Vendors Share Sterile Processing-Related 'Horror Stories'

Infection Control Today invited companies to submit examples of egregious practices witnessed in sterile processing departments in healthcare facilities across the U.S., to highlight techniques needing improvement.

Bob Marrs, BA, CRCST, CHL, director of consulting services/field operations for Aesculap, explains that many facilities are incapable of following manufacturers' IFUs (instructions for use) due to inadequate quantities and or quality of equipment in decontamination, both mechanical equipment and loaner trays. "Often hospitals do not posses a three-basin sink that is recommended in AAMI ST:79," Marrs adds. "These basins are dedicated for soaking, washing and rinsing. The majority of manufacturers' IFUs require all three steps in the cleaning and decontamination process and facilities that do not have a three-basin sink cannot meet this requirement. After manual cleaning, manufacturers often require placing loaner trays in an ultrasonic for cleaning. Ultrasonic cleaning is vital to the cleaning process because of its ability to pull debris out of very difficult-to-clean areas."

Marrs continues, "There are three issues related to ultrasonic cleaners that can turn this saga into a horror story. First, the facility does not own an ultrasonic. Second, the facility owns an ultrasonic and it does not work. Third, the ultrasonic is not utilized according to the manufacturers' IFU; for example, a factory setting of 4 minutes when the manufacturer of the loaner tray requires 10 minutes of ultrasonic cleaning time. All three issues place  hospitals in a very serious predicament."

Marrs points to a persistent lack of resources as a contributing factor to improper processes: "Due to an inadequate amount of mechanical washers, CSP staff are often forced to cut corners to try and keep up with this tremendous burden of trays. Washer decontaminators can be either poorly maintained or are altered to make room for more trays. This is a very dangerous practice because we know that if a device is not clean, it cannot be sterilized. It is vital that a facility follow the washer/decontaminators' IFU for proper decontamination of loaner trays. During sterilization audits, it can be found that washers where shelves or sprayer arms have been removed to make room for more loaner trays. There may also be washers that are missing sprayer arms, sprayer arms that are so clogged that that can not perform in the way that they were designed, and broken of missing sprayer arm bushings that result in the arms not rotating properly. Also, because of backlogs of these sets, CSP staff are not taking apart multi-level trays or leave the lid on the tray going through the washers. Again, this is defeating the purpose of mechanical cleaning because this impedes the water and detergent from reaching the devices."

Marrs adds, "Finally, in an effort to save money, the manufacturers of loaner trays often do not provide an adequate amount of loaner trays to facilities in order to provide the same level of care to each patient. This again places the facility in a very tough predicament because they are either forced to cut corners in the cleaning, decontamination, and sterilization process, or they must delay surgical cases. Facilities must be diligent in following the manufacturers IFUs to ensure that they are providing the best care possible for their patients."

Marrs makes the following suggestions for improvement:
1. Facilities should work to ensure that they have a three-basin sink in the decontamination area.
2. Facilities should have an operational, properly functioning, ultrasonic cleaner in the decontamination area and the IFUs for the ultrasonic and loaner trays should be followed.
3. Facilities should follow the washer/decontaminators' IFU for proper preventive maintenance checks. The washers should also be loaded properly to ensure proper decontamination.
4. Facilities should develop policies and procedures that require the manufacturers of loaner trays to provide an adequate amount of instrument trays to provide the same level of care to every patient.


Improperly loaded sterilizer. Photo courtesy of Aesculap


Sprayer arm is missing. Photo courtesy of Aesculap


Clogged sprayer arm. Photo courtesy of Aesculap


Marcia Frieze, CEO of Case Medical, Inc. says her company endorses best practices including thorough decontamination of all medical devices, and limited use of immediate use sterilization (IUS). "Many facilities adhere to these practices; nonetheless, some staff are routinely 'flashing' and only rinsing eye instruments in basins with high-purity water," Frieze says. "They claim that based on information from certified experts that only water should be used. It is their belief that detergents, especially multi-enzymatic cleaners, cause TASS, an inflammation of the eye that can lead to blindness."

Frieze continues, "Included in Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instruments from the American Society of Cataract and Refractive Surgery, is a statement that all debris inclusive of OVD be removed with detergent and water, followed by a thorough rinse. Agitation in a basin should not be used in the final rinse. Rinsing should be provided flow of water over and through the device. Some surgery centers are now installing small RO water systems at the rinse sink to address the requirement that high purity water with continuous flow be used. Our concern about cleaning also extends to the factory-based 'fast cycles' programmed in automated washers. Cycles have been reduced to 30 minutes with limited dry time and 15 minutes with no dry time at all. As a result contact time with cleaners may be less than 1 minute and the rinse about 15 seconds. Cool tap water used to avoid the time to pre-heat. This may suffice, provided all previous steps including manual cleaning and disassembling of devices are followed. However in practice, this can have serious implications if washers are overloaded, if rinsing is not adequate and if drying does not occur. Often, sterilization containers for IUS and certain low temperature sterilization cycles are simply wiped down with disinfecting chemicals and germicides. Cleaning with detergent and water, thorough rinsing and drying are critical steps in the decontamination of all surgical devices including eye instrumentation and containers, trays and inserts used for reusable packaging of surgical devices." 


