Time is valuable; write concisely.
Sixty-three words that could change the world are:
IIb, or not IIb: that is the question for the European Union Medical Device Regulation
Work in progress, please don’t forward, and please consider reading other articles first.
6 minute read.
Learn the EU-MDR Unique Device Identifier System from Voltron
6 minute read.
Life should be fun, and I try to find ways to bring fun into work. This article uses Voltron, Defender of the Universe, to teach the European Union Medical Device Regulations requirements for Unique Device Identifiers.
Truth Prevails
8 minute read.
These are the lasting impressions of 30 books I read while backpacking across Nepal and India. The trip took 2 1/2 months; this summary takes a few minutes at the average reading rate of adults.
Books in English were rare treats shared between travelers, a chance to learn from other people including those who had been traveling your route dozens of years ago. Guest-houses in remote villages often had book-exchanges where people from all over the world shared books they had chosen to bring backpacking.
My first book swap was at a monastery in Kathmandu that used the $6/night from guests to fund a free healthcare clinic for Tibetan refugees. The exchange had books hundreds of travelers from all over the world had felt was worth carrying and sharing on their journeys. I read a few books about meditation during my week-long stay, left a copy of “One Hundred Years of Solitude,” and took a book on Buddhism to read during the next stage of my journey. That process continued for 2 1/2 months, resulting in a wide range of books I’ll summarize after introducing Deepak.
For over 35 years Deepak has sold books from a push-cart near the Tibetan University and Deer Park in Sarnath, India, where the Buddha gave his first sermon 2,600 years ago. It’s a pilgrim site for followers and students of Buddhism, Jainism, and Hinduism. Deepak’s calm, friendly, unassuming personality invites conversations about the books he carries; I was fortunate to spend two weeks getting to know him and reading books from his small but mindfully chosen selection of books.
Deepak has discussed books, religion, and philosophy with scholars, pilgrims, professors, and travelers for three decades. His ethos is Truth Prevails. I met him while waiting for a security clearance; I had been invited to attend a conference on Philosophy of the Mind and Modern Science, held in conjunction with the Tibetan University’s 50th anniversary. and attended by the Dali Lama, who had created the university after the Chinese army moved into Tibet and his people fled to India.
The conference included leaders from the religions represented in Deer Park to discuss different philosophies of the mind with scientists from all over the world working on topics ranging from neuroscience to physics. Most attendees hurried passed Deepak on their way to the conference each day, not realizing the wisdom held in his book cart.
Most of my memories from that conference are from Deepak’s books and our conversations about what people have been seeking since before the Buddha gave his first sermon 2,600 years ago. Few understand the goal, but the path is available to everyone: humility, patience, and perseverance. I was fortunate to not be in a hurry to the conference so that I could spend time with Deepak, learning from him and his books.
Before I left, Deepak invited me to meet his family and gave me a statue of the Buddha he had painted, hoping I could find space in my backpack to carry it home. Today, it’s on my bookshelf at home, reminding me of Deepak, a wise and kind person who helped me get a little wiser and a little kinder.
I continue to receive joy from the books and wisdom he shared, and will give my take-home impression from those books after a fun fact.
A Fun Fact
If you look at the book-exchange photo, you can see an author’s name, Douglas Adams, who wrote the book at the exchange”The Hitchhiker’s Guide to the Galaxy.” It’s about budget-backpacking in space using an electronic book similar to a Kindle e-reader, and has been one of my favorite books since reading it as a teenager.
The e-Guide to the Galaxy, which is similar to a travel guide to backpacking in remote countries, gives practical advice to travelers on it’s cover: “Don’t Panic.”
The photo below is Elon Musk’s convertible sports car, floating in space, facing the Earth, with a camera over the shoulder of a mannequin made to look like it’s driving the car. Elon Musk launched his car into space the day I started writing this blog. Elon is a fan of science fiction books, and if you look closely at his dashboard you’ll see his advice: “Don’t Panic”
I still enjoy this fact, especially while writing about finding a copy of the Hitchiker’s Guide to the Galaxy in a Tibetan Buddhist monastery in Nepal. Life if fascinating, fun, and often out of our control, so “don’t panic” is the practical advice to give anyone on any journey.
Books I read on this journey
“The Cosmos is all that is or was or ever will be.”
I run around looking for the Friend
My life is almost over,
but I’m still asleep!
When it happens, if it happens,
that I meet the Friend,
will I get the lost years back?
Vigorous writing is concise. A sentence should contain no unnecessary words, a paragraph no unnecessary sentences, for the same reason that a drawing should have no unnecessary lines and a machine no unnecessary parts. This requires not that the writer make all his sentences short, or that he avoid all detail and treat his subjects only in outline, but that every word tell.
I read Siddhartha in one sitting. During the final chapter I realized I had been crying.
The Tao Te Ching was composed ~ 600 B.C., the same time as teachings of Confucius, The Buddha, and first authors of the Bible.
When there is no desire, all things are at peace.
Lao-Tsu is also known by Laozi; I’m lousy at remembering that.
The History of Hinduism
Many versions and authors
Hinduism originated from a belief that there’s one god and that god is indescribable; Hindu deities are ways to comprehend the limitless aspects of a god.
Many translations
The Upanishads are Hindu texts from ~ 3,500 years ago.
As the rivers flowing east and west
Merge in the sea and become one with it,
Forgetting they were separate rivers,
So do all creatures lose their separateness
When they merge at last into pure Being.
There is nothing that does not come from him.
Of everything he is the inmost Self.
He is the truth; he is the Self supreme.
You are that Shvetaketu, you are that.
The Buddha used the Hindu concept dukkha, which is approximately translated to “suffering” from obvious causes such as death, disease, and sadness but includes includes worry, anger, disappointment, impatience, judgement, or any unrest of the mind. Dukkha is anything other than experiencing a moment for what it is. My paraphrasing of the Buddha’s final words is:
“All I’ve taught is that there is suffering, the cause of suffering, suffering can end, and the path to end suffering is the middle way.”
All things created by the mind are impermanent. Practice your aim with diligence.”
Sudata’s biography: Born in Germany, defected from the Nazi army in WWII, wandered internationally to avoid prosecution, became a Buddhist monk, died peacefully.
Dance, Lalla, with nothing on
but air. Sing, Lalla,
wearing the sky.
Look at this glowing day! What clothes
could be so beautiful, or
more sacred?
Translation by Meera Uberoi
The Mahabharata is to Hinduism what the Old Testament is to Christianity, Islam, & Judaism.
Translation by Edward J. Thomas
Bhagavad Gita means “The Song of our Lord.” It’s a 2,500 year-old story about the god Krishna explaining older Hindu texts to a servant. It’s analogous to what the New Testament is to the Old Testament. My mind reacted negatively to the repeated message of “do your duty.”
When we hear about people suffering we become upset or worry, but do not do anything. We do not even wish them happiness. We may say the words, but we do not feel compassion, or we feel sadness and temporarily suffer with no benefit to anyone.
Elie wrote novels about surviving the Nazi holocaust, Night, Dawn, & Day. My summary would not do justice to his work and the stories he shared.
“Imagination is more important than knowledge.”
Einstein unlearned conditioned beliefs about time; he saw things how they really are.
There’s a difference between memorizing physics and understanding it, or “seeing it.”
Before studying physics Einstein was interested in philosophy similar to Buddhist philosophy of the mind; Buddhist philosophy is based on understanding, not doctrine, so that people can “see things how they really are.”
