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Erica Frenkel 談世界通用的麻醉機

Erica Frenkel: The universal anesthesia machine

 

Photo of three lions hunting on the Serengeti.

講者: Erica Frenkel

2011年 12月演講,2012年2月在TEDxMidAtlantic上線

 

翻譯:甘貞珍博士

編輯:朱學恆、洪曉慧

簡繁轉換:洪曉慧

後製:洪曉慧

字幕影片後制:謝旻均

 

影片請按此下載

MAC及手持裝置版本請按此下載

閱讀中文字幕純文字版本

 

關於這場演講

我們正在動手術,停電了怎麼辦?沒有燈光,沒有氧氣-麻醉氣體停止輸出。這種情形在全世界醫院裡不停地發生,使簡單的手術變成一場悲劇。Erica Frenkel展示了一個解決方案:世界通用的麻醉機。

 

關於Erica Frenkel

Erica Frenkel是UAM Global計劃主任,希望使全世界醫院都能擁有安全的麻醉裝置。

 

為什麼要聽她演講

Erica Frenkel協助領導UAM Global,這是一個試圖透過創新麻醉科技裝置增加外科手術安全性的社會企業。她曾擔任和平團志工,為Kaiser家族基金會執行全球媒體愛滋病宣言(Global Media AIDS Initiative)的工作,曾擔任柯林頓基金會、利比亞衛生部、默克疫苗公司和惠康基金會顧問,協助提倡公共健康議題。

 

Erica Frenkel的英語網上資料

Home: UAM Global

Twitter: @EricaFrenkel

 

[TED科技‧娛樂‧設計]

已有中譯字幕的TED影片目錄(繁體)(簡體)。請注意繁簡目錄是不一樣的。

 

Erica Frenkel 談世界通用的麻醉機

 

我今天要談的是為資源不足情況下所設計的醫療器材。我研究這些國家的健保系統,發現幾乎整個健保系統都存在一個重大缺口,就是缺乏安全外科手術的途徑。我們發現主要瓶頸之一是麻醉,沒有它根本無法動手術,它更與手術安全息息相關。事實上,我們期盼能有一個可行的模式,使任何環境下都能確保麻醉順利進行。

 

這是一個在美國或其他先進國家手術室中常見的場景,背景中有一台相當精密的麻醉儀器,這台機器使我們能施行手術、挽救生命。因為它的設計是依據環境需求,為了操作這部儀器,醫院必須提供一些配套措施;它須要一名訓練有素並有多年操作精密儀器經驗的麻醉師,監測氣體的流動,確保病患在手術全程中得到安全又適當的麻醉。它是一部用電腦程式控制的精密儀器,需要藉由特定的TLC(儀器)來維持它的運作。它很容易壞,若壞了,就需要一組瞭解它複雜性的生醫工程師進行修理、檢查零件、維持它拯救生命的功能。

 

這是一台相當昂貴的機器,必須是一個間預算足夠的醫院,才買得起這台高達五萬至十萬美元的機器。也許最顯而易見、最重要、我們所知的一些概念多少能說明這個問題;它須要能供應穩定電力和壓縮氧氣的基礎設施,還有其他使這部儀器得以運轉的重要醫療設備。換句話說,這部機器需要的許多設備都不是這間醫院能提供的。

 

這是一間位於馬拉威偏遠地區醫院的供電設備,在這所醫院中只有一位合格的麻醉師,她夠格的原因是,她接受過十二或十八個月的麻醉訓練。在這所醫院,甚至整個區域中,一位生醫工程師也沒有,所以當機器壞了,他們只能將就著用。他們會試著修理,但大多時候,這部機器就此報銷,這些機器會被扔進垃圾場。我剛才說過,這部機器的價格也許佔了這所小醫院全年預算的四分之一,甚至三分之一。

 