Richard Schule, director of clinical education for STERIS Corporation, outlines three examples of what not to do, followed by proposed best practices.

Example 1.
What Not to Do
Academic medical facilitys automated washer/decontaminator was being improperly used:
- Devices being processed without a quality system protocol that requires device testing
- Multi-tiered loaned instrument trays run thorough the wash cycle with lids left on, posing added challenges to the cleaning process between patient uses.
Proposed Best Practices
- Review equipment operator manuals.
- Review medical device IFUs.
- Perform washer verification testing upon start-up and document the testing.
- Perform periodic testing to establish reproducible results.

Lids on loaner trays during washing cycle. Photo courtesy of STERIS.

Example 2.
What Not to Do
Medical facilitys cleaning chemistries being stored improperly, near a steam sterilizer chamber. Excessive temperatures can impact the effectiveness of chemistries, and thereby compromise effective washing.
Proposed Best Practices
- Review the IFUs for the cleaning chemistries; follow guidance for proper storage conditions and location.
- Assure that training is established that empowers front-line staff to address quality events such as non-conforming products and processes, so that these events can be prevented.

Chemistries too close to heat source. Photo courtesy of STERIS.

Example 3.
What Not to Do
Ambulatory surgery center washer load/unload racks were being overloaded because one washer was down and there was a high volume of cases scheduled. Regardless of demand, a bottleneck is not an excuse for shortcuts or improper procedure.
Proposed Best Practices
Follow guidance from AAMI/FDA 2011 Summit:
- Perform cleaning according to the device manufacturers written instructions for use (IFU), before each patient use.
- Share lessons learned; this helps to reinforce what not to do.
- Develop and follow written procedures establish a formal program for reprocessing, including written standardized policies and procedures.
- Standards matter know the current standards and recommended practices.
- The CS department should be included in purchasing decisions to influence optimal reprocessing
- Assure that regular training is performed to keep the department up to date
- Perform regular assessments as part of a thorough quality system

Overloaded racks. Photo courtesy of STERIS.


Mike Eckenwiler, a consumables sales representative for Getinge USA, Inc., shares some interesting and horrifying insights on what happens when sterile processing staff fail to perform their jobs. While observing a spinal surgery during a hospital visit, something happened that left him guessing what exactly goes on behind closed doors. During the surgery, an operating room (OR) technician was assembling a bone drill. As she fed the drill into the drill guide, bone fragment and dried blood emerged from the other end. The tension in the room spiked, until the doctor shrugged it off stating, It's sterile blood right? and continued on with the operation. Eckenwiler says this is a prime example of what lurks in the murky water of misconception inside hospitals. "Staff isnt always aware of what is considered clean or sterile, and this poses an enormous threat to patients, as well as staff, who could potentially come into contact with pieces of equipment or instruments that are infectious," Eckenwiler says, There is a dependence on the cleaning procedures that occur within a central sterile department that can sometimes make the difference between life and serious infections which could lead to death.

Eckenwiler offers ideas for improvement to managers based on his experience. To maximize the hospitals efforts in preventing infection, he highlighted the need for cleaning verification. He drove the importance of implementing challenges in the cleaning process. Wash monitors and ATP testing both verify washing efficiency as well as notify SPD staff if something has gone wrong well before instruments make their way to patients.

Certain instruments such as the spinal drill below pose challenges in terms of effectively cleaning the inner channels. The hard-to-clean areas accumulate human waste and bacteria a serious threat to patients. Photo courtesy of Getinge USA, Inc.

During a site visit, Misty Whitecotton, a consumables Specialist for Getinge USA, Inc., encountered a serious problem with the cleaning of lumens. This particular facility had several known discrepancies in their cleaning processes, and had asked Whitecotton to provide suggestions for improvement. Utilizing a Getinge ATP monitoring tool, she fed a test sponge through one of the facilitys cannulated instruments. The sponge emerged from the distil end of the Smith and Nephew shaver covered in black debris. This was disturbing because the facility claimed this instrument had been cleaned. However, there was no procedure in place to verify the cleanliness. According to Whitecotton, During decontamination, the staff would simply pour alcohol down the channels of their cannulated instruments thinking it could kill anything. As a healthcare professional she quickly realized the problem. In addition to their lack of verification, the staff at this facility had a misconception on what clean was, and how to achieve cleanliness regarding high risk surgical equipment. Whitecotton added, If its not clean, its not sterile. This facility was potentially sending unclean and unsterile instruments for use on patients, increasing their risk of infection.

Following the discovery, Whitecotton sat down with managers and offered some suggestions. She explained that cannulated instruments need to be thoroughly manually cleaned during the decontamination process before sterilization.  Additionally, she urged the implementation of challenge devices. Challenging the cleaning process would verify the cleanliness of instruments as well as verify proper functioning of the washing/decontamination equipment within the department.

The black debris found on the test sponge passed through the irrigation/suction channel of a Smith and Nephew shaver. Photo courtesy of Getinge USA, Inc.


