Why Do 95 kPa Certified Bags Matter?

Brittany PullenNews

Why do 95 kPa certified bags matter significantly when transporting human and animal biological substances? When shipping and handling a specimen transfer, a used medical device or any biohazard material, leakage and spills can be dangerous and costly. 

The Sad and Dangerous Story of a Used Device Return 

Once upon a time, a medical facility shipped a used medical device containing biological substances back to an OEM for evaluation and only packaged it with bubble wrap, whatever box they could find in the moment and without proper labeling or markings. 

The box finds itself thrown haphazardly in the back of truck at pick-up, slid across the belly of a cargo aircraft, on the floor after falling off a belt during sorting and then finally making its way to the OEM dented, torn and a bit damp. Someone in receiving picks up the box, an individual in material handling processes the box and another person in quality opens the box. All three have been exposed to biohazard materials, along with all the other individuals over the course of the box’s journey.

Who’s at fault? The shipper? The carrier? The OEM? 

Yes, facilities handling and shipping items containing biological substances have a responsibility to ensure proper and safe shipping, but, OEMs also must specify that certified 95 kPa bags be used exclusively when returning a used medical device to ensure regulatory compliance and safety.

Shipping used medical devices happens more often than one might think. The return could be due to cleaning, repair, evaluation, disinfection or sterilization or other reasons. Removed from original packaging and used, a used device could pose risk of potential contamination with human or animal biological substances. 

DOT and IATA Regulations 

The Department of Transportation (DOT) and the International Air Transport Association (IATA) have strict regulations for the shipping of biological substances. The primary receptacle or secondary packaging must meet 95 kPa pressure differential testing as a part of triple packaging regulations. Simply put, these regulations require that the biohazard transport bags and receptacles withstand an internal pressure of not less than 95 Kilo Pascals and remain leak-proof. 

Checklist for comparing suppliers of 95 kPa bags:

  • Are bags tested and certified 95 kPa?
  • Do they feature various bag sizes and closures?
  • Can they accommodate a request for a custom bag?
  • Do they feature legible and correct outer labeling and markings? 
  • Are bags liquid-tight and tamper evident?
  • Do they contain internal absorbent materials? 
  • Do bags feature an outer pocket for documentation?

Don’t risk your reputation and the safety of others by using non-compliant 95 kPa bags or packaging – contact Vonco today.