The relationship between hospitals and the medical device industry needs more integration, proclaimed Mary Ann Hilliard, chief risk counsel for the Children's National Medical Center (Washington, DC) last week. Hilliard spoke at a risk management conference jointly held by AdvaMed, FDA, and Virginia Tech. The disconnected relationship causes problems when it comes to equipment use error among clinicians. Linking both industries would both improve processes and drive down errors. From Hilliard's perspective, although technology in hospitals is incredibly innovative, until there is collaboration between both industries, hospitals won't be able to reduce sentinel events. She suggested the presence of more human factors engineers and reliability experts in hospitals, especially when conducting root cause analysis. Another part of the solution is more transparency in sharing data--however, with current liability issues, this is a major challenge.
May 21st, 2007
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Brain-related illnesses generate more healthcare costs than any other therapeutic area—$1.1 trillion annually in the United States, noted Zack Lynch, executive director of the Neurotechnology Industry Organization (NIO). Lynch made his remarks to kick off the Neurotech Industry Investing and Partnering Conference, taking place May 17-18 in San Francisco. In 2006, neurotech products across these three sectors generated more than $120 billion in revenue with 10% growth. Despite its already large size, Lynch said neurotech is poised for large growth with several factors driving this demand. Primary among these, he said, is that neurotech companies address the largest unmet medical market. The total number of people affected by brain-related illnesses worldwide has reached more htan 2 billion people, which means that nearly one in three people suffer from a brain-related illness. “Major medical device companies like...
May 18th, 2007
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So maybe it’s not so strange to think of a patient as a washing machine. That is, it’s not a bad idea to give a patient the same kind of warranty that a washing machine or a television would have. That is what the Geisinger Health System group in Wilkes-Barre, PA is doing. A read more >>
May 17th, 2007
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Shelhigh Inc., which had its inventory of tissue-based implants seized by the government because of concerns over sterility, has gone to court to get them back, but the judge says he's not inclined to grant the company's wish, reports the Star-Ledger of Newark. The firm argues that it should be allowed to ship the products overseas because GMPs don't apply to products made for export. U.S. District Judge William J. Martini said he does not agree with that interpretation, but is giving Shelhigh more time to collect additional evidence. The company says it will likely be forced out of business if it can't sell the seized product. Update: On May 18 FDA issued a preliminary public health advisory about possible contamination of Shelhigh devices.
May 16th, 2007
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Bausch...
May 16th, 2007
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Tyco International Ltd. and Siemens, two multinational conglomerates that have been embroiled in corporate scandals, saw steps taken to resolve the controversies. Both companies have medical divsions that could be affected by the fallout. Tyco this morning announced it will pay nearly $3 billion to settle claims filed by shareholders in the wake of misconduct by top executives, some of whom were convicted of defrauding the company to line their own pockets. It is the largest-ever settlement by a single corporate defendant in a class-action suit, reports the Associated Press. Tyco is spinning off its healthcare division, which will be called Covidien. Siemens yesterday saw two former executives convicted of bribery, reports the New York Times. As part of the judgment, the...
May 15th, 2007
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Cardinal Health today announced plans to buy Viasys Healthcare for about $1.5 billion. Viasys, known for its rapid product innovation and fast growth, plays in a number of markets, including disposables, orthopedics, and respiratory. It was named one of MD&DI's 50 Companies to Watch in June 2006. This is the latest step in Cardinal's plan to move from being a distributor to being a major manufacturer as well. Its previous biggest splash was buying Alaris Medical Systems in 2004.
May 14th, 2007
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Transforming FDA LogoCDRH has unveiled two pathways to facilitate electronic Medical Device Reporting. This will hopefully increase the volume of MDRs, which are underreported. Small manufacturers who don't anticipate making many MDRs can use a program called CDRH eSubmitter, or CeSub. To use it, they can download special software, which runs on a PC and allows users to submit one report at a time. Large manufacturers, who may need to submit hundreds of reports per year, can use a batch submission protocol in accordance with the health informatics standard known as HL7. An information guide on HL7 can be obtained by emailing...
May 14th, 2007
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In today's world, it's no surprise that device companies are trying to develop products that will help protect the public in the event of a biologic (or nuclear) disaster. On Tuesday, FDA approved two filtering facepiece respirators that help reduce exposure to airborne germs in the case of a public health emergency. Manufactured by 3M Co. (St. Paul, MN), the devices are N95 certified, which means they meet certain criteria set forth by the National Institute for Occupational Safety and Health (NIOSH). The mask, which fits tightly over the nose and mouth, is supposed to filter out at least 95% of small airborne particles. Although they don't require a prescription, N95 respirators must be properly fitted to each person if they were to be used in the workplace by healthcare workers, for example. FDA requires that companies marketing these kinds of devices during health emergencies must ensure they are certified by...
May 11th, 2007
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Transforming FDA LogoThe Senate yesterday passed the FDA Revitalization Act, which includes the new version of MDUFMA, 93-1. The bill is getting more coverage in the media for its drug-industry reforms, particularly concerning safety issues, read more >>
May 10th, 2007
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