A friend awoke with chest pain and a cold sweat, and his daughter called 911. The EKG in the ambulance showed evidence of an acute myocardial infarction. Part of the heart muscle was dying.
Developed in the early part of the 20th century, the device the paramedics attached,the EKG, detects and records the flow of current as it travels along the heart’s “electrical” conduction fibers. The up and down squiggles, the “wave”, has a distinctive pattern when a person is having a heart attack. Like hieroglyphics on an ancient tomb, their meaning was baffling before Willem Einthoven learned how to interpret them. A descendant of Spanish Jews who fled to Holland at the time of Spanish Inquisition, Willem was born in Java. His father, a physician, died when Willem was 6 and a few years later his mother returned to the Netherlands. After college Willem went to medical school and he later became a professor of physiology at the University of Leiden, Holland’s oldest, a center of learning that was (according to local lore) created in 1575 by William of Orange for the town’s inhabitants after they were besieged by invading Spaniards and refused to surrender. Married to a cousin and the father of 4 Willem was a gymnast and fencer. He rode his bike to and from the university and often worked “until he was reminded to go home by his assistants upon request from his wife.”
After the computer in the ambulance interpreted the EKG, the paramedic radioed ahead, and the vehicle sped to a nearby hospital where a catheterization team was available 24 hours a day. When they arrived the doctor and squad were ready to go. Within half an hour a mild sedative calmed the man’s brain and a cardiologist was advancing device one, a narrow rigid yet flexible tube he had been inserted through a groin artery. Under fluoroscopy the physician pushed and maneuvered the tip through the aorta– the body’s central blood vessel. It quickly reached the coronary arteries– the vessels that drape over the surface of the heart and deliver oxygen to its muscles. The entrance to the coronary arteries is located in the aorta just beyond the point where it attaches to the heart.
As we age, smoke and eat rich food, plaques develop on the inner wall of many of the arteries that supply oxygen and nutrition to our bodies. These “barnacles” are full of inflammatory cells and fat. When their fibrous cap ruptures the body tries keep the contents from escaping. Platelets and clotting proteins pile onto the exposed gap. If the reaction is large enough, like a jack knifed 18 wheeler, it can close down the highway– in this case obstruct the flow of blood.
Dye was injected into the coronary arteries and the occluded vessel was identified. Device one was removed and a second catheter, device two, was inserted and passed to and through the coronary artery occlusion. This catheter had a strong balloon near its tip. It was inflated, the narrowed area was forced open, and blood flowed and oxygenated the heart. A third device, a “stent”, a thin mesh hollow tube made of stainless steel and cobalt-chrome, was advanced to and through the vessel. Its outer surface was coated with a polymer that “carried” a drug that was slowly released. The chemical helps preserve the stent’s patency. Blood now flowed through the tubing and the heart muscle was able to breathe again.
A cousin dodged death. Her surgeon had successfully clipped the bleeding brain aneurysm, the thin walled balloon like bulge in the wall of one of her arteries, but a few days later the cerebral spinal fluid that normally coats the outside of the brain wasn’t flowing. Pressure was building in her head. Her physician drilled a hole in her skull and inserted a thin tube into a liquid filled chamber in the center of the brain, the ventricle. He tunneled the other end of the tube under her skin and inserted it into her abdomen. Spinal fluid poured out of the brain, and the force that was squeezing the brain decreased.
The shunt, the small hose that relieved the pressure was created by an engineer in 1955. He was the father of Casey, an infant who had hydrocephalus, too much fluid and pressure on the brain. His doctors initially avoided the kid’s dad. They didn’t want to deal with his reaction when they told him that his son was going to die. John, the father, was 35, had been in Europe during the Second World War and was working in a hydraulics research laboratory. When his only child was born with multiple congenital defects he watched as the infant underwent a number of operations. Then his head started enlarging. Liquid accumulated in the brain chamber, the pressure in the skull increased, and the doctors didn’t have a good way to treat it. To decompress the situation, according to his troubled father, Casey was taken to “the torture chamber.” A doctor would insert a needle through his fontanel, the area on the top of his head where the skull bones had not yet fused. Using a syringe the M.D. withdrew fluid. Doctors eventually talked to dad and explained that if they tried to fix the problem by inserting one end of a tube into the cerebral cavity, they would need to attach the other end to a vein. Every time the child coughed or sneezed blood would flow up the tube, its hollow inside would fill with blood, and a clot would form.
Holter pondered the problem. He knew autos had pressure release valves. They used a ball that was displaced when the tension was high. In people a similar approach would fail when the head was in certain positions.
