Monthly Archives: May 2015

Do you need a decontamination Laboratory?

Do you need decontamination of your medical devices?
What are the reasons for decontamination of medical devices?

shutterstock_89087416First let’s explain decontamination. Decontamination is the process by which something is rendered free from microbial pathogens. Though much of the process is similar, decontamination is different from sterilization in that it might have environmental microbes, and thus not completely sterile.

Also, the item is not to be used on a patient after decontamination. Decontamination typically uses the same methods as sterilization including; liquid chemicals, ethylene oxide gas, gamma radiation, or steam autoclaving that are used by hospitals.

Now why would someone need decontamination?

Some reasons are…

  • The manager of the quality department of a medical device company is responsible for the complaints of devices. Maybe there is a trend with a particular malfunction and you need to analyze these malfunctions to determine the root cause. So, analysis of the device is required and the analyst should not handle a bloody, contaminated, used medical device. What do you do? You need to decontaminate the medical device. The malfunctioned medical devices need to be rendered free from pathogens prior to analysis.
  • Many companies are finding themselves on the receiving end of a FDA warning letter because of their lack of compliance with complaints. A good way to comply with FDA regulations is to perform a thorough investigation of every complaint. However prior to bringing the complaint to be analyzed by engineers, decontaminate the device so that it is safe for engineers for handling.
  • During clinical trials, companies want to retrieve used medical devices and analyze them after use. No failure of the device has been reported; however, information of the durability and other information of the medical device is valuable for FDA approval of the medical device.

Complaints and Customer Satisfaction

Complaint and improvementMany companies are using failure analysis to maintain customer satisfaction. They are realizing the benefits of analyzing complaints (from their medical devices) for all reported failures in the field. These devices have been used in a procedure or have possibly been exposed to a pathogenic environment and need to be free from pathogens prior to failure analysis. For example, a medical device is the subject of a complaint from a customer. The doctor or hospital believes the medical device malfunctioned, therefore the company requires an analysis of the device. However, the device needs to be free of pathogens for the analysis.

The Decontamination process serves to protect everyone involved in the analysis process and should not be tackled lightly. Some companies will find that performing decontamination in-house is more cost effective, while others will seek outsourcing.