The first web site dedicated solely to answering questions about lifesaving technology and treatment was launched last month through a joint venture between the Advanced Medical Technology Association (AdvaMed; Washington) and Body1 Inc. (Cambridge, Massachusetts). Called, the site was developed as an interactive service to provide consumers and medical professionals with in-depth information about new medical technologies, according to Pamela Bailey, president of AdvaMed.

"Each day in countless hospitals and physicians' offices around the world, medical technology is bringing hope to millions of people and their families by detecting life-threatening and debilitating diseases early and treating them more effectively," Bailey said during a press conference held to introduce the new site. "But the innovative technologies don't do much good if patients and physicians don't know they are available. That is where the power of the Internet as an informational tool comes into play," she said. Bailey cited a recent study by Penn, Schoen and Berland (Washington), showing that nearly half of all Americans look to the Internet for guidance on information about diseases, preventive health measures and medical breakthroughs.

In its collaboration with Body1, an Internet health care company, AdvaMed representatives said they have filled the gap, left by other health care companies, by creating a user-friendly web site written in lay terms that focuses on medical technologies. "You can go on the web site and read about a technology, learn what the technology is, and find out which physician in your area will be able to help you with it," said Blair Childs, AdvaMed executive vice president of strategic planning. Information on the site is written and submitted by AdvaMed's member companies. About 22 had signed on by mid-October and more are expected to join.

The four sections of the site include:

Medical Information. This section includes news on cutting-edge medical technology, up-to-date health news, "ask a doctor" and today's tips on current health and fitness issues.

Research Center. Here, patients can exchange information on clinical trials, track the progress of those trials and browse the latest medical technology information catalogues by condition.

MedTech Interactive Community. Patients can exchange personal experiences about illnesses, medical devices or surgical procedures.

Advocacy Center. This section contains facts on medical technology and payment issues, and it provides information on writing congressional members.

Bailey said that while nothing is better than patient consultation with a physician, "Accessing accurate and easy to comprehend medical information over the web can serve as an important step in the health care and delivery process." Having access to the site gives the patient the ability to enter the physician's office with information necessary to ask questions. "Before visiting the doctor, the patient can find out the consequences of selecting one type of care over the other," Bailey said.

Medical tech access enters political arena

A bipartisan group of 31 U.S. representatives has petitioned the House Ways and Means Committee to force the Health Care Financing Administration (HCFA; Baltimore) to reduce or eliminate barriers to new medical technologies. While the agency has attempted to reengineer some of its processes to produce what it calls a more open and accountable coverage system, the 31 representatives and their supporters asked Congress to add specific provisions of the bill, called the Medicare Patient Access to Technology Act, to new balanced-budget legislation. The measure would force HCFA to update Medicare payment programs each year, to improve and report annually on the "timeliness and appropriateness of reimbursement decisions" and to provide greater public openness to its decision-making procedures.

The work of HCFA can be rationalized as government's attempt to keep down medical costs, but Pamela Bailey, president of the Advanced Medical Technology Association, recently argued against that point of view in an interview with the Washington Post: "It's not a matter of money – or costs. Many of the new technologies are cost savers. They reduce the need for hospitalization."

H.R. 4395 also offered an opportunity for AdvaMed to become more aggressive in the political arena – as promised by Bailey when she took over the reins of the group last year. Earlier this year, the association called on both the Republican and Democratic Presidential candidates to support the legislation. And the group's statement specifically praised Gov. George W. Bush for raising the issue in his bid for the presidency. During a campaign address to seniors in early fall, Bush cited a report from the Lewin Group – which was commissioned by AdvaMed – criticizing HCFA's inability to provide sufficient access to new medical technology in behalf of older Americans. That report said that seniors often wait 15 months to five years or more for Medicare to add new technologies to the program.

The potential for developing those new device technologies was impacted a bit last month with the House of Representatives' approval of $10.5 million in additional funding to the FDA's device program, $7.7 million earmarked for additional premarket review activities. "By earmarking additional money for device reviews, Congress has recognized the critical importance of ensuring patients have access to the dramatic advances in medical technology that we will witness in the coming years," Bailey said in a statement from AdvaMed.