Stephen Kovach, director of education at Healthmark Industries, says he has witnessed problems associated with proper pouching technique, such as double pouching. "The staff are still rolling the inner seal and creating pockets of air which will challenge the sterilization process. AAMI ST 79 outlines how and when you should double pouch. Section 8.3.4 says, 'If the item is to be double-packaged, two sequentially sized pouches should be used (i.e., the sealed inner pouch should fit inside the other pouch without folding). The pouches should be positioned so that plastic faces plastic and paper faces paper... Double packaging in paperplastic pouches should not be performed without documentation from the manufacturer that the paperplastic pouch has been validated for this use.'"  

Improper double pouching. Photo courtesy of Healthmark Industries.

Kovach says he also sees bad seals. He explains, "I recently did an audit of a department and I found 10 percent of the heat-sealed pouches had bad seals. I also found that the push bar sealer had not had a PMA in over two years. Departments that have heat sealers are failing to verify that they are working properly. A heat sealer is considered a piece of medical equipment so it does mean it is in need of being tested on a routine basis. This is an item that is constantly in use and should be tested at least each shift to ensure it is providing a proper seal. To ensure a proper seal when using a heat sealer you need to make sure you have the proper temperature, dwell time and pressure. This coincide with the type of pouch you are using because different pouches can have different sealing  temperatures. So it is important to match up your temperature with the type of pouch you are sealing. One sign of a bad seal is what I call 'rivers' or gaps within the seal. If you see this, check your sealer and redo the pouch."

Example of a poorly sealed pouch. Photo courtesy of Healthmark Industries.

Kovach emphasizes the importance of understanding the role that water quality plays in cleaning, which is often noticeable in automatic washers: "I often can see the scaling on the inside chamber of the washers. It is my belief that if you are getting this amount of scaling or white powder on your washers wall, sooner or later it will show up on your instruments."

Scaling on the inside chamber of washers. Photo courtesy of Healthmark Industries.

Ralph Basile, vice president at Healthmark Industries, says a significant amount of time is spent helping healthcare facilities gain control of their cleaning process. "Over the years, we have seen great improvement in this area across the industry. However, one of the most persistent problems is a failure of the detergent delivery system. This is often the result of the peristaltic pumps in the washer losing prime, for one reason or another. Often the reason is a failure to follow the preventive maintenance recommendation of the washer manufacturer. But there can be other reasons as well. I witnessed the 'horror story' along these lines at two different institutions. After the audit and training session at both facilities, I went in to report the results to the department manager. In both cases, I told the manager the same thing, 'You have not purchased a new container of detergent in at least six months.' Unbelieving, they looked up the purchase history and to their chagrin, I was right. Was I using ESP? How did I divine such knowledge? In both instances, staff had made a mark at the detergent level with an indelible marker and written the date next to the line. A commendable practice, but unfortunately, no one had apparently gone back to see if the detergent was being drawn down and in both instances the detergent level had not changed in six months. For me, these experiences affirm the value of routine testing of cleaning equipment."


Chuck Hughes, vice president of infection prevention consulting services for Cantel Medical Corp./SPSmedical Supply Corp. provides the following evidence of the most common and problematic situations he sees in healthcare facilities:

- Grossly soiled instruments being transported without any pre-cleaning at point of use.

- Improper cleaning of instruments, ranging from manual cleaning above the water surface, not using ultrasonic per instrument manufacturer's IFU, improper loading of tray in mechanical washer, and cleaning rigid container on clean side with alcohol wipe.

- Improper placement of steam BI PCD.

As Hughes notes, "The worst I have seen is food trays coming through decontamination departments  for cleaning. There are several facilities that I know of first hand, and others that I have heard of."


Matt Rudolph, vice president of operations  and chief customer advocate at Spectrum Surgical Instruments/STERIS Specialty Services, says there are a number of instruments that pose great challenges for facilities when it comes to maintenance. "This is largely due to the fact that there is no way for the end-user to take apart and clean instruments such as Kerrison Rongeurs and the older generation of laparoscopic instruments," Rudolph says. "These instruments are examples of items that must be kept on a repair rotation with the vendor. The company will disassemble Kerrisons and remove bio-burden from the inner track as well as inspect, sharpen and align the track. Similarly, the vendor will strip the insulation off of the lap instruments and remove bio-burden and debris from the drive rod, shaft and linkage in the jaw. These examples are critical to patient safety as there is no way for the end user to effectively clean these items.
Rudolph says that healthcare customers can assist the vendor in doing their job better by taking advantage of free staff education. "After the vendor leaves the facility for the day, an educated staff can partner with the vendor by implementing such things as scissor sharpness testing, laparoscopic insulation testing and overall instrument inspection. The life of instruments will be extended if problems or repair needs are caught early."

Sterile, disassembled Kerrison Rongeurs showing trapped bioburden inside. These images were captured with Spectrum's Spectra-Scan Digital Mapping Technology to provide education to the customer. Image courtesy of Spectrum Surgical Instruments/STERIS Specialty Services.