Then Holter thought about the nipple on a baby bottle. It only opened when the tension was high. Then it closed. Using it as a model he designed a pressure sensitive valve. In place of a tip it had a “slit similar to the one on the nipple. He hooked the valve to a rubber, later a plastic tube, and his device worked. Unfortunately it lost its shape when the tubing was heat sterilized. Then he learned that Dow made temperature resistant silicone tubing. It didn’t take him long to sort out the details, and he created a pressure sensitive tube.
In three weeks Holter solved a dilemma that had plagued doctors for more than a century and his invention “is still widely used.18” Before the doctors were able to put a device in Casey’s head the infant had a cardiac arrest that lasted 30 minutes and his brain was damaged. With the shunt in place his very limited body survived five years.
At 96 a friend’s mother was clear minded and living alone when she fell and couldn’t get up. Four hours later help arrived. In the hospital physicians diagnosed and successfully treated sepsis caused by a urinary tract infection. But when they examined her heart they heard a loud woosh of blood, a heart murmur. A heart ultrasound revealed severe aortic stenosis. The valve that swings open and closed when the heart contracts, the gate that allows blood to flow out of the heart and into the vessels of the body, had grown quite stiff. Her days were numbered. The valve could be surgically replaced, but she was old and frail. Open heart surgery would be quite risky, but there now was another option. A recently approved device, a replacement aortic valve could be inserted into a groin artery, slid up the aorta and through the old stiffened valve. Once in place it would, umbrella like, open and close each time the heart contracted. People in Europe had been using the device for 5 years. At the end of that period of time the new valves were as successful as the surgically planted valves. She opted for the new gadget and did well.
My wife’s cousin was in her 80s and lived on the second floor. Her knees were arthritic and the pain of going up and down the stairs had become so intense that she seldom left home. She had heard “horror stories” about knee joint replacement but dreading the thought of a nursing home, she bit the bullet. Over the next year and a half each of her knee joints was replaced. The arthritic surface, the eroded area on the end of the bone, was sliced off and the raw area was “re-soled”. The day after each operation she was able to walk. Within months of the second procedure she felt normal, mobile, like she was ten years younger.
The first really successful joint replacements were performed by a talented surgeon named Charnley. A Brit with “febrile inventiveness and a powerful command of the English language” he helped care for the soldiers who were evacuated from Dunkirk, and spent most of the Second World War as a medical officer in Egypt. When he was 46 and skiing in Austria, he met and married Jill the woman who became Lady Jill after Charnley was knighted.20
In 1960, having established himself as an orthopedic innovator he turned an old T.B. hospital into a hip center. A local medical equipment manufacturer, Thackeray’s, fashioned the “metal femoral stem and polyethylene cup (acetabular) component.” Charnley used acrylic bone cement as grout, not glue, and successfully produced a low friction prosthesis that when implanted allowed people with bad arthritis to walk without pain. His achievement inspired a new approach to worn out joints. According to Arthritis UK we’ve now gotten to a point where 80% of “cemented hips should last for 20 years” When or if they fail and a person is healthy enough to undergo repeat surgery, it’s usually successful. “The results are less good after each revision,but 80% of re-dos are good for 10 years.”
While Charnley was developing his low friction hip, surgeons in various parts of the world tried to design workable knee replacements, and people with disabling pain were willing guinea pigs. In 1969, feeling that he didn’t have a “reliable knee implant” New York orthopedist John Insall, “designed and developed 4 of the devices that are currently used. A Brit, Insall was born in Bornemouth, a town on the U.K.’s south coast that boasts “seven miles of sandy beach and an exceptionally warm microclimate.” He decided to go to medical school because too many members of his family were already in the military and police. Turned down the first three times he applied, he graduated at the top of his medical school class, and worked for 2 years as a casualty medical officer. Then he traveled to India to learn and work. While there he wrote the hip transplant pioneer Charnley and asked for “an appointment as a House officer.” ”Charnley wrote back “India needs doctors to treat fractures and tumors, not hip replacements.” In 1963 war broke out between India and China and Insall left the country with eight dollars in his pocket. He eventually became a hand surgeon at New York’s Hospital for Special Surgery (HSS). Years later he met and played tennis with the engineer who helped him design the early knee prostheses.17
Currently over 700,000 American knees are restored annually. Some think that by 2030, over three million Americans per year will get a new knee. Four manufacturers make a majority of the implants. Many of us have been saved from death, poor mobility, or disability at least once in our lives as a result of an amazing array of “devices”.24