最後,我想你們明白,這裡的基礎設施不是很好,醫院連接的供電網很弱,經常停電,所以整所醫院經常只靠一部發電機運作。你可以想像,也會有發電機故障或燃料用盡的情形。世界銀行看見這種情況,估計在低收入國家中,一所像這樣的醫院每個月大約會遭受十八次斷電之苦。同樣的,壓縮氧氣和其它醫療設備簡直可說是奢侈品,缺貨期往往長達幾個月,甚至一年。

 

這種情況似乎很瘋狂,但我們現有的模式是,將這些針對我最初展示給你們看的環境所設計的儀器,捐贈或是出售給處於這種環境的醫院。這種作法不但不恰當,而且相當不安全。

 

我們在約翰霍普金斯大學的一位夥伴,大約一年前在Sierra Leone 觀察外科手術進行,那天的第一個手術是婦產科手術,一名婦女須要緊急剖腹生產,以保全她自己和嬰兒的生命。開始時一切都很順利,外科醫師已準備就緒,護士也在場,她很快就可以接受麻醉。因為情況緊急,所以這很重要,一切都進行的很順利-直到停電時。手術正在進行當中,外科醫師爭取時間完成手術,這是他能辦到的-因為他戴著頭燈,但護士只能在黑暗的手術室裡四處摸索,試著尋找任何能麻醉她病人的東西,使產婦保持昏迷狀態。因為沒電,機器無法運轉。也許你們當中許多人都動過像這樣平常的手術,也許有些人是經由這種手術生產,現在這卻成了一場悲劇。更令人沮喪的是,它並不是單一的偶發事件,這種情形在開發中國家很普遍,每年有三千五百萬例手術是在缺乏安全麻醉的情況下實施。

 

我的同事Paul Fenton博士就處於這樣的環境中,他是馬拉威一所教學醫院的麻醉科主任,他每天都在這樣的手術室中工作,試著為病人麻醉及教導他人如何進行麻醉,在他的醫院裡使用同樣既不可靠又不安全的設備。經過無數次手術後,你能想像,實在是難以形容的悲劇,他說,「我受夠了,我不幹了,實在夠了,我們必須有更好的儀器。」他走出大廳,前往堆放他剛剛抱怨過的那些儀器的丟棄處,我想大概就是這些科學儀器。他開始進行整修,他東拼西湊的,試著造出一台儀器,可在他所處的環境中派上用場。

 

這就是他製造出的成品,一部世界通用的麻醉機原型,一部能運作、麻醉病人的麻醉機-無論醫院的環境如何。十二年後,他回到家鄉同一所醫院中,將它稍做改善,使用於各個年齡層的病人身上。

 

現在讓我稍微解說這部機器如何運作,看!就是這部機器,當有電的時候,所有功能都從機器的基座裡發動,下方有一個內建的氧氣濃縮器。你們已經聽我提到氧氣好幾次了,基本上,為了傳送麻醉藥物,氧氣的純度必須盡可能高,因為你最後會用氣體來稀釋它,病人吸入的混合氣體必須含有一定比例的氧氣,否則會產生危險。所以,當有電的時候,氧氣濃縮器會吸入室內空氣。我們都知道,空氣免費,來源豐富,而且已經含有百分之二十一的氧氣,所以濃縮器只須要吸入空氣,將它過濾,將百分之九十五的純氧送入這裡,在此與麻醉氣體混合。

 

在混合氣體抵達病人肺腔之前,它會通過這裡,雖然你們看不見,但這是個氧氣偵測器,螢幕會顯示氧氣的百分比含量。現在,如果停電時,或者,但願不會發生,手術過程中突然停電,你不需手動操作,這部機器就會自動轉換模式,用這個入口吸入室內空氣。

 

所有其他部份都保持原狀,唯一的差別是,現在你只有百分之二十一的氧氣可使用,這曾經是手術中危險的賭局,因為你總是在悲劇發生後才發現送氧不足,但我們在這裡裝了長效備用電池,這是儀器中唯一使用電池的部份,但這使操作者無論在是否有電的情況下都能進行掌控,因為他們可以根據螢幕上的含氧百分比調整供給病人的氧氣流量。

