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Medical devices can range from bandages and medical clamps to surgical mesh and hip replacements. The medical devices industry is a $100 billion-a-year industry and works aggressively with the FDA to push thousands of devices onto the market every year. The FDA and the industry maintain that the 510(k) speedy approval process gives patients faster access to life-saving devices. However in actual fact there has been a huge increase in recalls and repeat surgeries, which calls into question if the 510 (k) review process is really protecting consumer’s health.

The Federal Food, Drug, and Cosmetic Act (FFDCA) is the law that ensures that safe drugs, cosmetics and medical devices enter the market place. In 1976 Congress passed the Medical Device Amendments of 1976, to the FFDCA, which established the framework for the current regulatory system, including the 510(k) process. Then, in 1990 and 1997, Congress passed more changes to the 1976 statute and the three enactments serve as the basis of the legislative framework for the 510(k) review process.

The law states that a moderate-risk device that is substantially equivalent, or similar, to any previously 510(k)-cleared device or any device that was on the market when the Medical Device Amendments were enacted—referred to as a predicate device—can be cleared for marketing, but with some exceptions. However when the FDA assesses the substantial equivalence of a device, it does not require evidence of safety or effectiveness. Also when a device is found to be substantially equivalent to a predicate device, the new device is assumed to be as safe and effective as the predicate, because of its similarity.

An example of the how the 510(K) clearance process is not working-are hip replacements. Every year hundreds of thousands of people get total hip replacements, surgically replacing their hip joint with a prosthetic. Implants are usually made up of a metal head that rotates inside a plastic cup. But in 2005, Johnson & Johnson's DePuy Orthopaedics introduced a new all-metal design. They maintained the new device was substantially equivalent to older models, through the 510(k) clearance process they got clearance for the hip device without conducting any clinical trials to test how it would perform in patient's bodies.

The DePuy implant caused patients many problems and almost half of all patients who got the implant required surgery to fix problems. The metal was eroding, releasing metallic particles into the blood and surrounding tissue of the joint and causing tremendous pain. After thousands of complaints and lawsuits, the device was recalled in 2010, after it had been implanted in almost 100,000 people.

This way of fast tracking medical devices into the market is leading to more and more recalls. The problem is these predicate devices were on the market before the Medical Device Amendments were never systematically assessed for safety and effectiveness. Therefore the 510(k) review process is not a good way to determine if a new medical device is safe. Even the Institute of Medicine in June 2011 concluded that the, “510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.”

The Institute of Medicine reviewed the clearance process for medical devices and called for the 510(k) process to be eliminated altogether, because does not guarantee safe devices. They found that from 2005 to 2009, three out of four recalled high-risk devices had not been approved with clinical data, but rather had gone through the 510(k) clearance process or had been exempt from review altogether. They have advised the FDA to scrap this clearance process and set up a new more rigorous regulatory system that really protects consumers.

The 510(K) clearance process is obviously not working and unfortunately if the anti-regulatory bills such Reins, RAA and RFIA and H.R. 4078 are enacted, the medical devices industry will be allowed to speed through thousands more faulty medical devices without clinical trials and or valid testing citing new stronger regulations would be burdensome to business and the economy! Medical devices should be about sustaining and improving the quality of life of Americans and stronger consumer protections should come before profit.

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When I opined about the confusion caused by the 2004 Food and Drug Administration (FDA) advice to pregnant women about eating seafood in The Hill’s Congress Blog back in February (Seafood should be next up on FDA plate), I had no way of knowing that my points would be so readily illustrated in the same space little more than a year later (Pollution no match for motherly love).

I commend Jessica Capshaw for championing a cleaner, safer world for this generation and the next. Cleaning up coal burning power plants is an important mission, and I support the clean air initiatives, but the information presented about seafood contradicts the current advice given to pregnant women by the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) in the 2010 Dietary Guidelines for Americans (DGA).

The current guidelines were adopted after a committee of scientists evaluated the safety of eating seafood during pregnancy and breastfeeding and recommended that pregnant women and breastfeeding mothers eat 8 to 12 ounces (2 servings) of a variety of fish per week, which can include up to 6 ounces of albacore (white) tuna.

There are just four rarely-eaten types of fish for this population to avoid (shark, king mackerel, swordfish and tilefish) because of methyl mercury. The nutrition we get in the womb can affect us all our lives and science shows that eating fish during pregnancy boosts brain and eye development in babies. But the amount of seafood pregnant women eat remains woefully low during and even after baby is born. Unclear and outdated advice from the FDA/EPA about eating seafood has created confusion among pregnant women and breastfeeding mothers, which can have unintended consequences for babies’ brain development.

