Sterile Inventory Quality Control: Small Changes Can Lead to Big Success


Sterile Inventory Quality Control: Small Changes Can Lead to Big Success

By Michelle Beaver

Time, space, poor resources, and lack of know-how -- any of these factors can contribute to problems with sterile inventory storage. Some factors are unavoidable, but knowledge can always be improved.

The two main types of sterile inventory include event-related sterility (ERS), which is more common, and time-related sterility (TRS).¹

In regard to ERS, expiration dates of sterile items are irrelevant (except for those set by manufacturers) unless the item or its packaging has been damaged. Time-related sterility, on the other hand, mandates that items are sterile in their current packaging only until a certain date. The item may then be re-sterilized and re-packaged and receive a new expiration date.¹

Sterility is compromised any time that microorganisms may have been introduced into a package, according to Barbara J. Gruendemann, RN, MS, FAAN, CNOR, and Sandra Stonehocker Mangum, RN, MN, CNOR, authors of the book, Infection Prevention in Surgical Settings.

Examples of events are touching warm and damp packs or instrument trays just removed from the sterilizer (microorganisms on hands may penetrate wrappers); finding tears or pinholes in wrappers; and sneezing or coughing on a package that is not totally sealed, such as a wrapped instrument set, the Gruendemann and Mangum book states.

The authors say that the choice between ERS and TRS practices is not a simple one, and that it requires careful evaluation. Regardless of which system is chosen, items should not be touched more than three times, and should only be touched under the following circumstances:

1. When placing an item from a sterilizer cart onto a storage shelf
2. Putting an item on a case cart or supply exchange shelf
3. Picking up the item for use¹

Report Card

When asked whether workers at the average healthcare facility properly care for sterile inventory, Bob Marrs, BA, CRCST, CHL, the director of St. Davids Medical Center in Austin, Texas, knows where he stands. Unfortunately, no! (they dont properly care for sterile inventory), he says. In my 17 years of working in perioperative services as a surgical technician and holding every position in central service/sterile processing, from instrument technician to my current position as director here (at St. Davids), I have found that the No. 1 area most often overlooked is adequate training in the care and handling of surgical equipment and instrumentation. This training should include all levels of surgical staff from technicians to RNs and all staff in central service/sterile processing departments, he adds. I would recommend offering this training to physicians as well.

Other experts, such as Penny Sabrosky, CSPDT, clinical manager of perioperative services at Hackley Hospital in Muskegon Mich., and president of the American Society for Healthcare Central Service Professionals (ASHCSP), agree that sterile inventory gets handled poorly sometimes. Workers at the average facility who handle sterile devices are so diverse that they are not always informed or knowledgeable about care for sterile inventory, Sabrosky says. The average touch-points for a sterile instrument tray to go from surgery to CS and back may be as many as 10.

Knowledge is key, says Natalie Lind, CRCST, CHL, education director for the International Association of Healthcare Central Service Materiel Management (IAHCSMM). Workers properly care for sterile inventory when they understand how to handle it, Lind says. I think that when sterile items are contaminated, it is most often because someone didnt know how to properly handle the item, not because they were careless or negligent.

Contaminated items can be costly, Lind adds. However, the real danger, in my opinion, is when items are contaminated and it goes unnoticed and those items are used in patient care and treatment. Healthcare facilities should educate everyone who comes in contact with sterile items on proper handling requirements. Unfortunately, they often concentrate on people who work in the sterile storage area and may overlook others such as people who work in the receiving area, environmental service employees who clean in areas adjacent to sterile items and delivery personnel who transport sterile items.


Patient safety is No. 1, but the bottom line is important too, and can be improved when staff properly handle sterile inventory, says Sabrosky.

I feel strongly that if facilities invest in proper and adequate space for storage, they save money over time, she says. Most often additional trays or products are purchased without planning where the products will be placed. After the product arrives, staff tends to slide and push other sterile products to the side or start piling them up, leading to compromised sterile packaging.

Marrs is also certain that better practices lead to better monetary returns. Without hesitation, I believe, the majority of facilities across the country would benefit greatly from intense training concerning the care and handling of this very expensive and intricate surgical asset (endoscopic technology, for example), Marrs says.

This equipment continues to present challenges with cleaning, disinfection, sterilization, storage, delivery and receipt, he adds. As this equipment advances technologically, it increases in cost just as quickly. We now work with laparoscopes that can cost as much as $15,000 and cameras that are breaking the $30,000 mark. With the increase in cost, it is not uncommon to see repair budgets growing to 5- 15 percent of the total operating budget.