 

無論在是否有電的情況下,有時病人須要我們協助呼吸,這是麻醉時會遇到的實際情形。病人的肺臟或許已經麻痺,所以我們加裝了一個手動式風箱,我們曾經見過在歷時三、四小時的手術中,病人藉著它進行呼吸。

 

這並不是一個複雜的儀器,我不敢說它簡單,就說它不複雜吧!它經過精心設計,你不必經過嚴格訓練,也不必是專業麻醉師就能操作。這很棒,因為在偏遠的醫院裡,你根本無法得到那種層級的培訓,它也是根據使用環境而設計的。

 

這部機器相當堅固耐用,它必須能承受住在偏遠醫院中可能發生的高溫和磨損;它不容易壞,若是壞了,機器裡幾乎每一個零件都能用老虎鉗和螺絲起子卸下及替換。最後,它的價格不高,這部機器的價錢是前面提過的傳統麻醉機的八分之一。換句話說,我們有了一部能進行手術及挽救生命的機器,因為它是為了使用環境而設計,就像我最初展示的機器一樣。

 

但我們並不就此滿足,它真的能用嗎?這樣的設計確實管用嗎?到目前為止,它表現得很好,我們已在4個國家、13所醫院中使用它,從2010年開始,我們已順利進行了兩千多例手術,並未發生任何臨床上的嚴重不良事件。我們樂壞了,這似乎是個經濟又可推廣的方案-對於一個普遍存在的問題來說,但我們還是想確認這是可以設置在醫院裡,最經濟且安全的設備。

 

因此,我們與一些非政府組織及大學展開幾項合作計劃,收集使用者方面的資料,觀察它適用於何種外科手術,以及改善機器本身的方法。其中一項計劃的合作者是巴爾的摩的約翰.霍普金斯大學,他們在巴爾的摩有一間很棒的麻醉模擬實驗室,所以我們將機器帶去,重現一些機器可能在手術室中面臨的危機,使它分別處於原本設計上預設的環境中,及一個受控制的安全環境下,評估這台機器的功效,我們因此得以將研究結果和實際經驗比較,因為我們打算在Sierra Leone的約翰霍普金斯合作醫院中安裝兩台這種機器,包括之前提到的進行緊急剖腹生產的醫院。

 

我談了很多關於麻醉的事,這正是我想談論的題材,我認為麻醉非常有趣,也是醫療中非常重要的一環,但它似乎未得到重視。我們從未留意它,直到我們無法獲得的時候,它才變得茲事體大。哪種儀器能使手術進行?哪種儀器能使手術安全進行?但你們知道,這個設計只是許多方法中的一個恰當的設計,可以對醫療結果產生重大影響,如果有更多醫療領域的人,能致力於解決一些低收入國家面臨的挑戰,可以開始進行設計,尋找解決方案,跳脫已知的框架,深入研究實際的醫療環境,也就是說,如果我們能針對世界上各個不同環境設計儀器,而不是為我們理想中的環境設計,我們就可能挽救許多生命。

 

謝謝各位。

 

(掌聲)

 

以下為系統擷取之英文原文

About this Talk

What if you're in surgery and the power goes out? No lights, no oxygen -- and your anesthesia stops flowing. It happens constantly in hospitals throughout the world, turning routine procedures into tragedies. Erica Frenkel demos one solution: the universal anesthesia machine.

About the Speaker

At Gradian Health Systems, Erica Frenkel works to bring safe anesthesia to hospitals all over the world. Full bio »

Transcript

I'm going to talk to you today about the design of medical technology for low resource settings. I study health systems in these countries. And one of the major gaps in care, almost across the board, is access to safe surgery. Now one of the major bottlenecks that we've found that's sort of preventing both the access in the first place and the safety of those surgeries that do happen is anesthesia. And actually, it's the model that we expect to work for delivering anesthesia in these environments.

