Medical Devices

Friends thought Paul Silber had bet the farm when he ditched a secure job as a toxicologist with Dallas-based Mary Kay Cosmetics, packed everything into a U-Haul van and headed for Maryland to start a company based on an obscure, yet promising, field of biotechnology.Five years later, Mr. Silber relishes the memory as his Baltimore-based company, In Vitro Technologies, announced that in 1995 it turned a profit for the first time on revenues of almost $1 million. And he's expecting big growth in the next several years.

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.

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.

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.

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.

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.

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.

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.

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.

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...

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.

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.

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.

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.

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.

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.

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.

Americans are aging, and so are their joints and bones. As rickety bones have made walking harder for millions of the elderly, countless companies have created medical devices to make getting around easier, creating a thriving industry in the process. Consumers spent $31.2 billion in 2000 on durable medical devices, which include artificial limbs, canes, wheelchairs, crutches, canes and hearing aids. That's nearly double the amount spent 10 years before, according to federal figures. Invacare Corp.

For most undergraduates, plastic cable ties are things they use to subdue the tangle of computer wires behind their desks. But for 11 budding engineers at the Johns Hopkins University, the simple, sturdy fasteners were the key to solving a problem that has vexed cardiac surgeons for decades - how to do a better repair on a breastbone they saw in half to gain access to the heart. The undergraduates in associate research professor Robert Allen's two-semester, biomedical engineering design course have conceived and built a hand-held device that can safely join and stabilize the two halves of the sternum, using cable ties that dissolve after the bone has healed.

Through giveaways and sponsorships, the mamanufacturers of drugs and medical devices can distort the way doctors care for patients, a group of prominent physicians and scientists warns today in a call for reforms. The group recommends that academic medical centers ban some common practices, regulate others and make a concerted effort to disclose doctors' financial relationships with makers of drugs and devices. "Marketing and market values should not be allowed to undermine physicians' commitment to their patient's best interest or to scientific integrity," the authors contend.