Q I attended a CS workshop recently, and one of the sessions was focused on the various functions in the reprocessing of medical devices and the need for monitoring and quality assurance. The speaker was very good although vague on some of the specifics of the actual monitoring processes. She did provide some excellent information on the most current recommendations and requirements for cleaning verification, and sterilization quality assurance. She also discussed the various tools, and methods that are available to implement a good QA program for cleaning and sterilization. However, in her presentation she implied that it was a requirement to maintain documentation on the seal integrity and the performance of heat sealers used for sealing peel pouches, but she was not able to provide a reference source or advice on how that could be done. Since the workshop, I have looked through the various standards – AAMI, AORN and the like – but have not been able to find any such recommendations, nor have I been able to find any products or tools for monitoring the seal integrity. Any information you might be able to share on this matter would be appreciated.

The AAMI guidance document TIR 22:2007 was updated in 2007 and compliments the ISO standard 11607:2:2006.

The rationale here is that you want assurance that your heat sealer does indeed perform properly and consistently. It of course is important to ensure that the appropriate temperatures, pressure and time are reached to adequately seal the type of packaging you are utilizing. As you know there are different materials used in the manufacturing of peel pouches i.e. paper, polymers, plastics, Tyvek etc. Each type of material may require a very specific temperature and time to ensure proper sealing without damaging the packaging material. Peel pouches differ from manufacturer to manufacturer, so it is critical that you obtain and follow the specific instructions from your packaging manufacturer. The instructions should provide all of the required parameters for sealing your peel pouches.

Figure 1

Figure 2

There are commercial QA products available on the market which will allow you to monitor, test, verify and document the quality performance of your heat sealer on a daily basis. One such product is the STERIKING Seal Control (figures 1&2).

The device is designed for operational qualification of the sealing process efficacy. In the sealing process the following quality properties of the seal shall be controlled:

• intact seal for a specified package seal width

• channels and open seals

• punctures or tears

• material delimitation or separation

On each Seal Control device the following documentation is maintained:

• date and time of test

• sealer identification

• sealing parameters

• control authorization

• test results

• corrective actions/adjustments to sealing parameters

• special notes/comments

• maintenance information

• authorized signature

The sheet paper of the Seal Control device is preprinted with a marking area for the aforementioned documentation and any corrective actions required or taken. A visual inspection of the Seal Control sheet must be conducted. The colored film of the sheet turns to a darker shade of green in the sealed areas, thus providing a valid visual assessment of the quality of the seal. The pre-sealed edges of the sheet are a reference for the darker shade of color. In the event that the test results are unsatisfactory the test has to be repeated. If the test results are satisfactory, the sheet must be signed by an authorized person and kept on file with QA records. Faulty heat sealers should not be used until serviced and their satisfactory performance can be verified with the Seal control QA device.

Q We have a new clinical leader in the OR who has requested that we leave stylets in the suctions in certain sets to help prevent loss. She stated if they are partially inserted loosely and that if the lumens are moistened it would allow for adequate heat transference and sterilization would occur. Would this be an acceptable practice?

A Steam cannot penetrate from the outside of the suction device into the lumen with a stylet in the way. The inserted stylet could present a barrier to steam permeation and prevent contact with the inner channel. Removal of the stylet allows sterilant contact within the lumen. One must remember that in "steam" sterilization the steam is the sterilant and as is the case in all sterilization methods the sterilant must come in intimate contact with all surfaces (internal and external) of the device to be sterilized for a prescribed period of time. The fact that the lumen may "heat up" does in no way mean sterilization has been achieved. Recommended practices AAMI ST79 2009 p. 65 and AORN 2009 p.621, 2010 p. 431 clearly state that "Any stylets or plugs should be removed prior to sterilization." And "Stylets should be removed from lumens so the sterilant can contact the inside."