HOSPITALS REUSE MEDICAL DEVICES DESIGNED FOR ONE-TIME USE ONLY
Patients aren't told. Regulators don't watch. Why?
USA Today 11/29/99
The dirtiest little secret in health care today is this: Across the nation, thousands of hospitals are reusing medical devices that are labeled "For Single Use Only. Do not resterilize."
The practice isn't limited to low risk items such as blood pressure cuffs, either. Hospitals routinely reuse the most invasive tools in a surgeon's kit: biopsy needles, breathing tubes, catheters that are pushed into beating hearts.
Such devices are not engineered for multiple use, and none comes with validated procedures for cleaning and sterilization, as required of multi-use devices. Yet the health care industry shrugs off the practice as safe, citing a lack of data that demonstrates patient risk.
That's a dubious conclusion. Dozens of interviews by USA TODAY with doctors, regulators, device makers, recyclers and analysts paint a picture of a risky practice shrouded in uncertainty and institutional denial - in effect, a vast, unregulated experiment with untested products on uninformed human subjects.
Sometimes the results can be calamitous. In one notorious incident earlier this year, the tip of a cardiac catheter broke off inside a 32-year-old heart patient, lodging in her atrium. The device, designed to be used exactly once, had been used six times. Over the years, victims of improperly recycled disposables have included:
Five infants who developed lung infections linked to the reuse of syringes.
A 57-year-old heart patient, who was partially blinded when a reused balloon catheter, used to expand clogged heart arteries, disintegrated in his chest.
A 72-year-old woman who developed a life-threatening abdominal infection when a reused guide wire broke off in her throat and punctured her duodenum.
No one knows how common such incidents are because no one keeps score. In one of the few comprehensive reviews of the subject, published in early 1997, ECRI, a highly regarded health services research agency, stated: "(Our) review and analysis of the published clinical studies conclude that there is no clear evidence that reuse of single-use medical devices is either safe or unsafe for patients."
Likewise, the U.S. Food and drug Administration, which approves medical devices for marketing, blandly asserts there are no data to support the "general reuse" of disposables.
But that's because no one has bothered to develop meaningful data. Only recently has the FDA begun studying the effects of reuse on cardiac catheters, and preliminary findings indicate it may be dangerous to reuse some models even once, much less five or six times. Earlier, an informal FDA survey of 3,000 reports to its Medical Device Reporting system found scores of instances in which patient harm might have resulted from reuse.
That data, combined with smaller studies, also indicating risk, make it impossible to argue that the data void masks a safe practice. But materials in single use devices have been found to be damaged by heat, chemical treatments and rough handling during sterilization processes for which they were not designed. Improper cleaning also has left debris, traces of sterilants and even whole blood on devices. At a minimum, dirty or inoperable devices lengthen surgeries and recoveries, and provoke pyrogenic reactions - aches, fevers, tremors, etc. - that compound patient misery and could in some cases be fatal.
DUBIOUS DEVICES No one knows how many single-use devices are reused. But they include:
Cardiovascular catheters. Risks: Infection, toxic and pyrogenic reactions, malfunction, eraboli.
Biopsy needles and forceps.
Risks: Infection, other reactions.
Anesthesia breathing circuits and endotracheal tubes.
Risks: Infection, chemical burns.
Surgical saw blades, drills, rasps.
Risks: Infection, tissue damage.
Devices for laparoscopic surgery.
Risks: Infection, organ perforations.
If the practice is so iffy for patients, who benefits? Three groups, including:
Hospitals: At least 31% of the nation's hospitals - 1,500 plus - reuse disposable devices, according to an ECRI survey. David Feigal, director of the FDA's Center on Devices and Radiological Health, suspects the actual number may be closer to 100%. And no wonder. Hospitals can save hundreds of thousands of dollars a year reusing disposable devices.
Trouble is, hospitals don't report which devices they recycle, or how often. And they do not inform patients that they will be treated with disposable devices that have been immersed in another patient" blood, then reprocessed in contradiction to the device" labels.
Manufacturers: Device makers insist on labeling $750 catheters and other expensive tools as "single-use" even though some research, including work done by the prestigious Cleveland Clinic has found that such devices may indeed have a limited afterlife. The FDA also says that manufacturers have marketed multi-use devices as single-use without any change in the device itself.
Doing do saves on development costs, protects makers from liability and increases demand for new devices. But mislabeling is also wasteful, which drives up health costs and encourages unregulated reuse. Either way, the industry opposes the suggestion that it be forced to rewrite the labels on commonly reused disposables.
Reprocessors: These companies help hospitals recycle their used and contaminated devices. There are more than 20, but even the FDA doesn't know exactly how many, because only eight have registered with the agency as required. The result is a poorly regulated industry, impacting public health, that is not publicly accountable.
No doubt the practice in this country is too widespread to ban. But a few obvious steps, only now dawning upon federal regulators, could help set everyone's heart at ease.
First, hospitals should inform patients they will be treated with reused disposables and offer alternatives, even if at higher cost.
Second, hospitals that recycle and third party reprocessors should be forced to register with the FDA and list the devices they reuse, how they are cleaned, and what problems result.
Third, the original device makers should be required to submit public documents explaining why a device is labeled as single-use.
Fourth, makers, hospitals and reprocessors should finance FDA-sponsored research to develop standards for the riskiest devices.
And fifth, hospitals and makers should submit data on adverse events in a way that clearly indicates whether reuse was a cause.
