Sterile Inventory: Handling With Care

July 19, 2011

By Kelly M. Pyrek

ICT spoke with Bob Marrs, director of consulting services/field operations for Aesculap, regarding issues relating to proper handling of sterile inventory.

Q: You have an expansive background in perioperative services and sterile processing, so you have seen quite a bit in your career what are the most common mistakes made in both departments when it comes to handling sterile items?

A: In my 20 years in the operating room and sterile processing as a certified surgical technologist, sterile processing department (SPD) technician, case cart coordinator, supervisor, manager and director, and now my one-and-a-half years as a consultant, I have witnessed numerous mistakes concerning the handling of sterile items/supplies. Among the deficiencies that I have noted are handling items before they cool properly, handling items too many times prior to use, not using the first in, first out (FIFO) principle, dropping items on the floor and either using them or placing back on the shelf, improper storage of sterile items, and not following the manufacturer's written instructions for use (IFUs) which I will elaborate on a little later.

- Handling sterile items before they are properly cooled. The Association for the Advancement of Medical Instrumentation (AAMI) recommends that all items be allowed to cool for a minimum of 30 minutes up to two hours. These items should not be touched until they are completely cooled. If these items are touched prior to proper cooling, the residual warmth can create moisture which will act as a wick and draw moisture from our hands into the package, rendering it unsterile.

- Excessive handling of packages prior to use. This is an area where following the manufacturers' written instructions is very important. Excessive and improper handling of sterile items will have a direct impact on the barrier characteristics of the packaging materials.

- Not utilizing the FIFO storage principle. This means that you place newly sterilized/dated items behind the items currently on the shelf to ensure that proper expiration dates are followed if applicable.

- Dropping items on the floor. This one is common sense; if a sterile item is dropped on the floor the package integrity is compromised and it MUST be either thrown away or re-processed. It is never appropriate to reuse this item.

- Improper storage. Remember, AAMI tells us that sterile items should be stored 8 to 10 inches from the floor, 18 inches from ceiling fixtures and 2 inches from an outside wall. AAMI also states that items should not be crushed, bent, punctured or otherwise compromised. This is an issue that many facilities deal with as they often have insufficient storage space. It is the responsibility of the SPD leader to work with the OR and infection prevention to ensure that they have adequate storage for sterile items. - Not following manufacturers' written instructions. I literally see this everywhere I go. With the Joint Commission's new stance on sterilization issued in June 2009, this topic will become significant as hospitals and ASCs look for solutions to their storage needs. Remember, we are required to follow manufacturers' written instructions for cleaning, disinfection, sterilization and storage of each product.

Q: People still seem to be confused about time- and event-related sterility issues can you provide some expert guidance?

A: There is still an issue out there for many facilities concerning event- versus date-related sterility. It is important to note that event-related sterility or shelf life involves numerous challenges. The four facets of this are the quality of the packaging material, the storage conditions, conditions during transport and the amount of handling. It is also important to note that although we now use event- versus date-related sterility, it is vitally important to follow the manufacturers' written instructions. All container, wrapper and peel-pouch manufacturers recommend a very specific time that their product maintains sterility on the shelf. I see many facilities that sterilize items and leave them on the shelf until they are used. As I look at the manufacturers' IFUs, I find items that have gone well beyond the specified date, sometimes years beyond. I recommend that facilities contact the manufacturers of all sterile-containment devices and ensure that they are following these instructions. It is also extremely important to make sure that policies and procedures outline how the facility is adhering to the written standards and IFUs.

Q: There is also much doubt over when/how items might become contaminated in the fast-paced, real-world scenarios these professionals face what are some suggestions for making smart decisions to protect patients from potential exposure to pathogens?

A: In many facilities this is a gray area. The bottom line for me is, "when in doubt, throw it out!" As we strive to provide quality patient care, we must look to our aseptic/sterile conscience. If you think that an item has inadvertently touched your hand while opening it on the sterile field, let someone know immediately so the issue can be resolved. If an item falls on the floor, unwrap it and replace it with a new sterile item. Unfortunately in America we are causing approximately 1 million healthcare-associated infections (HAIs) per year and actually killing approximately 100,000 patients every year. This number is mortifying to me and should be the top story in the news every day until we fix it. This is why trying to define what is contaminated and what is not becomes a moot point. As healthcare workers we must remember that these decisions are typically black and white. Either a device is sterile or it is not! We must remember that ultimately we are using these devices on a patient who is under the drapes and who does not get a say. It is imperative that we do the right thing for the patient.

Q: How can infection preventionists come to the assistance of perioperative and sterile processing professionals in terms of upholding proper practices relating to the handling of sterile items?

A: Teamwork, teamwork and more teamwork! If this is not the case at your facility, stop what you are doing. I recommend that infection preventionists work together with the OR and SPD to come up with achievable and sustainable solutions. Like the chain of infection, if one of the links is missing, in this scenario, the possibility that improper procedures are being followed increases. OR, infection prevention and sterile processing leaders should be actively working to monitor and decrease HAIs if this is not already happening. The SPD leader should be involved with the infection prevention, quality and safety committees, reporting on topics such as immediate use sterilization statistics, positive biologicals and sterilization recalls. They should also be involved when there is a surgical site infection (SSI) to ensure that devices involved with the specific patient were properly cleaned, decontaminated, sterilized, stored and delivered. I would also recommend that infection preventionists and OR professionals involve the SPD professionals in staff meetings and vice versa to build and promote teamwork. OR professionals and infection preventionists should round in the SPD department routinely as well.

Q: Is there anything else you feel that infection prevention, operating room or sterile processing professionals should keep in mind?

A: Infection prevention, operating room and sterile processing working in tandem is incredibly important to positive patient outcomes. I applaud facilities already working together and implore facilities that are not to begin immediately.