In 1895 a German researcher named Wilhelm Röntgen “noticed that when electric current was flowing through his Crook’s tube, a board on the wall that was covered with Phosphorus started to glow.” He asked his wife, Anna Bertha, to place her hand in front of a photographic plate, activated the tube and visualized bones and a wedding ring.”21 An invisible wave had somehow passed through the walls of the sealed tube and through a human body. He rechecked his findings a few times. When he was convinced what he witnessed was real he announced his discovery to colleagues and the newspapers and it became a phenomenon.26
He didn’t invent the sealed tube with the air sucked out of it. Named for its creator it had been around for a few decades and was called the Crookes tube. The wealthy British researcher who developed the device also happened to believe in the paranormal. In his later life William Crookes tried to communicate with his dead wife through a medium and, along with Charles Dickens and Arthur Conan Doyle, Crookes was a member of the Ghost club.27
In the years following the tube’s creation a few researchers had allegedly passed electricity through the airless device and had seen a weird glow, but they hadn’t discovered its significance. Rontgen did and he became famous. Not one of the creative geniuses of his day, Rontgen came from money so when he was expelled from a school in Holland for a boyhood prank he was able to go to get an education in Switzerland. His wife was a waitress three years his senior who he met and fell for. He was a good but not an amazing German researcher. But he was the person who saw what other had seen, and wondered what was going on; and he made an important discovery.1,25
Thanks to his invisible wave interventional radiologists are able to use a fluoroscope as a guide. Slipping a needle through the outer wall of the abdomen or chest, they can jab it into the deep worrisome shadow that’s being biopsied. The beam, as we’ve learned has to be used sparingly. Pulsing the x-ray lowers the radiation dose, and people who are exposed to the rays wear heavy lead aprons to protect themselves. There is no absolutely safe dose of radiation. When I was a medical student the head of radiology at Washington U was missing a few fingers. They were damaged when he held people erect while taking x-ray pictures.
By the time I finished medical school x-ray films were taken from many angles. Air (lung) was black. Bone was white and tissue grey. By altering the focus of our tube we could get a sharp view of various depths of a body. As computing became faster and programs became increasingly sophisticated, algorithms were added. Now, using advanced devices physicians can get deep detailed views of sections of the body, head and limbs. We can use x-ray beams (CAT scans) or strong magnets (MRI). And we can visualize much with medical Radar, ultrasound machines.
In the last 70 or so years devices that allow interventional physicians to thread a catheter into a leg artery and advance its tip to the vessels of the brain, heart and abdomen have been created and modified. If the main abdominal artery, the aorta, is significantly bulging or enlarging, it can be replaced surgically, or it can be splinted by a device, a synthetic expandable stent graft that is inserted through a leg artery and becomes the aorta’s inner wall.“In 2003, the interventional approach passed open aortic surgery as the most common technique for repair of abdominal aortic aneurysm, and in 2010, the procedure accounted for 78% of the repairs of all U.S. aneurysms that had not already ruptured.13
The arteries of the brain are currently accessible. Experts have learned how to thread hollow catheters through one of the four large arteries that supply blood to the region. Two carotid arteries run on each side of the front of the neck. Two “vertebral” arteries course through openings in the vertebrae of the spine. The vessels communicate and deliver blood to a ring of arteries on the underside of the brain. An aneurysm, a weakness in the wall of an artery that becomes a bulge, isn’t that uncommon. One in 50 of us will develop one. Some say 1% others up to 3% will eventually rupture. Half of the people whose aneurysms start bleeding die before they get to a hospital. The other half stop leaking blood but the flow of can start again within a few days. Surgically clipping a “ruptured” aneurysm is risky but it’s often necessary. And a rupture can be prevented by filling the ballooned area with clotted blood. Interventional radiologists have become proficient at inserting devices–small platinum coils, into aneurysmal defects. They detach, remain in the ballooned area, and a thrombus forms and fills the bulge. The device that made it possible to disengage the wire was developed by an Italian neurosurgeon named Guido Gugliemi. Born and trained in Rome, Guido was the son of a physician and originally planned to be an electronic engineer. In medical school he was drawn to the brain’s wiring. He saw an area that “constituted of millions of relays and millions of wires that transmit electricity and are connected to one another.” As a neurosurgeon he witnessed and treated ruptured aneurysms. Brain surgery was difficult and bloody. The engineer in him thought there must a way to use the interventional approach and induce a clot to form. He wanted to insert magnets and use electricity, and a friend thought his idea might work. Guido got financing and moved to Los Angeles with his wife and children. He checked out his approach and it didn’t pan out. Deciding to stay in L.A., he used his knowledge of soldering and electricity to develop a detachable wire. Turning the concept into a useable product required countless nights in the lab tweeking and testing his gadget. He eventually was able to predictably insert and detach the coil. His invention is currently used in 90 percent of the brain aneurysms that doctors treat. Most of the aneurysms wouldn’t have ruptured and in some hospitals the device is probably over used. After ten years in southern California Guido and family moved back to Rome.