Reusing medical devices labeled as "single use only" leaves safety in the hands of industries that have every reason to avoid accountability and cut corners. And it violates patients' expectation of scrupulously honest health care based on sound science. How did this come to pass?
These Devices are Safe
By Pam Furman
If USA TODAY would dig a little deeper, it would see that this whole issue has been stirred up by economic competitors of the reprocessing industry- the big device manufacturers. Why else would we be having a debate over a perfectly safe practice that has served doctors and hospitals well for more than 20 years?
The Association of Disposable Device Manufacturers (Tyco International, which includes U.S. Surgical and Kendall Healthcare Products; Boston Scientific; Johnson & Johnson; and Mallinckrodt) claim that their opposition to the reprocessing of devices labeled for single use stems only from concern about patient safety. They say the issue is not the sales their members have lost to reprocessing or the price reductions their members have given hospitals in order to persuade them not to reprocess. Rather, they say this is all about safety.
You know what? The manufacturers are right. This is all about safety - and the fact is that reprocessing is a patient-safe practice that helps hospitals and doctors deliver the highest-quality medical care. Let's look at the real story.
Compared with new single-use devices, the safety record of reprocessed devices is as good or better. Indeed, these new devices account for several thousand more reports of patient injury and device malfunction than reprocessed devices.
When we look beyond the numbers to those who use reprocessed devices, the message is clear and consistent: Proper reprocessing is safe. The American Hospital Association states that "hospitals have reprocessed devices labeled 'single use' ... for years, with excellent success.
The American Society for Gastrointestinal Endoscopy, a physicians group, states: "There is an extensive body of research demonstrating that many devices labeled as 'single use' can be reused after proper cleaning and restoration, with no risk to patients .... The only beneficiary of such disposal is the manufacturer of the items." Other doctor's groups, including the American College of Cardiology and the North American Society of Pacing and Electrophysiology, have expressed similar support for reprocessing.
What do our public health agencies say about reprocessing?
A physician with the Centers for Disease Control and Prevention recently stated that he "would just be absolutely amazed if (reprocessing) is a major health problem and the (leading hospitals) have failed to realize it."
And the Food and Drug Administration says it "has been unable to find clear evidence of adverse patient outcomes associated with the reuse of a single-use device from any source."
Devices have been safely and effectively reprocessed more for more than 20 years. Hospitals rely on the millions of dollars saved through reprocessing to provide care to indigent patients and to purchase new medical technologies.
Yet, despite the overwhelming evidence in support of reprocessing, the manufacturers say reprocessing must be stopped. What they forget to say is that the "single-use" label is not a government requirement, but rather, their choice.
And they don't mention that every time a hospital safely uses a reprocessed device, a manufacturer loses a sale. The manufacturers say this is all about safety; now you know the rest of the story.
Pam Furman is executive director of the Association of Medical Device Reprocessors.
Hospitals' Reused Tools: Reassessing the Risk to You
By Dan Hawkins, U.S. News, Nov. 29, 1999
Amid mounting congressional and consumer pressure, the U.S. Food and drug Administration has proposed new guidelines on reusing disposable medical instruments the practice of recycling cardiac catheters, biopsy forceps, and other device intended to be used once and thrown away.
The practice, as described in the September 20 issue of U.S. News (still posted on the Internet @ www.usnews.com as of 1/7/00-Ed.), is gaining popularity as hospitals are pressured by insurers and HMOs to squeeze expenses. Recyclers insist the process is safe, but critics say it heightens the risk of patient infection and device malfunction.
Under the proposed guidelines, which would apply to both hospitals and outside reprocessors, medical devices would be divided into three categories: high, moderate, and low risk. The FDA would require reprocessors of high-risk instruments to provide data showing they are safe and effective. Reprocessors of moderate-risk devices might only need to state that they conform to recycling standards. And reprocessors of low-risk instruments would likely only have to follow manufacturing guidelines and register with the FDA; they would probably be relieved of FDA inspections. The FDA has not yet assigned specific instruments to any category, nor has it commented on whether patients should be notified about instrument reuse.
Critics say the proposed guidelines are significantly flawed. In particular, they note that the regulations wouldn't take effect for at least a year and could be delayed for up to five years. "If the FDA is so concerned about high-risk devices, why wait so long to do something about them?" says Josephine Torrente, president of the Association of Disposable Device Manufacturers, whose members stand to gain financially from stricter regulation.
Contamination. Evidence also points to serious problems with the reprocessing of biopsy forceps, instruments that could fall into the low-risk category. In a recent independent study, David Hambrick, director of the gastrointestinal laboratory for Montclair Baptist Medical College in Birmingham, Ala. Found that 14 of 20 medical devices - nearly all forceps - that he sent to a well-known reprocessor came back contaminated.
In another development, the FDA last month cited reprocessing giant Vanguard Medical Concepts, based in Lakeland, Fla., for numerous problems with reprocessed biopsy forceps. Agency investigators found deficient testing for contamination, and incorrect use of a sterilizing gas. (Vanguard says it now uses and improved system for reprocessing forceps.) Under the proposed guidelines, reprocessors of biopsy forceps might no longer be subject to FDA inspection.
Johnny Baird, a 74-year-old retiree from Arlington, Texas, is one patient who thinks the proposed guidelines don't go far enough. A doctor at Arlington Memorial Hospital accidentally burned Baird's right cornea during 1993 cataract surgery. Baird points to a hospital incident report stating that a recycled, disposable laser tip was used in his care. The hospital says the tip was new and denied that it caused the burn. Today, Baird is nearly blind in the affected eye and in such pain that he plans to have it replaced with a glass one. His case, which he won in district court, and lost on appeal, is pending before the Texas Supreme Court.
