Most medical device companies have product returns which are biohazardous. Some of these returns are biohazardous because hospitals didn’t follow their internal procedures, some are products that would have been disposed off by the hospital, but due to an issue in surgery they must be returned to the manufacturer, and some products are intended for reuse but must go through some level or inspection or calibration prior to being returned to the surgery center.

The vast majority of medical device companies are not properly set up to handle true biohazardous returns, and the FDA and OSHA seem to be catching on.

While the regulations surrounding biohazardous returns and handling bloodborne pathogens hasn’t changed, we are seeing more and more companies recognize the gaps in their processes and training, and are looking for a way to reduce the risk to their employees.

Some of the major gaps the companies face in attempting to meet the requirements are:

  • the facility has not been suitably set up to handle the product flow
  • they do not have the appropriate equipment and materials to properly decontaminate
  • they don’t have a bloodborne pathogen training program in place
  • they don’t have the proper quality system procedures established

The largest issue to companies filling these gaps is a cost benefit. In many, if not most, cases it would take significant capital to prepare the facility, purchase the right equipment, create and update the quality system, and hire the correct employees or consultants to create and oversee the training courses. When considering the small quantity of units that are returned, requiring this level of biohazardous decontamination, the price per unit can skyrocket quickly.

Outsourcing this service is a very attractive proposition, due to both, the cost benefit of tapping into existing infrastructure & processes and the opportunity to alleviate the concern of your employees, coming in contact with these products and potential causing you liability issues.

You must keep in mind though, that even when you outsource these types of services, you still need to meet the Department of Transportation’s requirements surrounding the safe packaging & shipping of biohazardous materials.

At LSO we understand this is a sensitive issue, and one that many companies are just beginning to acknowledge. We can walk you through the process of setting up an effective decontamination program, and give you access to our standard, audited processes. We offer quick solutions to meet this concern, and will make sure that you and your employees are protected.

We would love to hear your feedback. Please comment below and let us know your thoughts on this topic.

  • What are your thoughts about decontamination of product returns?
  • Do you know of situations in which a company may have experienced a regulatory issue regarding this?
  • What are some of the ways that you have remedied the situation?