In 1958 Earl Bakken Bakken created the first wearable battery-powered cardiac pacemaker. He did it by modifying a circuit for a transistorized metronome, a gadget used by musicians to keep the beat. He got the plans from a magazine called Popular Electronics. The device was developed after a local heart surgeon named C. Walton Lillehei spoke with Bakken and asked him if it was possible.
The heart is a muscular cavity whose contraction is controlled by the special cells in the sino-atrial node. One or more times a second they emit a quantum of energy. The current flows down the main conduction fibers of the heart, reaches all the muscular filaments, and they shorten in unison. After the cells have released their energy, sodium, potassium and calcium seep in and out and recharge the node. The power can’t be stored, so when the heart’s pacemaker is fully energized it discharges. When our hearts don’t beat like they are supposed to, there are currently wide arrays of battery powered devices that take over and emit periodic mini jolts. They are implanted on the heart’s outer surface or slipped into one of the upper heart chambers then attached onto the inner lining.
As a teenager Bakken was the “nerd who took care of the high school public address system, the movie projector, and other electrical equipment.” After serving in the army signal corps during the Second World War, he married a medical technologist. While courting her he hung out at the hospital and met doctors and others. He repaired their broken devices and realized that hospitals need people to keep their medical equipment working. He set up a shop in his garage and that’s where he made a wearable pacemaker that was the size of a few decks of cards.
When he turned the first pacemaker over to the doctors they inserted it into the heart of an animal with heart block. Dr Lillihei saw the gadget was working, removed it from the animal and planted it in a child whose ventricular septal defect had just been sewn shut.
The congenital opening between the two largest chambers of the heart, the ventriculo septal defect, is the heart’s most common congenital abnormality. Doctor Lillihei, working at the Mayo Clinic started learning how to patch the gap in 1954 and by 1958 he had performed the operation a number of times. While sewing in a patch, a suture can easily capture the electrical fiber that runs along the border of the heart defect. When a surgeon ties the knot, the main fiber is constricted and the electrical energy can’t flow. Hearts stop beating or contract very slowly and children die. .
It would be an understatement to say pacemakers have, over the last 60 years, become a big business. There are multiple manufacturers in the U.S. Europe and Asia. Over 200,000 devices are planted annually. In the U.S. Cardiologists spend a lot of time, inserting them, checking battery life, replacing batteries if indicated, and remotely “interrogating” the devices and seeing how often and how well they worked.
There’s also a pacemaker that’s inserted into the body of the occasional person who has recurrent ventricular fibrillation and survives. The rhythmic catastrophe is usually seen when someone has an acute myocardial infarction or has a disease of the heart muscle, a cardiomyopathy. Fibrils of the heart quiver and fail to beat in unison, the heart muscle doesn’t contract, blood stops flowing and a person drops dead. .
The arrhythmia can be treated with a sudden jolt of electricity. The current brings all muscular activity to a screeching halt. Fibrils of muscle rest for a second or two. When they next shorten they tend to do so in unison and the heart starts pumping blood. If a heart is shocked within the four minutes after it started fibrillating the brain isn’t usually damaged, and people have an excellent chance of surviving and continuing to be fully functioning individuals.
There are defibrillators in airports and many shopping centers. They’re not pricey, and they are easy to operate. But many are afraid to use them. U.C. Berkeley put one near a volley ball court. It’s in a locked case where no one can get to it if someone drops. Hard to figure what they were thinking.
In the absence of a defibrillator we commonly resort to plan B and give CPR. Our efforts push some blood through the system, but not nearly enough.
My hospital required I retake a class in CPR every 2 years. The last time I took the course the teacher said people who develop a lethal rhythm need to be shocked early. If the jolt is delivered within a minute, 90% of people survive (presumably without noticeable brain damage). After 2 minutes 75% survive and at 4 minutes only 55%.
There are defibrillators up and down the halls of Chicago’s O’Hare Airport. A survey performed shortly after they were installed found the gadgets had already been used 14 times, and 9 of those shocked came back to life.
When someone witnesses a sudden death, confirms the heart isn’t beating, and has access to an AED –automated external defibrillator, they merely need to open the case and listen.
An automated recorded voice tells them what to do next:
“Attach the electrode pads.
Don’t touch the patient.
Analyzing. Shock advised.
Charging. Stand clear.
Push the flashing button to deliver shock. Stand clear.”