Isn't it comforting to learn in the "Opposing View" on recycling single-use devices that the next time you are lying on the operating table letting the good doctor shove an only slightly used (say 4 times previous) heart catheter up through your abdomen into your heart - that you are really benefiting the indigent by allowing the hospital to save enough dollars to take care of them? Yeah right! And the bill says: 1 heart cath (new $750)- 4X used $250. Right again!
One night over dinner in a restaurant in Ciudad Juarez, a businessman was telling me about a Kuwaiti potentate who owns a 747 with a gyroscopically rotating prayer room perpetually oriented toward Mecca. This Kuwaiti has serious heart problems, the businessman continued, so he had converted the plane's upper deck into a cardiac intensive-care unit with all the latest technology. I made suitable murmurings of awe. The businessman smiled patiently, and then got to the part that impressed even him: "The plane is also equipped," he said, "with a living donor." A heart donor, that is. it was a poor man of compatible tissue type whose reward, it seemed, was living well for a little while and the promise that his family would live well afterward.
Ok, Ok already, we'll keep it coming as long as fiscally and physically possible. My gosh you brought literal team and some laughter to this old guys eyes with your letters, many thanks ....... "It is indeed with a heavy heart I read you are contemplating permanent retirement for UpBeat." Tx George Kearns, Punta Gorda, FL)
A number suggested that unthinkably, but possibly, at least a number of those non-responding people have become part of the great transplant data base in the sky, but regardless they should be removed from the mailing list. We have done that with as much generosity as possible.
But there was one event that probably capped the decision, outside of the fact that enough money came in to operate for another year. I received a letter from a fellow recipient, Ken Molica. I don't know Ken all that well, but I believe he is on his third transplanted heart through no fault of his own. In fact he used to be a professional race car driver. In addition to mentioning that he would very much like to see UpBeat continued, Ken added that he had recently heard from a mutual friend, Cliff Steer, and he was getting on well in his recovery from cancer. (I would be more concise, but unfortunately when I set aside the letter intending to use it, it somehow sunk into my "computer desk glacial moraine.)
I was shocked and annoyed. Here I was spending great portions of 1998 whining about my debilitated condition (but aren't you doing it again?), yet this fellow heart recipient, who has done more for organ donation and anti-smoking than most of us, had been sick, yet had not said a thing to me about it. I Will add it was sick again in that he's already had a kidney transplant. I do have Cliff's letter regarding UpBeat, received before I heard from Ken:
What's this I hear about you closing down the presses? You do a great service! Not only that, it probably gives you something to live for. Keep it up!
Cliff Steer, The Heart Man
With fellow Txs' with such an outgoing spirit, how can I stop?
"The story naturally stuck with me. Maybe it was just the usual mix of horror story and envy that we crave when we tell ourselves stories about the rich. Maybe it was just a story, a nice twist on the old Yiddish conundrum: "If the rich could hire other people to die for them, the poor would make a wonderful living." But it left me with a lingering sense that the rules of the natural world, rules by which the rest of us live and die, might not apply to the very rich: They have money enough to buy a man's heart, literally. Enough to buy time."
This is a delusion to which the rich themselves are highly susceptible. "The rules are - - - there are no rules. Aristotle Onassis once said, and you can understand the attitude, given the unreal quality of the lives the rich lead. Opening paragraphs of the Natural History of the Rich by Richard Conniff, Worth Magazine, Jan/Feb 2000. Contributed by Marguerite Supler, Gloucester, VA.
Now here's kind of a macabre thought, but it's often come to mind as I return home from yet another formal hospital stay and am removing the various snap-tabs for monitors, Band-Aids for blood and IV work, and lastly those ubiquitous wrist bands. Although they are frequently barely readable, I have often wished I had the foresight to save them right from the start of my transplantation epoch. What a bathroom wall presentation they would now make!
In a more positive vein, a long, long time ago UpBeat published a sort of morality cartoon showing a stork like bird attempting to eat a frog while the frog had the bird firmly clasped by the neck. The caption was, "Don't ever give up." I guess that sort of became my motto and I'm sure that of many, many others. I finally found T-shirts available with this epic picture printed on them in about 4 colors. The are available from: Johnson Smith Co.(Yes, the very same that had the 1+" thick novelty catalog in the 40's and 50's.)as item #98257 Give Up T/S @ $14.98. Phone 941-747-6645 or order off the Net at www. lonezone.com.
Greg Osterman, 45 has a legitimate claim to fame: He's the only heart transplant recipient who has run a marathon. Make that two marathons: a 4:45 at Bermuda in 1998 and a 5:12 at Flying Pig in Cincinnati this past spring. But Osterman doesn't care about fame; he's just happy to be alive. Soon after his transplant operation seven years ago, the Loveland Ohio resident was diagnosed with non-Hodgkin's lymphoma. To treat the cancer, surgeons removed Osterman's gallbladder and portions of his small and large intestines. "We all have setbacks in life," says Osterman, a member of the Leukemia Society of America's Team in Training and a motivational speaker who frequently visits local youth groups. "You have to get on with your life and not give up."
Contributed by Certified Athletic Trainer, Mike Smith,
Gloucester, VA- Official Trainer to UpBeat.
Here's an inside tip on what sounds like an Oscar movie: Return to Me Release date: Tuesday, April 11,2000 Plot Outline: A man who falls in love with the woman who received his wife's heart must decide which woman it is who holds his heart. A sweeping romantic drama, Distance Calls centers on a widowed veterinarian and a woman reporter who was the transplant recipient of his deceased wife's heart. The two are brought together when she interviews him for a story about her transplant.