A Buddhist philosophy is that wisdom comes from removing doubt rather than adding conviction. The mathematics of physics and results of modern experiments are ways to remove doubt about how things really are.
&
&
Humankind can see black holes by detecting Hawking radiation.
Stephen Hawking explains Classic & Quantum Physics using a vocabulary of a few hundred words. He wrote these books in his wheelchair, selecting letters and words from a computer screen by twitching his cheek. I think he sees things how they really are.
Meet Balram Halwai. The White Tiger: Servant. Philosopher. Entrepreneur. Murderer.
After 18 years of starting and stopping this book I came within 40 pages of finishing it. Other people have been more persistent; 100 Years of Solitude has more than 600,000 ratings and 22,000 reviews on Goodreads.com
Translation by Sarvepalli Radhakrishnan
The Buddha said, “Let a wise man watch his thinking. The mind moves with extreme subtlety and is not noticed. It seizes whatever it desires. To watch the mind is conducive to happiness.”
We appreciate life when we embrace its impermanence.
Buddhist teachings can seem confusing. Some say “go right,” others say “go left.” They are coming from the center.
“In the sweetness of friendship let there be laughter, and sharing of pleasures.”
Richard J. Herrnstein & Charles Murray
Data supports their claims, and they don’t claim more than data reveals.
I’d be interested in knowing how peoples’ actions impact the quality of their lives and the lives of others. A modern version of the Bell Curve could analyzes our actions, which are less debatable than our intelligence.
Many authors, edited by Steven Fraser
A lot of people have opinions about The Bell Curve.
I believe many people are reacting emotionally to a bigger problem that I would rather discuss: how to measure and improve happiness and social equity on a planet that will have 10 Billion people by 2050.
Many authors: owners are Maureen & Tony Wheeler
I carried both books in my backpack for months, including hiking over the Himalaya mountains in a heavy backpack. They facilitate traveling with an open mind.
Interesting, to me
I read “Bird of Passage” while staying in the guest house that the authors had stayed 17 years prior. I realized this while I was reading them describe the host’s cooking and watching the same owner prepare our dinner.
The guest-house host was the catalyst for me being invited to the first international conference on “Mind and Modern Science,” held at the Tibetan University and attended by the Dalai Lama for the University’s 50th anniversary, an auspicious visit because he had created the university after his exile from Tibet. At that conference I saw the Dalai Lama offer respect to Samdhong Rinpoche, the author of a book on Tibetan meditation that I coincidentally found at a coffee shop and summarized in this blog.
I taught physics, study religious philosophy, and enjoy American wild-west movies: In the Himalaya Mountains, I stayed at guest house that was decorated with physics posters, Buddhist art, and Clint Eastwood western-movie posters written in Dutch. It was the home of a Dutch physicist and his wife of twenty years, a Nepali Buddhist. They don’t receive many backpackers, and he was just as excited as I was to stay up all night discussing physics, philosophy, Buddhism, and how to make tasty homemade pasta.
Albert Einstein, Stephen Hawking, and Walpola Sri Rahula (when quoting the Buddha) use the words “relativity, space, and time” to describe concepts. Hawking and Rahula use the word “annihilation” when discussing something that ceases to exist in physical form. In other books by Einstein and Hawking they uses phrases that originated with the Buddha, 2,600 years ago. That had bothered me for years; I wouldn’t understand the root source until six months after returning from this trip and reading Einstein’s later essays and biography (I’m editing my original post with this information in August 2018, soon after reading Einstein’s essays). Einstein was influenced by the philosopher Schopenhauer who developed theories similar to Buddha’s, and Einstein would later discuss Buddha’s insights and compare them to his way of thinking. Einstein obviously influenced other physicists which may be why the words and way of speaking propagate. Plus, I believe the Buddha “saw” physics of the universe but didn’t have the words to describe them 2,600 years ago. He was too far ahead of his time, described things as best he could but admitted that words are limiting. The more I study what we know of his original words the more clear it becomes to me that he understood physics concept like the conservation of matter and atomic structure, but didn’t have the pre-existing language or tools to explain them. And, he was more focused on calming the human mind than teaching science; he created the phrase “conditioned genesis” to describe all phenomenon but only in the context of removing suffering from all humans. Today, we are just beginning to understand that all matter is a form of conditioned genesis, of particles being created and annihilated in a continuous process.
Post-Script
I published this blog in February 2018. In March 2018, Stephen Hawking died at age 76, more than 50 years older than he was expected to live when he was diagnosed with amyotrophic lateral sclerosis.
“I have lived with the prospect of an early death for the last 49 years. I’m not afraid of death, but I’m in no hurry to die. I have so much I want to do first”
“My advice to other disabled people would be, concentrate on things your disability doesn’t prevent you doing well, and don’t regret the things it interferes with. Don’t be disabled in spirit, as well as physically.”
He was able to train with astronauts in zero-gravity simulators, where the first rule is “don’t panic.” I’m happy every time I imagine the joy he must have experienced. Rest in Peace Professor Hawking.
Mindful meditation for pain relief
7 minute read.
Meditation and mindfulness reduce suffering from pain. The United States Veterans Administration advocates mindful awareness, a process each person must follow until finding what works for their unique situation. Many books and online resources are available to help your process; here’s what worked for me, I hope it helps you. Read more
Hiking over the Himalaya Mountains
I hiked over one of the world’s highest mountain passes in a four-week journey, part of a three-month backpacking trip through Nepal and India. This blog describes the hike, some of the people I met and their life in the Himalayas, altitude sickness and helicopter rescues, and methods I used to complete the trek without pain medications; part of my intention of this trip was to stop taking medications for pain because they led to a sluggish mind and unwise decisions.
The Path
I took a bus from Kathmandu to the village of Besisahar, being dropped where the dirt road ended and a hiking trail began. Most of the trail is known as the Annapurna Circuit, a centuries-old trading route betweenNepal and what was formerly Tibet before the People’s Republic of China assumed ownership in 1950.
The Annapurna trail is still used by locals and adventurous tourists. It cuts into the sides of mountains, crossing rivers with suspension bridges swinging hundreds of feet in the air. Two people could not pass on the narrow bridges, so we’d coordinate who went first. Goats, cows, and buffalo used the bridges; I gave right-of-way to anything with horns, and played with anything that was cute.
I had a backpack with two months worth of clothes, a few day’s worth of food and water, a few books, a camera, and a Frisbee. Other than socks and underwear, my gear and clothes were purchased from thrift stores near my home in San Diego, California, for less than $50 total. I also purchased a lightweight down jacket made from Patagonia, California’s first Benefit-Corporation that combines socially responsibility with being profitable-enough. (I would love #ProfitableEnough to become a common concept)
The Annapurna trail passes through villages, passing people’s front doors. Most families offer simple beds and dinners to travelers. Their ancestors had done the same thing to Tibetan traders for generations.
Most villages don’t have schools. Some do, and nearby villagers walk the trail for hours to reach them. There are not medical services. Poverty is common, and the area was recovering from a recent civil war that killed 19,000 people and displaced 200,000. Foreign aid doesn’t reach them. Despite these challenges, the Himalayan people are kind, industrious, hard-working, and peaceful. Himalayan people say, “what is there to do?” as a way to be present in the moment and only worry about what is within their control.
