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6/22/2017 » 6/25/2017
2017 OSAP Annual Conference

FAQ - Instrument Processing - 2016
 FAQ - Instrument Processing - 2016

 

 

Is there a specific location on the sterilization pouches that dates, load, sterilizer # should be placed?

Ask OSAP is not in the position to know the regulations in all states. It is recommended that you contact your state dental board and/or state public health agency (i.e., state health department) to find out more about any relevant regulations in your state.

Ask OSAP can provide you with some general information on this matter.

The 2003 CDC guidelines for infection control in dentistry states as follows:

Storage of Sterilized Items and Clean Dental Supplies

The storage area should contain enclosed storage for sterile items and disposable (single-use) items (173). Storage practices for wrapped sterilized instruments can be either date- or event-related. Packages containing sterile supplies should be inspected before use to verify barrier integrity and dryness.

Although some health-care facilities continue to date every sterilized package and use shelf-life practices, other facilities have switched to event-related practices (243). This approach recognizes that the product should remain sterile indefinitely, unless an event causes it to become contaminated (e.g., torn or wet packaging) (284). Even for event-related packaging, minimally, the date of sterilization should be placed on the package, and if multiple sterilizers are used in the facility, the sterilizer used should be indicated on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure (247). If packaging is compromised, the instruments should be recleaned, packaged in new wrap, and sterilized again. 1

Practical Infection Control In Dentistry states as follows:

 After packaging is completed, the package should be labeled (Table 16-5). Automated labeling devices are available that can preprint the information on self-adhesive labels. This provides an efficient method for creating legible and standardized labels. If a handwritten label is used, the marking pen should be indelible, nonbleeding, and nontoxic. Felt-tip ink pens or a very soft lead pencil may be used. Do not write on paper or cloth wrapping materials. Peel packages should be labeled on the plastic portion or on the self-sealing tab 2

TABLE 16-5 Information to include on the Package Label

· Sterilizer identification number

· Load number

· Operator’s initials

· An indefinite shelf-life label (if using event-related shelf life) with the date of sterilization, or, if using time-related shelf-life policies, an expiration date

· Package contents 2

 

Additionally, ANSI/AAMI ST79:2010 states as follows:

8.3.2 Package labels

Package labels (e.g., process indicators, labels for product identification and lot number, expiration statement labels) should be capable of remaining securely affixed to packages throughout the course of their handling from sterilization to use. If a marking pen is used to label paper-plastic pouches, the labeling information should be written only on the plastic side of the pouch. If a marking pen is used to label wrapped packs, basins, instruments, or other surgical supplies, the ink should be nontoxic, and the labeling information should be written on the indicator tape or affixed labels.

Rationale: Important identification information must not be lost during handling. Writing on the paper side of the pouch or on a wrapper (whether woven or nonwoven) could cause damage to the package (which might not be noticeable) and thereby compromise the barrier protection. Use of permanent markers with nontoxic ink is recommended to avoid toxins being deposited on packs or instruments.3

Resources

1)     Kohn WG, Collins AS, Cleveland JL, Harte JA, Eklund KJ, Malvitz DM, Centers for Disease Control and Prevention (CDC). Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep 2003;52(RR-17):1-61. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm    Accessed on May 17, 2016.

2)     Molinari JA and Harte JA. Practical Infection Control In Dentistry – Third Edition. Wolters Kluwer / Lippincott / Williams & Wilkins. Pages 226 - 227.

3)     Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2010: Comprehensive guide to steam sterilization and sterility assurance in health care facilities; 2013. Page 68. 

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