Another review of the movie In this romantic comedy, a man loses the love of his life, only to find her heart beating in the body of someone new. Veterinarian Bob Rueland (David Duchovny) is happily married until his wife dies in an auto accident. Two years later, Bob is still devastated by his loss when he's approached by reporter Grace Briggs (Minnie Driver), who received his wife's heart in a transplant. She's planning a story about her experiences and would like to talk to Bob about the person whose heart is now beating inside her. As an attraction develops, Bob has to decide whether he's falling in love with Grace or with his wife's memory. Return to Me was directed and co-written by actress Bonnie Hunt, who also appears in a supporting role, alongside Robert Loggia, James Belushi, and David Alan Grier. -- Mark Deming
Contributed by Tx Dave Cannavo, Lawrence, MA
Look Ahead at Future of Medicine
By The Associated Press 12/15/99
Crystal ball gazing is a risky hobby at best -- but it is hard to think of an area where the uncertainties are greater than in the realm of medicine.
Just a generation ago, who would have predicted that surgeons would someday take out gallbladders without making big incisions, that genetic manipulation would be a routine source of useful drugs, that pills would lower cholesterol, grow hair and improve sexual performance?
"We are doing things now that we wouldn't have dreamed of even 10 years ago," muses Dr. Robert O. Bonow, a heart specialist at Northwestern University. "A lot of this is unimaginable."
Some research directions are set and some goals are clear, and the Associated Press asked experts in several medical specialties to make their best guesses about what we can expect in the next 25 or 30 years. Here are their answers:
-- CANCER: Optimism for screening, therapy - DR. ROBERT MAYER, chief of the Gastrointestinal Cancer Center, Dana-Farber Cancer Institute, Boston.
I'm very optimistic that we're going to make great inroads into cancer prevention.
Developing a vaccine against the hepatitis C virus will be critically important in preventing liver cancer. The abolition of tobacco will reduce cancer enormously, as will the use of prophylactic compounds such as tamoxifen for breast cancer or aspirin and folic acid for colon cancer.
Screening technology will also undergo a revolution. Virtual colonoscopy, a very elegant computerized x-ray technique to simulate the appearance of the colon, will very likely improve patient ease and compliance with this very important test.
Mammography for breast cancer will likely improve through computerized technology, and better and more specific blood tests will make screening for prostate cancer more effective.
We will be able to identify and counsel individuals with strong family histories of malignancy far better.
I hope we will be able to refine gene therapy by either replacing an abnormal gene or turning it off.
Gene therapy may also focus on stimulating the body's own immune response to selectively destroy the tumor, or take advantage of the unique genetic pattern in malignant cells to target biological treatments to those cells.
I hope newer forms of systemic treatment will be more specific, making them far less toxic and far better tolerated.
-- TRANSPLANTS: Educating the immune system - DR. J. RICHARD THISTLETHWAITE, chief of transplant surgery, University of Chicago.
First, new surgical techniques will make it far easier for living donors to give organs or parts of organs to those in need.
The donor shortage has created a lottery where the winners get transplants and the losers die. The government and the transplant community are trying to devise schemes to provide equal access. In time, human organ donation will be replaced by transplantation of animal organs. Herds of genetically mutated pigs are being developed to provide organs for transplant on demand.
Second, new medicines will let us educate the immune system to look at a transplanted organ as "self' rather than "nonself." Medicines today that prevent organ rejection are expensive and dangerous. They suppress all immune responses and must be continued for life. Transplant patients are trading one disease for another -- organ failure for immunosuppression. We are close to being able to use short-term therapy to achieve immune tolerance so that we can stop all medications.
Finally, we will be able to change organs themselves by transplanting genes to help prevent organ failure and organ rejection. Cell transplants, like nerve cells, rather than organs, will be used to treat illnesses like diabetes and Parkinson's or Alzheimer's disease. And then the ultimate science fiction dream that will become reality will be the ability to clone entire new organs from single cells.
Ultimately, we should be able to actually grow new kidneys, new hearts --any organ or tissue.
-- MENTAL HEALTH: Brain scans will aid diagnosis
- DR. STEVEN E. HYMAN, director, National Institute of Mental Health. I think changes in our approach to mental illness will be among the most revolutionary, compared to other areas of medicine. Right now, diagnoses, while they can be made with relative certainty for illnesses such as depression and schizophrenia, still remain anchored in symptoms and behavior. Thirty years from now we're going to have diagnoses based on brain scans, or brain scans plus genetic tests. That will provide a great deal more certainty.
The second thing is, within the next decade, we will have discovered many genes that create vulnerability to mood disorders, to schizophrenia, to autism and to several other mental disorders. These discoveries will play out so that by 30 years from now, we will have treatments that will really make an enormous difference in these illnesses.
Advances in science will really drain the stigma out of mental illness.
It is still unfortunately true that many people who suffer depression are made to feel in some way that it's their fault, or if they were just trying hard enough, they could shake it off. I think the science will help the public understand broadly that these are real disorders of an organ, the brain, just as coronary artery disease is a disease of another organ, the heart, and that these conditions have nothing to do with moral weakness, or in no way reflect something that can just be shaken off without treatment.
-- GENETICS: Tools for targeting treatment
- DR. DAVID R. COX, professor of genetics and pediatrics, Stanford University.
Genetics is like fire. It can burn you, or it can cook your dinner.