Part of what’s in everyone’s control is our kindness towards others. Nepali culture encourages compassion, shown by how kids would run into the street to greet me when I approached a village. They’d clasp their hands, bow, and say “Namaste,” the Hindu word for “I see the divine in you.” I’d clasp my hands, bow, and wait to feel the sentiment before returning the word, “Namaste.”
Feeling compassion and speaking truthfully makes everyone happier. Imagine if our culture encouraged pausing to seek compassion for a person before saying, truthfully, “I hope you’re well.”
The poorest backpacker is wealthier than these kids can imagine, and many share treats. A consequence is a that kids start seeing backpackers, most of whom are caucasian (white), as sources of things rather than as people. They don’t say Namaste, they shout, “Money! Chocolate! Sweet!” You can’t see the divine in each other with a hierarchical relationship, so I gave the most valuable thing I have, time.
Many Himalayan families had been in travelers’ photos, but had never used a camera or seen their own picture. I lent my camera to kids, letting them learn by playing with it.
They’d take photos of their parents, show them, and try again with new button combinations. In return, they’d teach me Nepali words for what they saw. This is co-learning, a powerful tool for connecting with students.
Kids took many of these photos, letting us see the world through their eyes.
I was hiking uphill each day, gaining 400-500 meters of elevation. Each night got colder; before going to bed, I’d huddle around kitchen fires, learning to cook Himalayan food while talking with families.
Most guest houses were people’s homes, and they juggled family duties while preparing our dinners. One host, Narme Llama, was a third-generation Tibetan with newborn twins. He had a warm smile, had learned four languages, and helped take care of his new daughters while running his business.
I arrived at the end of season without tourists, so a bed was free. A meal cooked over their wood stove was 200 Rupees ($2 U.S.). Ginger tea was 60 Rupees. They saved money to send their older daughter to boarding school in the nearest city, two-days away, for $15/month. They were lucky to save $2 per month, which would have to support them in old age. There were no schools nearby, and all jobs were physical labor that didn’t need an education, but Narme-Llama valued education. He realized their government wouldn’t build roads, schools, or hospitals in rural areas, but was grateful for his family and the values installed by his grandfather that helped make their exile from Tibet and independence in the Himalayas peaceful, despite being viewed as unwelcome refugees. Images of Buddha were on the walls; the Buddha taught how to seek your own happiness, because no one else can do that for you.
Sometimes a guesthouse would have other backpackers, or travelers with a guide, and we’d share time around a fire learning different perspectives on the world.
Some travelers had smart-phones with translation apps and solar-chargers, allowing us to communicate with almost anyone. Even tiny villages had WiFi; people couldn’t get toilet paper, but could browse the internet. Our world could be moving towards a global democracy, where people solve problems rather than politicians, or we could could be moving towards replacing democracy with “dataism.” (Read “Homo Deus.”) Wherever we’re going, 7.6 billion people using smart-phones will get us there faster.
After a week of hiking the villages became smaller and farther apart. Hiking became more challenging because of the high altitude; everything was over 10,000 feet (3,000+ meters, almost two miles high). I hiked uphill 4 to 8 hours per day, gaining approximately 500 meters before stopping to sleep and acclimate. Trees became rare, and snow-capped mountains became common. Tibetan prayer-flags highlighted mountains I’d eventually cross.
At higher elevations, people from poor castes walk downhill to collect firewood each day, walking back uphill to sell it. Tourists use more firewood than the local ecosystem can resupply; to balance this, the government agency overseeing this area has encouraged gas stoves. The alternative was burning yak-dung, which isn’t as smelly as you’d imagine, but I wouldn’t try it at home.
Mules resupply villages with gas tanks and food that can’t be grown in high elevations. The mules also brought supplies for tourists, like Snickers candy bars that would be sold to hungry hikers by guest-houses.
In the town of Manang we had to wait four days because all guest-houses in the region were full of people from Kathmandu, who had traveled to vote in the national election. In Nepal, people must vote in the town they’re registered, usually where their ancestors were born. This was Nepal’s second election; their democracy was new, and followed a ten-year civil war that had divided the people between the poor and wealthy.
Nepali soldiers patrolled the streets, enforcing a curfew with guns rather than logic. Nepal uses their soldiers as defense, police, and national park protection. Until the civil war, they were the only people with guns, and without checks-and-balances they abuse their power in rural areas. I believe this will change now that Nepal has a democracy; I’ve never had a gun pointed at me in a country with a functional democracy.
The curfew didn’t affect our stay in Manang because there was nothing to do at night, especially when temperatures were below freezing. We’d walk up and down the street then return to our guesthouse to get warm around a yak-dung fire.
The guesthouse where we stayed was decorated for what the owners imagined a typical traveler would enjoy. Their home look like a rustic version of a 1970’s television sitcom; for some reason, they assumed that a typical traveler expected a Tiki bar. We’d sit under the Tiki bar, heating our tea in steel mugs on the yak-dung burning stove.
Frisbees are surprisingly useful for meeting people, and not just when throwing it. One of our group had found a wild herb in the lowland mountains and used my Frisbee to prepare it for sharing with our small group. Use your imagination…
We spoke with local families about the election. Most people didn’t understand the differences between political ideologies, they simply hoped for a better life. The communist party overwhelmingly won elections in rural areas. In cities, the status-quo remained. Their new democracy would share government decisions between parties. Regardless of this year’s outcome, it’s a step towards more people having a voice in their future. They celebrated with parties in the street.
After the elections, I started hiking through remote areas. My head hurt from spinal injuries, my hips hurt from arthritis and inflammation, and the screws in my ankle caused the bones to throb with pain. I walked silently, concentrating on being mindful, something I’ll discuss more soon.
You see more wildlife when walking silently. Some, like this yak, are not subtle. Others are easily missed; there are at least four mountain goats in this photo:
And at least two in this photo:
Many people do not get altitude sickness. I’m not one of them. The photo below was taken from the window of a shelter, where I stayed for three nights to recover from altitude sickness before risking the final day of hiking.
For almost a week, I had been hiking at over 3,400 meters (~11,000 feet), gaining 300-500 meters each day. I had a headache and craved oxygen. My body fought two needs: deep breaths to get oxygen vs. tightening my windpipe to keep out the cold, dry air. I have asthma, and my breath “wheezed” on steep sections of the trail.
When you’re emotionally detached from discomfort, you’re able to differentiate between transient discomfort and symptoms of altitude sickness. At 4,880 metres (16,010 ft, ~ 3 miles) I realized that my headaches and dizziness were signs of trouble, so I descended to a shelter at 4,540 meters.
I stayed in a small room with one window that allowed cold wind into the room. I laid awake for hours, trying to stay warm as ice formed in my water bottle. It was -17 degrees by 2am. My heart was pounding at 124 beats per minute, more than twice my normal resting rate. Every muscle in my body was tense, sending blood to vital organs. I couldn’t descend; in daylight, it was six hours down a narrow and dangerous trail to the next shelter. I concentrated on relaxing until my jaw unclenched, which led to my teeth chattering at 124 beats per minute. I had preferred a clenched jaw.
By sunrise, my pulse was down to 80 beats per minute. I didn’t move that day, and by that evening my pulse was ~ 60 beats per minute, still more than my normal resting rate, but reasonable considering I was 3 miles high.
