It is well known that surgical/device pre-treatment is a point of contention between many sterile processing (SP) and operating room (OR) teams. When post-procedure pre-treatment isn’t performed correctly (or at all), SP teams are stuck with having to remove hardened biological/organic material, adding extra work, prolonging the reprocessing cycle, and jeopardizing patient safety (e.g., retained bioburden, instrument/device damage).
Healthcare Purchasing News (HPN) reached out to SP leaders, consultants and solutions vendors to solicit their opinions on why point of use (POU) pre-treatment is such a challenge and proven methods they have employed to improve compliance.
The battle with biofilms
Let’s start by getting back to the basics with biofilm. Preventing the formation of biofilms, defined as “surface-attached communities of bacteria embedded in an extracellular matrix,” is a relentless battle in healthcare environments with the constant contamination of environment surfaces and objects.1
So-called “build-up biofilm” that forms on reusable medical devices “represents a great challenge for healthcare-associated infection control and prevention,” as noted by the editors of a Hygiene journal special edition on the topic.2 They go on to state:
“Evidence-based strategies and practices to prevent biofilm formation and the chemical fixation of existing biofilms, as well as to remove biofilms from environmental surfaces and reusable medical devices, are required to minimize pathogen transmission and, therefore, to deliver safer care to the patients.”
Performing cleaning and decontamination as soon as possible after an item has been used – at the point of use - is an evidence-based practice recognized throughout the healthcare industry (CDC, AORN, AAMI, APIC, etc.).
If POU pre-treatment of contaminated instruments and devices in the OR is a proven strategy to help prevent biofilm formation, why isn’t compliance 100% across the board?
Challenges to compliance
Researchers from the Graduate School of Nursing, Uniformed Services University of the Health Sciences, in Bethesda, Md., conducted a literature review on POU treatment compliance and published their findings in the January 2024 issue of the journal Military Medicine. An interesting aspect of this research was the extrapolation of POU treatment non-compliance implications for Military Health System policies and future considerations.
If poor pre-treatment compliance makes decontamination more difficult when the OR and SPD are housed together in a stable, well-equipped hospital environment, just imagine the impact when compliance failures take place during “large-scale combat operations.”
With studies indicating “that drying times beyond 15 minutes significantly reduce the effect of subsequent cleaning to remove protein residues, including prions,” time is of the essence whether the surgical procedures are taking place in a hospital or on the battlefield.3 As the researchers stated, “Completing POU treatment is critical to a successful surgical mission in both the hospital and austere environment.”
Based on their literature review, the researchers identified these barriers to POU treatment compliance: “complex POU processes, intricately designed surgical instruments and endoscopes, lack of healthcare worker (HCW) knowledge and competency, and inadequate or ambiguously written policies.” They pointed to “Training, competency assessments, and clearly written policies and procedures” as “cost-effective, evidence-based, and feasible solutions.”4
Turning back to the civilian healthcare delivery environment, contributors to this article commented:
“It can be difficult for any sterile processing department to achieve 100% compliance with all that we are responsible for,” said Randalyn Harreld, CRCST, CIS, CER, CHL, C.S.P.D.T, C.A.S.S.P.T, BLS, AAS, clinical education, manager, U.S., Belimed. “The amount of ‘best’ practices that have come into play, the variations in instructions and the entities providing guidelines and standards can be difficult to follow 100% of the time.”
“I believe POU pre-treatment is such an issue because people often will not prioritize a process change until it is mandated or a hospital is written up for noncompliance,” said Ascendco Health Co-Founder & CEO Brian Reed. “And they are getting written up.”
“When I perform audits, point of use treatment (POUT) failure is usually one of the top things that is a compliance issue,” said David Jagrosse, CRCST, CHL, President, David Jagrosse Consulting. “To be clear, it is in the IFUs and AAMI standards but from a technical standpoint, it is not that we can’t process instruments without pre-treatment having been performed, but rather, it makes it almost impossible and much more challenging and very time-consuming.”