It holds great promise in the next 10 years ... it won't fundamentally change medicine. It's more information, another piece of the puzzle.
By mapping the human genome, to say that you know how it all works is silly beyond belief. That's like saying if I spread all the parts of a car on the garage floor, I can understand each of them and how they cause a car to run.
So how will it be practical? Today we go to the doctor and describe a variety of symptoms. The physician considers a variety of ailments and narrows down what it could be.
Genetic medicine will be much more targeted because it will be tied to how your cells work. We'll know that a gene makes some protein product. But there are minor changes from one person to another.
That means that in maybe one out of five patients, the genetic treatment will work. Genetic medicine will be more targeted because it will be evidence-based, rather than medicine based on expert opinion.
What about the other 80 percent? This will be a new region where research and clinical practice will overlap. Large numbers of people will be enrolled in clinical trials. The public will be an active participant in medicine, and research and clinical practice will be close to one in the same.
So genetic medicine has tremendous potential for improving people's lives. We'll need an ethical framework to guide us as the research moves forward. We'll be in a real mess if we don't do that.
-- HEART DISEASE: Better drugs, virtual operating rooms
- DR. ROBERT O. BONOW, chief of cardiology, Northwestern University
We will have much better drug therapy for various forms of heart disease. Heart failure will be more easily treated by rapid, early administration of drugs to people with heart attacks. These will not just open the arteries but also allow the heart to withstand damage better. We will also have new and ingenious ways of preventing blood clots in arteries, so there will be fewer heart attacks.
We will be much better at getting devices into arteries to open them up. Surgical techniques will undoubtedly be robotic. In a virtual operating room, a surgeon will sit and operate on the heart of a patient who is in a different place.
Gene therapy will be well understood. Right now, we are at the early stages and don't know the risk involved of inserting genes in various places. Hopefully in 25 years, we will be at a point where we can treat the genetic abnormalities in heart disease by inserting the right genes and removing the wrong ones. This could prevent the development of atherosclerosis, keep arteries from developing blood clots and generate heart muscle when tissue dies.
Our diagnostic imaging techniques clearly will be a lot better. What we do now will seem old-fashioned and laughable in 10 or 20 years. We will have much more information about the function of the heart, have images of the blood vessels themselves and have three-dimensional pictures so we can look at the heart from the inside out, all without penetrating the body.
I hope some of the most important things we will be doing then are not in the high-tech realm but merely better implementation of what we now already know about smoking cessation, diet and exercise as a means to reduce heart disease and stroke.
-- MEDICAL ETHICS: Designed babies, brain implants
- ARTHUR L. CAPLAN, director of the Center for Bioethics, University of Pennsylvania.
It's going to become very uncommon that you wouldn't want to know your genetic makeup. Few women today over 35 would think of having a baby without getting an amniocentesis (a test for certain fetal abnormalities). It just became part of what a responsible person does. Just take out the genetic discrimination part of the insurance problem, then people won't be afraid of other types of genetic testing.
I think we'll also be watching another heated debate about assisted suicide, not a debate about what to do if you're terminally ill, but a debate about what to do if you're demented. Do you have the right to end your life? I think there will be a debate about whether to use scientific knowledge to design babies, not by changing their genes, but by at least screening embryos, testing embryos for their traits. There will be some discussion about whether eugenics is a good thing to try to improve your kid.
I think we'll see more artificial organs, man-made parts. I think we will see the first effort to use implants into the human brain to repair things, so someone might get an implant to boost their memory or to help their dyslexia. I think we'll also see strong pressure to identify children in school who might be at risk or encounter problems through this kind of forensic study of the brain.
I think in 25 years someone will have made the first artificial life form, a virus or a bacteria in the lab, using gene mapping.
-- STROKE: Strides in prevention, nerve restoration - DR. ANTHONY J. FURLAN, medical director, Cerebrovascular Center, Cleveland Clinic.
New risk factors for stroke are constantly being identified. Most excitingly, new genetic markers of atherosclerosis may allow us to identify persons at risk for stroke at an early age. Once the genes involved are identified, their activity can possibly be modified.
New pills to prevent stroke will be much more potent inhibitors than aspirin of cells called platelets that trigger blood clotting.
An exploding area is a procedure called endovascular therapy to prevent and treat stroke, where we dilate the carotid artery using angioplasty balloons and metal scaffolds called stents. New catheters will allow us to access and repair small brain arteries that are blocked by clots or that are leaking due to an aneurysm. Some novel devices under study allow us to remove clots from blocked brain arteries within seconds, limiting damage.
There is hope that the treatment window will be opened beyond the current three hours.
Newer, more powerful and safer clot-dissolving drugs will be combined with drugs that limit the damage the blocked artery causes to brain cells. Other strategies, such as extreme body cooling, will also slow down stroke damage in the brain. Lastly, the field of restorative neurology will lead to novel stroke recovery therapies, such as brain cell transplants.
-- AGING AND LONGEVITY: Lowering risk factors for Alzheimer's, others
DR. CALEB E. FINCH, director of biogerontology program, University of Southern California.
Who the heck knows? Science moves so fast and so unpredictably.
The human lifespan has been increasing steadily for at least 100 years. We have no way of knowing if this powerful trend will hit its ceiling or continue to increase as improved public health measures and medical technology become more widely available.
One thing is clear: A number of unhealthy behaviors, including heavy smoking, exposure to toxins in the environment, foods that lead to chronic elevations in blood sugar, and lack of exercise, can lead to shortened lifespan. Whether changing these will truly change the underlying pattern of human aging is unknown.
