Medical Plastic Data Service Magazine



Our 27th Year of Publication
Page  11 of 11

Cover Story

Why Anticounterfeit Packing for Medical Devices?

Bhupesh Sood
Business Head, SECGLOBAL

By Bhupesh Sood (MBA, WHO – AAR , Certified Six Sigma Green Belt, Data Science Foundation, MDR 2017, ISO 13485, ISO 9001, ISO 14001, ISO 45001, WCA)

WHO defines Counterfeit as:A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of ingredient(s) or with fake packaging. It is widely accepted that counterfeiting medical devices is a threat to  the patient safety. With regulators becoming more stringent, the requirements must be adhered to , to stay in business, for a longer duration.

Universally, falsifying is thought to represent one to two percent of worldwide exchange. The secretive idea of forging makes it difficult to precisely measure the size of the fake clinical gadget issue in the United States. While some exploration shows that up to eight percent of clinical gadgets are fake all around, it is exceptionally improbable that the figure is that high inside the U.S.

While exact estimation is difficult, the documented seizures statistics from the Department of Homeland Security, FDA recalls, and highly publicized counterfeit discoveries, nonetheless provide evidence of widespread counterfeit proliferation within the legitimate supply chain.Anticounterfeit measures secure both the maker and the end customer. A counterfeit medical device, when used, places the patient at serious risk and impacts the maker through potential loss of reputation, cost of removing these phony product out of the system and additional effort to prevent further issues occurring.

Another major challenge is anti-diversion. This is to ensure that products that have been developed for a specific market, perhaps with materials that are not allowed in other countries but are authorized for the intended market, validated, compliant and fit for purpose, are not removed from the supply chain, repackaged and sent into a country that should not receive that item. It can be potentially dangerous for patients and is illegal. Therefore, the challenge is to avoid both counterfeit and diverted products.

Passive methods apply to the packaging. Medical devices have 3 levels of packaging: The primary packaging (pouch), which then goes into a secondary box (product box) and finally packaged into a shipper where there will be multiple products stored in one package.

To abstain from duplicating, producers can apply obstructions to every one of these things of bundling. Regardless of whether that be a 3D image, UV ID code, 2-D scanner tag with one of a kind numbering/serialization or shrouded content printed utilizing security or attractive ink. These are not planned as end-client checks yet as impediments to the forger. A prepared individual can rapidly build up if the item is bona fide and can take things further by referencing the one of a kind numbers utilized in the security checking through a confirmation site.

A unique serial number or reference number (URN) is a randomized number printed onto the product’s packaging and as it’s unique, it can be used to define exactly who manufactured the item, where it was manufactured and the country of origin. This sort of serialization at the device level is crucial in the battle against forging. Serialization not just enables to confirm the item as authentic, yet additionally offers the capacity to follow item development all through the production network, improve effectiveness and in particular, secure the end client.

Modern technologies can then use the serialized data in barcode format, which can be scanned at any point throughout the supply chain and checked with online systems to verify its authenticity. In the event that the look-into returns with no read/copy, at that point we know there is an issue with the device and it tends to be dismissed out of the production network and extra activity taken to expel these fake devices. These techniques unmistakably work, are basic and financially savvy to execute.


Organizations need to make sure that they put into practice the correct systems and processes that can support them in meeting global standards and country-specific requirements now and in the future. Implementing a fit-for-purpose validated labeling solution with in-built serialization capabilities, which can provide very high volumes of unique, secured and “intelligent” serial numbers for this process would therefore be vital.


1. Keeping up with Counterfeiters: The Battle Against Counterfeit Medical Devices By Steve Ellison , Steve Ellison, PRISYM ID
( )

2. Unifying Efforts against Counterfeiting Medical Devices, Saudi Food and Drugs Authority Initiative, Nazeeh Alothmany, PhD, Vice Executive President for Medical Devices and Equipment, Saudi Food and Drugs Authority, Third WHO Global Forum on Medical Devices Geneva, May 9th-12th, 2017

3. Barry McDonogh, Vice President of Business Development, TruTag Technologies Inc.
( )


Bhupesh Sood (MBA, IPR - WIPO (Switzerland), WHO -
AAR, Trainer and Auditor, Certified Six Sigma Green Belt,
Data Science Foundation, MDR 2017, ISO 13485, ISO 9001,
ISO 14001, ISO 45001, WCA)


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