I acclimated by hiking to higher elevations during the day, descending to sleep at night. On one of these hikes, I found an emergency satellite phone. Three years prior, almost 400 people were trapped at this location by a surprise snowstorm; 42 died, and 175 suffered frostbite. I was not reassured by the satellite phone, which was made from a coffee can and something that looked like the dish-drying rack by my sink at home.
I’ve summitted mountains all over the world, and frequently rock-climb in the Sierra Nevada mountains, where the amount of focus for each motion makes you not notice almost all other thoughts or feelings. This requires concentration; your mind is sluggish from high altitudes, low oxygen, and physical exertion, and it wants to be anywhere other than the present moment. Hiking above 17,000 feet can require 10 to 15 seconds of focus per step, requiring 6-8 hours of unbroken concentration. For me, I also must remain aware of the nature of pain in my body. For example, the metal screws in my ankle can wear into the bone, leading to a risky situation if I can’t walk effectively, and my normal headaches must be continuously evaluated to ensure it’s not progression to severe altitude sickness.
If you think about how difficult it is to concentrate on something unpleasant you have an idea of the real challenge of high-altitude hiking, maintaining concentration on both pleasant and unpleasant feelings 6-8 hours per day for several weeks.
Here’s my metaphor for being mindful while hiking. You’re the pilot of a bus that represents your body and passengers that represent your thoughts. You’re responsible for piloting the bus and being aware of the passengers. The road and other drivers are external situations often out of your control, but you must be aware of them, too. Sometimes your bus isn’t in perfect condition, you may have deflated tires or weak shock absorbers, but you must still pilot it over any road condition. Your passengers are like kids on a bus, sometimes joyful sometimes crying and always there.The passengers constantly tell your about your deflated tires, weak shock absorbers, pain in your ankle, pain in your neck; they warn you to look out for other buses even when the risk is negligible; they worry about where you’re going or question where you’ve been; they ask about work project you need to finish, wonder what other people in your life are doing, and talk about other aspects of your life not relevant to the immediate situation of piloting your bus over a rough road with weak shock absorbers and the potential to get a flat tire. But, some of those voices are telling you when to rest, ensuring your headache is not a symptom of life-threatening altitude sickness, notifying you of potential risks to avoid such as slippery ice or a possible avalanche or another driver on the road out of control, and other things critical to your safety at the moment.
Your challenge is to acknowledge the voices of all passengers while maintaining focus on piloting your bus regardless of its condition. You can simultaneously acknowledge pain, shortness of breath, worry, anxiety, fear, calmness, and joy while concentrating on being in control of your bus while other drivers are on an ever-changing road.
I focused on piloting my bus and eventually reached Thorang-La Pass, 5,416 meters above the see, almost 3.4 miles in the sky.
As soon as I sat down to rest I realized that one of the other four people there was suffering severe altitude sickness. Her eyes were rolled back into her head, her breathing was in brief gasps, and her pulse was more than 150 beats per minute. She was in shock, and it was likely that pressure was building insider her brain.
None of us spoke the same language; we carried her into the tea hut while her guide was trying a satellite phone to call help. Over the next few hours, we kept her warm in the tea shop while preparing a helicopter landing zone. We carried her and her bags onto the helicopter, which would prioritize getting her to a lower elevation, and then to a hospital.
Shortly before reaching the summit I had a cup of tea in a coffee shop, of sorts. A cheerful entrepreneur had brought gas stoves and tea to a shelter at 17,900 feet. I paid $1.50 for a cup of hot tea; I would have paid a hundred. We kept the woman warm in her hut; I wonder what she would have paid.
The helicopter cost $10,000. It was a private service, and the patient’s guide received a commission for calling it. The tea shop entrepreneur made $1.50. Three years ago, when the storm trapped 500 people here, local people dug through snow without concern for how they would get paid. There’s no right or wrong, just facts. Mindfulness is being aware of facts, but differing judgement until those facts are necessary to make a decision.
I was alone again when the helicopter left and started walking down the other side of the pass. I had been so focused on the rescue that I hadn’t felt pain or symptoms of altitude sickness. I started to notice the pain again. Descending steep trails is harder on your joints than hiking uphill, and my head and joints screamed with pain. When I had descended enough to reduce the effects of altitude sickness, I stopped to eat a Snickers. It was the first food I could hold down in 24 hours; at that moment was the most delicious thing I had ever eaten. In the time it took for my teeth to break through a peanut, all discomfort faded. I had no thoughts, just awareness. The experience continued for several weeks and to a lesser extent remains a year later.
I’m not exagerating that this hike was a life-altering experience. I have a difficult time describing the feeling it because words don’t exist. I’ve read people who believe it’s a call from God, a spiritual awakening, or simply the by-product of brain neurons rearranging to detach from feelings of suffering and attaching to feelings that are more healthy. Some people simply are that way naturally, always seeming positive without worry or unhealthy focus. It took me almost a year to try describing what happened to me, including what’s continued to work for a year, in another article on mindfulness and meditation.
The short version is I benefited from simultaneously focusing on my pain and altitude sickness with the joy of eating a Snickers while being aware that from that point my journey was all down-hill, both literally and metaphorically.
I walked downhill for a few more hours, found a guest house, and enjoyed the sunset. The sunset was beautiful because of ice crystals forming in the air; the lenticular clouds coming from mountain peaks indicated pressure was building and snow would arrive. Two days later it began snowing on the mountain pass I had just summited, and it was raining in the areas of where I would spend the next two weeks. I started hiking through the rain, going off-the-beaten-path and into the Kingdom of Mustang.
Other blogs share key experiences during this trip through Nepal and India. Too much happened to list every detail, but many come out at appropriate times with friends. Many of my side-stories are interesting in the context of main stories in these blogs. If you and I meet, I hope we spend enough quality time together to share stories.
Continue to:
Or, jump forward two weeks:
What the Buddha Taught
This is a summary of What the Buddha Taught, a book published in 1959 by Walpola Sri Rahula based on historical records and original texts. I refer to it in several articles about traveling through Buddhist countries and in articles about public health, especially mindful meditation to relieve chronic pain, so I thought it would be useful to provide a summary within my blog. I’ll share a bit about the book and author then dive into the summary.
15 minute read.
The book
What the Buddha Taught is accepted as a historically accurate introduction into original teachings of the Buddha. Walpola Rahula wrote What the Buddha Taught in the 1950’s, publishing it in 1959, and it continues to be used in college courses on Buddhism or Eastern Religions.
I first read What the Buddha taught in a two-week Eastern Religions course in 1997, part of an accelerated semester I scheduled between regular spring and summer semesters. I was studying civil and environmental engineering and wanted to take what I considered to be simple, easy courses in accelerated semesters so I could focus on the more challenging technical courses during full semesters.
Since 1993 I’ve traveled with sub-goals of exploring ancient cities, technologies (especially civil engineering), and religions. I’d like to start documenting more of the experiences and lessons for the benefit of others, but writing is challenging for me so I do it bit-by-bit.
As I write this article in 2018 I’m enjoying the irony that What the Buddha Taught remains one of the most informative and educational books of my life, one that I continue to see more in as I mature, and that continuously influences my life positively. For me, I’ve come to realize what a genius the Buddha was, a scientists who studied and grew to understood the human mind and a teacher able to explain how others could understand complex concepts.
