Friday, April 24, 2009
FDA Office of Device Evaluation Holds Internal Meeting
The Food and Drug Administration held a rare all staff meeting on Wednesday within the Office of Device Evaluation. The NY Times cited an internal email memorandum sent by Dr. Donna-Bea Tillman, the Deputy Director for Clinical Affairs within the Office of Device Evaluation, calling for a meeting to discuss the "strategic direction of the device center." It is unclear exactly what was discussed or came from this meeting.
The FDA has recently come under fire yet again, with agency officials being accused by their colleagues and reviewers of acting illegally and potentially jeopardizing patient safety. This is in addition to the criticism we reported on by the Government Accountability Office with regards to the Class III medical device approval process.
It is unclear how all of these recent events will affect the future of medical device approval process.
NY Times : Rare F.D.A. Meeting to Discuss Complaints on Device Approval...
FDA : Office of Device Evaluation
Flashback : FDA Scrutinizing "New" Medical Devices...
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Monday, April 20, 2009
FDA Scrutinizing "New" Medical Devices
The Wall Street Journal is reporting that the Food and Drug Administration is requiring Johnson & Johnson, Medtronic, Inc., Royal Philips Electronics, and a various other medical device manufacturers to further explain and justify their products' safety and efficacy.
This is a part of the Safe Medicals Act of 1990, passed by Congress, that tightens control and testing of Class 3 devices. There is some concern that these new actions by the FDA will lead to further increases the cost of development of new medical equipment and lengthen the time to clinical use in patients.
While the bill was made into law in the 1990s, the FDA has had significant problems fully implementing all of the aspects of it, and this has allowed Class 3 devices to be put into use based on a previous statute. The FDA is reviewing all of these devices now, and calls on companies to test efficacy and safety under the "new" 1990 guidelines, or possibly seek reclassification of devices.
From the WSJ:
Mary Long, an agency spokeswoman, said it could take several years for the agency to finish the process. Manufacturers would be granted a grace period to submit enough evidence backing their devices under the more-rigorous standard. "It is a priority, but it will really depend on the kind and amount of information we get on each type," she said.
We support our patient safety above all else, but mention this FDA review because of the potential impact it may have to current and future medical device development.
WSJ : Medical Devices Face new Scrutiny from FDA
Library of Congress : Safe Medical Device Act of 1990 (H.R. 3095 and S. 3006)
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Thursday, August 14, 2008
WSJ: Boston Scientific Stent Study Flawed
The Wall Street Journal has published an article by Keith Winstein that looks at the methodology of the 2006 study that Boston Scientific has submitted to the Food and Drug Administration to gain U.S. approval for the Taxus Liberté coronary stent. The study, published in the Journal of the American College of Cardiology in 2007, found that Taxus Liberté stent wasn't inferior to the Taxus Express stent, an already approved device from the company.
From the article:
Boston Scientific, of Natick, Mass., has roughly 40% of the $5 billion a year world-wide market for coronary stents. The company's Taxus Express is the top seller in the U.S. In considering approval of the Liberte, the FDA asked the company to show that its anticlogging performance in patients was "non-inferior" to the Taxus Express.
In 2006, the company said that it met this test. Using a standard probability measure known as the "p-value," it said that there was less than a 5% chance that its finding was wrong. In April 2007, in the Journal of the American College of Cardiology, the company's researchers for the first time specified the p-value: 4.87%.
Scientists generally regard studies with p-values above 5% to be failures, and medical journals typically won't publish them, because they don't provide a high level of certainty needed to ensure that results would apply to all patients, not just those under study. Put another way, science traditionally requires 95% certainty that a study proved its premise.
But the Journal's calculations found that the Liberte study's p-value was about 5.1% -- failing to rule out the possibility that patients getting the Liberte stent will have markedly more artery recloggings than those receiving the Express.
Although the difference seems small -- 0.2 of a percentage point -- it is the difference between success and failure for a product on which Boston Scientific has spent some tens of millions of dollars.
Read the whole thing, while it is still available: Boston Scientific Stent Study Flawed
WSJ Health Blog: Questions Raised Over Boston Scientific Stent Data...
Study abstract: Polymer-Based, Paclitaxel-Eluting TAXUS Liberté Stent in De Novo Lesions J Am Coll Cardiol, 2007; 49:1676-1683
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Wednesday, June 25, 2008
Should FDA Approval Waive Liability?
