Healthcare Purchasing News - June 2024

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CLINICAL INTELLIGENCE FOR THE HEALTHCARE ECOSYSTEM JUNE 2024 | VOL. 48, NO. 6 WWW.HPNONLINE.COM TECHNOLOGY ADVANCEMENTS IN INFECTION PREVENTION ... 14 Orthopedic Service Line Strategies ... 8 Wound Management ... 12 Device/Instrument Cleaning ... 16 Air Quality + Smoke Evacuation ... 30


Enzymatic pretreatment humectant spray designed to keep instruments and rigid scopes moist for up to 72 hours.

Multi-tiered enzymatic detergent with advanced proteolytic action & rust inhibitors for the effective decontamination of surgical instruments and endoscopes


Sourcing & Logistics

8 > Commitment is Key to Starting an Orthopedic Service Line, Says Expert


32 > Creating Visibility at Scale


Surgical/Critical Care

12> Wound Management Update from Medline


Infection Prevention

14 > Preventing Infections with Artificial Intelligence


Sterile Processing

16 > The 3Ps of Cleaning in Sterile Processing: People, Processes and Products


22 > Product Testing: The Overlooked 4th Pillar of a Robust Sterilization Process Monitoring Program


26 > Sticky Residue: A Possible Contaminant That Shouldn’t Be Overlooked


28 > Bursting Pouches


Special Report

30 > Surgical Smoke Evacuation Update


2 | June 2024 | Healthcare Purchasing News
Departments 4 > Reflecting on HSPA 2024 6 > What’s on the Web, Advertiser Index 8 16 12 30 CONTENTS > JUNE 2024 14 COVER PHOTO/ILLUSTRATION CREDIT: 110247398 © ALPHASPIRIT, 121869141 © TARTILASTOCK | DREAMSTIME.COM

Reflecting on HSPA 2024

The way our internal production schedule is set up has our team diligently working away on editions well ahead of the month the edition hits your inbox or mailbox. I just returned from the Healthcare Sterile Processing Association (HSPA) conference that took place April 21-23 in Las Vegas. And although this is the editorial for the June edition, I can’t help but keep reflecting on the conference, particularly the advancements being made in this space and the individuals who make it all happen.

On April 22, at the conference at the Caesars Forum, in a session entitled “The Instrumental Role of Data and Analytics in Sterile Processing,” John Erickson and Alison Sonstelie discussed data, key performance indicators, and methods for collecting data.

Erickson has been in Sterile Processing for 18 years and started his career as an entry-level technician, advancing to roles such as educator and manager. Sonstelie is a Client Success Manager at Ascendco Health. One of her current roles involves helping clients leverage their data to improve their operations. Prior to joining Ascendco, she worked in Sterile Processing and Supply Chain for over 10 years. During that time, she was elected

to the HSPA Board of Directors, was part of the 2014 Healthcare Purchasing News CS/SP Department of the Year and participated in several AAMI workgroups.

Sterile Processing professionals are often left reacting to chaos and process breakdowns. The key to moving into a proactive approach is to get a better grasp of current performance. Data and its collection points are the foundation for understanding the department’s current state and making improvements.

The entire session was full of tips for Sterile Processing professionals to start using data and analytics, even without fancy software. You can read my writeup on this session here:

Also, I had the pleasure of presenting the 2024 Sterile Processing Department of the Year Award to two representatives from Ann & Robert H. Lurie Children’s Hospital of Chicago at the conference.

I’ve been to a lot of healthcare conferences during my career, and I was, and still am, astounded by the commitment and passion that Sterile Processing professionals have in their profession. I truly think we need to do more as an industry to celebrate these unsung heroes who are keeping patients safe “behind the scenes” by bringing them front and center.