We will know a lot about genetic risk factors for diseases. Already, there are four or five strong candidates each for Alzheimer's disease, heart disease, cancer and diabetes. Relatively early in life, it will be possible for most people to know if they have any major genetic risk factors. There will be specific recommendations and guidelines for how to minimize those risks.
A major opportunity will emerge in organ replacement, as genetic engineering of stem cells progresses. In principle, it should be possible to take a skin cell and grow any type of cell that is needed. It may not be too fantastic to imagine regrowing whole bones and joints and hearts and kidneys. The scientific problem is to discover how to regulate the genes we all have in our adult cells.
I'm highly optimistic that human lifespan will include increasing duration of health. I look to the remarkable example of Jeanne Calment, who died at 122, having lived almost all of her adult life in excellent physical health and capacity for social interactions.
-- INFECTIOUS DISEASES: Pandemic likely, but also disease eradication
-- DR. JAMES HUGHES, director of CDC's National Center for Infectious Diseases.
Infectious diseases currently are the leading cause of death worldwide and the third-leading cause of death in the United States. When I'm asked what do I worry about over the next 25 or 30 years, it's obviously hard to predict. We know we're going to be surprised.
We're going to see increases in this problem of antimicrobial resistance. That is a major problem. Think about the need to use antimicrobials appropriately.
We're going to continue to see large regional and national and even international foodborne-disease outbreaks, with this globalization of the food supply that has occurred. More widespread use of food irradiation could reduce the risk.
We can't help but notice the number of diseases transmitted from animals to people, most recently the West Nile-like virus infections in New York City, transmitted by mosquitoes. The Nipah virus in Malaysia and Singapore that spread from pigs to people, causing encephalitis with a very high mortality rate. The avian influenza episode in Hong Kong, providing the reminder that we are constantly threatened by the next flu pandemic.
Within the next 25 to 30 years we should just assume we will have an influenza pandemic. We are overdue.
Will some diseases be eradicated? We certainly hope so. WHO targets the end of 2000 for the global eradication of polio. The Guinea worm eradication program is proceeding. Measles is a future candidate.
The development of new generations of safer, more effective, easier-to-administer vaccines will undoubtedly help us greatly. That leads you to the need to strengthen the public health system. Progress can be made.
Contributing to this report were AP writers Brenda C. Coleman, Brigitte Greenberg, Daniel Q. Haney, Linda A. Johnson, Janet McConnaughey, Lauran Neergaard, Malcolm Ritter, Katharine Webster and Joseph B. Verrengia.
Donor Heart Still Ticking 20 Years Later Calif. Woman Reaches Univer- sity of Arizona Transplant Milestone
By Jane Erikson, The Arizona Daily Star, 12/ 7/99
University Medical Center's longest-surviving heart transplant patient just celebrated 20 years with her donor heart. "I feel great," Marjorie Rorabough, 59, of Loma Linda, Calif., said in a telephone interview yesterday. Rorabough became UMC's fourth heart transplant patient on Dec. 3, 1979. Ten years later, she became the first UMC heart transplant patient to undergo heart bypass surgery. Two blocked arteries were repaired. She attributes her longevity to "doing everything they've told me to do" - and then some. In addition to taking daily medications to keep her donor heart healthy, she attends no fewer than six aerobics and dance classes each week. In two weeks, she will fly to Michigan to spend Christmas with relatives. Rorabough is now on a waiting list for a second heart transplant, not unusual for long-term survivors.
"Most people have some evidence of graft (donor heart) arteriosclerotic disease by the time they reach 10 to 15 years post-transplant," said Dr. Jack Copeland, chief of cardiothoracic surgery. He performed Rorabough's transplant and bypass surgery.
The average one-year survival rate for heart transplant patients is about 85 percent nationally, according to the United Network for Organ Sharing, based in Virginia. The UMC team, which has performed 559 heart transplants since March 1979, has achieved one of the highest patient survival rates in the world: 94 percent of the hospital's heart transplant patients survive at least one year. Survival longer than 15 years is extraordinary for a heart transplant patient. Copeland said the longest-surviving heart transplant patient to date may have been a woman he transplanted in 1974. He was then in training at Stanford University, the nation's first heart transplant center. The woman died a few months ago, after nearly 25 years with her donor heart, Copeland said yesterday.
Transplant patient survival rates improved markedly after 1985 when the breakthrough anti-rejection drug cyclosporine became available. The drug suppresses the immune system's natural inclination to "reject" a donor organ. Rorabough has taken the medication ever since. But for nearly six years after her 1979 transplant, she took huge doses of prednisone, asteroid drug that also suppresses the immune system. Among prednisone's severe side effects is the depletion of bone mineral content. The resulting osteoporosis has robbed Rorabough of 5 inches of her original height. She now stands at 5 feet, 2 inches, down from her original 5-foot-7. "She's a really great lady. She's got a great attitude," Copeland said of Rorabough. "I never had any doubts about making it. I never really thought about dying," she said, recalling her choice to undergo a transplant when the procedure was still considered experimental. On the prospect of undergoing a second transplant, she said, "I don't give up easily."
