Decontamination responsibility on customer complaint investigation

[Thanos Gkiatas]

I am working in a medical device company and we often receive contaminated samples for investigation, our product is administration sets used with infusion pumps for chemotherapy, parental nutrition etc; When our products are coming under customer complaints from the hospitals, sometimes contain blood, as they are in direct contact with the patient. The issue here is, who's responsible to clean/decontaminate the samples before shipping back for investigation? and what if those samples contain medicine fluids or drags for chemotherapy as well; who is suppose to clean and empty the samples?
Couriers also refuse to ship these samples containing drugs or they ask a lot of money for a dedicated and special shipment.

Any feedback on this is more than welcome and thank you in advance,

Kind regards,
Thanos

 

[ScottK]

I am working in a medical device company and we often receive contaminated samples for investigation, our product is administration sets used with infusion pumps for chemotherapy, parental nutrition etc; When our products are coming under customer complaints from the hospitals, sometimes contain blood, as they are in direct contact with the patient. The issue here is, who's responsible to clean/decontaminate the samples before shipping back for investigation? and what if those samples contain medicine fluids or drags for chemotherapy as well; who is suppose to clean and empty the samples?
Couriers also refuse to ship these samples containing drugs or they ask a lot of money for a dedicated and special shipment.

Any feedback on this is more than welcome and thank you in advance,

Kind regards,
Thanos

Hi Thanos. I have dealt with this situation in several companies and I have always put the responsibility for cleaning and sanitizing on the customer. Always.
I cannot put my coworkers at risk of disease. We are not a sterilization or cleaning company and don't have the equipment or training to deal with contaminated product.

How I handle this is that whenever a return request is received I send the customer a blank certificate of decontamination. This certificate requires that the customer certify that the product has been fully decontaminated and there is nothing hazardous left (biological or chemical) when it leaves their hands.

I required that the completed and signed certificate be emailed back to me when they ship, and place a copy in the box with the parts, on top of the packaging.

If they refuse to comply, they can't return the part and will get no investigation, credit, replacement, etc.

If a return is received with no certificate of decontamination, the we will not open the box until one is received.

This is all written at the top of the form so the requirements are clear.

You must protect the safety of your co-workers. That's the bottom line.

 

[Thanos Gkiatas]

Thanks a lot ScottK!

 

[Sidney Vianna]

Scott gave you excellent advice. I would, however, make one point. DO NOT trust any paperwork blindly, such as a certificate of decontamination, to lower your guards.

Sometimes, certificates are not worth the paper they are written on. Make sure your workforce still take precautions and examine the device thoroughly. I used to audit an organization that made drug dispensing devices used in hospitals. From time to time, they would receive a device for servicing that, despite having been "certified cleaned" by the hospital, when they started disassembling the unit, they would find controlled substances inside. Sometimes even the DEA would have to get involved.

Not always customers are right; sometimes they can not be trusted to what they certify. Be aware because, as Scott mentioned, your workforce health and safety is very important.

 

[ScottK]

Scott gave you excellent advice. I would, however, make one point. DO NOT trust any paperwork blindly, such as a certificate of decontamination, to lower your guards.

Sometimes, certificates are not worth the paper they are written on. Make sure your workforce still take precautions and examine the device thoroughly. I used to audit an organization that made drug dispensing devices used in hospitals. From time to time, they would receive a device for servicing that, despite having been "certified cleaned" by the hospital, when they started disassembling the unit, they would find controlled substances inside. Sometimes even the DEA would have to get involved.

Not always customers are right; sometimes they can not be trusted to what they certify. Be aware because, as Scott mentioned, your workforce health and safety is very important.

True - In our procedure we require the wearing of nitrile gloves when opening any return.

I learned this the hard way in a prior job where we got back some parts with what looked like dried blood. We sent the person that handled the parts to the Dr for bloodborne pathogen testing (all was clear) and added the glove requirement. Been carrying that with me to every job since.

 

[Anonymous16-2]

This is great information for me! I'm currently working on a procedure for decontamination for medical devices and found this. I'm wondering if any of you have an SOP that could share with me.

Thanks!

 

[Mike S.]

This is all written at the top of the form so the requirements are clear.

I wonder if you also stated that the customer could be held legally liable if the contamination was not really done and done properly if it might make them think 3 times before just signing the cert and shipping it while still contaminated.