History of the Buddha
The Buddha was born in 563 AD as Siddhartha Gautama in what is now Nepal. He was the son of a king, living a life of luxury, with a bride and son. At age 29 his life changed when he saw four people who epitomized human suffering: an old person, a sick person, a dead person, and an ascetic denying worldly pleasures in pursuit of spiritual purity. Siddhartha left his life of luxury to understand and cure human suffering.
Siddhattha wandered for six years, studying under famous religious leaders of the time and practicing asceticism to the point of seeming to be emancipated. He never experienced the permanent peace of mind he sought so he abandoned all traditional religious beliefs and went on his own way. Alone, he sat under a tree and meditated, determined not to move until he understood the nature of suffering. A young woman saw his emancipated body and thought he was either dead or a spirit of the tree and offered him rice milk; upon drinking the rice milk strength returned to his body and he became enlightened, from then on known as the Buddha, “The Enlightened One.”
The Buddha spent five weeks near the tree, processing his enlightenment. He didn’t believe anyone would understand, but a traveling Brahman, a man born into the religious class, said that there would be some who would, so for the sake of mankind he should try. The Buddha walked to the village of Sarnath to meet his former teachers, giving his first sermon and “setting the wheel of Dharma in motion.” His former teachers began following him, and for 45 years he taught the young, old, rich, poor, kings, servants, sages, and madmen; his message remained the same until his death at age 80.
After the Buddha died, what Buddhists consider parinirvana, a group of senior monks agreed upon what the Buddha taught, developing them into poetic songs, poems, or chants, that could be recited by groups of people, facilitating memorization and providing a sense of redundancy; the more people who recited the more likely it could be preserved unadulterated. 400 years later the teachings were transcribed into writings known as the Pali Cannon and Dhammapada.
It’s ironic that the Buddha never claimed to be anything other than a human, rebelled against organized religion, and repeatedly encouraged independent thought and analysis, yet in the 2,600 years since the Buddha gave his first sermon Buddhism has become the world’s 4th largest religion, including many who believe that Siddhartha was one of many Buddhas or that all of us have the potential for becoming a Buddha within us. Walpola Rahula used the Pali Cannon, Dhammapada, and analysis of of languages used in the Buddha’s time to summarize what the Buddha taught.
The Four Noble Truths
The first teachings of the Buddha remained unchanged throughout his life and can not be dismissed today; the Buddha taught the four Nobel Truths.
The first Nobel Truth is that suffering exists. The Buddha used the word Dukkha, which is often simplified in English as suffering, but Dukkha is more complex. It includes what is commonly known as suffering, the suffering of getting old, the suffering of disease and sickness, the suffering of loss, pain, anger, sadness, doubt, worry, or any unrest of the mind in suffering, including loss of what is pleasurable. In short, suffering is attachment to things, feelings, or ideas that are impermanent or transient.The second Nobel Truth is the cause of suffering, which is desire, or thirst. Desire for more, desire for less, desire for something to continue, desire for something to end, thirst for becoming, thirst for annihilation.The third Nobel Truth is that suffering can end.The fourth Nobel Truth is the path leading to the cessation of suffering, which the Buddha called the middle way between extremes of indulgence and denial, achieved through the Eightfold Path of Right Speech, Right Action, Right Livelihood, Right Effort, Right Mindfulness, Right Concentration, Right Thought, and Right Understanding.
The Eightfold Path
Scholars group the Eightfold Path differently than original texts, defining them in terms of ethical conduct, mental discipline, and wisdom. Ethical conduct is Right Speech, Right Action, and Right Livelihood. Mental discipline is Right Effort, Right Mindfulness, and Right Concentration. Wisdom is Right Thought and Right Understanding.
The Eightfold Path is:
Right Speech, abstaining from telling lies; slanderous talk; saying things that may bring about disunity or disharmony among individuals or groups of people; harsh, rude, or impolite words; idle, useless, or foolish babble or gossip. When one can not use Right Speech one should practice Noble Silence. This means speaking truthfully, kindly, and beneficially to all; in today’s modern world that would include not sharing information that one hasn’t verified, including on social media and other forms of communication that weren’t known in the time of the Buddha.
Right Action, abstaining from destroying life, stealing, dishonest dealings, illegitimate sexual intercourse, and to strive to help others lead a peaceful and honorable life in the right way. I believe in Right Action and try to practice it, but never understood the nuances of “illegitimate sexual intercourse.” There’s not a lot of original references of the Buddha on this matter; my assumption is that it’s difficult to practice Right Action and Right Speech without including illegitimate intercourse.
Right Livelihood, abstaining from making one’s living in a way that brings harm to others, such as making or selling weapons, intoxicating drinks, poisons; killing animals, cheating, etc. One should earn a living doing things that are honorable, blameless and free from harm to others. I believe that Right Livelihood would also result from Right Speech and Right Action, and that in today’s world Right Livelihood would include abstaining from selling products using advertising that creates a sense of desire or false sense of need in others.
Right Effort, the will to get rid of unwholesome states of mind, prevent unwholesome states of mind from arising, and to produce wholesome states of mind. With respect to Dr. Rahula and vocabulary in both 600 BC and the 1950’s, I believe the intention of Right Effort, sometimes referred to as Right Intention, includes the effort to place oneself in the right situations and mindset for practicing the Eightfold Path. For example, to help Right Speech one should avoid associating with people who engage in or condone unwholesome speech. In other words, Right Effort includes right choices for practicing other aspects of the Eightfold Path.
Right Mindfulness, to be aware of the activities of one’s body, the sensations and feelings of one’s body, the activities of one’s mind, and one’s ideas, thoughts, and perceptions.
Right Concentration, to focus on four stages of mental development. In the first stage unwholesome thoughts like ill-will, anger, lust, worry, or doubt are discarded and feelings of joy and happiness are maintained. Subsequent levels develop one-pointedness of mind, the ability to concentrate on one thing while maintaining joy and happiness, and cummulate with pure equanimity and awareness. I’ve read similar explanations, and my research and experiences would relate Right Concentration to Right Mindfulness; it’s the ability to concentrate on one’s mind or a situation, which is related to Right Mindfulness. In other words, our minds are easily distracted and situations have many aspects, so Right Concentration is focusing on that moment, unperturbed, in a way that’s Mindful, with feelings of joy, happiness, and eventually equanimity.
Right Thought, selfless detachment with thoughts of non-violence, loving kindness, and compassion towards all beings. I would like to add that Right Thought includes both volitional wholesome thoughts and, eventually, seemingly involuntary unwholesome thoughts that may arise in early stages of development and can be observed with Right Mindfulness.
Right Understanding, seeing how things how they really are, having no doubt in the Four Noble Truths, and obtaining the highest wisdom. Right Understanding is different than memory or knowledge, it’s a deeper level of wisdom, truly seeing how things really are. This is possible through meditation, which is often misunderstood or misrepresented in western culture. The word “meditation” is a combination of concentration and analysis. I describe this in detail using my experiences meditating in Kushinagar, India, where the Buddha died; to meditate while maintaining Right Mindfulness is to put forth Right Effort and practice Right Concentration, and when what’s being analyzed is one’s own happiness, one would medicate on Mindfulness and be Mindful while concentrating. This circular pattern is common in Buddhism, and part of the symbolism of “the Wheel of Dharma,” which represents the Eightfold Path.
Nirvana
Nirvana is the state of no suffering. It is realization of the Noble truths and Eightfold Path in understanding and practice, not blind faith.