Contributed by Tx Dave Cannavo, Lawrence, MA
Amazingly enough in this now gigantic world of transplantation, I have been fortunate enough to know Margie as a. friend and fellow Tx at Loma Linda, where she has been followed for the past 12 years. In fact, to really "drop names ", we had lunch together in early October along with many of the "long-tenured" heart transplants of Loma Linda. She has done much to assuage the worries and fears of fellow transplants, even though professionally she was a nurse, and thus knows more than is provident to say. One of her favorite stories is how not only did she convinced Dr Copeland to perform what was then an unheard of by-pass on her transplanted heart, but forced him to give up a weekend of skiing in order to do it! One aspect has always been the brightest characteristic - her cheerfulness, even in the face of pain and other personal adversity. There is just no time when Margie can't smile. She sincerely wants a new heart. I sure hope she gets it. DM
By David Kinney - Associated Press Writer
HERSHEY, Pa. (AP 1/8/00) Building an arti-ficial heart seemed so easy in the 1960s: design a pump, implant the contraption in a patient's chest and hook it up to the arteries.
How naive medical researchers were in that era of moon shots.
Building an artificial heart means design-ing a pump that beats 100,000 times every 24 hours with neither lubrication nor maintenance, that pumps faster when the body is exercising and slower when the body is sleeping, that causes neither infection nor clots, that has a constant power source. That, they quickly learned, is a very different matter.
Today's researchers are close to the elusive goal they have pursued since the Kennedy ad-ministration: a permanent, fully implantable re-placement for the heart.
Surgeons can now hook patients to assist pumps for a few months, even years, until trans-plants become available or until their hearts re-cover. Many of them go home with batteries and monitors to wait.
Within a few years, researchers say, patients should be able to leave the hospital for good with some sort of device pumping their blood.
Many will go home with the next genera-tion of assist pumps, or LVADs, left ventricular assist devices, attached to their diseased hearts. Today's LVADs are temporary, requiring vents and cords poking out of the patients' skin, but the new pumps will be smaller, entirely implant-able and should last five years or more.
Patients with more serious heart disease will probably need total artificial hearts instead. The artificial heart -- medicine's Holy Grail for four decades -- replaces the natural organ.
This time, when researchers say a few years, they mean it.
"I can show you talks people have given over the years, and they all say, 'Five years away. Five years away.' That was back in the 60s," said Dr. William Pierce, semi-retired director of Penn State's artificial organ program.
"When we say three years now, we have durability tests. We have animals who've sur-vived for more than a year. Those estimates are real," he said.
The reason: This generation of pumps is vastly improved. The biomaterials that come in contact with blood are safer. The components are smaller. And designers know more about how the body reacts to a pump made of titanium, velour and plastic.
"It's a very, very long road, and it's very complicated," said Dr. Robert Jarvik, one of the field's best-known pioneers. "There's vastly more knowledge than when we started.
" Houston's Texas Heart Institute and Danvers, Mass.-based Abiomed, Inc., appear to be first in the race to a total artificial heart. They plan to test a "replacement heart" in humans at the end of 2000.
The other, Penn State, is about three years from testing its artificial heart in humans.
But the university is also part of a larger race to make the assist pumps work indefinitely. Penn State's totally implantable assist pump, built with Arrow International, Inc., of Reading, Pa., was used for the first time in October in a 67-year-old patient in Germany. That patient is doing well, the pump was implanted in a second patient recently and more are planned in the com-ing months.
Among the others nearing the testing phase:
-- Dr. Robert Jarvik, who designed the first pump intended for permanent use, says his latest assist pump will be tested on humans for the first time this month in England.
-- Dr. Michael DeBakey, the famed heart surgeon, with Houston's MicroMed Technology Inc. and NASA;
-- Thermo Cardiosystems Inc., maker of today's most widely implanted assist pump, HeartMate.
Thousands could benefit. About 40,000 people suffer from end-stage congestive heart failure, meaning their hearts do not pump strongly enough. The best therapy is a transplant, but the number of donor hearts has leveled off at 2,000 a year. Many patients do not qualify for transplants because of their age or weight.
Officially, the number of patients waiting for donor hearts totaled 4,285 in October, accord-ing to the United Network for Organ Sharing. In 1998, 769 patients died before a heart became available.
Proponents of the artificial heart say it will not only help those waiting for hearts, but could also benefit hundreds of thousands of patients with clogged arteries.
Almost 40 years after the artificial heart programs were launched in the can-do '60s, 15 years after the pumps flopped spectacularly in the 1980s, researchers' optimism is palpable. But it is tempered by the decades of dashed expectations.
Dr. O.H. Frazier of the Texas Heart Insti-tute recalls the boundless enthusiasm of his men-tor, Dr. William Hall, one of the pioneers of the artificial heart program.
Frazier recalls Hall telling him that by 1980 there would be 100,000 Americans with artifi-cial hearts.
"I thought, 'Well, that's great. We'll have solved heart disease by the time I'm 40, and then I can cure cancer before I die,'" Frazier remem-bered. "Tragically, Dr. Hall died a few years ago of heart failure, and we're still waiting for this technology."
Along the way, surgeons have found pow-erful new tools to treat heart disease.
None is more important than the LVAD, developed in the shadow of the total artificial heart. Some researchers are betting that LVADs- with a few improvements over cur-rent designs -- could do the job of their more celebrated cousin.
For now, the U.S. Food and Drug Admin-istration has approved LVADs to keep patients alive for transplants.
Most LVADs sit in the abdomen and take over most of the work of the left ventricle, which pumps blood to the body. Weakening of the left ventricle is the cause of most cases of congestive heart failure.
The most widely used is HeartMate. The 5-pound pump is attached to the heart by tubes. A vent and cords jut out of the stomach. One cord runs to a regular wall outlet or battery. The oth-ers are connected to devices that control and monitor the pump as it swishes and clicks like a milking machine.
