Reprocessing a single-use medical device
The present invention provides a method for reprocessing single-use medical devices. The method can include removing a coating from a single-use medical device, validating the removal of the coating, cleaning the single-use medical device, and applying a new coating to the single-use medical device.
1 . A method for reprocessing a single-use medical device comprising:
removing one or more polymeric coatings on a surface of the single-use medical device by contacting the one or more polymeric coatings on the surface of the single-use medical device to, or with, one or more solvents;
preparing the surface of the single-use medical device for a polymeric recoating;
applying the polymeric recoating on the surface of the single-use medical device; and
validating the polymeric recoating on the single-use medical device,
wherein validating the polymeric recoating comprises:
hydrating the polymeric recoating;
performing a friction force test on the polymeric recoating to test a lubricity of the polymeric recoating, wherein the lubricity is measured in grams grand average force over a 15 pull test cycle; and
confirming the polymeric recoating has a lubricity within an acceptance criteria, wherein the acceptance criteria includes a grams grand average force of less than or equal to 171 grams grand average force,
wherein the friction force test is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500 grams, a velocity of the single-use medical device through the clamps of 1 cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.
2 . The method of claim 1 , further comprising flow testing a lumen of the single-use medical device by providing a flow of water to the lumen via a pump and confirming a flow rate through the lumen is within a threshold.
3 . The method of claim 1 , wherein removing the one or more polymeric coatings further comprises soaking the single-use medical device in a tank containing an enzymatic solution, wherein the enzymatic solution has a temperature of about 15 degrees C. to about 30 degrees C., and wherein the enzymatic solution is circulated within the tank via a pump.
4 . A method for reprocessing a single-use medical device comprising:
removing one or more polymeric coatings on a surface of the single-use medical device by contacting the one or more polymeric coatings to, or with, one or more solvents;
applying at least one polymeric recoating on the surface of the single-use medical device; and
validating the at least one polymeric recoating on the single-use medical device,
wherein validating the at least one polymeric recoating comprises:
hydrating the at least one polymeric recoating;
performing a friction force test on the at least one polymeric recoating to test a lubricity of the at least one polymeric recoating over a 15 pull test cycle, wherein the lubricity is measured in grams grand average force; and
confirming the at least one polymeric recoating has a lubricity within an acceptance criteria, wherein the acceptance criteria includes a grams grand average force of less than or equal to 171 grams grand average force
wherein the friction force test is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500grams, a velocity of the single-use medical device through the clamps of 1cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.
5 . The method of claim 4 , wherein removing the one or more polymeric coatings further comprises soaking the single-use medical device in a tank containing an enzymatic solution, wherein the enzymatic solution has a temperature of about 15 degrees C. to about 30 degrees C., and wherein the enzymatic solution is circulated within the tank via a pump.
6 . The method of claim 1 , wherein validating the polymeric recoating further includes determining a hydrated thickness of the polymeric recoating and confirming the hydrated thickness of the polymeric recoating is less than or equal to 50 μm.
7 . The method of claim 4 , wherein validating the at least one polymeric recoating further includes determining a hydrated thickness of the at least one polymeric recoating and confirming the hydrated thickness of the at least one polymeric recoating is less than or equal to 50 μm.