“OR staff may not understand the critical importance of immediate post-procedure pre-treatment of instruments,” said Joan Melendez, president & CEO, Xcelrate UDI. “Failure in this area risks patient safety, damages instruments, and delays processes.”
Explain the “why”
Explaining to the OR why their part in pre-treatment is important and benefits their workflows, and ultimately their patients, is key to gaining support.
“It’s like what Tom Cruise said in Jerry Maguire: ‘Help me help you,’” said Jagrosse. “The OR wants instruments turned over. They need them back for the second, third and fourth cases of the day. If they don’t do this pretreatment, it makes it almost impossible to turn these instruments over in a timely and efficient manner.”
Harreld refers to “obedience, accountability, and the inevitable ‘that’s not my job’ mentality.”
“Sometimes things don’t happen because people don’t want them to happen,” said Harreld. “More times than I’d like to admit I’ve seen many disregard point of use care, stating that it simply isn’t their job, they don’t have time, the spray is too much, too tedious, etc.”
“If the team understands ‘why’ something is being asked of them, and not just being asked to do it, usually the compliance rate will go up, and even better ideas can come into play all while increasing morale and outcomes,” she added.
Ongoing education and training are critical to long-term POU pre-treatment compliance success. Melendez recommends that hospitals “Prioritize joint sessions for the OR and SPD staff on correct sterilization techniques, regulatory updates, including FDA guidelines, and ISO 13485 standards. This approach ensures high-quality patient care through adherence to compliance, fostering a culture of excellence and continuous improvement,” she explained.
Understand the challenges
“As Sterile Processing professionals we should consider how we can help the OR reach pre-treatment goals,” said Jagrosse. “For example, one hospital purchased 4 oz spray bottles for pre-treatment application that the sterile processing team supplies on the case carts.”
“Have the right products and workflow that fit the need of your unique inventory,” said Harreld. “Make sure a point of use product process and workflow are set up. Many times, it might not work spraying liquid in the OR when the patient is still there, and no core is available or soiled utility space to complete the job. Maybe your workflow doesn’t allow for this to happen. Make sure we set our teams up for success to make POU pre-treatment mandatory and possible.”
Engage in collaboration
Harreld recommends SP teams partner with all areas responsible for POU pre-treatment and set a game plan together. She stated:
“Create a committee and let infection control be the driver of the safety component while a chief surgeon can also be the facilitator in the OR to help push the task. Implement a policy that addresses the process and include SPD during the education portion of this. Be consistent and hold the line when or if people start to push back.”
“Keep a team approach and mentality during this whole process and make sure to work together, as it’s the collective duty to take part in this important practice,” she added. “The procedure areas, clinics, operating room personnel, infection control reps, and doctors all need to collaborate with sterile processing to make this joint effort realistic and achievable.”
Melendez recommends strengthening communication between SP and OR teams through regular meetings and feedback sessions to facilitate a collaborative approach to address pre-treatment issues.
Eddie Conklin, CRCST, CHL emphasized the vital roles of surgical technicians and decontamination technicians and the workflows that link them, stating:
“Being at the point of use, a surgical tech sees each individual instrument being used and knows the extent of bioburden, especially on complex or difficult instruments. Their AST standard addresses this; if the instrument is not precleaned at a minimum it should be separated for the decontam tech. Decontam techs’ workflows are large volume, and they work in batches to cover several ORs.”
“The instruments should be counted, the count sheet validated, and the instruments placed back in their original containers,” Conklin continued. “Extra items, such as peels, should be separated to avoid missing instruments at assembly and to improve first pass yields, quality, and efficiency. Indicators, pan locks, white arrows, tags, and labels should be removed.”
Back it with documentation
As Harreld pointed out, “Almost all recommendations, including guidelines from AST, AAMI and AORN, mention the importance of point of use care, so it is everyone’s responsibility. We need to be setting expectations and holding our teams to them to ensure they understand how it helps the longevity of the instruments and makes the cleaning process safer and more effective.”