Most people who check out one of the brief You Tube videos on AED’s, automated external defibrillators, realize how simple their operation has become. If they’ve seen episodes of the T.V shows like “ER” they’ve witnessed the drill a few times. Which doesn’t mean it’s not frightening to perform the task on a live person.
The devices that shock hearts have become more common but they aren’t ubiquitous and are only noticed by people who are tuned in. A survey in a Netherlands train station (per a project manager from Kings County Washington) found that half the people questioned “couldn’t identify an AED”, and less than half of them wouldn’t consider using one of the devices.
After 40 years 300,000 people are still dropping and dying each year and the survival rate to hospital discharge is 8.4%.
Some people with damaged hearts have repeated episodes of Ventricular fibrillation. Muscle cells periodically stop working as a group and their heart stops beating. A few wear pacemakers that shock the heart when it starts fibrillating. Richard Cheney the former Vice President of the U.S. was one of those people. He had the first of his five myocardial infarctions when he was 37 years old. Unpopular in many circles, Cheney feared terrorists might try to assassinate him by remotely instructing his defibrillator to shock him, so he asked his doctor to replace his defibrillator with one that wasn’t remotely accessible.22 When he was in his 60s his heart started failing, it didn’t propel enough blood with each contraction. Doctors inserted one end of a tube into his left ventricle and the other end of the aorta. Blood was pumped through it by a small electrical motor. It helped for a while. At age 71 Cheney received a heart transplant and did well.
When I was in medical school we were taught that most colon cancers originated near the lower end of the bowel and could be detected by a probing finger or by passing a well lit, metal, foot long, hollow sigmoidoscope through the anus. Decades later doctors used snake like scopes with lenses connected to fiber optic bundles. (The eyes of a fly are made up of thousands of individual visual receptors. They work together to create an image.) Doctors learned how to guide the instruments around corners, view the entire large intestine, and biopsy or remove growths or tissue as needed. By the year 2000 our endoscopes had an optic chip near the tip and doctors monitored their progress on a T.V. screen. The devices could be totally immersed in chemicals that killed any virus or bacteria that hadn’t been removed with vigorous washing. Sedating drugs controlled the discomfort of the exam.
In 1998 the 42 year old husband of a famous T.V. personality Katy Couric died of colon cancer. She became a spokesperson for early detection of cancer by periodically screening the colons of people without symptoms, and colonoscopy became big business. Gastroenterologists became skilled, could usually pass the scope to the far end of a colon in 5 to 10 minutes. I typically performed five or more procedures in a half day. A similar chip based scope allowed us to see the stomach and duodenum, treat bleeding vessels, and biopsy worrisome abnormalities.
The small intestine, the 9 to 30 foot long stretch of bowel between the stomach and the colon absorbs food and fluids and is essential to life. It can be partially visualized with a scope, but passing the instrument is difficult and tedious. There’s a “capsule” that allows us to view the bowel another way. It’s produced by a high tech company headquartered in a once sleepy Israeli town in the Jezreel valley, a village where, in the 1970s, immigrants from Yemen sold pita filled with falafel in the sun filled town square. The small bowel device and its function are best understood by comparing it to an I-phone. The phone can snap a picture and send it by text or Email to another I-phone half way around the world. The Israeli company uses a camera and similar technology, packaged in a capsule. The “pill” also contains a flash so it can take photos in the dark. There’s a “transmitter and batteries that last 8 hours. “
A person with a potential small bowel problem swallows the gadget. As it passes through the stomach and lengthy small intestine it snaps two photos a second. It can’t store the images, so it instantly transmits them wirelessly –like a text photo—to a receiver, worn on a belt by the patient who swallowed the pill. At the end of the exam the capsule is passed in the stool. The storage disc is then plugged into a computer and a program turns the thousands of snapshots into a video that can be viewed and interpreted by a knowledgeable physician or technician.14
A medical “device”, according to the FDA, is something used to help “diagnose, treat, mitigate, or cure a human or animal disease or condition. The category includes everything from instruments and apparatuses– to machines or implants. Chemicals that don’t have to be metabolized to work are devices. Before they are sold in the U.S. “devices” must be registered, listed, and correctly labeled. Production has to be performed “in accordance with good manufacturing practices.” If something goes wrong, if there is an adverse event, the FDA must be notified.3
Each year “over 4000 new, low-risk (class I) devices are marketed”. They don’t need to be approved, but recalls and problems need to be reported to the agency.
At the same time High riskdevices go through an extensive authorization process. Annually 50 to 80 of them are approved by the FDA.