Group Publisher Chris Driscoll | 978-880-8345

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EDITOR’S NOTE 4 | June 2024 | Healthcare Purchasing News
with us:

What’s on the Web

Wastewater Testing a Pivotal Tool for Monitoring H5N1 Outbreak

Researchers at Emory University “used a hydrolysis probe-based reverse transcription-polymerase chain reaction (RT-PCR) to measure H5 concentrations in wastewater dating back to February 4 at three sentinel Texas treatment plants near the H5N1 outbreak epicenter.” The virus was not detectable until mid-March, but numbers went up substantially then, coinciding with “flu-related emergency department visits in the associated Texas public health regions” declined.

Read on:

Widespread Overuse of Antibiotics in Patients Hospitalized with COVID-19

New evidence from WHO shows extensive overuse of antibiotics during COVID-19 pandemic worldwide, which may have exacerbated the spread of AMR. Only 8% of hospitalized patients with COVID-19 had bacterial co-infections requiring antibiotics, yet three out of four or some 75% of patients have been treated with antibiotics ‘just in case’ they help.

Read on:

Legislative Proposal to Address Shortages of Generic Medications

U.S. Senate Finance Commi ee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a legislative proposal to address ongoing economic problems leading to shortages of generic medicines—including chemotherapy drugs and ADHD medications. The proposal, released as a discussion dra , would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants.

Read on:

New Study Shows Positive State of the Industry in 2024 has released its third annual report on the state of nursing in 2024. Among the takeaways, nurses reported feeling happier and more satisfied with their work than in 2022. There was a 44% increase in nurses that replied “that they were happy they chose the nursing profession vs. 2022, and job satisfaction rose 64% from 2022 to 2023.

Read on:

Editorial Advisory Board

Jimmy Chung, MD, MBA, FACS, FABQAURP, CMRP, Chief Medical Officer, Advantus Health Partners and Bon Secours Mercy Health, Cincinnati, OH

Joe Colonna, Chief Supply Chain and Project Management Officer, Piedmont Healthcare, Atlanta, GA; Karen Conway, Vice President, Healthcare Value, GHX, Louisville, CO

Dee Donatelli, RN, BSN, MBA, Senior Director Spend symplr and Principal Dee Donatelli Consulting LLC, Austin, TX

J. Hudson Garrett Jr., PhD, FNAP, FSHEA, FIDSA, Adjunct Assistant Professor of Medicine, Infectious Diseases, University of Louisville School of Medicine

Melanie Miller, RN, CVAHP, CNOR, CSPDM, Value Analysis Consultant, Healthcare Value Management Experts Inc. (HVME) Los Angeles, CA Dennis Orthman, Consulting, Braintree, MA

Janet Pate, Nurse Consultant and Educator, Ruhof Corp.

Richard Perrin, CEO, Active Innovations LLC, Annapolis, MD

Jean Sargent, CMRP, FAHRMM, FCS, Principal, Sargent Healthcare Strategies, Port Charlotte, FL

Richard W. Schule, MBA, BS, FAST, CST, FCS, CRCST, CHMMC, CIS, CHL, AGTS, Senior Director Enterprise Reprocessing, Cleveland Clinic, Cleveland, OH

Barbara Strain, MA, CVAHP, Principal, Barbara Strain Consulting LLC, Charlottesville, VA

Deborah Petretich Templeton, RPh, MHA,Chief Administrative Officer (Ret.), System Support Services, Geisinger Health, Danville, PA

Ray Taurasi, Principal, Healthcare CS Solutions, Washington, DC

6 | June 2024 | Healthcare Purchasing News This index is provided as a service. The publisher does not assume liability for errors or omissions. Index of Advertisers Aesculap ............................... C4 American Express C3 Clorox Company 3 Cygnus Medical 19 Dale Medical Products 27 DETECTO ................................. 7 Healthmark Industries ....... 29 Medtrica 5, 13 MIRION TECHNOLOGIES | DOSIMETRY SERVICES DIVISION ............ 21 Parker Laboratories 17 Ruhof Corporation C2 STRYKER ORTHOPEDICS 10


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Commitment is Key to Starting an Orthopedic Service Line, Says Expert

Persistent education and communication lead to success

What does it take to implement a new orthopedic service line at an organization? Healthcare Purchasing News had the opportunity to sit down with Christine McCracken and talk about how to implement one at your organization.