Here we have a scene that you would find in any operating room across the U.S. or any other developed country. In the background there is a very sophisticated anesthesia machine. And this machine is able to enable surgery and save lives because it was designed with this environment in mind. In order to operate, this machine needs a number of things that this hospital has to offer. It needs an extremely well-trained anesthesiologist with years of training with complex machines to help her monitor the flows of the gas and keep her patients safe and anesthetized throughout the surgery. It's a delicate machine running on computer algorithms, and it needs special care, TLC, to keep it up and running, and it's going to break pretty easily. And when it does, it needs a team of biomedical engineers who understand its complexities, can fix it, can source the parts and keep it saving lives.

It's a pretty expensive machine. It needs a hospital whose budget can allow it to support one machine costing upwards of 50 or $100,000. And perhaps most obviously, and perhaps most importantly -- and the path to concepts that we've heard about kind of illustrate this -- it needs infrastructure that can supply an uninterrupted source of electricity, of compressed oxygen and other medical supplies that are so critical to the functioning of this machine. In other words, this machine requires a lot of stuff that this hospital cannot offer.

This is the electrical supply for a hospital in rural Malawi. In this hospital, there is one person qualified to deliver anesthesia, and she's qualified because she has 12, maybe 18 months of training in anesthesia. In the hospital and in the entire region there's not a single biomedical engineer. So when this machine breaks, the machines they have to work with break, they've got to try and figure it out, but most of the time, that's the end of the road. Those machines go the proverbial junkyard. And the price tag of the machine that I mentioned could represent maybe a quarter or a third of the annual operating budget for this hospital.

And finally, I think you can see that infrastructure is not very strong. This hospital is connected to a very weak power grid, one that goes down frequently. So it runs frequently, the entire hospital, just on a generator. And you can imagine, the generator breaks down or runs out of fuel. And the World Bank sees this and estimates that a hospital in this setting in a low-income country can expect up to 18 power outages per month. Similarly compressed oxygen and other medical supplies are really a luxury and can often be out of stock for months or even a year.

So it seems crazy, but the model that we have right now is taking those machines that were designed for that first environment that I showed you and donating or selling them to hospitals in this environment. It's not just inappropriate, it becomes really unsafe.

One of our partners at Johns Hopkins was observing surgeries in Sierra Leone about a year ago. And the first surgery of the day happened to be an obstetrical case. A woman came in, she needed an emergency C-section to save her life and the life of her baby. And everything began pretty auspiciously. The surgeon was on call and scrubbed in. The nurse was there. She was able to anesthetize her quickly, and it was important because of the emergency nature of the situation. And everything began well until the power went out. And now in the middle of this surgery, the surgeon is racing against the clock to finish his case, which he can do -- he's got a headlamp. But the nurse is literally running around a darkened operating theater trying to find anything she can use to anesthetize her patient, to keep her patient asleep. Because her machine doesn't work when there's no power. And now this routine surgery that many of you have probably experienced, and others are probably the product of, has now become a tragedy. And what's so frustrating is this is not a singular event; this happens across the developing world. 35 million surgeries are attempted every year without safe anesthesia.

My colleague, Dr. Paul Fenton, was living this reality. He was the chief of anesthesiology in a hospital in Malawi, a teaching hospital. He went to work every day in an operating theater like this one, trying to deliver anesthesia and teach others how to do so using that same equipment that became so unreliable, and frankly unsafe, in his hospital. And after umpteen surgeries and, you can imagine, really unspeakable tragedy, he just said, "That's it. I'm done. That's enough. There has to be something better." So he took a walk down the hall to where they threw all those machines that had just crapped out on them -- I think that's the scientific term -- and he just started tinkering. He took one part from here and another from there, and he tried to come up with a machine that would work in the reality that he was facing.

And what he came up with was this guy, the prototype for the Universal Anesthesia Machine -- a machine that would work and anesthetize his patients no matter the circumstances that his hospital had to offer. Here it is back at home at that same hospital, developed a little further, 12 years later, working on patients from pediatrics to geriatrics.

