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Why "Defining a Process" Is Not Enough For Medical Device Recalls

January 31, 2022

Hospitals and doctor’s offices are filled with medical supplies and devices that are utilized to save people’s lives every single day and just like cars, that equipment gets recalled. How does your facility manage the critical, yet complicated, medical device recall process?

To help their audience better understand the impact and management of medical device recalls, the folks at Power Supply have asked our Founder Guillermo Ramas to participate in their Expert Series.

Over the next 12 months, Guillermo will be tackling some of the most pressing issues facing hospital supply chain & clinical departments related to medical device recalls, and educate around many of the myths and misconceptions involved in this topic.

Below is the entire article, first published by Power Supply. You can find the original pdf for download here

When Good Intentions Have Terrible Consequences. Why “Defining a Process” Is Not Enough.

By Guillermo Ramas

Have you ever heard“We have a process… it isn’t perfect, but it’s a process…”? I have. A few times over the years. And to me, that’s always a red flag. Let me explain.

Many times, this phrase means is that the person knows the process has flaws. They also know it could and should be improved, but they haven’t been presented with a solution to improve it or they simply don’t see the issue as their responsibility.

This often happens with processes that touch many departments in different ways and involve multiple stakeholders. And yes, you guessed it; supply chain has a few of those…

Let’s consider the following scenario:

A nurse one day experiences a situation where a surgeon grows irate because a specific item is out of stock and consequently, a planned surgery cannot take place or at the very least, the physician is inconvenienced and needs to improvise. Later, when the item is back in stock, the nurse grabs a number of these items and places them in a “stash”, separate from any official stock locations, to ensure there is a reserve and minimize the risk of going through the same unfortunate scenario again.

This is simply a result of the nurse doing what the nurse thinks is best to ensure the system runs smoothly and the patients are well taken care of. The nurse is overriding the organization’s inventory control system for the sake of “improving” it.

Nothing wrong with the intention, right? If anything, at first glance we would all think the worst that is happening is that the safety stock level is artificially inflated and there will be lower risk of a stock-out (albeit at a cost to the organization).

Let’s then suppose a few days later, the organization receives a letter from the manufacturer of this product telling them there is a medical device recall being issued for a particular lot and their organization is affected since they received several units from said lot.

The organization’s recall management process kicks into action and several supply techs go to the inventory locations where this item is stored, check the units on the shelf and pull all the affected units they find. They consider the recall dealt with, but they obviously miss the “stash” …

Several weeks later, the nurse uses some of the units that were placed in the personal stash or puts them back on the shelf and unfortunately, some of those units are affected by the medical device recall. They are now being used on patients; with the consequent risk this entails.

Given that the number of recalls has skyrocketed in the last 5 years, this risk has grown significantly. It is further compounded by the recent supply shortages we have experienced.

And this not only happens with recalled items; it also happens with expired product, defective product, corrected use instructions (in instances where new labels are required to be affixed to the packaging), etc.

This is a common situation where a Health System has a defined process for managing recalls and they think having a process is “enough” or “the best they can do”, but it results in terrible consequences because they do not account for well-intended behavior”.

Often, hospital staff understand that these situations sometimes take place, but they are unclear as to how to deal with it, for various reasons.

You might be wondering why this isn’t simply addressed with training, education, and awareness.The answer isn’t that simple.

To answer these challenges, we need to design solutions that make it easy for human beings to have faith in the system. They need to be intuitive and fail-safe and account for human behavior. Most importantly, if we are going to solve problems that have been dogging healthcare supply chain for decades, we need to look at the problem from an entirely new perspective.

Get the help you need form Notisphere with medical device recall management. Sign up for a free trial today!

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