The Buddha did not ask that his doctrine be followed blindly, he encouraged investigation, analysis, and removing one’s own doubt. He repeatedly emphasize that each person was in control of his or her destiny, that no one else could be responsible, and that mindlessly following traditions or honoring gods would not eliminate suffering: one must practice the path.
The Buddha may have expressed the path differently to different people based on their level of awareness or unique situations at the moment. As Walpola Rapula said, “Practically the whole teaching of the Buddha, to which he devoted himself during 45 years, deals in some way or other with this Path.”
Anyone can practice any aspect of the Path and improve themselves based on their needs and abilities at the moment. This was simplified by one of the Buddha’s first teachings where he said, “each day do more of what you know to be wholesome and less of what you know to not be wholesome.”
The five hindrances to practicing the Eightfold Path and achieving Nirvana, the end of suffering, are:
Lustful desiresIll-will, hatred, or angerTorpor or languorRestlessness or worrySkeptical doubt
The Eightfold Path contains a way to recognize and move beyond the five hindrances. Right Mindfulness which includes being aware of but not judging when any hindrance is present in oneself, to observe the feeling arising or going away, to gain wisdom on the cause of hindrances arising and ceasing.
There are seven factors of enlightenment, and Right Mindfulness includes being aware when they are present in oneself, observing them arising or going away. The seven factors of enlightenment are:
Mindfulness, being aware of physical and mental activitiesInvestigation into various problems of doctrine; I summarize this as critical investigation and removing doubt through wisdomEnergy, to work with determinationJoyRelaxation of both mind and bodyConcentrationEquanimity, a calm mind, tranquility, disturbance
Right Mindfulness is part of allowing detachment from hindrances and acknowledging factors of enlightenment.
Attachment and the Mind
Suffering includes attachment to things, thoughts, ideas, or feelings that are impermanent, transient, or false. We become attached to things that impact our senses: sight, sound, touch, taste, smell, and formations of the mind.
In Buddhist tradition, “mind” not what many people in western cultures consider a “brain” or “intellect.” Mind, called manas or citta in some eastern philosophies, is a faculty, a sense organ, similar to the eye in that it senses, but the mind senses thoughts, ideas, perceptions, feelings, etc. The mind is related to other senses in that it perceives sensations of all senses and attaches meaning to them. That meaning becomes our thoughts, ideas, feelings, etc., which can also elicit physical sensations such as a bad dream causing an elevated heartbeat.
Our mind is part of our consciousness, the part of our life that registers our senses interacting with the world. After consciousness interacts with the world we have perception, identifying the sense as light, sound, flavor, etc. After perception there is sensation; the perception can be sensed as pleasant unpleasant, or neither pleasant nor unpleasant. After sensation there are mental formations, which include volitional actions, things of choice. I learned that this includes subconscious actions, such as muscle tension that’s determent to relaxation, contributing to suffering; one can see this through Right Mindfulness and Right Concentration if one puts forth the Right Effort. Similarly, mental formations can include volitional actions such as attention, determination, concentration, wisdom, energy, etc. Our karma is our volitional action, which is often misused in the western world as the results of our actions, but the Buddha taught that karma was simply volitional choice in words, actions, thoughts, reactions, etc.
When we become attached to any sensation, idea, thought, etc. we may wish to avoid it, may want more of it, or may neither wish to avoid it or crave more of it. We may wish it to not end, or may wish it to not begin again. Attachment to mental formations creates an illusion of “self” that is a cause of suffering.
No self
The Buddha repeatedly said that attachment to the idea of a self, or a soul, or something unknowable, was a false view that created suffering. What we view as a “self” is a series of interactions between consciousness, perceptions, sensations, and mental formations; there is no “self” to be found.
Walpola Rahula shared a story about a Buddhist monk called Nagasena who used a horse-driven chariot as a metaphor when discussing the Buddha’s teachings of “no-self” with a king. I’ll paraphrase it here:
One of the king’s first questions is on the nature of the self and personal identity. Nagasena greeted the king by acknowledging that Nagasena was his name, but that “Nagasena” was only a designation; no permanent individual “Nagasena” could be found. This amused the King, who asked, “Who is it that wears robes and takes food? If there is no Nagasena, who earns merit or demerit? Who causes karma? If what you say is true, a man could kill you and there would be no murder. ‘Nagasena’ would be nothing but a sound.” Nagasena asked the King how he had come to his hermitage, on foot or by horseback? The king replied that he had come in a chariot. “But what is a chariot?” Nagasena asked. “Is it the wheels, or the axles, or the reigns, or the frame, or the seat, or the draught pole? Is it a combination of those elements? Or is it found outside those elements?” The king answered no to each question and Nagasena said, “Then there is no chariot!” The King acknowledged the designation “chariot” depended on these constituent parts, but that “chariot” itself is a concept, or a mere name.
“Just so,” Nagasena said, ‘Nagasena’ is a designation for something conceptual. It is a mere name. When the constituent parts are present we call it a chariot; When [matter, consciousness, perception, sensation, and mental formations] are present, we call it a being.”
Attachment to a self is a cause of suffering because it is a false view. The eightfold path is a path to wisdom where one can see the right view, especially through mindfulness.
Mindfulness
Mindfulness is awareness of all senses, the nature of their rising and falling, and the impermanence of all feelings, thoughts, and ideas. I felt the best way to understand mindfulness was to read the Buddha’s teaching of The Foundations of Mindfulness. It’s long, so I’ll paraphrase it:
There is only one way to overcome suffering, to attain Nirvana: the four foundations of mindfulness. One should live observing the activities of the body, feelings, mind, and mental objects.
Begin observing the body by sitting quietly, legs crossed, body straight, and mindfulness alert, observing the breath. Know when you are breathing a deep breath, know when you are exhaling a deep breath. Know when you are breathing a short breath, know when you are exhaling a short breath. Experience the whole-body breath, and train yourself to concentrate and experience the calming of your whole-body breath. Observe the origin and disolution of body activities.
Further, know when you are sitting, know when you are lying down, know when you are falling asleep, know when you are waking. Be mindful when bending or stretching, eating, drinking, chewing, attending the calls of nature, speaking, or keeping silence. In all mindfulness of the body apply full attention, observing activities of the body internally or externally. Reflect upon your hair, skin, bones, kidneys, lungs, tears, urine, etc. Reflect upon bodies in a cemetery, reduced to flesh, reduced to skeletons, reduced to dust; reflect upon how our bodies are of the same nature. Be mindful of the body until detached.
Live observing feelings, knowing what feels pleasant, feels unpleasant, feels neither pleasant nor unpleasant. Know when experiencing worldly feelings, know when experiencing spiritual feelings, know when experiencing feelings internally or externally. Be mindful of feelings until detached.
Live observing the mind, knowing when the mind is with lust, without lust, with hate, without hate, with ignorance, without ignorance, concentrated, not concentrated, liberated, not liberated. Be mindful of the mind until detached.
Live observing mental objects. Know when the five hindrances are present or not present, knowing that sense-desire is present, knowing that sense-desire is not present, that anger is present, that anger is not present, that torpor and langour are present, that torpor and langour are not present, that restlessness and worry are present, that restlessness and worry are not present, that doubt is present, that doubt is not present. Live observing the five hindrances until detached.
Further, know when the five aggregates of clinging are present and when they are not present, how they arise and how they disappear. The five aggregates are material forms, feelings, perceptions, mental formations, and consciousness; live being mindful of the five aggregates until detached.
