Who is responsible for cleaning medical devices before return for repairs?

B

Bunny

#1
Are hospitals responsible for cleaning medical device equipment before returning it to the manufacturer for repair? The medical devices I am referring to are electronic equipment that is used in patient environments, but do not come into direct contact with the patient. This equipment may occasionally have small amounts of blood and bodily fluids on it.

In some cases, representatives from the manufacturer will be at the hospital troubleshooting along with the hospital staff. Can the hospital still be responsible for cleaning the equipment or does the burden get transferrred to the manufacturing representative?
 
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rob73

looking for answers
#2
Not sure about the US but in the UK it is illegal to send contaminated equipment through the post, the MHRA make this quite clear in their vigilance documents. So if its equipment being returned to you I would say the onus is on the hospital to decontaminate the equipment.
As a company we will not accept any returned equipment unless it has a valid decontamination certificate from the hospital.
Rob
 
B

Bunny

#3
That is good to know. Is it safe to assume that the EU would take the same approach?
Does anyone know about the US hospitals?
 

Statistical Steven

Statistician
Staff member
Super Moderator
#4
Bunny

Unfortunately there is no guidance and enforcement is uneven. Some hospitals will sanitize prior to sending, others will not. My advice is to have a procedure for e decontamination of the devices when the arrive at the service facility.

Just my $0.02:2cents:
 
B

Bunny

#5
I am in the process of setting up the in-house procedure and that is when the question arose. The service team wants to put the cleaning burden on the hospitals. I wanted to see if there was a way to do that.
 
M

MIREGMGR

#6
It's common for our facility to receive product from the field that obviously has not been cleaned, even perfunctorily. I'd say that is more common than to receive cleaned items.

And, even if a returned item appeared clean and came with a certification of sanitation, how do you know that the sanitization was effective?

What are the consequences to your business operations if it's determined that your facility, or worse yet some shipped product, has been contaminated via some accidental indirect contact with something that came in from a user site?

At my company, our procedure assumes incoming product from user sites is contaminated. We assume that that product has not already been sanitized irrespective of what we've been told, and sanitize it before any further actions are taken. Until sanitization, we control contact with that product so as to avoid secondary contamination.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#7
It's common for our facility to receive product from the field that obviously has not been cleaned, even perfunctorily. I'd say that is more common than to receive cleaned items.

And, even if a returned item appeared clean and came with a certification of sanitation, how do you know that the sanitization was effective?

What are the consequences to your business operations if it's determined that your facility, or worse yet some shipped product, has been contaminated via some accidental indirect contact with something that came in from a user site?

At my company, our procedure assumes incoming product from user sites is contaminated. We assume that that product has not already been sanitized irrespective of what we've been told, and sanitize it before any further actions are taken. Until sanitization, we control contact with that product so as to avoid secondary contamination.
Excellent point...probably some OSHA requirement to use Universal Precaution.
 
J

Jerome

#8
We have a somewhat similar problem, but how does one go about sanitizing electronical equipment?
Any information sources anyone?
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
Bunny - we don't generally get returns direct from hospitals, they usually go to our customers first, but we make it an internal requirement that any part returned to us has to have a certificate of sanitization if it was used in the field.
If we get a return without that certificate we won't even open the package.

Our RMA form that we send to customers calls this out and has has two check boxes:
___ This product was not used
___ This Product was used: All returns of used and potentially contaminated product must contain the following:
  1. Statement of cleaning and disinfection.
  2. Very brief description of how the items were cleaned and disinfected.
  3. Statement that the use of universal precautions is not required.
  4. These statements and information must be conveyed on the returning company?s letterhead and signed by a manager.
  5. Contact information for the signer is also required.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#10
We have a somewhat similar problem, but how does one go about sanitizing electronical equipment?
Any information sources anyone?
Jerome

If you have a medical device, then decontamination is part of the design control process if the device has bodily fluid contact.
 
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