I have been working with medical devices for a long time – since 2004 to be exact. It started with working on Hospira’s analgesic infusion pump called the PCA3. An analgesic infusion pump is used in a hospital setting when a patient is in severe pain. The pump delivers powerful narcotics (usually Morphine, Dilaudid, Fentanyl) to a patient who has undergone a severe traumatic event like:
- A gun shot
- A major surgery
- Second or third degree burns
My responsibility to the project was straight-forward but challenging:
1. Get the requirements from Marketing and the Clinicians.
2. Document the Requirements for Design Verification.
4. Manage the project’s schedule and budget.
5. Write the software for the new auto-programming features which would eliminate ALL human errors during medication administration.
6. Run the Hazard Analysis and Fault Tree Analysis process with the engineers to ensure we had every failure mode covered with a control and redundancy.
8. Handle the configuration management of the project including: merging different code baselines, releasing the code to manufacturing and signing off that everything was done according to our process.
9. Travel to Chicago, San Diego, New Jersey and other US cities to meet customers face to face. I always find meetings to be more productive when they are face to face. I know things are different now due to COVID-19.
This was a Class II FDA Regulated Medical Device and people’s lives were on the line if we all failed to work together and build the safest analgesic pump the world has ever seen.
My chest hurts, is it heartburn?
Like everyone else, I have been to a hospital emergency room either for myself or due to family members being severely ill. But, I never imagined that I would be the one whose life needed saved after suffering from a widowmaker heart attack at age 47. It was May 9th, 2022 and I had just left the park in Fortville and was on my way to see my parents in Fishers Indiana. While driving in my car, my chest started to hurt. I kind of thought to myself that it must be heartburn and could have been something I ate. It was night time and I knew I was going to be at my parents in 10 minutes, so I just kept driving. However, the pain got worse. I also started to notice something like “vertigo” where everything felt surreal. My car started to go off the road and I would have to correct it. Now I was really scared and a lot of pain.
I pulled over to the side of the highway and began to panic. I picked up my cell phone and tried to dial 911. I COULDN’T. My brain was telling my hands to move and press 9-1-1, but nothing was happening. I tried to talk, but I couldn’t. What is going on I thought to myself. What am I going to do? I can’t drive, I can’t talk, I can’t dial 9-1-1 !!!!
The Fishers Fire Department and a defibrillator to the rescue
I didn’t know what else to do at this point, so I somehow pushed my door open and crawled out to the middle of the highway. I saw the oncoming lights of a car on the highway, but I didn’t care. I just put my hands up in the air hoping they would see me. I heard the screeching of the tires as the car I assume was trying to avoid from running over me…
This part gets hazy. I hear a man’s voice – I think he is on the phone dialing 911. I hear another voice. It is a female voice. She is saying some kind of prayer. I can’t talk, I can’t move. I am in a ton of pain. It seemed like an eternity, but the Fishers Fire Department arrived in no time. But after they arrived, things went black…
The next thing I remember is waking up in the back of an ambulance. I hear the sirens, I hear some people yelling, the ambulance is moving fast as I jerk around from side to side. This is when I knew something serious was happening and that perhaps I was having a heart attack. The paramedics were yelling to the driver to get me to Community North in Indianapolis now. I can see the paddles of the defibrillator as they are basically shocking me back to life. I lose consciousness again.
The good Doctors and Nurses at Community North Heart and Vascular putting in a stent to save my life
I gain consciousness again. I can barely see again – just white lights and people yelling. My pants are being ripped off. I can’t move or talk. I then hear a buzzing sound and feel something above my genital area. My pubic hair is being shaved off my groin. I can hear what the healthcare workers are saying, but I won’t comment on that . So what is happening is that they are preparing to insert a stent into my heart, but it need to be inserted through my groin. Who knew? Not me.
Everything goes black as they start to put me under for the Operation Room. You will have to ask my surgery team at Community North what happened next.
I wake up in a hospital bed. My daughter Stella is holding my hand on the right side. My mom is holding my left hand. I’m like “what happened”? My family tells me that I have had a widow maker heart attack. The cardiologist tells me that I just suffered a widow maker heart attack and that I am lucky to be alive. What??? She tells me that they have done their best and gave me the “Bentley” of heart stents from Boston Scientific called the Synergy XD. What a relief, I guess? I am so confused at this point. So is Dr. Sheila Gamache.
When begin to discuss what happened. She looks at my medical history and tells me that she is perplexed as to why I would have a heart attack. I am thin, low cholesterol, no diabetes, perfect blood pressure, I exercise, I eat fairly well (just not enough). Every doctor has told me that I have better health than people in their 20s. I have very little plaque build up on my arteries. No family history of heart disease. So what the heck happened?
I begin to tell my Cardiologist and care team about how much stress I have been under lately. I won’t get into the details of that right now, but I will open up about it later in life. Due to some life stressors, plaque broke off the wall of my arteries and then travelled into my left ventricle and created a dam. I later learned that my heart stopped three times and the maximum time that it had stopped was 66 seconds. I now have to live with the ramifications of my brain not receiving blood and oxygen which is not good. I have cognitive problems that I will have to deal with the rest of my life. The BIGGEST thing my care team told me to do was to take care of myself first and eliminate the stress from my life. I heard them loud and clear. Sometimes things can be a blessing in disguise.
So, what is the moral of this story and how can LFT Software help you? Well, you never know when a friend, colleague or family member is going to just drop right in front of you. Will you know what to do? Do you know CPR? Do you know how to find the nearest defibrillator? No one ever things it is going to happen to them until it does. You should always be prepared. Look around. Those AED defibrillator devices on the wall save over 1,700 lives every year. When it comes to engineering, it is important that you don’t lose sight of what you are building and who you are building it for. It isn’t just some piece of software. At LFT Software, we do our best to not just build high quality working software, we do our best to understand the needs of the end user. We have done a ton of research on end users, user testing, patient risk management. That is the only way you know you have built a “safe” and “effective” medical device. Usability and safety are directly correlated when it comes to medical devices. I learned this from various other human factor engineers like
Don’t wait until tomorrow to see your doctor. Don’t wait until tomorrow to learn CPR. Don’t wait until tomorrow to find the nearest defibrillator at your work, your kid’s school, sporting events, etc… This is an important misperception; heart attacks are not just an older man’s disease. More women and even teenagers are dying from cardiac arrest. Remember, you have to take care of yourself first! You are no good to anyone dead.