Most of the other 3500 devices that are “permitted” each year are minor modifications of an existing product. In terms of safety and effectiveness they are “substantially equivalent” to the currently used item. The verification process they go through, called 501k, is not particularly stringent. Only 8 percent need “special controls and clinical data.” “Bench testing “is sometimes adequate, and some gadget-tool-appliances have to be checked out “under conditions of clinical usage. “ When lasers for “cutting or ablation” of tissue replaced heated wire cautery, they were approved by the 501k process.
The substantially equivalent requirement has periodically been misapplied. On occasion a manufacturer obtained FDA clearance without revealing the actual use of the device. At other times the FDA and manufacturer misjudged. The new product didn’t seem that different–but it was, and it should have been extensively tested before it was widely used. In hindsight that probably was the scenario when the metal on metal hip prosthesis was approved.
For years surgeons had replaced painful arthritic hips by inserting a metal stem into the femur. The socket in the pelvis was covered by a “plastic (polyethylene.)” insert. It made sense to many that if both articulating surfaces were metal the joint would last longer and work better. The manufacturer and FDA apparently decided that making the socket metal, not polyethylene, was a minor change—that the modified prosthesis was actually “substantially equivalent.16” It was not necessary to test people. Cobalt and chromium alloy prostheses received FDA clearance in July 2008 without a clinical study. They were then implanted in 100,000 patients. Over time the metal on the articular connecting surface of the bone tended to erode. Sometimes particles “migrated into the surrounding tissues and the bloodstream. 21% of the alloy prostheses had to be replaced or revised within 4 years and 49% within 6 years.”4
Also approved by the 501k process, transvaginal mesh was used when surgeons operated on pelvic organs that prolapsed, slipped down and were protruding into the vagina. No clinical trials were conducted at the time, and sixty-one products were marketed between 1985 and 1996. Made of a type of plastic called polypropylene, their lattice corralled parts of the intestine or a bladder. Over the years the mesh caused a number of complications “including pain, adhesions, bowel obstructions, and infections.” In January of 2016 the FDA issued a high risk warning, and in April 2019 the agency told manufacturers to stop selling the material.5
Manufacturers and clinical facilities have to report device-related deaths and serious injuries to the FDA. In 2002 the agency received 2500 reports from clinical facilities and 3500 from consumers.
“Over 1000 devices are recalled each year.” Half have low risk drawbacks. Most of the rest are intermediate risk. And 10 to 20 of the problems are serious. Recalls require manufacturers halt production and dissemination of the devices, and they must alert clinicians. Post recall doctors and nurses are supposed to keep an eye and ear out for difficulties with “Heart valves, joint prostheses, implants, cardioverters, defibrillators, respirators, infusion pumps, hemodialysis equipment, cutting and coagulation equipment, endoscopes, etc.”6
The FDA, via a new precertification program is working with industry to try to find a way to evaluate the effectiveness and safety of software as a device.”9 “81% of North American adults own a smart phone, and many companies are trying to use technology to monitor health and help manage certain chronic diseases.” Some devices can detect the heart rate; others the number of steps a person takes during a day.
In 2020 a corona virus that modern man’s immune system had never previously encountered jumped from a bat to a man. It often made people very ill and was extremely contagious. At times it caused an infectious process that filled the lungs with fluid and made oxygenation impossible. Many were saved by respirators that mechanically ventilated lungs for days to weeks. But in hard hit areas like Italy and New York there weren’t enough ventilators for everyone who needed them. The president, the press, and politicians of the time regularly attacked and blamed one another every time there was a mishap or an unheeded warning.
The nation was caught shorthanded even though government officials had anticipated a potential need for the devices and had ordered many a few years earlier. By April 20th few had arrived. The dearth of respirators was big news and people wanted to know who screwed up.
The blood that flows into the heart from the body enters through the right upper chamber, the atrium and progresses to the pumping chamber, the right ventricle. The ventricle pumps the blood into the lung. The human lung is a collection of about 500 million tiny air chambers called alveoli. A cubic millimeter of lung tissue contains about 170 of them. They are surrounded by thread like vessels, capillaries. Erythrocytes, red blood cells stream through them. The cells deliver their carbon dioxide to the alveoli and collect oxygen.
Air is sucked into the lungs when a vacuum is created by breathing– expanding our chest and lowering our diaphragms. Earlier in the 20th century when the muscles of a child with polio were so weak that the person couldn’t inhale, he or she was placed in a long sealed tube. Their head hung out of the top. Multiple times a minute the machine created a vacuum and air was sucked into a person’s lungs.
