SIDS.

These products include infant positioners, mattresses, crib bedding, pillows, crib tents and baby monitors.

Baby products that claim to cure, treat or prevent any condition are considered medical devices, and are subject to FDA regulations designed to protect consumers and patients.

The agency has never approved a product to prevent SIDS—the unexplained death of a baby younger than age 1—and is asking manufacturers to stop marketing their products with these claims until they have received FDA clearance or approval, or to change their labeling to remove all medical claims.

“These products are absolutely not necessary and they can be very dangerous,” says Susan Cummins, M.D., M.P.H., chief pediatric medical officer in FDA’s Center for Devices and Radiological Health.

Dangerous comforts

FDA is aware of 13 infant deaths in the past 13 years associated with sleep positioners, which are used to keep the baby in a desired position. The Consumer Product Safety Commission has received reports of babies found in hazardous positions after being placed in a positioner.

Other products can also be hazardous. Babies can slide down and be trapped by wedges designed to keep them on their back, says Cummins. Blankets, quilts, soft toys and pillow-like crib bedding can smother, she adds.

It’s a matter of A-B-C, says Cummins:

• Alone in their own bed. Don’t keep the infant in your bed next to you and risk that the baby will be accidentally suffocated if you roll over.
• Back to sleep—every sleep. “The safest way to put the baby to sleep is on his or her back every time,” says Cummins. “Do not put the baby on his side or on his stomach.”

Since the national Back to Sleep campaign in 1994 urged parents to place babies on their backs, there has been a 60 percent reduction in SIDS, Cummins says.

• Crib. The baby should always be placed in a crib or bassinet to sleep.

Cummins describes the ideal sleep environment for an infant as being free of anything that could block the infant’s movement or breathing.  All that’s needed is a firm crib mattress and a tight-fitting sheet.

To parents who have visions of a crib filled with comforts, she says, “Though a crib full of plush toys and soft bedding may look appealing to you, it is hazardous for your baby during his or her first year of life.”

“Your baby will develop faster in that first year than any time after. Newborns can’t even hold up their head, yet by their first birthday they are walking or nearly so,” says Cummins. “In between, your baby will learn to roll, sit, turn, crawl and even may start to climb!”

“So in that first year, your baby constantly and rapidly develops new skills, even in the crib during sleep time,” she says. “Make your baby’s crib a safe place to sleep and move, with nothing to get in the way.”

Safe Sleep Resources

FDA is starting a new website on SIDS prevention claims for parents, caregivers and manufacturers of sleep products for babies. Its purpose is to:

• inform parents and caregivers about the risks associated with over-the-counter products that claim to prevent SIDS.

• help manufacturers understand and comply with FDA laws and regulations governing medical devices, which are designed to protect consumers and patients.

The site also offers advice to parents on reducing the risk of SIDS and a list of “baby safe sleep” resources.

“The sleep environment is the one place where the baby is alone, so we want to make sure it’s safe,” says Cummins. And in this case, she says, less is more.

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

Posted October 17, 2011

PHOTO by Debsch

Wouldn’t it be cool to have Twilight vampire eyes for Halloween?

Or deep violet eyes to match your purple sweater?

How about your favorite sports team’s logo on your eyes just for fun?

You can have all of these looks with decorative contact lenses (also called fashion contact lenses or color contact lenses, among other names). These lenses don’t correct vision—they just change the appearance of the eye.

But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law.

They are not “one size fits all.” An eye doctor (ophthalmologist or optometrist) must measure each eye to properly fit the lenses and evaluate how your eye responds to contact lens wear. A poor fit can cause serious eye damage, including:

• scratches on the cornea (the top layer of your eyeball)
• corneal infection (an ulcer on the cornea)
• conjunctivitis (pink eye)
• decreased vision
• blindness

Places that sell decorative lenses without a prescription may give you few or no instructions on how to clean and care for your lenses.

Failure to use the proper solution to keep contact lenses clean and moist can lead to infections, says Bernard Lepri, O.D., M.S., M.Ed., an optometrist at FDA. “Bacterial infections can be extremely rapid, result in corneal ulcers, and cause blindness—sometimes within as little as 24 hours if not diagnosed and treated promptly.”

“The problem isn’t with the decorative contacts themselves,” adds Lepri. “It’s the way people use them improperly—without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care.”

Where NOT to Buy Contact Lenses

FDA is aware that many places illegally sell decorative contact lenses to consumers without valid prescriptions for as little as $20.

You should never buy lenses from:

• street vendors

• salons or beauty supply stores

• boutiques

• flea markets

• novelty stores

• Halloween stores

• record or video stores

• convenience stores

• beach shops

• Internet (unless the site requires a prescription)

These are not authorized distributors of contact lenses, which are prescription devices by federal law.

How to Buy Decorative Contact Lenses Safely

Get an eye exam from a licensed eye doctor (ophthalmologist or optometrist), even if you feel your vision is perfect.

Get a valid prescription that includes the brand name, lens measurements, and an expiration date. But don’t expect your eye doctor to prescribe anime, or circle, lenses. These bigger-than-normal lenses that give the wearer a wide-eyed, doll-like look have not been approved by FDA.

Whether you go in person or shop online, buy the lenses from a seller that requires you to provide a prescription.

Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye doctor for follow-up eye exams.

See your eye doctor right away if you have signs of possible eye infection:

• redness

• eye pain that doesn’t go away after a short time

• decrease in vision

High Price for Fashion

Laura Butler paid $30 for her decorative lenses and $2,000 in medical bills. And she nearly lost an eye.

While at the beach in July 2010, Butler of Parkersburg, W.Va., bought a pair of blue contact lenses at a souvenir shop. The brown-eyed Butler was on vacation and just wanted to try a different eye color for fun, she says.

No instructions came with the lenses and the store didn’t sell contact lens solution. “They felt fine, but they moved around on my eyes and I had to adjust them with my finger,” says Butler.

As she was driving home the next day, Butler felt a sharp pain in her left eye. “It was such excruciating pain, I had to quickly pull over on the side of the road.” It took her 20 minutes to remove the contacts, she says, which had stuck to her eyes like suction cups. She drove home “with pain that was indescribable.”

A trip to the ER and then to an ophthalmologist gave Butler a diagnosis: corneal abrasion. “The doctor said it was as if someone took sandpaper and sanded my cornea,” she says. “He said he wasn’t going to sugar-coat it, that I could lose my eyesight or could lose my eye.”

Butler saw the doctor every day for 10 days and was under his care for seven weeks. “He took really good care of me and I didn’t get an infection,” says Butler. “But the pain was agonizing. I used to lay on the floor and roll back and forth in a fetal position for hours.”

Butler couldn’t see well enough to drive for eight weeks, had a drooping eyelid for five months, and still has decreased vision in her eye, she says. And she found out her optometrist could have ordered two sets of lenses for $50 and charged $60 for an eye exam.

Her advice: Don’t buy fashion lenses. If you do, “Take the time to go to the doctor, pay the extra money, and save yourself the agony.”

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

October 12, 2011

To learn more:

• Decorative Contact Lenses

• FDA Educational Flyer: Buying Contact Lenses Without a Prescription is Dangerous! (PDF – 108KB)

• Contact Lenses: No Prescription, No Way (video from American Academy of Ophthalmology—AAO)

• Halloween Contact Lenses Can Be Scary for Your Eye Health (video from AAO)

• Halloween Hazard (from AAO)

For related FDA Updates 

• ‘Lucky 13’ Tips for a Safe Halloween