It is time for accurate science-based messages that tell Americans what the World Health Organization and the United Nations’ Food and Agricultural Organization have been saying; the danger isn’t in eating too much seafood, it’s in not eating enough. It’s a message that’s spelled out in a new video from the National Oceanic and Atmospheric Administration in which Dr. Emily Oken of Harvard Pilgrim Healthcare Institute says, “when we conducted…focus groups with pregnant women they followed the precautionary principle often; if there’s any risk I’d rather be safe than sorry. But not recognizing, because no one had told them, that there was risk to eating no fish as well.”

The rhetoric and the advice about eating seafood has not caught up with the science in this country and now does far more harm than good. Unfortunately, this is not a completely unusual scenario. Concerned parents around the world began avoiding vaccines after it was reported that the life saving shots were causing autism. Science thoroughly discredited such proclamations, but not before a resurgence in preventable diseases. There is no doubt that we owe the public carefully thought out, scientifically based messages that they can use to make informed decisions about nutrition and health. We eagerly await updated advice about seafood and nutrition during pregnancy and breastfeeding, which members of congress encouraged FDA to adopt last year.

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The Obama administration must warn drug makers that the government may soon ban agricultural uses of some popular antibiotics that many scientists say encourage the proliferation of dangerous infections and imperil public health, a federal magistrate judge ruled on Thursday.

The order, issued by Judge Theodore H. Katz of the Southern District of New York, effectively restarts a process that the Food and Drug Administration began 35 years ago, but never completed, intended to prevent penicillin and tetracycline, widely used antibiotics, from losing their effectiveness in humans because of their bulk use in animal feed to promote growth in chickens, pigs and cattle.

The order comes two months after the Obama administration announced restrictions on agricultural uses of cephalosporins, a critical class of antibiotics that includes drugs like Cefzil and Keflex, which are commonly used to treat pneumonia, strep throat and skin and urinary tract infections.

Siobhan DeLancey, an F.D.A. spokeswoman, would not say whether the government planned to appeal. “We are studying the opinion and considering appropriate next steps,” she said.

In a separate move, the F.D.A. is expected to issue draft rules within days that ask drug makers to voluntarily end the use of antibiotics in animals without the oversight of a veterinarian.

But neither the judge’s order nor the F.D.A.’s expected rule changes are likely to fundamentally alter the large-scale agricultural uses of antibiotics because farmers and ranchers now say the drugs are being used to prevent animal diseases, not to promote growth. The F.D.A. has so far refused to propose restrictions on antibiotic uses to prevent disease even when the drugs are delivered in feed or water, and Judge Katz’s order does not extend to disease prevention uses.

Gwen Venable, a spokeswoman for the U.S. Poultry and Egg Association, said that poultry producers “judiciously use antibiotics to maintain the health of their flocks.”

“Our association has not had an opportunity to review the judge’s order, so we cannot comment on the impact of the specific decision at this time,” she said.

Environmentalists and health advocates cheered Judge Katz’s ruling, as they have largely cheered the F.D.A.’s incremental efforts to begin restricting some of the less discriminating antibiotic agricultural uses because they welcome any improvement in the decades-old issue.

“The rise of superbugs that we see now was predicted by F.D.A. in the ’70s,” said Jen Sorenson, a lawyer for the Natural Resources Defense Council.

But agricultural trade groups were more critical. Ron Phillips, vice president of public affairs for the Animal Health Institute, an association representing companies that make animal medicine, said that the judge’s order could slow efforts to reduce agricultural uses of antibiotics by diverting resources from the agency’s collaborative efforts with industry.

Antibiotics were the wonder drugs of the 20th century, and their initial uses in humans and animals were indiscriminate, experts say. Farmers were impressed by the effects of penicillin and tetracycline on the robustness of cattle, chickens and pigs, and added the drugs to feed and water, with no prescriptions or sign of sickness in the animals.

By the 1970s, public health officials had become worried that overuse was leading to the development of killer infections resistant to treatment. In 1977, the F.D.A. announced that it would begin banning some agricultural uses. But the House and Senate appropriations committees passed resolutions against the ban, and the agency retreated.

“In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence the F.D.A. has changed its position that such uses are not shown to be safe,” Judge Katz wrote in his order.

Eighty percent of antibiotics bought in the United States are used in animals, not humans. Meanwhile, outbreaks of illnesses from antibiotic-resistant bacteria have grown in number and severity, killing thousands.

Environmental and health groups petitioned the F.D.A. in 1999 and 2005 to restart the process to ban the drugs for promoting animal growth. The Natural Resources Defense Council, the Center for Science in the Public Interest, the Food Animal Concerns Trust, Public Citizen and the Union of Concerned Scientists filed suit against the F.D.A.

On Thursday, Judge Katz ruled that these groups had won their case without need for a trial.

Judge Katz ordered the F.D.A. to alert drug manufacturers that it intended to prohibit the use of penicillin and tetracycline to promote growth in animals. The manufacturers can request a hearing to present evidence that these uses are safe. If the companies have such evidence, the drugs can continue to be used for growth promotion, the judge wrote.