BCC Contaminated Conductive Gel: A Catastrophe To Distributors

Burkholderia cepacia complex also known as Bcc is a type of bacterial commonly found in water and soil. It can survive for a prolonged period in a moist environment. It can be spread through water and person to person. Infection by Bcc can cause symptoms of fever and fatigue. However, an infection of Bcc to an individual with a weakened immunity can lead to a rapid decline in lung function and cause death. Due to this, the regulatory body for the medical device globally takes a tough stance towards medical consumables contaminated with Bcc. 

When water is used in a non-sterile room to manufacture ultrasound gel or ECG gel, it can be contaminated with Bcc. How does this affect distributors who buy and sell medical consumables contaminated by Bcc?

Product Recall And Loss Of Money

The immediate effect a distributor would suffer from a Bcc contaminated medical gel is a significant loss of money. Once an order for the recall is made by the regulatory body for medical devices, as a distributor, you must comply. Usually, you’d have to send the contaminated gel back to the manufacturer. This would be an extra cost for you in time and money. You have to recall the product from the end users you’ve sold the contaminated gel. Then you have to prepare the logistics to send them back to the manufacturer.

Very likely you will not get a refund for the recall. So you will end up losing more money in the end. This is still considered the best outcome. However, if the situation is worse, you could be liable for legal action taken by the end user for the cause of damages to their business.

Damaging Your Reputation

Building your business brand and maintaining your reputation as a reliable medical consumable distributor takes time. Selling a Bcc-contaminated gel could ruin your reputation and cause you to lose customers very easily. To your customer, it gives the impression that you did not vet the manufacturer or the quality of the gel carefully, which means it’s risky to do business with you. Winning back your customer’s trust will take a lot of work, and you might lose your customer for good.

Real Case Studies

Conductive gel recall due to Bcc contamination is quite common and happens globally. Sometimes, the recall will be covered by the media. The recall will usually be classified as class 2 as a medium risk or class 1 as a high risk. The class refers to the risk which could cause temporary or serious health consequences. While Bcc is not deadly to the healthy individual, it could cause death to patients with health issues. As such, the media would cover the news to spread the information to as many people as possible. 

Click the link below to read more stories:

Ultrasound gel was recalled due to bacterial contamination.

FDA slaps most serious classification on recall of potentially contaminated ultrasound gels

CHATTANOOGA Ultrasound Gel Products and Lotions Recall due to risk of bacterial contamination

Bcc Free Conductive Gel

At Tele-Paper, we make sure the ultrasound gel and ECG gel we supply are Bcc free. We check the batch results tested for Bcc contaminant by a medical laboratory accredited with Standards Malaysia certification. The laboratory meets the requirements of MS ISO/IEC 17025 which is similar to ISO/IEC 17025. This accreditation signifies that the lab is competent, impartial and consistent in their testing ensuring reliability and accuracy of the results. The test parameter is Burkholderia cepacia in 1g and the test methodology is USP 60, Tests for Burkholderia cepacia Complex. For every batch, we only accept if the result shows that Bcc is absent. We also could provide the test results to our customers for the batch they order upon requests.

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Tele-Paper Export Bcc Free Ultrasound Gel and ECG Gel Globally

We export our Sonomed ultrasound gel and ECG gel to customers around the globe in Europe, Asia, Africa, Australia, South America, and North America. Our gel is used along with our Medical Chart Paper worldwide.

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