You know who would make a logical spokesperson for medical liability policy? The guy who starred in the 1998 remake of The Parent Trap. That's right, Dennis Quaid is making the case that he should be able to sue pharma giant Baxter over a dosing error that nearly killed his baby twins...
Quaid last month urged Congress to preserve patients' rights to sue drug and device makers in state courts, after his twin newborns nearly died after accidentally overdosing on a blood-thinning drug sold by Baxter International. He has sued the company.
While Quaid's example is clearly ridiculous on account of the fact that it was a facility error, not Baxter's, Reuters goes on to highlight that...
...Democrats in Congress are considering legislation to protect a patient's ability to sue drugmakers if the Supreme Court further restricts the lawsuits, backing so-called "pre-emption" of state laws by federal.
This all, of course, comes in the wake of the recent decision that the manufacturer of a device that's gone through the PMA process cannot be held liable.
That said, the effect upon medical innovation of leaving the door open to liability at a state level would be disastrous. At best, it increases the legal overhead associated with doing business as a device or drug manufacturer, thus further increasing the cost of medical care.
However, worse than that, it takes the focus off of the root cause: the purpose of the FDA is to ensure the safety and efficacy of the medical products on the market. If a faulty product slips through (as is inevitably the case), the liability lies with the arbiter of "good enough": the FDA.
If being good enough for the FDA isn't, then the federal government might as well dissolve the agency and spend our tax dollars elsewhere, letting case law (and lay-person juries) decide what the public requires in terms of safety. Obviously a less desirable solution, but it remains the only logically intact one should we leave the door open for every ambulance chaser to try and extract a ransom from big-name medical manufacturers.
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Wednesday, March 26, 2008
FDA Issues Guidance for Drug Eluting Stents
Following up on the recent regulatory storm regarding drug eluting coronary stents, the FDA has issued guidance notes for the industry for the development, testing, clinical studies, and manufacture of the devices.
From the FDA:
This draft guidance, announced in today's Federal Register discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers—the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety.
The full document is below, so you can print it right from here.
FDA Document: Guidance for Industry: Coronary Drug-Eluting Stents- Nonclinical and Clinical Studies
Press release: FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
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Thursday, March 20, 2008
US FDA Setting Up Shop in China
The US Food and Drug Administration is setting up shop in The People's Republic of China. Well, at least a small shop manned by eight full time US FDA staff.
From the FDA:
This is an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou."In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. "Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."
Building the FDA's capacity outside of the United States supports the agency's "Beyond our Borders" initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA's counterpart agencies around the world and enhanced technical cooperation with foreign regulators. The permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.
It's obvious that greater regulatory scrutiny needs to be applied to food and drugs (and medgadgets!) made in China, but we're doubtful that eight new employees, operating only with the permission of the notoriously restrictive, secretive and corrupt Chinese government, are really going to effect much change.
More from the US Food and Drug Administration...
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Thursday, January 10, 2008
Analysis of Medical Device Regulation
A study from the Stanford University Program in Biodesign looks into the nature of medical device regulation in the United States, its complexity, post-market surveillance, and how it differs from pharmaceutical oversight.
Article abstract in the Journal of Medical Devices...
Press release: Stanford researchers publish review of US medical device regulation
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Wednesday, September 5, 2007
The Math of Donor Organ Matching
In the world of kidney transplants, people often find themselves in a frustrated position of being willing, ready, and able to donate a kidney to a family member, yet cannot do so because the kidney does not match the recipient. To address the issue, multi-way kidney donations are being used to find more matches, and mathematicians within the field of number theory are working on algorithms that will best match the largest groups possible.
Finding the best matches is a complex task. Doctors tend to consider some patients higher priority than others. For example, although dialysis allows most patients to survive after their kidneys have failed, patients who cannot be treated with dialysis will die without a transplant. If a patient had donated a kidney when healthy, a sense of justice calls for that patient to receive one when sick. Doctors also favor giving higher priority to children.Furthermore, some matches are better than others. Donor and recipient must have compatible blood types and sufficient immunological compatibility for a transplant to be possible. But in addition, there are degrees of immunological compatibility: the better the match, the longer a transplanted kidney is likely to keep working. Another consideration is that transplants are least expensive and easiest on doctors and families when the donors and patients live near one another, so that all the surgeries can take place in the same locality.