Further, live observing the seven factors of enlightenment: mindfulness, investigation of mental objects, energy, joy, relaxation of body and mind, concentration, and equanimity.
Further, live contemplating the Four Noble Truths. Know that this is dukkha (suffering). Know that this is the origin of dukkha. Know that this is the cessation of dukkha. Know that this is the path leading to the cessation of dukkha.
Whoever practices the four foundations of mindfulness in this manner shall achieve Nirvana, enlightenment, freedom from suffering.
Meditation
The Buddha continuously emphasized that one should investigate his teachings, to see the deeper truth, to remove all doubt; the way to do this was meditation, which in the Buddha’s method was closely related to mindfulness. In other words, to meditate on the nature of one’s mind, to reflect on the nature of suffering, and to examine the cause-and-effect of one’s actions.
Meditating on mindfulness begins with being aware of one’s mind. This can be done in a focused, intentional manner such how the Buddha suggested: sit upright and focus on one’s breath, noticing the rise and fall of each breath, observing but not controlling. Similarly one can observe the rise and fall of all senses including distractions of the mind. But, meditation can, and should, be developed so that it’s natural and occurring throughout each day. In other words, as you’re observing your mind’s activities rising and falling, coming and going, you can meditate on the cause of their arising and the nature of their falling, learning for yourself the nature of suffering, it’s causes and it’s cessation. This leads to wisdom and the Right Understanding of yourself and the Right View of how things are for yourself and others.
Wisdom and compassion come from practicing the Eightfold Path, and both are necessary for Nirvana, freedom from suffering. Meditation is a method to gain wisdom from the Eightfold Path using one’s intellect, concentrating and analyzing, learning from experience to “see how things really are.”
Final words
The final words of the Buddha were shared with 1500 monks in attendance. He began by reemphasizing that all he ever taught was that suffering exists, the cause of suffering, the cessation of suffering, and the path leading to cessation of suffering. He asked if anyone had doubt about his teachings, and that if they were too embarrassed to speak out that they should tell one someone else to speak on their behalf. He then ensured that no one was too blame for his death, a final act of compassion directed towards the person who prepared what was not known at the time to be his final meal. Then the Buddha said his final words and final advice,
“All things conditioned by the mind are transient: practice your goal with diligence.”
My parting words for this article
I share some of my experiences in Buddhist countries and my practice of mindful meditation throughout my blog. I am not Buddhist; I see the truth in many things that the Buddha taught based on experience, not faith. When I learned more about the Buddha I became interested in what I did not yet see and began to practice the Eightfold Path with an open mind.
I wish you happiness and freedom from suffering.
Workshop Rules
I have two rules in my workshops: don’t smoke, and put away cell phones, tablets, and laptops. No one questions the first rule, but many professionals want to keep their electronic devices for multitasking during workshops. I created this blog to provide an analogy to smoking that I hope helps people see the benefits of putting aside electronics and focusing on our workshop activities.
3 minute read.
Cultural norms
Not smoking is an obvious rule in today’s world, but not long ago it was culturally acceptable to smoke in professional settings. Tobacco companies even used scientists and educators in advertising campaigns because our professions are considered to be forward-thinking, using facts to make decisions, and in an ideal world we work to benefit society. But even scientists and educators are fallible, and in the 1960’s and 70’s our minds overrode scientific reasoning because of cultural acceptance. In other words, we do not make decisions based only on facts, we make choices based on what’s socially acceptable.
Cell phone and media is addictive and leads to reduced mental well-being but is still culturally acceptable therefor as accepted as cigarettes once were. I believe it’s our responsibility as scientists and educators to make decisions based on facts, scientific research, and what’s best for society. Even if we don’t feel distracted or addicted there’s evidence that other people may become distracted or addicted therefore we should strive to create a culture of awareness; just like lighting up a cigarette in the 1960’s encouraged people to do the same, checking your phone or email during team meetings encourages others to do the same or interrupts their thought process. This contributes to less effective meetings and wasted time, which leads to deadline pressures and a false sense that checking messages throughout the day is a necessary. In other words, even if you ignore addiction to media, our work is less effective when people are distracted.
Multitasking
Multitasking is a myth for most people. We are more effective when we focus, setting clear goals and monitoring our progress for effectiveness rather than jumping between topics. The combination of improved learning and neutral-to-positive impact on the group is why I maintain the two rules of not smoking and not having access to phones, tablets, and laptops.
I stand by these rules because of my observations, review articles, and original studies such as:
M.I.T. Sloan Management Review: Surviving a Day Without Smart Phones
International Journal of Pharmaceuitacal Investigation: Smartphone usage and increased risk of mobile phone addiction: A concurrent study
Frontiers in Psychology: Cell-phone addiction: A review
New York Times: Is your child a phone addict?
American Psychology Association: Multitasking: Switching costs
University of California: What do we lose when we multitask?
In my workshops I say that we can change the rule if a group of students presents their personal observations and fact-based evidence demonstrating that changing the rule would be either positive or neutral for the learning and well-being of our group. That’s fair, and how I believe scientists and educators should make policies that influence society.
In addition to the two rules of no smoking and no phones, my workshops have a few guidelines that promote better physical and mental health. These have less established evidence, but I have personal observations that support what early research is suggesting. Please see my workshop guidelines to learn more.
I wish you health and happiness.
Post-Script: continuous improvement
If you’re smoking and would like to stop, or have any unhealthy behavior you’d like to analyze, please see my article on steps away from addiction or speak with your doctor about modern medicine to reduce nicotine cravings. To increase focus and reduce chattering mind, consider mindfulness and meditation; I experienced benefit from both and modern research is supporting the benefits of this ancient practice on health and mental well-being.
How to make state of the art medical devices
7 minute read.
Beginning in 2020 the new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s often misunderstood by both companies and patients. It does not mean the latest technology, it means the most commonly agreed upon technology, or “generally accepted state of the art.”
This European law is better explained through examples using automobiles, comparing today’s state of the art with new technology in the 1980’s television series Knight Rider, where David Hasselhoff fought crime in a talking, self-driving car.
Watching the 1-minute trailer may brighten your day:
Today, we have talking and self-driving cars, but they are not considered “state of the art” by government regulations, which require state of the art safety features. You’re probably familiar with generally accepted state of the art for automobile safety:
SeatbeltsBrake lightsAir bagsChild safety-seat securing hooksSide-impact safe doors
Self-driving cars exist but they are not mandatory because there’s not enough evidence that they protect public safety yet. Self-driving cars are a new, high-tech feature but are not “generally accepted state of the art.” Similarly, some medical device features seem like good ideas but aren’t “generally accepted state of the art” because there’s not enough evidence that they reduce risk to patients. The MDR requires companies to continuously review competition and public safety reports to prove that they’ve reduced risk to patients As Far As Possible, which includes having state of the art products.
This is easily understood with for cars; in 2016 an estimated 16,000 lives were saved in the U.S. thanks to seat belts. But, healthcare is a bigger risk than automobile accidents, with 80,000 – 250,000 unnecessary deaths in the U.S. each year due to healthcare errors. Similar data worldwide led to the EU MDR, and the U.S. is considering similar healthcare reform. But medical device safety is more complex than car safety, and state of the art is a combination of design, manufacturing process, surgeon training, etc. I’ll demonstrate this with a few examples.