During the Second World War the military needed a device that forced air into the lungs. Driving oxygen into the circulation allowed pilots to fly at high altitudes. The devices were developed by Dr. V. Ray Bennett and Dr. Forrest Bird. After the war each went on to develop forced air ventilators. One of the inventors, Forrest Bird, had a father who flew combat planes during the First World War and had taught his young son how to fly a plane.
Positive pressure ventilators were commonly used in the 1950s for people with severe pneumonia who couldn’t move air into their lungs. Over the subsequent 60 plus years Bird, Bennet, and others modified and improved the devices.
Shortly after the 2003 SARS respiratory epidemic the department of Homeland Security decided to stockpile an additional 70,000 respirators. They might be required in a moderate influenza pandemic. Before the government ordered the machines a panel of experts decided which bells, whistles and capabilities the respirators would need. The machines on the market were costing $10,000 a unit and the group, presumably, thought they were overpriced. They decided new respirators should not cost more than $3,000 each. In 2008, the government asked companies to bid on the project. As developer and supplier they chose Newport Medical Instruments, a small outfit in Costa Mesa, California, a company that was “small and nimble.” After the deal was inked the government gave Newport $6 million to develop the machines and said they would pay the rest when the devices were delivered. Reading between the lines it sounds like the people at Newport knew they would lose money on the deal. “but would be able to make up for any losses by selling the ventilators around the world.”
Research started and every three months, government officials visited Newport’s headquarters. “There were monthly scheduled requirements and deliverables.”
In 2011, 3 prototypes were sent to Washington and the company planned to “file for market approval and start producing the machines in the fall of 2013. Then the company was sold. Established 45 years earlier by physicians, Newport Medical was Japanese owned. Covidien, a company that was formed when Tyco “spun off” its health care division, purchased Newport for a little over $100 million. Then Covidien wanted the government to provide additional funding and a higher sales price. The government said OK. The U.S. gave Covidien an additional $1.4 million. The next year Covidien decided they wanted out the contract. The deal “was not sufficiently profitable” The government agreed and awarded a new contract for $13.8 million to the giant Dutch company Phillips. In July 2019 the F.D.A. signed off on the new Philips ventilator, the Trilogy Evo. The government ordered 10,000 units in December, setting a delivery date in mid-2020. In January 2020 a major coronavirus epidemic started spreading out of China.
On March 31, 2020 a Pennsylvania subsidiary of Phillips was producing the cheap portable ventilators but they didn’t deliver them to the U.S. They sold them to other countries. Called Trilogy Evo the ventilators were priced at $3,280 each. the company is currently negotiating with a White House team for43,000 additional ventilators. In March 2020, invoking the defense production act, President Trump told General Motors to make the ventilators.
In 2017 the top 10 device makers had over $170 billion dollars in revenue and the top 30 took in more than $270 billion. Devices are responsible for roughly 6% of U.S. health care spending or about $200 million a year.10
Like pharmaceuticals –MRI machines, vascular catheters, endoscopes etc. are very expensive. Little is known about how companies and hospitals negotiate. A friend who purchased equipment for a chain talked about the days after the hospitals he worked for merged with another hospital group. He visited one newly acquired facility at a time and met with the local doctors. They had attitudes and beliefs about which scopes, artificial joints, heart valves, etc. were easier to use, more effective, and more durable. Some cared about the brand of material used to sew wounds shut. Since many surgeons could choose where they admitted their patients, where they performed their procedures, the hospitals needed their business. At times my friend had to buy a brand of equipment that wasn’t perceivably better and was more expensive.
Given our current system I think an attempt to regulate the cost of medical devices doesn’t make sense. In Europe, on the other hand, medicine is commonly state run. Administrators have a greater say and can more effectively use price as a bargaining factor. Not surprisingly European nations pay less for medical devices than we do in the U.S.
To even out the costs and to help make health care affordable to all, Congress, as part of the Affordable Care Act (Obamacare), enacted a 2.3 percent medical devise tax. It was briefly collected then put on hold, and recently was repealed. .
The world’s largest device maker, Medtronic, the Minnesota Company with revenues of about $30 billion a year, spent a decade acquiring and integrating 20 smaller companies. Then, in 2015, the American corporation purchased a company headquartered in Ireland called Covidien. As discussed earlier it was a 2007 spin off of Tyco.
After the merger was consummated Medtronic moved its official headquarters to Ireland. According to The Street: Medtronic’s 49.9 billion acquisition of Dublin-based Covidien, the largest tax inversion deal ever — was going to leave shareholders with a big tax bill, while allowing the Minnesota-based company to pay little or no U.S. corporate taxes.