Manufacturers’ instructions for use (IFU) are a vital resource for both the OR and SP teams to understand their roles in instrument cleaning and maintenance. Melendez recommends ensuring all OR team members have access to and understand manufacturers’ IFUs.
“Additionally, implement tray worksheets to accompany each instrument tray, serving as a checklist to ensure adherence to SOPs and IFUs,” she added.
Capture and measure compliance
According to Jagrosse, most hospitals will establish key performance indicators (KPI) for POUT. Then the question becomes, how do they set a baseline, measure compliance, and track improvements?
“Some organizations measure POUT compliance in decontamination on paper but departments with instrument tracking systems will have the ability to scan a case cart and scan a barcode to document deviations. Because if you don’t measure it or have a handle on it, it doesn’t exist.”
Address issues in a timely manner
Jagrosse pointed out that access to real-time data on POUT compliance enables timeliness of response, stating:
“Some places will collect the data and wait until the monthly meeting saying, ‘we had 72 instances of non-compliance,’ but that means nothing when speaking in a crowd setting. In other instances, an SPD team will identify a deviation, attempt to address it with the OR team at the end of the day, which is again too late, and they may often answer ‘It wasn’t me, I was relieved for lunch,’ so now there is no ownership of the deviation.”
“There must be accountability and the best way to do that is in real time and not daily or monthly,” Jagrosse continued. “There are tracking systems that allow us to immediately identify deviations and even send text alerts to key leaders. If you get those real time notifications and directly address an issue with the corresponding OR team, then you will be able to engage with the team responsible for the deviation.”
According to Reed, Ascendco Health applies analytics to the events captured and recommends to the hospital when and where they should perform audits (e.g., on certain trays, staff members, times of day).
“When hospitals are recording events and performing audits, they have seen an over 95% reduction in events,” said Reed. “It’s important to note that the tracking and auditing goes both ways. With our system, the OR team uses a dedicated smart phone or tablet to record events on trays coming from the SPD, such as missing/damaged instruments, holes in sterile wrap, etc. We didn’t invent event recording, but we made it easier to record events as it becomes part of the SPD and OR workflows.”
Keep patient safety as the focus
“The more hospitals push their care teams to attend to more patients and increase surgical volumes, we must calculate more time for these additional responsibilities to take place and avoid the awful habits of taking shortcuts,” said Harreld. “This comes into play with priority sets and turnovers, inventory issues, etc. OR minutes equals money, but we also have safety to always consider.”
References:
1. Biofilms on medical instruments and surfaces: Do they interfere with instrument reprocessing and surface disinfection, American Journal of Infection Control (AJIC), November 2023, https://www.ajicjournal.org/article/S0196-6553(23)00314-0/fulltext
2. The Impact of Biofilms on Cleaning, Disinfection of Surfaces and Reprocessing of Reusable Medical Devices, Hygiene, https://www.mdpi.com/journal/hygiene/special_issues/biofilm_cleaning
3. Rubak P, Lorenzen J, Ripadal K, Christensen AE, Aaen D, Nielsen HL, Bundgaard K. Can a humid storage environment of surgical instruments before reprocessing increase patient safety and durability of instruments? J Hosp Infect. 2022 Apr;122:64-71. doi: 10.1016/j.jhin.2022.01.012. Epub 2022 Jan 22. PMID: 35077808.
4. Eberhardt GL, Atwood BI, Smith JD. Point of Use Treatment for Medical Devices: From Bedside to Battlefield. Mil Med. 2024 Jan 9:usad499. doi: 10.1093/milmed/usad499. Epub ahead of print. PMID: 38198220.
Kara Nadeau | Senior Contributing Editor
Kara Nadeau is Sterile Processing Editor for Healthcare Purchasing News.