Now let me show you a little bit about how this machine works. Voila! Here she is. When you have electricity, everything in this machine begins in the base. There's a built-in oxygen concentrator down there. Now you've heard me mention oxygen a few times at this point. Essentially, to deliver anesthesia, you want as pure oxygen as possible, because eventually you're going to dilute it essentially with the gas. And the mixture that the patient inhales needs to be at least a certain percentage oxygen or else it can become dangerous. But so in here when there's electricity, the oxygen concentrator takes in room air. Now we know room air is gloriously free, it is abundant, and it's already 21 percent oxygen. So all this concentrator does is take that room air in, filter it and send 95 percent pure oxygen up and across here where it mixes with the anesthetic agent.

Now before that mixture hits the patient's lungs, it's going to pass by here -- you can't see it, but there's an oxygen sensor here -- that's going to read out on this screen the percentage of oxygen being delivered. Now if you don't have power, or, God forbid, the power cuts out in the middle of surgery, this machine transitions automatically, without even having to touch it, to drawing in room air from this inlet.

Everything else is the same. The only difference is that now you're only working with 21 percent oxygen. Now that used to be a dangerous guessing game, because you only knew if you had given too little oxygen once something bad happened. But we've put a long-life battery backup on here. This is the only part that's battery backed up. But this gives control to the provider, whether there's power or not, because they can adjust the flow based on the percentage of oxygen they see that they're giving their patient.

In both cases, whether you have power or not, sometimes the patient needs help breathing. It's just a reality of anesthesia. The lungs can be paralyzed. And so we've just added this manual bellows. We've seen surgeries for three or four hours to ventilate the patient on this.

So it's a straightforward machine. I shudder to say simple; it's straightforward. And it's by design. And you do not need to be a highly trained, specialized anesthesiologist to use this machine, which is good because, in these rural district hospitals, you're not going to get that level of training. It's also designed for the environment that it will be used in.

This is an incredibly rugged machine. It has to stand up to the heat and the wear and tear that happens in hospitals in these rural districts. And so it's not going to break very easily, but if it does, virtually every piece in this machine can be swapped out and replaced with a hex wrench and a screwdriver. And finally, it's affordable. This machine comes in at an eighth of the cost of the conventional machine that I showed you earlier. So in other words, what we have here is a machine that can enable surgery and save lives because it was designed for its environment, just like the first machine I showed you.

But we're not content to stop there. Is it working? Is this the design that's going to work in place? Well we've seen good results so far. This is in 13 hospitals in four countries, and since 2010, we've done well over 2,000 surgeries with no clinically adverse events. So we're thrilled. This really seems like a cost-effective, scalable solution to a problem that's really pervasive. But we still want to be sure that this is the most effective and safe device that we can be putting into hospitals.

So to do that we've launched a number of partnerships with NGOs and universities to gather data on the user interface, on the types of surgeries it's appropriate for and ways we can enhance the device itself. One of those partnerships is with Johns Hopkins just here in Baltimore. They have a really cool anesthesia simulation lab out in Baltimore. So we're taking this machine and recreating some of the operating theater crises that this machine might face in one of the hospitals that it's intended for, and in a contained, safe environment, evaluating its effectiveness. We're then able to compare the results from that study with real world experience, because we're putting two of these in hospitals that Johns Hopkins works with in Sierra Leone, including the hospital where that emergency C-section happened.

So I've talked a lot about anesthesia, and I tend to do that. I think it is incredibly fascinating and an important component of health. And it really seems peripheral, we never think about it, until we don't have access to it, and then it becomes a gatekeeper. Who gets surgery and who doesn't? Who gets safe surgery and who doesn't? But you know, it's just one of so many ways that design, appropriate design, can have an impact on health outcomes. If more people in the health delivery space really working on some of these challenges in low-income countries could start their design process, their solution search, from outside of that proverbial box and inside of the hospital -- in other words, if we could design for the environment that exists in so many parts of the world, rather than the one that we wished existed -- we might just save a lot of lives.

Thank you very much.

(Applause)
 


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