Transforming FDA LogoMembers of a Senate appropriations subcommittee yesterday declared that FDA read more >>
April 16th, 2008
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Transforming FDA LogoHHS Secretary Mike Leavitt said FDA plans to open an office in China to better get a handle on contaminated medical devices, drugs, foods, and other products being exported from that country, the Associated Press reports. The agency expects to begin work there next month, with the official office opening coming in October. This signifies a change in strategy for the agency, which had been trying to detect unsafe products during customs. That's no longer feasible, Leavitt said, because it is impossible to inspect all of the massive numbers of imported products. So now, he...
April 15th, 2008
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A research team in France has developed a robot that can deliver a general anesthetic for operations, Agence France-Presse reports. So far, it has been tested on 200 patients in 12 European hospitals. The system includes a bispectral monitor, a technology developed by Massachusetts-based Aspect Medical, which records brain activity and analyzes the depth of the anesthetic.
April 14th, 2008
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Remote monitoring has made great technological strides in recent years. But it hasn't been as widely adopted as it could be because it isn't covered under current reimbursement systems. That may change if a bill introduced in the House yesterday becomes law. It requires Medicare to cover remote monitoring services used to manage care for patients with congestive heart failure and cardiac arrhythmia. It also requires CMS to work with stakeholders to develop a standard of care for using remote monitoring for those conditions. The bill also provides for a demonstration program to evaluate whether Medicare should cover remote monitoring services for diabetes, epilepsy, and sleep apnea. The bill, sponsored by Reps. Anna Eshoo (D-CA), Charles Pickering (R-MI), John Tanner (D-TN), and Kenny Hulsof (R-MO), drew swift praise from AdvaMed. "What was once only science...
April 11th, 2008
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St. Jude Medical Inc. (St. Paul, MN) is buying New Jersey-based EP MedSystems (West Berlin) for $92.1 million. St. Jude hopes the purchase helps to accelerate the company's growth in the echocardiography market. EP MedSystems makes a range of products in cardiac rhythm management, including an intracardiac ultrasound catheter system, an electrical stimulator for the heart during diagnostic studies, and a system that records images of the heart and related data for clinician use or for patient records.
April 10th, 2008
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FDA yesterday sent a warning letter to device makers about using heparin to coat devices such as stents and stent grafts, the Wall Street Journal reports. The agency has raised the number of deaths since January 2007 that it attributes to contaminated heparin to 62. The letter advises device firms to review their sources of heparin in light of recalls by Baxter and a German company, both of whose brands of heparin were found to be contaminated. In late March Covidien recalled orefilled syringes which contained heparin. We may not have seen the last of the recalls.
April 9th, 2008
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A federal judge has granted an injunction halting Medicare's laboratory competitive bidding demonstration project. Judge Thomas Whelan ruled that the project could cause "irreparable injury" to laboratories and patients. The American Clinical Laboratory Association has long opposed the project on the grounds that it could put smaller laboratories out of business, but also because it raises concerns about quality of care and fails to distinguish between certain types of tests. The ACLA renewed its call for Congress to repeal the project. What does this have to do with medical device manufacturers? Medicare has other competitive-bidding projects underway, including one on durable medical equipment. Perhaps the judge's ruling will eventually have an impact on those as well....
April 9th, 2008
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FDA officials are not consultants to OEMs. Which is not to say that FDA doesn't want to help, Barbara Cassens, director of the agency's San Francisco District Office, told those at the RAPS Horizons conference in late March. But its job is enforcement, and there simply isn't enough time to spend more than an hour with companies that are seeking resolution on FDA-483 observations or warning letters. Cassens and Ron Johnson, an FDA consultant, presented a demonstration highlighting common mistakes OEMs can make when at FDA meetings. These include not being prepared, not asking FDA who will be attending the meeting, making poor use of time, making rash committments, and leaving the table without a clear plan of action. The speakers also discussed how difficult it can be to understand FDA's position in the process, because as stated above, the agency is an enforcer, not a consultant. "You have to respect FDA's role," Cassens said, "but also realize that we are people too." Johnson...
April 8th, 2008
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It's no surprise to any device maker that there are myriad inconsistencies in regulatory schemes from country to country. Efforts by the Global Harmonization Task Force (GHTF) to bring these inconsistencies to a minimum have been largely successful. But the work is nowhere near finished. Device manufacturers who are waiting for not just harmonization but blanket uniformity may misunderstand the goals of the GHTF. They are going to be disappointed, explained Paul Brooks, vice president and country manager of BSI PS Healthcare US and a member of the GHTF. "Our goal is to bring regulatory bodies together, not make them exactly the same," he said during the RAPS Horizons conference, held in late March in San Francisco. Brooks and Michael Gropp, global regulatory strategist for Medtronic, spoke to attendees about the global regulatory environment and how harmonized regulations are being adopted -- or better yet, adapted. "The idea [among manufacturers] is that harmonization is a big bang...
April 8th, 2008
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One of the biggest challenges in manufacturing a combination product is figuring out when to apply the medical device Quality System Regulation and when to apply the drug Good Manufacturing Practices. Linda Alexander, president of Alquest Inc., said it's pretty straightforward during the phases where different components are made separately. Apply the QSR when making the device and apply GMPs when making the drug or biologic. But, she said, the decision is much more difficult once one reaches the phase of manufacturing the overall product. She spoke in March at the PharmaMedDevice conference held in Philadelphia. A draft guidance published in 2004 offers some advice, but it is still up to the manufacturer to sort out which parts of the QSR apply and which parts of the drug GMPs apply, Alexander said. "You must justify what you choose to follow, especially in areas where they conflict," she said. She said device manufacturers who may not have...
April 8th, 2008
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