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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Dr. Larry Corey

Dr. Larry Corey, M.D., president and director of Fred Hutchinson Cancer Research Center, has been elected to membership in the American Academy of Arts and Sciences.

The Academy is one of the nation’s oldest and most prestigious honorary societies and independent policy-research centers.

The current membership includes more than 250 Nobel laureates and more than 60 Pulitzer Prize winners.

Dr. Corey has led the Hutchinson Center since January 2011 and has held other leadership positions there since 1996, first as head of infectious disease sciences in the Clinical Research Division and later as senior vice president and co-director of the Center’s Vaccine and Infectious Disease Division.

Dr. Corey is an expert in virology, immunology and vaccine development. His research has focused on herpes viruses, HIV and other viral infections, particularly those associated with cancer.

He also is principal investigator of the Hutchinson Center-based HIV Vaccine Trials Network, an international collaboration of scientists and institutions that combines clinical trials and laboratory-based studies to accelerate the development of HIV vaccines.

Dr. Corey is a professor of laboratory medicine and medicine, adjunct professor of pediatrics and microbiology, and holder of the Lawrence Corey Endowed Chair in Medical Virology at the University of Washington. He is also an infectious disease physician at Seattle Cancer Care Alliance.

Dr. Corey is the Hutchinson Center’s second president to be elected to the Academy. Yeast geneticist Lee Hartwell, Ph.D., a 2001 Nobel laureate, was elected in 1998. He led the Center from 1997 until 2010.

Corey is among 220 leaders in the sciences, social sciences, humanities, arts, business and public affairs who have been elected to the American Academy of Arts and Sciences 2012 class of fellows.

Since its founding in 1780, the Academy fellows have included: George Washington and Benjamin Franklin in the eighteenth century, Daniel Webster and Ralph Waldo Emerson in the nineteenth, and Albert Einstein and Winston Churchill in the twentieth.

The new class will be inducted at a ceremony Oct. 6 at the Academy’s headquarters in Cambridge, Mass.

Pancreas (head, body, and tail of the pancreas, and the pancreatic duct) and nearby organs and structures (duodenum, common bile duct, and small intestine). - Don Blis/NCI

From the NCI Cancer Bulletin

Researchers have discovered a physical mechanism that prevents chemotherapy from reaching pancreatic cancer cells, as well as a way to reverse that mechanism.

Dr. Sunil Hingorani of the Fred Hutchinson Cancer Research Center and his colleagues reported their results March 19 in Cancer Cell.

Pancreatic adenocarcinoma, the most common type of pancreatic cancer, is notoriously resistant to chemotherapy and radiation therapy, leading to an overall 5-year relative survival rate of less than 5 percent.

Using mice with tumors that are genetically similar to human pancreatic adenocarcinomas, the researchers found that, as the tumors grow, a thick matrix develops and surrounds the tumors’ cells.

The matrix exerts tremendous pressure on the tumors—pressure that greatly exceeds the normal pressure found within blood vessels—causing the tumors’ blood vessels to collapse.

This collapse prevents chemotherapy drugs in the blood stream from reaching the tumor cells.

Dr. Hingorani and his colleagues identified a substance called hyaluronic acid that forms a large part of this pressurized matrix.

When they treated the mice with an enzyme called PEGPH20, which breaks down hyaluronic acid, the pressure within the tumors returned to normal, and the blood vessels regained their normal shape and function.

When the researchers treated mice with a combination of PEGPH20 and the chemotherapy drug gemcitabine, 83 percent of tumors within the pancreas shrank after only one cycle of treatment, and all tumors shrank after three cycles.

Similar responses were seen in metastatic tumors. Mice that received the combination therapy survived almost twice as long as mice that received PEGPH20 plus a placebo.

“When able to penetrate the tumor bed, gemcitabine can indeed be an effective agent against this disease,” wrote the authors. An early phase clinical trial is testing the combination of PEGPH20 and gemcitabine in people with metastatic pancreatic cancer.

To learn more about pancreatic cancer read the NCI pamphlet What You Need to Know About Cancer of the Pancreas.

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.

Blood, placenta tissue and other specimens will be saved.

A Seattle Children’s project to reduce premature births and still births opens a new facility today to store tissue from pregnant women that researchers from around the world can use to study both normal and abnormal pregnancies.

The biorepository will be run by the medical center’s Global Alliance to Prevent Prematurity and Stillbrith (GAPPS).

Specimens stored at the facility will include maternal blood and urine, cervical vaginal swabs, placenta tissue, and cord blood.

Samples will are collected from the first trimester through the postpartum period.

The specimens will be linked with information about the mothers’ preconception history, course of her current pregnancy, environmental exposures, medical and reproductive history, mental health, nutritional intake, and behaviors.

Participation is voluntary, and the identity of participating mothers is kept confidential with the specimens being identified only by number.

“While pregnancy specimen biobanks have been developed before, this is the first time that specimens paired with information about mothers and their pregnancies have been made widely accessible,” said Dr. Craig Rubens, executive director of GAPPS.

The repository currently has more than 8,000 individual specimens available to scientists, with 800-900 specimens being added each month.

The collection includes contributions from women representing a wide range of racial, ethnic, regional, and socioeconomic backgrounds.

Among the goasl of the GAPPS Repository project are to:

• Help researchers discover biomarkers and create screening tools to identify women and babies at risk for preterm birth and stillbirth

• Use those findings to develop diagnostic tests, treatments, and prevention strategies

• And to support research to identify the causes of poor birth outcomes and the fetal origin of adult diseases in the hope of developing cures.

“Many adult health problems can be traced to fetal development,” Dr. Rubens said. “With these specimens, researchers can begin to understand what causes adverse pregnancy outcomes, and develop novel interventions to prevent them.”

To learn more:

• Visit the GAPPS website: www.gapps.org.

• Go to the GAPPS Flickr page to see more photos of the repository.

• Lifetime Achievement Award: Rick Linneweh, CEO, Yakima Valley Memorial Hospital

• Outstanding Health Care Executive: Rick Cooper, CEO, The Everett Clinic

• Outstanding Health Care Professional: Margaret L. Hall, Northwest Hospital & Medical Center

• Innovation in Medical Devices: Physio-Control

• Innovation in Biopharmaceuticals: Seattle Genetics

• Global Health Organization: SightLife

• Community Outreach: Providence Senior and Community Services

• Wellness Program (Western Washington): Group Health Cooperative

• Wellness Program (Eastern Washington: Baker Boyer Bank