Expiration dates; alcohol disinfection; OR consents; local anesthesia; marking surgical sites; moderate sedation - Clinical Issues

AORN Journal,  August, 2003  by Dorothy Fogg

• E-mail
• Print
• Link

Question: The patellar blades for our arthroscopic shaver have an expiration date on the package. The company sales representative claims we can disregard the expiration date because AORN standards define shelf life as event related rather than time related. Based on this, we are being told to consider the shaver blades sterile unless an event has occurred to compromise the packaging. We do have an event-related shelf-life system in place for sterile packages processed internally. Nevertheless, we have considered the manufacturers' expiration date valid if it is printed on the package of an item they provide. May we consider the shaver blades sterile under our event-related policy or should we defer to the manufacturer's expiration date because we did not process the item?

Answer: If the blades from the manufacturer have an expiration date on the package, they should not be used after that date. The manufacturer's expiration date may refer not only to sterility, but also to product integrity. This is particularly true of products constructed of rubber, silicone, plastic, or other degradable components, but any product can degrade over time. Regardless of the reason for the specified expiration date, the product should not be used after that date. You would be assuming full liability if you used the item and the patient suffered any untoward or adverse event. The manufacturer has no obligation to stand behind any item used in a manner contrary to the product labeling. It may be possible for you to contact the manufacturer and request that the product be revalidated to the original design and performance specifications, reprocessed, and then returned to you with a new expiration date. Some manufacturers provide such a service. If you have a substantial inventory at or near the expiration date, a revalidation and return system could provide some savings rather than having to discard and replace the items. If your inventory of expired products is minimal, it may be more cost-effective simply to discard and replace the items.

Question: What is the correct practice for cleaning laryngoscope blades used by the anesthesia department? Currently, they are being cleaned and soaked in an alcohol solution for 20 minutes. Would it be better to soak them in a glutaraldehyde solution and, if so, for how long?

Answer: Glutaraldehyde is preferred over alcohol for disinfection of laryngoscope blades. According to AORN's "Recommended practices for cleaning and processing anesthesia equipment,"

   reusable items such as ... laryngoscope
   blades should be cleaned and
   then processed by high-level disinfection
   or sterilization ... (1(p211))

Laryngoscope blades are categorized according to the Spaulding classification system as semicritical items, which means that they come in contact with nonintact skin and mucous membranes. (2) Semicritical items should be free of all microorganisms, although small numbers of bacterial spores may be present. Both ethyl alcohol and isopropyl alcohol in appropriate concentrations are good surface disinfectants for hard, smooth surfaces, but they do not inactivate bacterial spores nor do they kill hydrophilic viruses, such as echovirus or Coxsackie virus; therefore, they are not considered high-level disinfectants. Furthermore, alcohol-based products are flammable and should not be used routinely or stored in the OR.

Glutaraldehyde-based products are well-recognized and frequently used high-level disinfectants. There are a variety of glutaraldehyde products on the market in a variety of formulations and concentrations. The neutral or alkaline glutaraldehyde formulations possess microbicidal and anticorrosion properties superior to those of acid glutaraldehydes. (2) Recommended contact times to achieve high-level disinfection vary according to the particular product and its formulation. Manufacturers' recommendations should be followed. Other US Food and Drug Administration-approved, nonglutaraldehyde-based, high-level disinfectants also are available. These products may be equally appropriate for disinfecting laryngoscope blades.

Question: Sometimes patients arrive in the OR holding room with a consent that has been completed by the surgeon and signed by the patient but not witnessed. Alternatively, there may be no patient signature and no witness. What is the nurse's role regarding OR consents? Should the nurse sign as a witness if the patient already has signed the form? Is the nurse allowed to obtain the patient's signature if the consent is not signed?

Answer: Any person can witness the surgical consent, but the surgeon is responsible for informing the patient of the benefits, risks, and alternatives to the surgical procedure. Witnessing the consent simply means witnessing the named individual giving written permission for the named procedure to be performed by the named surgeon or surgical health care provider. If the patient already has signed the consent, it would be impossible for someone not present at the time to witness the patient's signature. The nurse, therefore, should not sign as a witness to a consent that already is signed. The nurse may ask the patient to sign again next to the previous signature or, at a minimum, have the patient initial his or her previous signature. This would allow the nurse to actually witness the patient giving written permission (ie, consent.) Likewise, it is permissible for the nurse to obtain the patient's signature on a previously unsigned consent form and then to witness that consent.