Researchers from the University of Cincinnati and BlackHagen Design are conducting a survey on sustainability issues related to the medical device industry. Results will be presented at the IDSA national conference in late September. The survey asks about attitudes toward sustainability/environmental friendliness within current healthcare practices, and about any efforts that device companies are making to be more environmentally friendly without compromise of care.
To take the survey, go here.
Masimo Corp., a leading manufacturer of pulse oximeters, has settled a patent lawsuit brought by two competitors without incurring liability, according to the Associated Press. Shaklee Corp. sued Masimo in July 2007, claiming that Masimo violated a patent for the calibration technology in Shaklee’s pulse oximeters. Soon after, NIR Diagnostics Inc. also joined the suit. Both companies sought damages and injunctions. Masimo countersued. But now, Shaklee and NIR have dropped their claims with prejudice, and Masimo has dropped its claims without prejudice.
DeviceTalk will return on Tuesday, September 2.
TomoTherapy Inc. said it has received 510(k) clearance for its TomoDirect radiation therapy technology, according to a release posted on devicelink.com. TomoDirect is a new discrete-angle, sliding-beam delivery mode for the firm’s Hi·Art treatment system. The Hi·Art treatment system combines integrated CT imaging with conformal radiation therapy to deliver radiation treatments with fast and precisely, while reducing radiation exposure to surrounding healthy tissue. TomoDirect allows clinicians to choose which angle to use, and which modulation level to use.
The temporary treatment for those experiencing severe allergic reactions is to inject themselves with epinephrine. For 25 years, the preferred injector has been the EpiPen, made by DEY LP. But a pair of identical twins with severe food allergies decided they didn’t like the EpiPen’s design, and came up with their own. Eric and Evan Edwards invented the EpiCard and founded Intelliject. Even though the product’s primary mode of action is as a drug, the Edwards brothers considered their idea a medical device, and used human factors principles when designing it. They sought out a number of caregivers and patients for their opinions on what they liked and disliked about the EpiPen and about the Edwards’ designs. The end result is a product that is smaller, simpler to use, and hides the needle except for the five seconds during injection. It has voice commands that tell the user exactly what to do during the process. The user takes the EpiCard out, pulls off a safety tab, and holds an end of the product against any part of his or her body for five seconds. During that time, the needle comes out, injects the epinephrine, and retracts back into the device. The voice on the device then tells the user that the injection is complete, and tells them to get to a hospital. By contrast, the EpiPen needle remains exposed after the injection, and users have to be careful when putting the injector back in its case.
Intelliject plans to file a New Drug Application with FDA in 2009. An NDA is required because the product’s primary mode of action is as a drug.
A Washington state couple who used an unproven medical device to treat people with hepatitis and cancer have been sentenced for fraud, reports the Seattle Times. Donald and Sharon Brandt offered treatments at their clinic with what they called a “vibe machine.” They claimed it used radio frequencies to cure diseases. But they never sought FDA approval for the device, and at least one person they attempted to treat died. The charges arose from an investigation by FDA and the Washington State Department of Health. The Brandts had earned almost $808,000 in treatment fees since 1995.
Donald Brandt, who sometimes posed as a doctor despite not having a medical license, was sentenced to 30 days in prison and four months of home detention. Sharon Brandt was sentenced to five months of home detention.
FDA has issued a new rule on labeling changes made to a PMA device, drug, or biologic. Plaintiffs’ lawyers say the changes will shield device and drug companies from lawsuits by limiting the changes firms can make to product warnings, reports Bloomberg News. The biggest change is that a “Changes Being Effected” supplement — known as a “Special PMA” supplement in the device world — is now required “only if there is sufficient evidence of a causal association with the drug, biologic, or medical device.” FDA says that during premarket reviews, it goes to great lengths to ensure that warnings and other components of labeling are based on sufficient scientific information. Therefore, it says, labeling changes should be held to the same standard.
Of course the plaintiffs’ lawyers don’t like that. Scientific information sometimes gets in the way of their arguments.
A report by the Office of Inspector General says that CMS’s claims in 2006 that it had sharply reduced the amount of fraud related to Medicare’s medical equipment spending was misleading, reports the New York Times. CMS had claimed it reduced improper spending related to medical equipment to $700 million. But the real figure is more like $2.8 billion, according to the OIG report, obtained in draft form by the newspaper. (An official version is expected to be released next week.) The discrepancy apparently comes from instructions CMS gave to its auditor, AdvanceMed Corp. CMS allegedly told AdvanceMed to only review the documents submitted by vendors, and not to verify them against physicians’ records. Hence, AdvanceMed reported that 7.5% of claims were not supported by appropriate documentation, but the real figure is closer to 31.5%.
Congress is angry, as it should be. “This agency is incompetent,” said Rep. Pete Stark (D-CA). Indeed, it looks that way.
Medtronic has sued NuVasive Inc., a rival in the spinal implants arena, claiming that it has infringed spine-related patents held by its unit Medtronic Sofamor Danek, the Associated Press reports. The suit involves 12 different patents. Medtronic has made huge investments in its spine business recently, most notably by acquiring Kyphon. NuVasive CEO Alex Lukianov called the suits an “attempt to intimidate NuVasive,” since it is a threat to the aforementioned investments.
A study funded by C.R. Bard has found that if ventilator tubes are coated with silver, the risk of gravely ill patients catching pneumonia is reduced by 36%, Reuters reports. Bacterial pneumonia is one of the most insidious hospital-acquired conditions, and patients can get it from infections caused by ventilator tubes. Half of the antibiotics used in hospital intensive care units are prescribed to help prevent bacterial pneumonia in patients put on ventilators. Silver is widely used as an antimicrobial agent and has been shown to reduce bacterial pneumonia infections in animals. So Bard wanted to see if a silver coating would help reduce the infections in humans. The study tested the coated tubes between 2002 and 2006 on 1500 patients expected to be placed on a ventilator for more than 24 hours. When all was said and done, 4.8% of those with silver-coated tubes developed ventilator-associated pneumonia, compared with 7.5% of patients who were on ventilators with uncoated tubes. The coating also appears to have delayed the onset of pneumonia in the patients who did contract it. There was no impact on death rates, however.
Kudos to Bard for stepping up to the plate to enable these findings to come to light. Ventilator makers should start using coatings on their tubes, if they haven’t already.
Medtronic’s quarterly profit grew 11%, thanks mostly to sales of Endeavor, its drug-eluting stent that won FDA approval this year, reports Bloomberg News. It also benefited from growth in its spinal discs unit. For the fiscal first quarter ended July 25, the firm posted income of $747 million, or 66 cents per share, compared to $675 million, or 59 cents per share, for the same period a year earlier. Revenue rose 19% to $3.7 billion. The spinal and stent divisions each grew about 30%.
