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NEWS
By Philip J. Hilts and Philip J. Hilts,New York Times News Service | February 24, 1992
WASHINGTON -- The head of the Food and Drug Administration is making clear to manufacturers of more than 100 untested medical devices already in use that they must present data from rigorous safety tests or face restrictions on their products.Like breast implants, which were restricted earlier this month, these products were in use before 1976 when a law went into effect governing federal approval of new medical devices. The law also required federal review of the older products but set no timetable for that.
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NEWS
By Ian Duncan, The Baltimore Sun | May 3, 2014
A child's medical device left near the AMC movie theater in White Marsh Saturday triggered a brief evacuation of the cinema, Baltimore County police said. Police spokesman Lt. Robert McCullough said police received a call around 3:30 p.m. for a report of a suspicious package. About 30 minutes later the child's parents returned and retrieved the device, which McCullough described as a nebulizer. Such devices convert liquid medicine into mist that patients can inhale. Social media users first reported being evacuated from the theater and posted pictures of police responding to the scene.
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NEWS
By New York Times News Service | April 25, 1994
CHICAGO -- Big chemical companies and other manufacturers of materials used to make heart valves, artificial blood vessels and other implants have been quietly warning medical equipment companies that they intend to cut off deliveries because of fears of lawsuits.While the suppliers' new policies have not yet forced important products from the market, medical equipment makers that are scrambling to protect themselves from the impending cutoffs say they are having trouble lining up alternate suppliers.
HEALTH
By Andrea K. Walker, The Baltimore Sun | May 30, 2013
Owning a cane, wheelchair or walker is a little bit like owning a car, said Brad Barnhart, a physical therapist at North Oaks, a senior living community in Pikesville. Skip maintenance, and it could lead to unsafe conditions. Barnhart, with more than 25 years of experience in senior living settings, provides some tips on keeping medical devices in good shape. How often do you see patients who aren't maintaining their cane, walker, wheelchair or other medical device, and how big of a problem is it?
NEWS
By LOS ANGELES TIMES | July 19, 2005
WASHINGTON - Government regulators lack an effective system to monitor the safety of medical devices, which include items as diverse as incubators for premature babies, surgical clamps and cardiac pacemakers, a scientific panel concluded in a report issued yesterday. The Food and Drug Administration, which is responsible for the safety of medical devices as well as drugs, needs additional legal authority from Congress and better internal procedures, according to an Institute of Medicine panel.
NEWS
By Tom Pelton and Tom Pelton,SUN STAFF | May 27, 2002
A 5-year-old boy is crushed to death by a defective hospital bed because a recall notice sat unread on a desk. An attorney dies when a faulty surgical tool inflates his skin and blasts air into his brain because another warning wasn't heeded. A manufacturer tries to recall faulty heart valves but can't find 40 percent of the patients with them. Administrators at many hospitals complain that the U.S. system for recalling defective medical devices is flawed and itself should be recalled and repaired.
NEWS
By Meredith Cohn, The Baltimore Sun | January 23, 2011
Marc Miller survived a motorcycle crash in October near his Baltimore County home, but his foot had been dragged along the pavement and badly damaged. That injury would require both the most advanced medicine and an ancient therapy — leeches. Trauma doctors at Johns Hopkins, the University of Maryland and other U.S. hospitals routinely use leeches as a temporary measure to keep blood flowing as new vessels grow in a damaged area. The animals kept blood moving in and out of a new skin flap sewn onto Miller's foot.
NEWS
July 20, 1996
GOOD PRODUCT liability law is always a delicate balance between the rights of consumers to be protected from dangerous or faulty products and the protection of manufacturers from frivolous claims. When the product in question is a medical device, the passions aroused by faulty products can be especially intense.Before ending its most recent term, the Supreme Court gave consumers an important victory, ruling that federal regulation of medical devices does not necessarily protect the manufacturers from liability.
BUSINESS
June 23, 1993
United Airlines bars devicesUnited Airlines has become the latest airline to bar the use of portable electronic devices that emit electromagnetic waves on its flights during take-offs and landings, effective July 1.Passengers may not use electronic devices, which include laptop computers and portable audio tape and compact disc players, when the plane is on the ground or flying below 10,000 feet because of the possibility of electromagnetic interference, the...
NEWS
By LOS ANGELES TIMES | October 28, 2005
Hospitals warn us to turn off our cell phones for fear of interfering with Dad's heart monitor or Aunt Millie's life support. However, new research shows that cell phones interfere only minimally with medical equipment. In a report published in the October issue of Mayo Clinic Proceedings, researchers measured interference between 16 medical devices, such as heart monitors and defibrillators, and six types of cell phones. Although cell phones interfered with the signal of seven devices, they affected the machines' function only 1.2 percent of the time.
