Radiation-sterilized, packaged medical device

• US 4,813,210 A
• Filed: 10/01/1987
• Issued: 03/21/1989
• Est. Priority Date: 09/27/1985
• Status: Expired due to Term

• Current Assignee: Nissho Corporation (Nitto Denko Corporation)
• Original Assignee: Nissho Corporation (Nitto Denko Corporation)
• Inventors: Masuda, Toshiaki, Fukui, Kiyoshi, Omiya, Hitoshi
• Primary Examiner(s): Culver, Horace M.
• Application Number:
  US07/105,463
• Time in Patent Office: 537 Days
• Field of Search: 53/425, 53/426, 53/449, 53/434, 53/469, 53/472, 53/512
• US Class Current: 53/425
• CPC Class Codes: A61L 2/08 Radiation
• CPC Class Codes: A61L 2/26 Accessories or devices or components used for biocidal treatment

Abstract

A packaged medical device comprising a medical device; a gas-permeable sterile bag containing the medical device therein; a wrapping member made of oxygen-impermeable material and wherein said medical device-containing bag, previously subjected to radiation-sterilization, is sealed; and a deoxidizing agent contained in the wrapping member together with the medical device-containing bag. The packaged medical device does not give off an odor upon unsealing and is free from decrease in strength of plastic parts thereof.

Claims

1. A process for producing a radiation-sterilized medical device comprising the steps of:

placing a medical device within a gas-permeable sterile bag;

sealing said gas-permeable sterile bag;

sterilizing said gas-permeable sterile bag containing said medical device by gamma rays;

placing said sterilized gas-permeable bag containing said medical device and also placing a deoxidizing agent within an oxygen impermeable wrapping member; and

sealing said oxygen-impermeable wrapping member.

2. A process of producing a radiation-sterilized medical device according to claim 1, wherein said sterilizing is medical device according to claim 1, wherein said sterilizing is conducted by dry radiation-sterilizing in a gaseous atmosphere.

3. A process of producing a radiation-sterilized medical device according to claim 1, wherein said deoxidizing agent is based upon activated iron oxide.

4. A process of producing a radiation-sterilized medical device according to claim 1, wherein said medical device is a hollow fiber blood processing device.

5. A process of producing a radiation-sterilized medical device according to claim 4, wherein said hollow fiber blood processing device is a dialyzer containing cellulose acetate hollow fibers.

6. A process of producing a radiation-sterilized medical device according to claim 4, wherein said hollow fiber blood processing device is an artificial lung containing silicone rubber hollow fibers.

7. A process of producing a radiation-sterilized medical device according to claim 1, wherein said medical device is a catheter made of a silicone rubber.

8. A process of producing a radiation-sterilized medical device according to claim 1, wherein said oxygen-layer-aluminum layer-polyethylene layer.

9. A process of producing a radiation-sterilized medical device according to claim 1, wherein said oxygen-impermeable wrapping member is made of a laminated polyester layer-polyethylen layer-aluminum layer-polyethylene layer.