Meanwhile, as final decisions on the budget were being pushed, House and Senate Republicans were working on a bill restoring cuts in Medicare reimbursements for health care providers that Congress and the President enacted in 1997 as part of budget balancing activities. The White House was lobbying against the increase, saying that too much of the restored money would be siphoned off by managed care firms.

Needlestick bill OK'd by House, on to Senate

The U.S. House of Representatives last month approved H.B. 5178, the Needlestick Safety and Prevention Act, mandating use of improved sharps to reduce the incidence of needlestick accidents. The bill reflects recent OSHA requirements by mandating that health care facilities update and review their Exposure Control Plans to reflect changes in needle technology and to document all needlestick injuries. Reportedly from 800,000 to 1 million healthcare workers are accidentally stuck by a needle each year, an event which makes them susceptible to resultant infections, from simple bacterial infections to Hepatitis C and HIV.

Initially, Sen. Jim Bunning (R-Kentucky) said that he would put a "hold" on the legislation, reportedly to protect MedPro (Lexington, Kentucky) which makes devices for destroying needles after their use. Bunning later said he had changed his mind after OSHA agreed to state, on the record, that needle destruction devices do reduce the risk of injury.

If the bill passes in the Senate, President Clinton reportedly plans to sign it.

Following House passage of the measure, various companies making safety medical needles used the action to promote their particular products. Bio-Plexus (Vernon, Connecticut), for instance, makers of the Punctur-guard line of products, noted the high rating of its products by the Centers for Disease Control and Prevention (Atlanta, Georgia) and ECRI (Plymouth Meeting, Pennsylvania). Med-Design (Ventura, California) reported having 24 safety needle products covered by 14 U.S. patents, 16 international patents and numerous patents pending. Specialized Health Products International (Bountiful, Utah) reported having "16 different and unique technologies for providing needle safety." Medisys Technologies (Baton Rouge, Louisiana) is marketing its patented CoverTip safety needle device, which uses an actuator to cover and blunt the needle tip.

FDA warns of thermotherapy injuries

The FDA last month issued a letter to physicians warning of the possibility for "serious thermal injuries and related complications" in using microwave energy to treat benign prostatic hyperplasia (BPH). The agency said that while the procedure is generally safe and has been used in more than 25,000 cases, it is concerned about "unexpected procedure-related complications. The agency said that since 1996 it has received 16 reports of injuries related to microwave thermotherapy. Of these, 10 resulted in fistula formation and 6 resulted in clinically significant tissue damage to the penis or urethra."

The letter said the FDA is addressing the problems by working with three companies to make sure that their labeling and training programs "address these complications." The companies are EDAP Technomed (Vaulx-en-Velin, France), maker of the Prostatron device, purchased earlier this month by Urologix (Minneapolis, Minnesota); Urologix, which makes the Targis system; and Dornier Medical Systems (Kennesaw, Georgia), which has received clearance for, but not yet marketed, its UroWave System.

CDRH sets radiological reengineer meeting.

The FDA's Center for Devices and Radiological Health (CDRH) has scheduled what it calls an "open public workshop" for Nov. 15-16 in Gaithersburg, Maryland, to discuss possible reengineering in its radiological health programs and processes.

The CDRH said the intent of the meeting is to gather suggestions concerning the prioritization of its resources in dealing with radiation problems, exchanging safety and manufacturer information related to this sector and improving its processes for implementing new product standards. It is inviting to the meeting all those concerned with radiation-emitting systems.

Besides including presentations on CDRH reengineering activities in this area, it will offer breakout sessions to discuss the topics of Prioritization, Information Exchange, Standards and Product Testing. Overall, CDRH said it is seeking "stakeholders' reaction and buy-in to proposed changes" in the unit's radiological health program.

The session will be held at the Gaithersburg Holiday Inn. The agency is providing for online registration, with acknowledgment of registration then being sent by e-mail.

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