NEWS
By Robert E. Fischell | May 14, 2013
Government leaders are asking us to out-innovate, out-export and out-work our competitors in order for the United States to turn this economy around. But what if our own government was instituting policies that proved to be some of the biggest obstacles in achieving those goals? For more than four decades, I have dedicated my life to developing novel medical technologies, such as implantable insulin pumps, rechargeable implantable pacemakers, heart stents and more. These therapies have improved the health and saved the lives of millions of patients in America and throughout the world, and spurred the creation of tens of thousands of jobs.
HEALTH
By Andrea K. Walker, The Baltimore Sun | March 15, 2012
Maryland will get nearly $10,000 as part of a national settlement involving kickbacks to doctors to encourage them to implant pacemakers and implantable cardioverter defibrillators in patients, Attorney General Douglas F. Gansler announced Thursday. Medtronic Inc, the developer of the medical devices, settled with the federal government for $23.5 million. Medtronic paid physicians who agreed to participate in clinical studies or registries involving their pacemakers and ICDs, according to the agreement.
SPORTS
By Chris Eckard, The Baltimore Sun | October 1, 2011
Kathleen Hammett smiled and her eyes became glassy as she watched her daughter trying to spell out the letters of her name on a piece of paper. "She's about to turn 4," Hammett said. It's not a miracle that Clara, a cheery girl with curly blonde hair and blue eyes, is about to celebrate another birthday. But it's nothing short of one that Hammett, who suffered a hemorrhage after giving birth four years ago this weekend and battled breast cancer less than a year later, could watch her girl grow up. On Sunday, the 40-year-old from Hollywood, Md., will run in the Medtronic Twin Cities Marathon in Minneapolis as one of the 25 Medtronic Global Heroes - runners with implanted medical devices who overcame serious medical conditions.
BUSINESS
By Gus G. Sentementes, The Baltimore Sun | July 5, 2011
In a conference room in downtown Baltimore, F. Blix Winston compared the Food and Drug Administration to a "slow-moving bulldog. " "You don't want to get bitten," Winston, an expert on the federal regulation of medical devices, told a crowd of about 50 entrepreneurs and academics recently. "You don't want to tangle with the FDA," he warned. "The FDA has the power to come in and padlock a company's doors. " Winston's presentation was part of a new approach by Maryland economic development officials to promote the state's life sciences industry.
NEWS
By Sandeep Rao | February 24, 2011
Europeans have long extolled centralized planning and tolerated large government bureaucracies. But when it comes to approving medical devices, Europe has taken a decidedly decentralized approach — to the great benefit of patients and health care workers. It is an example the United States would do well to follow. Consider the field of cardiology. A national medical conference, such as the American Heart Association Scientific Sessions, gives you a glimpse into the future.
NEWS
By Meredith Cohn, The Baltimore Sun | January 23, 2011
Marc Miller survived a motorcycle crash in October near his Baltimore County home, but his foot had been dragged along the pavement and badly damaged. That injury would require both the most advanced medicine and an ancient therapy — leeches. Trauma doctors at Johns Hopkins, the University of Maryland and other U.S. hospitals routinely use leeches as a temporary measure to keep blood flowing as new vessels grow in a damaged area. The animals kept blood moving in and out of a new skin flap sewn onto Miller's foot.
FEATURES
By JOE BURRIS and JOE BURRIS,SUN REPORTER | January 3, 2006
The walls in Robert Fischell's home office in Howard County are filled with framed patents from home and abroad, a testament to a man whose mind is up and running in the wee-morning hours conceiving lifesaving medical devices. The 76-year-old inventor opens a briefcase atop his desk and displays some of his latest handiwork, devices he says will do more for modern medicine than his previous breakthroughs. Yet what could be greater than the first implantable insulin pump, the rechargeable pacemaker and flexible stents for coronary arteries?
BUSINESS
By Timothy B. Wheeler and Timothy B. Wheeler,SUN STAFF | February 11, 2000
Recycling may help cut down on waste, but a powerful Maryland state senator believes it could be too risky for the operating room. Sen. Thomas L. Bromwell, chairman of the Finance Committee, has taken aim at a quietly growing practice by hospitals and doctors of re-using disposable medical devices. The Baltimore County Democrat has introduced a bill, scheduled for a hearing today in Annapolis, that would forbid hospitals and clinics in Maryland from re-using so-called "single-use" devices unless they first notify patients and get their signed consent.
NEWS
By Kevin A. Schulman | February 19, 2007
DURHAM, N.C. -- 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 purchase an appliance these days, the manufacturer asks me to register the product by mail or over the Internet so it can match me with the product details.
NEWS
By JONATHAN D. ROCKOFF and JONATHAN D. ROCKOFF,SUN REPORTER | August 16, 2006
At Union Memorial Hospital in Baltimore, the medical director has pored over patient records to determine which antibiotics are to blame for a potentially fatal infection. In Ohio, physicians at Akron General Medical Center are experimenting with rats to determine whether a popular painkiller also slows the spread of cancerous cells. And in Los Angeles, doctors at Cedars Sinai Medical Center are teaching computers to interpret heart scans. Across the country, tighter finances and tougher competition are prompting many community hospitals to move beyond their core business of administering tests and performing surgery.
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