Is double packaging obligatory for surgical single-use scalpels?

[Sahar Boostenay]

Hello all,

I'm working at a company which provides regulatory consulting services for companies developing medical devices.
One of our costumer is a company which its product is a surgical scalpel with a special agronomic handle (the scalpels are for single use and will be supplied sterile).

My question is regarding the packaging. Do surgical instruments, such as these scalpels have to be double packed (e.g. double pouch) or is a single package (a blister) good enough?
I could not find a specific requirement on the standards and guidelines.

Thanks.

 

[planB]

Hello all,

I'm working at a company which provides regulatory consulting services for companies developing medical devices.

That means , you are charging your customer with the free advice you get from here ...?

Anyway, have a look at ISO 11607:2006, section 6.2.2: "The sterile barrier system shall allow the product to be presented in an aseptic manner." While a single pouch may be sufficient for maintaining the device sterile over the labelled shelf life, double pouches are one way to allow aseptic presentation at the point of use.

HTH,

Gerhard

 

[Sahar Boostenay]

Thank you very much dear Gerhard.

 

[dr1vn]

I've seen a non-sterile nurse open up a single-pouched sterile blade above a draped table into the sterile field. This way the sterile blade falls out of the packaging without being in contact with anything else. You probably could do the same thing with your scalpel as long as your packaging design allows for the scalpel to slide out easily...

 

[Ronen E]

That means , you are charging your customer with the free advice you get from here ...?

@ the OP - How can you charge clients for an expertise you don't have? Or perhaps they're paying for your expertise in surfing web forums?...

 

[Ronen E]

I've seen a non-sterile nurse open up a single-pouched sterile blade above a draped table into the sterile field. This way the sterile blade falls out of the packaging without being in contact with anything else. You probably could do the same thing with your scalpel as long as your packaging design allows for the scalpel to slide out easily...

I would have 2 concerns with this technique:

1. If you handle something not sterile above a sterile field, can you guarantee the field remains sterile?

2. A delicate surgical tool (e.g. a scalpel) falling on a hard surface (e.g. draped table) could get damaged.