Read more about the math from MathTrek @ Science News...
Flashback: How to Barter a Kidney ...
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Tuesday, June 26, 2007
Curing the FDA
Law.com has a great commentary by Peter Schuck, Professor of Law at Yale, on the problem with the current state liability law surrounding drug and device companies. With the exception of Michigan, FDA clearance of a device does not protect a company from liability, meaning that different state courts can rule differently as to what damages a plaintiff might be entitled to should the jury of 12 people, with nothing better to do for a few months, decide in their favor...
This capricious state of affairs is the reason I think that the states or Congress should establish a qualified regulatory compliance defense to tort liability under which FDA approval would ordinarily, but not always, pre-empt such liability. In practice, this means that a drug manufacturer that receives FDA approval could obtain summary judgment against injured claimants, unless they could show that the manufacturer failed to fully inform the agency of risks about which it should have known.This issue has gained fresh saliency for two reasons. First, the FDA is now issuing regulations whose preambles assert that state tort law is pre-empted. The courts will decide whether only Congress, not the agency, can do this -- an issue I do not address. Second, criticisms of FDA safety regulation have sharpened, most recently with reports that a popular diabetes drug, Avandia, increases heart problems. As I explain below, the remedy for the FDA's shortcomings is not to use tort law as a separate regulatory system but rather to strengthen its regulatory capacity, as Congress is about to do, and to limit tort to situations where manufacturers misled the agency.
New, improved drugs can save countless lives and improve the quality of life for millions. This social cornucopia, however, depends on the willingness of the pharmaceutical industry, operating in a fiercely competitive international market, to invest vast sums of money and many years of research and development in hopes of coming up with a blockbuster drug like Lipitor to make up for the far more numerous duds. But since a few adverse jury verdicts can destroy a product -- or even a company -- drug manufacturing is a high-stakes roll of the dice. To elicit the necessary large, long-term investments, some legal predictability is needed.
He goes on from there, intelligently outlining arguments as to what's to be done, making a great case for severely restricting the plaintiff's ability to gain compensation on a properly regulated product. It's really a breath of fresh air to see a well reasoned commentary online (as opposed to a preaching-to-the-choir rant).
More from Law.com...
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Friday, June 1, 2007
FDA Flexes Muscles Against Shelhigh
We've heard of the FDA revoking approval, or issuing recalls. But we didn't know they could seize products and block shipments -- perhaps because it's rare that a company lets things get that far.
Shelhigh is one such company. Makers of a heart valve fixative process for cardiothoracic surgery, they've been manufacturing with substandard practices for years, causing accelerated aging in their contaminated surgical implants, FDA alleges. After countless warnings, the FDA got tough:
A seizure is an enforcement action taken as a last resort to remove a dangerous product from commerce. The FDA initiates the action by filing a complaint with the District Court where the product is located, and a US marshal is then directed by the court to take possession of the goods until the matter is resolved. The complaint against Shelhigh was filed on April 16, 2007.The US Marshal did not physically remove the devices from the plant but rather "seized them in place," meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products without the prior written permission from the US Marshal. The firm's products have also been embargoed by the state of New Jersey.
In fact, the story here is not that the FDA can recruit US Marshals and can function like the DEA when it needs to -- the real story is that they waited five years between their first warning and their second, and sent a half-dozen increasingly shrill warnings over 18 months before finally acting in May:
It's difficult to understand how Shelhigh believes it has a legal leg to stand on in light of the FDA's last 7 years of warnings, threats and promises. Investigators documented deficiencies in the firm's Union City facility in 2000 and 2005, and those inspections resulted in warning letters to Shelhigh in April 2000 and December 2005.A December 14, 2005 warning letter spelled out what Shelhigh was facing. "Your failure to comply with any post-approval-requirement, the FDA explained, constitutes a ground for withdrawal of the Human Device Exemption and commercial distribution of a device that is not in compliance with these conditions is a violation of the Federal Food, Drug, and Cosmetic Act."
...As for its part, according to Mr Gaudio, the FDA would not comment on why it waited 5 years between warning letters and then nearly a year-and-a-half between the December 2005 letter and the seizure, or why it then waited 2 more weeks after the seizure to send Shelhigh a formal request for a product recall.
More from the FDA...
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Monday, April 23, 2007
FDA's Drug Safety Podcasts
FDA's Center for Drug Evaluation and Research is now offering the latest drug notices via podcasts for all interested:
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information. The broadcasts, commonly known as podcasts, can be transmitted to personal computers and personal audio players.The service is part of the agency's ongoing effort to broaden and speed its communications concerning the safety of marketed medications when unexpected adverse events are reported to FDA. The broadcasts are an addition to FDA's traditional print- and Web-based public health advisories (PHAs) and anyone can subscribe to them for free at http://www.fda.gov/cder/drug/podcast/default.htm.
Press release: FDA Announces Audio Broadcasts on Emerging Drug Safety Information ...
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Monday, March 5, 2007
For Want of a Screw...
A medicine professor at Duke University, named Kevin Schulman, wrote a nice piece recently about the need for better record-keeping for medical devices and parts. This was prompted by an unwelcome post-op discovery: a new screw in his knee:
Like a growing number of aging baby boomers, I recently had knee surgery. During a follow-up visit, my doctor showed me an x-ray of my knee, and I saw that a metal screw had been implanted during the surgery. I didn't know the screw was being placed there, and I knew nothing about who had made it, how well these devices had performed in long-term studies or whom I would tell if I had a problem with the device.
When I buy an appliance these days, the manufacturer asks me to register the product so it can match me with the product details. In health care, we don't do this. If there is a product recall, I won't know whether to be concerned about the screw in my knee because I don't know its make, model or lot number...
Active monitoring would match product with patient. If a patient has a problem but does not see the original physician or visit the same hospital, the new clinical team would have access to all of the information on the patient's device and other medical history. Moreover, the medical staff could report concerns back through the system to the FDA and the manufacturer.
Such a system also could notify patients about product recalls and other developments, or it could be used to survey patients to study questions about medical devices.
He's right, and the technology to do this is readily available. Let's shake a leg and hop to it.
More writing from Prof. Kevin Schulman...
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Wednesday, January 10, 2007
Second Sight Medical Retinal Prosthesis Receives FDA Approval for Clinical Trials
2nd Sight Medical has just received USFDA investigational device exemption (IDE) to begin clinical trials for their Argus II Retinal Prosthesis System.
In case you haven't been following Second Sight, their retinal prosthesis uses an array of electrodes to stimulate the retina, restoring a low level of vision in patients with degenerative diseases. Their first implant had 16 electrodes, the new Argus II has 60...
The Argus II implant consists of an array of electrodes that are attached to the retina and used in conjunction with an external camera and video processing system to provide a rudimentary form of sight to implanted subjects. An IDE trial of the first generation implant (Argus™ 16), which has 16 electrodes, is ongoing at the Doheny Eye Institute at the University of Southern California. The Argus 16 was implanted in six RP subjects between 2002 and 2004 and has enabled them to detect when lights are on or off, describe an object's motion, count discrete items, as well as locate and differentiate basic objects in an environment. Five of these subjects are now using their Argus 16 retinal prostheses at home.
The next generation Argus II retinal stimulator is designed with 60 independently controllable electrodes, which should provide implanted subjects with higher resolution images. Second Sight remains the only manufacturer with an actively powered permanently implantable retinal prosthesis under clinical study in the United States, and the technology represents the highest electrode count for such a device anywhere in the world.
More from Second Sight's main page, their clinical trials page, and their full press release...
Flashbacks: Second Sight Implant: Positive Results Reported in the Study; Diamond Coating for Second Sight Implant
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Monday, November 20, 2006
They're Back!
The sad saga of pseudoscience and gold-digging might finally be over. The silicone gel-filled breast implants have been officially cleared by the FDA:
After rigorous scientific review, the U.S. Food and Drug Administration (FDA) today approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif...Now that the products have been determined to be safe and effective, FDA will continue to monitor them by requiring each company to conduct a large postapproval study following about 40,000 women for 10 years after receiving breast implants. FDA often requires postmarket studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events.
FDA's decision to approve these implants was based on a thorough review of each company's clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, FDA conducted inspections of each company's manufacturing facilities to determine that they comply with FDA's Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.
In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. However, these issues will be addressed further in the postapproval studies conducted by the companies...
Full information about the risks and benefits of the devices can be found in the package and patient labeling mandated by FDA. The patient labeling outlines some of the important factors women should consider when deciding whether to get silicone gel-filled breast implants. Some of these factors are: breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime; many of the changes to a woman's breast following implantation are irreversible; rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured; and a woman will need regular screening MRI examinations over her lifetime to determine if silent rupture has occurred. The device labeling states that a woman should have her first MRI three years after her initial implant surgery and then every two years thereafter. The cost of MRI screening over a woman's lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. The labeling also states that if implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.
FDA's press release...
Well, the truth is that the saga is not over. This Dow Corning's web page is still up and running...
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Tuesday, November 14, 2006
Recalls Spark Stricter FDA Device Safety Procedures
The LA Times reported that the Food and Drug Administration is to revise, patch up and enhance its procedures on handling safety issues with pacemakers, stents, defibrillators and other medical devices it regulates:
How the FDA handles safety issues with the products it regulates already is under scrutiny and is expected to receive even more attention from Democrats now that they will be the majority party in Congress.With medical devices in particular, concern grew after last year's slew of high-profile recalls or safety warnings affecting more than 200,000 defibrillators.
It also calls for streamlining the now-disjointed way the agency collects reports of possible problems from multiple sources, including manufacturers and doctors.
Proposals include expansion of a pilot program that collects safety reports in real time from hospitals, as well as tapping into medical device data amassed by the Veterans Affairs Department, the Defense Department and the Centers for Medicare and Medicaid Services.
The FDA also wants all medical devices marked with a unique number, which would allow them to be better tracked in a recall.
Better device tracking and data collection, if used properly (that's a big if), could provide vast improvements in device quality and tracking. Of course, all this tracking and data collection can't be paid for in Medgadget Bucks, so in the end the taxpayer or consumer will end up footing the bill. However, as more medical treatments are delivered via engineered devices, the public seems willing to pay for increased peace of mind.
More from the LA Times...
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Monday, November 13, 2006
Defibrillators Buried with Patients
Why is it so hard to convict a doctor of malfeasance? Because they bury all the evidence. Har Har...It appears that tired old joke might also carry over to manufacturers of implantable cardioverter defibrillators (ICDs). Apparently, research recently presented at the American Heart Association meeting in Chicago points out that too few of the devices are going back to manufacturers for analysis...
High-profile recalls of defective devices have raised awareness of ICD safety, but researchers said they do not know the true rate of malfunction because the devices are not routinely checked after death.Kirkpatrick [Dr. James Kirkpatrick of the University of Pennsylvania, presenter of these data - ed.] said most devices now are buried with patients. Of those that are removed, 44 percent are disposed of as medical waste, while 22 percent are donated for animal use or for human use in developing nations.
The survey found that most of the 100 morticians surveyed (87 percent) would be willing to return the devices to manufacturers for analysis. Of the 160 ICD patients questioned, 82 percent said they would give their consent.
At least a few of the devices are being re-used for some good. Hard to imagine that failed devices aren't required to be sent back for analysis. Or maybe this is just referring to devices that weren't the cause of death?
We'd link you to the article, but this was only a conference presentation, so we'll send you to Reuters...
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Monday, October 16, 2006
Counterfeit Glucose Test Strips Hit Market
The Associated Press is covering the release of counterfeit blood glucose test strips, used with the LifeScan OneTouch blood glucose monitor. LifeScan is a subsidiary of Johnson and Johnson, Inc.
The counterfeit test strips could give incorrect blood glucose values, leading patients to take too little or too much insulin and suffer injury or death, the FDA said. The agency said it hasn't received any such reports.Diabetics who purchased the counterfeit test strips should stop using them, replace them immediately and call a doctor, the FDA said.
The counterfeits are:
* OneTouch Basic/Profile, lot numbers 272894A, 2619932 and 2606340.
*OneTouch Ultra, lot number 2691191.
The FDA is investigating but did not know how many of the counterfeits were sold, an agency spokeswoman said. They were distributed nationwide but primarily in Ohio, New York, Florida, Maryland and Missouri by Medical Plastic Devices Inc., of Quebec, Canada, and Champion Sales Inc., of Brooklyn, N.Y., the FDA said.
It's unclear from the original article how the strips were identified as counterfeit, rather than just faulty, although most large-scale manufacturers have rather complicated identification schemes on their products, allowing for easy spotting of a fake. We can hope that's the case here; either that, or JnJ stumbled across a great recall loophole: "These parts aren't faulty, they're counterfeit!."
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Thursday, October 12, 2006
FDA Takes Input on Regulating Nanotech
Ah, regulatory science. On October 10th, the US Food and Drug Administration hosted a meeting looking for input on regulation of products implementing nanotechnology. Expert inputs abounded, running the gamut from heartily approving of the current regulatory environment, to saying the US government has "acted as a cheerleader and not as a regulator"...
"The success of nanotechnology will rely in large part on how FDA plays its regulatory role," said Michael Taylor of the University of Maryland's School of Public Health.The key is to use science to weigh both the benefits and the risks of nanotechnology, said Matthew Jaffe of the U.S. Council of International Business. That's a balance the FDA already seeks to strike in assessing other products.
"We believe the regulatory process that is in place is significant and adequate to address the issues before the FDA," Jaffe said.
Kathy Jo Wetter, of the civil society organization ETC Group, told the FDA it was understaffed, underfunded and ill-equipped to deal with nanotechnology. Wetter said hundreds of nano products have already crept onto the market with little scrutiny.
"Unfortunately, so far the U.S. government has acted as a cheerleader and not as a regulator," Wetter said.
Carolyn Cairns, a senior researcher at Consumers Union, told the FDA that nanomaterials should be regulated like any other new chemical substances and subjected to a full battery of tests before use.
Martin Philbert, a University of Michigan professor of toxicology, counseled the FDA to "avoid overregulation while remaining vigilant."
While everyone does a great job of pointing out their opinions, no one's really stated what they would specifically like to see changed. Watch this space to see how the FDA addresses the issue.
More from Andrew Bridges' AP article...
More from the FDA's Nanotech page...
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Friday, September 22, 2006
The Device Reprocessing Battle Continues, Now with Clever Acronyms
Patient Groups United Against Reprocessing Dangers wins the Medgadget Acronym of the Month for September, for not having to resort to picking sTRange LeTTers to construct PatientGUARD. All frivolities aside, PatientGUARD is heading for the state legislature in New Jersey...
[PatientGUARD] plans within the next month to call for legislation that would restrict the practice in New Jersey.Those restrictions would include requiring written patient consent prior to using a reprocessed single-use device, giving physicians the chance to reject using them, requiring detailed record-keeping when the devices are used and shifting liability for any problems from the original manufacturers to the companies that reprocess the devices for hospitals.
The coalition, organized by the HealthCare Institute of New Jersey, joins a simmering debate in the medical community over the safety of reusing surgical blades, diagnostic catheters and other medical devices.
Those requirements seem reasonable (and don't necessarily prohibit reprocessing), but of course we see predictable rhetoric from both sides of the argument...
Since 2004, when FDA began requiring reports of patient complications or device malfunctions to note whether a medical device had been reprocessed, millions of devices have been reprocessed without any problems, according to the Association of Medical Device Reprocessors. The association said thousands of problems with new devices have been reported in that time.However, the HealthCare Institute of New Jersey, which represents several companies that make medical devices, alleges FDA oversight is inadequate. The institute says that reusing devices after they have been cleaned and sterilized puts patients at risk for infection or injury.
Shocking. Interest groups continue to argue the point they were created to support. As if under some odd circumstances the Assoc. of Medical Device Reprocessors is going to decide single use devices shouldn't be reprocessed, or that medical device manufacturesr relying on a razors-and-razorblades business model to stay afloat would advocate their own destruction.
More from Linda Johnson's AP article
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» The Lung Flute Cleared by FDA for Sputum Induction (September 11, 2006)
» FDA To Regulate Complex Diagnostic Tests (September 7, 2006)
» US Marshals Seize Defective Infusion Pumps at Alaris Facility (August 30, 2006)
» Attention Medical Device Engineers: The FCC Wants to Hear from You (August 22, 2006)
» Reprocessing of Single-Use Devices: Good Idea/Bad Idea? (August 2, 2006)
» Medtronic to Pay US$40M to Settle Kickback Suits, Retrain Sales and Marketing Staff, Admits No Guilt (July 19, 2006)
» Union of Concerned Scientists Surveys FDA Staff; Results Not Promising (July 19, 2006)
» Abiomed Tubing System: FDA Approved (July 13, 2006)
» New Standards for Medical Device Manufacturing in India...or Just Fees? (July 7, 2006)
