Ever heard of the “lethal bed story”? Theranos Series
We will dissect Theranos quality issues so you DO NOT repeat them in the future, BUT have you ever heard of the urban legend of the Pelonomi Hospital in South Africa?
When every Friday morning the occupant of a particular ICU bed was found dead, after excluding numerous logical explanations, such as bacterial infections, the nurses concocted the “lethal bed story.”
Only later was it revealed that the janitor would unplug the life support equipment while cleaning the floors, accidentally killing the patient in the process.
Although the life support equipment was performing as intended, failure to include any warnings against unplugging or alarms alerting to equipment disconnection from the power source resulted in patients’ death.
QUE QUE?! Yeap, this happened, and I am 100% sure that we can do better than this! And this is exactly why you should care about Risk Management.
I thought it was worth mentioning this lethal design failure from 2007 turned into an urban legend at the Pelonomi Hospital to expose the impact of poor Risk Analysis.
Theranos is a pop culture, and they DID have Risk Management issues as well, which DID HARM patients.
Take a look HERE at Therano’s FDA Risk Management Observation 4 from the Palo Alto inspection.
Simply put, Theranos, for whatever reason, did not or did an incredibly poor job considering the risks associated with their in vitro diagnostic device (IVD). The latter results in the exact outcome that Theranos had, which is a faulted technology that harmed patients.
Risk Management is not optional. It is a global regulatory requirement simply because we have a collective interest in ensuring that medical devices are safe and effective for patients.
The reality is that Risk Management is one of the most complex requirements, and this is what you can start doing to get your risk management ducks in a row:
Risk Management Shielding Action - Numero Uno #1
Just like any good process, you want to start with a plan that is specific to each device/device family.
You would think “duh, of course, you need a plan first”
but there is a tendency in the industry to jump into identifying risks. The new Risk Management guidance (ISO 14971:2019 and ISO/TR 2497:2020) emphasizes the importance of creating a Risk Management Plan first, and this is ultimately good advice.
The purpose of this plan is to help you establish the company’s risk acceptability criteria:
What is Low Risk vs High Risk, Acceptable vs Not So Much
along with all the detailed steps for risk analysis, risk evaluation, risk control, and review and reporting.
Risk Management Shielding Action - Numero Dos #2
You want to go HARDCORE on identifying risks associated with your medical device at ALL stages in the device’s life-cycle: from product design to procurement to production to market use and surveillance.
DO NOT DO what Theranos did: #NADA!
For example, think of all possible risks from:
When the device arrives at the hospital: e.g. improper labeling
It is opened in the OR: e.g. sharp edges, slippery surfaces.
Implanted: e.g. improper fit, damaged sterile package, insufficient material volume
Explanted: e.g. difficult to remove due to tissue adhesion
You get the point!
In all cases, the goal is to analyze, evaluate, control, and monitor the risks associated with each life-cycle stage. Also, the risks associated with the hazards, including those resulting from user error, should be calculated in both normal and fault conditions.
#ShieldYourself #ShieldToSavePatients
Risk Management Shielding Action - Numero Tres #3
It is now time to go on CONTROL mode
All identified unacceptable risks must be reduced or eliminated through risk control measures and monitoring. Your priority should be achieving inherent safety by design or reducing/eliminating risks by design which means this feedback into, wait for it
Your Design Specification Matrix!
This was a MAJOR ISSUE with Theranos. For example, let’s say you are developing biopsy forceps, and one potential identified hazard is material degradation due to high temperatures during steam sterilization. To reduce or eliminate this risk, you can use a thermo-resistant material, and add pressure and temperature recording and alarms as further measures.
By the way, BIOMATERIALS, do you love them, or do you love them?!
The bottom line, identifying the device’s design risks prior to getting them to market eliminates costs associated with recalls and MOST importantly prevents patients' harm.
It is just the RIGHT thing to do!
Please, take this time to go deep into your device’s Risk Management. This is critical for building your armor to shield your genius medical solution, your company, your investors, and most importantly the patients and communities you want to serve.
#ShieldSomeMORE
if you’d like access to the entire Theranos series and more Shielding Actions, get it HERE
If you are building a medical device and have no clue of what I am talking about, this is an emergency, please call me immediately!
And if you would like more help and clarity, also Book A Call to learn more about how Genius Shield can help you bring your invention to market seamlessly + safely like only the Genius Shield team can!
May the innovation force be with you