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Inventory Control - Class II (IIb for CE) medical device

#1
We manufacture and distribute a class II (IIb for CE) medical device. I'm curious to know what best practice or industry standards exist for inventory management when it comes to medical devices. I have not found much in the standards.

We try to track where devices are shipped to in case of issues such as a recall. Our invoices also track to device serial numbers. However, sometime there is a break down. We also sometimes have a miscount of inventory. Our records system will say there are 100 devices in stock when in actuality there are 83, or something along those lines. We do use a bit of a clumsy chain of software packages and in-house software to manage everything. We'd like to improve on this, but it's not in the budget at the moment.

What kind of inventory accuracy is generally needed? What's deemed acceptable. I assume there's always going to be some inventory inconsistencies, but not sure what best practices would be.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
You might want to look at official guidance regarding traceability and recall (example here).
What you need to and can do depends on how you sell - direct to users or through distributors, one device at a time or in batches etc.
Other than that I would look at general (not medical device specific) stock management practices - there is abundant literature on best practices online.
 

Edward Reesor

Trusted Information Resource
#3
Traceability and recall are some of the highest items in the priority list (next to product quality). When I perform internal audits, I ask the staff to track both ways (upstream as well as downstream), meaning I will ask the question, "What if one of our critical suppliers informs us that the product they sent has been flagged for a recall. Can we track every device we made that used that part?". It's a harder task to perform (IMO) but they get the reason why we need to perform it.

Regarding inventory and correct numbers, you need to perform inventory counts on a regular basis to maintain an accurate count. If the numbers are incorrect, you need to figure out why, and perform a CAPA to realign your practice. We had an off count, discovered the underlying reason and are currently in the process of correcting it. It was actually a very simple change we made to the process. We gave ourselves a few months for the process to be implemented and verified effective before we can call it a success. We also discovered that by correcting the issue, we will have the added benefit of being more efficient in how the inventory is managed (sounds intuitive but we had a greater potential for things getting "lost").
 

yodon

Staff member
Super Moderator
#4
Good advice by @Ronen E and @Edward Reesor.

I assume there's always going to be some inventory inconsistencies, but not sure what best practices would be.
I can't see any reason why this would be considered acceptable. From a business standpoint, you could well be losing money! From a risk standpoint (and since you're II / IIb it's not insignificant), these could be going places where they're not intended.
 
#5
Good advice by @Ronen E and @Edward Reesor.



I can't see any reason why this would be considered acceptable. From a business standpoint, you could well be losing money! From a risk standpoint (and since you're II / IIb it's not insignificant), these could be going places where they're not intended.
I understand that the goal is always 100% accuracy. I was just being pragmatic. I've never known any business I've worked with to maintain a perfect inventory count, so I figure there must be a means to measure and assess as well as some level of tolerance? I could totally be wrong.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
I understand that the goal is always 100% accuracy. I was just being pragmatic. I've never known any business I've worked with to maintain a perfect inventory count, so I figure there must be a means to measure and assess as well as some level of tolerance? I could totally be wrong.
Are you referring to medical device businesses? 100% should be the goal even if you never fully achieve it.
Put it in your Quality Objectives and address under Management Review.
 

chris1price

Trusted Information Resource
#7
I would only reiterate what the others have said, your goal must be 100% accuracy. If nothing else, your invoicing and despatch notes should identify where to and how many have been shipped. If these are not reliable, how can you invoice correctly?
 
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