Bruised and Battered

Some sterile objects bear more brunt than others. Common victims, according to Danielle Lucero, manager of sterile processing at The Childrens Hospital, in Denver, include very delicate and fine instruments like your .5 forceps or eye instruments.

Organization is imperative, according to Lucero. We have the OR staff separate the delicate instruments after they have been used in a case and put in an emesis basin so heavy instruments are not laid on them and damage them, she says. When the operating room (OR) staff help separate the delicate instruments after a case that helps to cut down on replacing and repairing items.

Other commonly damaged items include cameras, scopes, light cords, powered surgical equipment, drills, saws, reamers and batteries, Marrs says. He adds that these items are often damaged because of improper delivery from the OR to the decontamination area, improper cleaning techniques, fluid invasion, improper storage, being dropped, and experiencing inadequate cooling time after flash sterilization.

With the endoscopic devices, I have coined a term that I call the Birds Nest Phenomenon, Marrs says. This is when you receive a cart in your decontamination area and it looks like someone took the time to build a beautiful birds nest out of your cameras, light cords and scopes. Instead of a bird sitting in the middle of the nest it usually holds a heavy instrument tray or trays. This phenomenon is wide spread and causes damage in the form of cut cords and crushed scopes.

Many OR staff members neglect the fact that powered equipment should be completely cooled before it is used again, Marrs adds.

These devices are usually lacking in inventory due to cost and ORs are required to flash sterilize them for rapid turnover, he says. When these devices are brought to the OR suite directly from the flash sterilizer they are placed in a basin of cold water, wrapped with a wet towel and used immediately. This practice greatly decreases the life expectancy of these expensive surgical devices.

School Days

Marrs recommends an ongoing training program for proper care and handling of surgical devices. This training should be given to all new OR and CS/SPD staff and it should occur at least once annually, he says. You can increase the frequency if you find a trend or have a specific device that is being damaged. This training is a great way to build a relationship with your vendors by including them as trainers. It is a great time to ask surgeons to speak at in-services to show how they use a device. You can also ask them to be involved with care and handling trainaing.

I would also recommend a program where your OR and CS/SPD staff spend time in each others work areas, he adds. OR nurses and technicians should spend time working in sterile processing and CS/SPD staff should spend time observing in the OR. This will help cultivate a culture of shared respect for all of the staff involved. I will help the CS/SPD staff understand why and how the equipment that they touch everyday is used. It will also show them how an incomplete or improperly cleaned and sterilized device impacts customer service and more importantly, patient care. This swap will also give the OR staff a new found respect for just how difficult a task is put before the CS/SPD staff.

No Space in the Place

Small spaces are a big problem and often makes organization difficult, according to Lind. Space is a huge issue, she says. Healthcare facilities often overlook the fact that new technologies, procedures, and equipment that are introduced into a facility often mean additional sterile items such as instruments and supplies. That can impact storage areas significantly.

Lind suggests that anyone working in seriously limited space should:

  • Make use of every useable spot

  • Standardize disposable products and instrument sets to minimize unnecessary duplication

  • Instead of ordering a large shipment once a week, consider ordering two smaller shipments at spaced intervals to reduce the amount of space needed

  • Review all items and make certain that they are still useful

Lack of space is felt far and wide throughout the industry, Marrs says.

If you talk with anyone who has been around an OR or CS/SPD department, one common denominator will be the lack of space to adequately perform our jobs, he says. We never have enough space. When working with inadequate space, organization is a must. Unfortunately, if you wander through sterile storage areas, you will typically find shelves that are over-stacked and bins that are over stuffed. The Association for the Advancement of Medical Instrumentation (AAMI) recommends that all storage shelves be eight to 10 inches from the floor, 18 inches from the ceiling and two inches from outside walls.

Manufacturers of certain items, such as total joint sterile trays and surgical custom packs, are part of the problem, according to Sabrosky. They are heavy and bulky not ergonomically sized for correct to proper handling, she says. Manufacturers continue to produce bulky, heavy trays that are almost impossible to keep sterile by normal means of processing. Even in the operating room, staff struggles to keep items sterile when lifting the trays and packs from the case cart, to the sterile field.

Not all products are a pain though, Sabrosky contends. Products are being introduced all the time to help reduce punctures and rips in the sterile wrapped instrument trays, including paper liners, foam edges, plastic containers rather than the traditional metal, she says.

However, all of the products add to the bottom line of the budget, she adds. Foam corners can run up to $4 per each tray wrapped. That is $400 additional operating expenses to the budget each day for a 100 trays! It may be more advantageous to invest in rigid containers or shelving over time to save the integrity of the sterile package.


