What method should be used to sterilize a Millar Mikro-Tip Pressure or Pressure-Volume Catheter?

Millar recommends the use of Ethylene Oxide gas for sterilization. Transducers should be completely dry before sterilization as water on the units may react with ethylene oxide and reduce its effectiveness. Aeration may be performed at room temperature or in a heated aeration (max. 145 ºF, 63 ºC) cabinet. Transducers may be gas sterilized in the white plastic shipping tray it was received in. If used, the tray, with lid, should be placed in a breathable polyethylene bag (e.g., 3M™ Steri-Lok™).  The recommended sterilization procedure is outlined below:

Preheat phase: Starting Temperature 110 ºF (43 ºC) min.

Duration 30 minutes

Initial Vacuum: 6.0 inHgA (20.3 kPa)

Rate: 3 minutes

Nitrogen Flush: 2 cycles

Nitrogen Addition to : 28.0 ± 0.5 inHgA (94.8 ± 1.7 kPa)

Rate: 1.4 ± 0.5 inHgA/min. (4.7 ± 1.7 kPa/min.)

Evacuation: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)

Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa)

Conditioning

Humidification: 1.5 ± 0.5 inHg (5.1 ± 1.7 kPa)

Steam Conditioning: 10 min. + 5 min. - 2 min.

Humidity Dwell: 30 ± 5 min.

7.5 ± 0.5 inHgA (25.4 ± 1.7 kPa)

Relative Humidity: 15-70%

Ethylene Oxide Concentration: 500 ± 50 mg/L

Dwell Pressure: 16.5 ± 1.0 inHgA (55.8 ± 3.4 kPa)

Dwell Time: 2 hours - 1.0 + 30 min.

Temperature: 110-130 ºF (43-54 ºC)

Relative Humidity: 30-70%  (35-44% nominal)

After Vacuum

Vacuum: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)

Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa)

Vacuum Hold: 10 min.

Gas Wash A: 3 cycles (minimum)

Release: 28.0 inHgA/min. (94.8 ± 1.7 kPa)

Rate: 1.4 ± 0.5 inHgA/min. (4.7 ± 1.7 kPa)

Vacuum: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)

Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa)

Release (Filtered Air): 28.0 ±0.5 inHgA (94.8 ± 1.7 kPa)

Rate: 2.0 ± 0.5 inHgA/min. (6.6 ± 1.7 kPa)

Aeration

Duration: At least 8 hours

Temperature: 110 ± 10 ºF (43 ºC)