Spine implants:
new technology, not state of the art
This is an example of a new medical technology that’s not state of the art: motion preserving spine implants.
Before motion-preserving spine implants, surgeons used spine-fusion implants to prevent spinal vertebra from moving, usually to protect the spinal cord, sometimes to reduce pain (this is a controversial topic – learn more.)
A concern developed that fusing one set of vertebra caused more motion in other vertebra which led to problems in 6 to 8 years. In the 2000’s several start-up companies developed “motion preserving” spine implants to replace fusion devices.
Motion-preserving devices have not become state of the art because the benefits are unproven and the new technology has higher risks than previous technologies. The added risk come from surgeons having to learn new procedures that are more complex than previous spine implants, and from unknown long-term consequences of the new technologies. The implants shifted over time and many patients suffered unnecessarily. Manufacturers settled class action lawsuits and national health insurance programs refuse to pay for the procedure, especially because it’s 10X more expensive than previous spine implants. Long-term studies of patients with motion-preserving implants haven’t shown benefits that justify the risks or costs.
In other words, new spine technology does not mean it’s state of the art healthcare, it could be adding both risk and costs to public healthcare.
Previous medical device regulations did not enforce state of the art safety, which is why products that add risk and cost are still on the market. Unfortunately, most patients rely on their physicians to advise them despite many surgeons are unaware of the risk/benefit analysis or cost. And, some physicians are incentivised by medical device companies to suggest the more expensive implants. All of this is why the MDR will hopefully benefit society.
Robotic Surgery:
beneficial, not state of the art
This is an example of even new, beneficial technology may not be state of the art because not all hospitals are capable of using the new technology yet.
Many spine surgeries use robotic surgery or some type of nerve-monitoring technology to protect patients’ spinal cords during surgery. This new technology is generally considered beneficial, therefore would almost be considered “state of the art” by the MDR definition, but it is not because it is only true in specific cases where the hospitals have sufficient infrastructure and surgeons are sufficiently trained and experienced. The EU MDR applies to all countries in the European Union, therefore to be state of the art the technology would have to apply to the infrastructure and training of almost 30 European countries.
In other words, a company can sell nerve-monitoring equipment to hospitals based on improved results, but not all spine implant companies would be held to the standard of robotic surgery outcomes because these new technologies aren’t yet “generally accepted state of the art.”
Hip implants:
established technology, not state of the art
Hip implants have been available since 1940, before David Hasselhoff was born, yet we still struggle understanding what is and what is not state of the art because designing, manufacturing, and shipping medical devices is much more complex than automobile safety features like seat belts and child safety seats.
To emphasize the complexity of state of the art for medical devices I’ll use terminology that probably seems confusing unless you’re familiar with hip implants, which is a challenge for patients having informed choices in healthcare.
When a patient needs a hip implant they rarely don’t review the current materials, noting differences between percentages of Chrome in CoChMg femoral heads, hardness and pitting resistance from heat-treating, or smoothness from polishing. We don’t know to investigate the density and cross-linking of UHMWPE in plastic liners, or the pore size, edge sharpness, and structure of nano-material porous structures on the acetabular component and femoral stem. Nor do we know if the coating is Ti6Al4V or Ti6Al4V ELI, much less know if their processing ensures that a titanium oxide layer forms and prevents the toxic material Vanadium from leaching out.
Are the the tools and instruments used for the surgery state of the art? Tools that are improperly categorized or instruments that aren’t user-friendly have led to mis-matched implants that failed and require secondary surgeries. Do the instruments ensure proper alignment of the hip stem? As little as 3 degrees variance can add risk of eventual failure.
Has the company’s quality system ensured replacing all instruments with updated versions? Are surgeon’s adequately trained, especially knowing that research shows that 60% of the reason for an implant failure is the skill of the surgeon. What if a surgeon has higher failure rates, is that tracked and monitored so a patient can make informed choices?
What about how the implant was made? We don’t know if manufacturing processes have state of the art cleaning procedures or if a company’s quality control is state of the art and would catch mistakes.
An example of a quality-system gap in hip implants is the Sulzer hip stem recall. 35,000 hip stems were shipped with toxic machining oil still in them. Over 9,000 were implanted before the mistake was caught, and almost 4,000 people had their femoral bones erode, requiring another surgery and impacting their ability to walk for the rest of their lives. Over $1 Billion in lawsuits bankrupted Sulzer, but patients said they’d rather walk normally than have received insurance money.
The reason for Sulzer’s recall was traced to a seemingly simple decision on their manufacturing line that even today would be difficult to detect and monitor, much less simplify for patients to understand. The Sulzer hip implant recall was just one example, many more exist.
Oh shit, now what?
The EU-MDR can’t define what is state of the art for every situation so it requires that each product be compared to competitive products’ safety features every 1-2 years. In other words, each company must prove that they are “state of the art,” and what is considered state of the art will change based on competitive technologies and what is “generally considered state of the art.”
Companies must submit two documents supporting their product, post-market surveillance and clinical data. Post-market surveillance is current, real-world data on the safety of each product or group of products. Clinical data includes competitors’ products, safety data, and alternative treatments; post-market surveillance includes the manufacturer’s product safety. State of the art is demonstrated by comparing clinical data to post-market surveillance.
For now, companies must do their best to find clinical data publicly. In the future all companies and the general public will have access to this information online. The MDR is creating new agencies that will look at this data and see if medical device features truly improve patient safety; if so, those features will become state of the art. This is similar to how governments currently treat automotive safety.
Government regulations require state of the art in new cars but do not enforce all innovations until there’s enough evidence that these features impact public safety. Agencies such as the U.S. National Highway Traffic Safety Administration (NHTSA) keep consumers informed about new technologies that aren’t required.
Over time, these features may prove that they add to public safety enough to be considered state of the art, at which time they may become required by regulations. Similarly, medical devices sold in Europe will be tracked online in the EUDAMED database, which is still being designed and will probably continuously improve.
The EU-MDR will try to minimize risks to patients by ensuring that new technologies are compared to generally accepted state of the art in terms of patient safety, and that new technologies are justified when the benefits outweigh additional risks. See my article on risk-benefit analysis for that step.
Summary
“State of the art” for the EU MDR does not mean the latest technology, it means the features and systems that are proven to reduce risk to patients.State of the art must be established every year for Class III and IIb medical devices, two years for Class IIa devices, and “as necessary” for Class I devices.State of the art is complex, based on a combination of product features, manufacturing processes, training, and the realities of hospital systems in diverse countries.The MDR will create an online database, EUDAMED, with transparent, public data on medical device safety. That data will be used to determine “state of the art,” but until then companies must seek and use published research data.
State of the art requires complying with Risk Management priorities, which is described in another article Reducing Risk As Far As Possible
Learn more
There’s more to MDR. For example, there are requirements on how to update safety concerns and which information must be displayed on a company’s web page. You can learn in my articles on The Big Picture or, if you’re familiar with previous European medical directives, “MDR: the medical device regulation formerly known as MDD“
The MDR will be mandatory by 2020; to be fully prepared consider working with one of these training or consulting companies to help your team prepare.
Oriel STAT-A-MATRIX an international organization since 1968 (I consult with Oriel)
Qunique, based in Switzerland and expanding internationally
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For fun…
Someone spent 10 years converting their 1984 Trans Am into a replica of David Hasselhoff’s Knight Rider car, complete with the same voice and 1980’s “state of the art” technology. Watch it here: