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Articles from 2008 In June

CT Heart Scans Often Unnecessary?

The article goes on to blame "the American devotion to the newest, most expensive technology" for rising healthcare costs. And once again, the Times rages about the alleged inadequacies of the 510(k) process. While people in the device industry may not take these sorts of conclusions seriously, undoubtedly there are politicians and opinion leaders who will. So it's important to pay attention to pieces like this.

AdvaMed Speaks Out Against Anti-Preemption Bill

"A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients," said AdvaMed President Stephen J. Ubl. The case, Riegel v. Medtronic, concerned a patient who was injured by a Medtronic catheter in 1996. The 1976 law stated that makers of PMA products cannot be sued in state courts if the products did not violate federal laws and regulations. It established FDA as the sole arbiter of safety and effectiveness of PMA products. This "preemption" of lawsuits in state courts does not apply to 510(k) products, nor to PMA products that are found to be adulterated or misbranded. (The Medtronic catheter was neither. Instead, it was misused by the patient's doctor.) The consequences of allowing such cases to proceed in state courts could allow states to set their own standards for safety and effectiveness of PMA products, which would be chaotic, Ubl said. âEURoeThe Supreme CourtâEUR(TM)s 8-1 decision in Riegel v. Medtronic re-affirmed what most Federal courts have regarded as settled law since 1976 -- that the FDA, not differing state regulations and multiple jury verdicts, should determine the safety and effectiveness of medical technology," he said. "This bill will not improve patient safety but will result in needless delays in patient access to essential medical technologies, more lawsuits and ultimately higher health care costs.âEUR

Some States Cracking Down on DTC Genetic Tests; Feds May Follow

And the Federal Trade Commission is looking in to whether some of these firms have used deceptive advertising and marketing. The firms say people have a right to know their genetic information so they can use it in health and lifestyle planning. Some of them say they are not in the business of medical testing, but of personal information services. But critics and some government officials say that the test results inevitably constitute medical advice, and that there needs to be a way to determine whether the genetic tests used are valid. The firms run the samples at labs that are regulated by CMS, but critics say that only proves that the tests are analytically valid, not clinically valid. Some of these firms appear to be legitimate businesses, and some appear to be fronts to sell dietary advice and supplements. That means finding the right balance could be difficult.

Anti-Surgical Mesh Patient Group Formed

To get Congress involved because it is unlikely the device industry would take the initiative on its own. * To require changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a PMA or 510(k) product; results of clinical trials, if any; and all known risks and complications. * To provide patients, upon discharge, with adverse event reports that they could directly send to FDA if necessary. Information about the implantable would already be filled in by the hospital. * To set up a fund to help those harmed by surgical meshes, which would alleviate the need for some patients to sue. "Every single day, there are new victims," Keeton wrote. "This has to be stopped."

RFID Devices Might Cause Medical Equipment to Malfunction

"The intensity of electronic life-supporting medical devices in this area requires careful management of the introduction of new wireless communications such as RFID," the authors note. Devices that were tested included external pacemakers, defibrillators, infusion pumps, anesthesia devices, and mechanical ventilators. The tests were performed in a nonclinical setting, and incidents of EMI were put into categories of hazardous, significant, or light.

FDA Report: MDUFMA Reforms Sped Up PMA Reviews

Statistics for FY 2007 are not yet available. However, average 510(k) review time rose slightly, from 87 days in FY '05 to 95 days in FY '06. And the report also noted that third-party reviews dropped in 2007, compared to 2006. That was before reforms to the program included in the FDA Amendments Act of 2007 were implemented, though.

Imaging Agent Linked to 4 Deaths

A fifth patient suffered cardiac arrest but was revived after receiving Definity, which is made by Lantheus Medical Imaging, a unit of Avista Capital Partners. Warnings for Definity and a competitor, GE's Optison, have been strengthened, and an FDA advisory panel is meeting tomorrow to further discuss safety issues associated with contrast agents. Lantheus will present a paper to the panel claiming that there is no difference between patients who received Definity and patients who received no contrast agent at all. The agency has not made any conclusions regarding the safety of Definity. A paper presented at the American College of Cardiology meeting in March argued that warnings for Definity and Optison may do more harm than good, as they could lead to less use of contrast agents, whose benefits outweigh their risks.

Boston Scientific to Raise $140 Million by Selling Part of Investment Portfolio

In the second deal, the firm will sell its investment in a portfolio of venture funds and companies to Paul Capital Partners, a private equity firm, for about $40 million. These moves come in addition to those announced earlier, including selling off non-core businesses and laying off employees. Big device companies can be a source of investment capital for start-up device companies. So start-ups shouldn't be expecting any boost from Boston Scientific anytime soon.

Diaphragm-Pacing Device Approved

The NeuRx, made by Synapse Biomedical, consists of four electrodes implanted in the muscle of the diaphragm that electronically stimulate contraction. It was approved on a Humanitarian Device Exemption, as it is not expected to be used on more than 4000 patients per year.

Lack of Access Denies Patients Joint Replacements

According to the study, which was published in the journal Medical Decision Making, some Canadian doctors didn't refer patients on the grounds that they couldn't get rehab treatment. This also raises a problem for older patients who are more frail. The healthcare system will need to address this issue soon, as the demand for joint replacements continues to rise.