“It is not inconceivable that [Medtronic] may not be taxed at all.” on its U.S. operations, said Robert Willens, tax consultant and professor at Columbia University.11
In 2018 Medtronic, now an Irish company, had net earnings of 3.104 billion, Half the money came from sales to physicians and hospitals in the U.S. “Medtronic’s total revenues grew from $28.8 billion in fiscal 2016 to $30.6 billion in fiscal 2019.15 “
- Of the 5 medical device companies having the greatest annual revenue:
- Johnson and Johnson with $26 billion in revenue is headquartered in New Brunswick, New Jersey;—————-
- $19 billion GE Healthcare is based in Chicago; ———-
- $16 billion Royal Phillips calls Amsterdam home. —————
- $16 billion Siemens is based Munich.12
EINTHOVEN–EKG
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.842.6331&rep=rep1&type=pdf
Wilhelm Roentgen
https://medium.com/@ranlevi/how-x-rays-were-discovered-by-mistake-aea9c4a83c4a
https://www.nobelprize.org/prizes/physics/1901/rontgen/biographical/
https://biography.yourdictionary.com/wilhelm-conrad-rontgen Crookes https://www.bbvaopenmind.com/en/science/leading-figures/the-ghosts-of-william-crookes/
https://www.mayoclinic.org/diseases-conditions/brain-aneurysm/diagnosis-treatment/drc-20361595
http://www.qrasupport.com/FDA_MED_DEVICE.html
balancing regulation and innovation https://www.nejm.org/doi/full/10.1056/NEJMp1109094?page=0
https://www.devicewatch.org/reg/510k.shtml
https://www.medpagetoday.com/obgyn/generalobgyn/69741
https://www.jwatch.org/fw115315/2019/04/17/fda-companies-must-stop-selling-vaginal-meshes-pelvic
ensuring safe and effective medical devices https://www.nejm.org/doi/pdf/10.1056/NEJMp020184
close loop for diabetes blood sugar control https://www.nejm.org/doi/10.1056/NEJMoa1907863
mobile apps–diabetes https://www.nejm.org/doi/full/10.1056/NEJMra1806949
https://www.nejm.org/doi/full/10.1056/NEJMoa1907863
global medical device companies https://www.mpo-mag.com/
mpo-mag.com/issues/2018-07-01/view_features/the-2018-top-30-global-medical-device-companies
13. Dua, A (2014). “Epidemiology of aortic aneurysm repair in the United States from 2000 to 2010”. J Vasc Surg. 59 (6): 1512–7. doi:10.1016/j.jvs.2014.01.007. PMID24560865.
https://www.timesofisrael.com/us-approves-israeli-pill-camera-to-screen-colon/
The Insall Legacy in Total Knee Arthroplasty. Giles R. Scuderi, MD; W. Norman Scott, MD ; Gregory H. Tchejeyan, MD http://www.iskinstitute.com/articles/Insall_Legacy.html
Ranawat knee surgery https://www.youtube.com/watch?v=eIhged17w6k
Holter’s brain drain https://uh.edu/engines/epi2582.htm
Trans catheter aortic valve—TAVR https://www.nejm.org/doi/full/10.1056/NEJMe2000240
Early arthroplasty Industry https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1888784/
The Race to Make Ventilators. Planet money pod cast March 31,2020
Respirators for U.S. stockpile Posted by Steve Kelman on Mar 30, 2020.
https://fcw.com/blogs/lectern/2020/03/comment-kelman-ventilator.aspx Respirators: https://nypost.com/2020/04/01/advancements-in-breathing-devices-for-wwii-fighter-pilots-paved-way-for-modern-ventilator/
http://asthmahistory.blogspot.com/2017/06/1937-80-evolution-of-mechanical.html
How many alveoli in a lung
https://www.atsjournals.org/doi/full/10.1164/rccm.200308-1107OC
Earl Bakken founder of Medtronics https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6655043/pdf/CLC-24-422.pdf
cardiac pacemaker http://www.vhlab.umn.edu/atlas/umn-cv-history/1957-58.shtml
Cheney fear of terrorists shocking him
https://www.theguardian.com/world/2013/oct/19/dick-cheney-heart-assassination-fear
https://www.annalsthoracicsurgery.org/article/S0003-4975(06)00803-4/fulltext
ventriculo septal defect
https://www.annalsthoracicsurgery.org/article/S0003-4975(06)00803-4/fulltext
http://www.vhlab.umn.edu/atlas/umn-cv-history/1957-58.shtml
pacemaker
http://www.vhlab.umn.edu/atlas/umn-cv-history/1957-58.shtml
cerebral aneurysm
https://neuronewsinternational.com/guido-guglielmi/ https://neuronewsinternational.com/celebrating-25-years-of-the-guglielmi-detachable-coil/