Most facilities cannot realistically conduct a complete overhaul of their sterile inventory services, and may not need to, but every facility can incorporate small tips, such as double wrapping packages.

This can be quite effective, and so can Tyvek pouches, according to Gruendemann and Mangum, who write, A double-wrapped package will reduce the possibility of contamination during unwrapping. Sterilized items (except those in rigid containers or peel pouches) should be wrapped in two thicknesses of paper or non-woven fabrics a dust cover (sealed, airtight plastic bag) protects a sterile package from dust, dirt, lint, moisture, and vermin during storage. After sterilization and immediately following aerating or cooling to room temperature, infrequently used items may be sealed in plastic 2 to 3 mm thick.

Some simple tips, according to Sabrosky, are to:

1. Provide carts for transportation of sterile supplies
2. Rotate stock using the first in-first out principle
3. Hold product horizontally in front of body during transportation.
4. Provide solid shelving instead of stainless racks (stainless racks may have sharp edges)
5. Try not to stack trays

At The Childrens Hospital in Denver, staff members have found that it is helpful to use a lanolin vinyl sheeting on all their tables. This helps decrease damage to surgical instruments, Lucero says.

I think that having tray liners or mats in the bottom of all trays helps decrease instruments from being damaged, she says. When the scrub techs are taking them out they are not catching on the baskets and damaging instruments.

Here at Childrens all scissors are checked for sharpness and accuracy after every use, she adds. We have a tracking system here and we know when the last time a set has been sent out for sharpening and know what sets need to be sent out the next month.

This has resulted in fewer complaints from the OR, she says.

According to Marrs, an important tip is to allow all packs to dry completely before they are released to the OR.

Packs should never be touched or transported to the OR when they are warm, he says. When the packs are touched when warm they can wick moisture from your hands and contaminate them. Training must happen daily and be ongoing to ensure accountability and that we provide clean, functional and sterile devices to our patients 100 percent of the time, every time.

Principles of Sterile Inventory Maintenance

Storage conditions provide the cornerstone for appropriate sterile inventory. According to Gruendemann and Mangum, appropriate storage conditions for sterile packs include the following:

  • Limited access to the storage area or closed cabinets

  • Separate storage of clean and sterile supplies

  • Clean, dry, dust-free, lint-free area

  • Temperate between 65 degrees and 72 degrees F and a humidity level between 35 and 50 percent

  • Materials (should be kept) 8 to 10 inches from the floor, 18 to 20 inches from the ceiling (to allow for functioning of sprinkler systems) and 6 to 8 inches from an outside wall (to avoid condensation and subsequent contamination)

  • Closed shelving is preferred

  • Sterile items remaining on shelves and unused for a period over one year should be evaluated

  • If a sterile package is dropped, it may only be considered safe if the packaging is impervious and has not been damaged. Items wrapped in woven materials should never be used if dropped, for contaminants can penetrate them.¹

Marrs contends that OR staff should put all devices back into the containers that they came in, after use, for transport back to decontamination.

In terms of maintaining proper temperature and humidity in storage areas, a systematic approach is best, he adds.

For accountability purposes, this task should be assigned to a specific team member every day, he says. You can create a log sheet that includes the initials of the person verifying that you have met the correct temperature and humidity range daily. This storage area should also be under positive pressure with four air exchanges per hour.

Different Strokes for Different Folks

Inconsistency runs rampant nationwide when it comes to handling sterile inventory, according to Marrs.

I am always amazed (by these inconsistencies when) I travel and meet other professionals around the country, he says. I have found that how we do our jobs differs greatly from facility to facility. I am more intrigued and saddened by the number of facilities that do not have a copy of the AAMI Standards and Recommended Practices in their facilities. Most of these folks say that they research as much as they can online and wing the rest. This is a very frightening thought.

One other very troubling fact that I find is the lack of certified professionals working in CS/ SPD departments across the country, he adds. AAMI recommends that all personnel in CS/SPD departments be supervised by a person that has successfully completed a central service management certification examination. I am troubled because I have spoken with leaders that just do not believe in certification and others who will not do everything in their power to help their staff become certified.

Marrs believes that leaders in the industry have a responsibility to encourage certification, and to provide resources toward this goal whenever possible.

I am grateful for New Jersey leading the way with this push, he says. New York is very close behind New Jersey and we in Texas are starting this effort, and I know a number of other states are moving forward with this as well.


1. Gruendemann BJ and Mangum SH. Infection Prevention in Surgical Settings. W.B. Saunders Co. 2001.

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