Baxter Novacor and Thoratec Laboratories Corp., both California companies, also sell implantable VADs.
More than 4,000 patients have used them -- so many that the procedure is almost routine for surgeons like Frazier.
On one recent afternoon, he reflected on the technology during a break from the operating room. Due back minutes later to remove a pump from a patient, he told a story of an LVAD patient from 10 years ago.
"When we put the pump in I was massaging his heart all the way to the O.R. until I could get him down there," Frazier said. "He got a transplant, eventually went home and that's the last time he's been in the hospital, actually. So it's a remarkable technology."
A scientific study of the benefits of the LVAD, conducted from 1986 to 1994, showed that 33 percent of recipients of HeartMate died within 60 days, but of the rest, 9 out of 10 were still alive a year later.
Another group of patients met the criteria to get HeartMate, but because Waltham, Mass.-based Thermo Cardiosystems was a small company, not enough pumps were not available. Only one-third of the patients were still alive 60 days after getting a new heart.
"So you took patients that would have died, and you gave them a 60 percent chance of liv-ing," Frazier said. "Certainly, every' one of these patients I see that I supported, I know I'm in a sense looking at a ghost."
Chuck McKissick feels that way.
McKissick, of Norwich, N.Y., had a heart attack at 38 and another one at 43. Six months after the second one, McKissick was in terrible shape. He slept all day, and couldn't walk across his mobile home without stopping for a breath. His heart pumped 1.4 liters per minute, 20 per-cent of normal.
He got a HeartMate in May.
"I feel 100 percent better, oh, God yes," he said from an apartment near Penn State's Hershey Medical Center, where he awaits a transplant.
He can walk around the apartment, cook dinner, walk out on the patio. Plugged into the batteries, he's free for hours. He can leave the apartment, take a walk, go shopping.
With each patient who uses an LVAD tem-porarily, the artificial heart designers learn more about how to turn them into permanent alternatives to transplants.
Thermo Cardiosystems, with help from the National Institutes of Health, is conducting a randomized study of HeartMate in 140 patients at 20 sites. Some patients get the LVAD, the others medicine and other treatment. If all goes as planned, the company hopes to ask the U.S. Food and Drug Administration to approve HeartMate as an alternative to transplant.
"That's our goal," said Michael Klein, chief executive officer of Thermo Cardiosystems. "We have competition with a lot of the other folks out there, but we have a tremendous amount of experience.
" The competition --Thermo Cardiosystems, too -- is looking to improve on HeartMate.
The LVADs they are testing have none of the cords and are much smaller. Some look un-like anything in a human. Several groups are pinning their hopes on a turbine the size of a C battery that looks and works like a jet engine., and the natural heart can be a backup in case of a pump failure.
MicroMed, Thermo Cardiosystems and New York-based Jarvik Heart, Inc., all have con-tinuous flow pumps in testing.
"We won't be able to make it in the exact configuration of a natural heart, but we've never been able to make a bird, either. We still fly," Frazier said.
Abiomed and Penn State, meanwhile, are proceeding separately on total artificial hearts that closely resemble nature's work: pumps that beat out an unrelenting rhythm.
Both are implantable, with neither vents nor electrical cords going through the skin. The con-cept is a vastly improved version of the Jarvik-7 and Penn State hearts implanted in the 1980s.
For many patients, the total artificial heart may be necessary even if LVADs succeed as per-manent devices. Thousands of patients couldn't be treated with an assist pump, including those with problems on both sides of the heart, or those who suffered massive heart attacks. |
That medicine is on the verge of a replace-ment heart-- again -- is a stunning recovery for a field that once damaged itself by cultivating too much media attention.
In 1982, William DeVries shocked the world, and some of his colleagues, when he im-planted the ill-fated Jarvik-7 into a patient named Barney Clark.
The world saw disturbing images of a sick Clark tethered to a console of electronics. Four others would get the Jarvik in the next two years. Only one lived beyond a year. Most in the field acknowledge now that the Jarvik was too experimental to meet the public's expectations.
But the race was on.
"We felt a little bold," said Dr. Bartley Griffith, a surgeon at the University of Pittsburgh Medical Center, who implanted more than 20 Jarvik-7s. "I was younger, full of vim and vigor. Hadn't had all the tragedies, those things that hap-pen to you as you get olden"
Griffith gave his first Jarvik to Thomas Gaidosh, 47, and the operation was a milestone. After four days on the device, he got his donor heart and became the first patient to leave the hospital after a Jarvik operation. He lived 11 more years, long enough to be best man at Jarvik's wed-ding.
DeVries' attempt to turn the Jarvik into a permanent treatment failed, partly because Will-iam Schroeder's 620-day ordeal -- he had four strokes and a constant fever-- turned the public against the procedure. But the scientists build-ing the next generation of devices learned too much to consider those early tests mistakes.
There were medical insights about clotting and infection. They learned that they need to treat the implantation like a regular, scheduled surgery, using fresh, rested surgeons and otherwise healthy patients rather than rushing dying people into O.R.
"We learned these devices were not like re-ligious agents. They couldn't resurrect someone who was too far down," Griffith said.
And they learned how public opinion can turn a medical advance into a debacle.
Age has tempered their arrogance and ex-perience has made them wiser, but their ambi-tions remain the same. And this next foray into artificial hearts will be different, they promise.
"I'm very excited," said David Lederman, Abiomed's chief executive. "But 1 don't want to exaggerate where we are. I think if we do that, we will make the same mistakes that were made before, and we will turn something that is very exciting into a catastrophe."
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