McCracken is an occupational therapist who has spent 12 years as a clinician and 15 years in healthcare leadership, starting and improving service lines, focusing on orthopedics. She has a bachelor’s degree in occupational therapy from Western Norway University

of Applied Sciences, a master’s of business management from Walden University, and a post-professional doctorate in occupational therapy from Rocky Mountain University of Health Professions. Chris is a certified and licensed occupational therapist and a certified project management professional. She holds a fellowship from the American College of Healthcare Executives (ACHE). She has served as a Baldrige examiner for the Tennessee Center for Excellence. She currently serves as the president for East Tennessee Healthcare Executives Affiliation, an independent chapter of ACHE.

SOURCING + LOGISTICS 8 | June 2024 | Healthcare Purchasing News

What is an orthopedic service line?

Any service line, not just orthopedic, refers to an approach to care where you are looking at the entire care episode from the patient’s perspective. What that means is trying to align all the services for a particular group of patients. Orthopedics would be one, but even in a subspecialty of that, you might have hip and knee replacement as the main focus of your service line.

So, for each particular group of patients, there is a specialization for that type of patient, which obviously increases the depth of knowledge and skill. For instance, if you’re a surgeon who only does those types of procedures, you’ll have a much higher volume than those that do general orthopedics.

The service line helps to standardize the process through using evidence-based practices to ensure that there is as little variation as possible. Once it has been proven that a certain method or a certain evidencebased practice is the best, then one ought to be following that. And so, this type of approach benefits the patients because everything is better coordinated. There’s better communication and collaboration, which ultimately leads to better outcomes, but it also benefits the organization because you’re improving cost efficiency. You also avoid duplication of certain services or processes and very often a good service line ends up being a center of excellence. That in itself helps with marketing to patients and actually retaining and recruiting staff too, because people want to work for the best.

Who or what needs to be included when planning a new service line?

In the question itself is one of the key ingredients to this service line, which is to know who the stakeholders are and include all of the stakeholders so that it is truly a well-rounded service. And we’re not just barging ahead with doctors and nurses and then ignoring everybody else.

What’s involved in adding a service line, first and foremost in my opinion, is leadership commitment. If you have that commitment, you can mitigate almost any other challenge, whereas if you don’t have that commitment, it’s easy to lose sight of the process, streamlining, and the need to follow best practices. When things get tough, we might have to make decisions that are maybe not so popular. Every time the entire team needs to know that decisions are made in favor of how a service line needs to run.

As for key stakeholders, you would have a few either formally or informally and influential physicians who

agree to be part of the service line and that will then help drive the initiatives and it will help drive other physicians to buy in. It will also help with commitment to the service line to try to get everybody to kind of come along. You also need a subject matter expert, such as a service line administrator who is dedicated to making this approach work. That is very helpful because there is a lot of pulling the strings and coordination that has to occur. Service line work goes across the traditional departments of a hospital or a clinic because, again, the service line looks at the entire episode.

And I think a big key to adding a service line is just being aware that it requires persistent and frequent education and communication to everybody who’s involved, because again, this is a little bit of a different approach to care and it’s not intuitive to people who have worked in healthcare for many years.

The last thing I would mention is having an actual service line team that consists of percent additive representatives for all the stakeholders so that we can understand the concerns of the frontline workers, the patients, etc.

How can one plan for staffing when starting an orthopedic service line?

You would expect to have board certified orthopedic surgeons—it’s very helpful to have nurses who are certified by the National Association of Orthopedic Nurses. The team in general should be structured in such a way that everybody works at the top of his or her license. Meaning that if you’re a doctor, you do the things that only a doctor can do. If you’re an RN, you do the things that only an RN can do and so forth.

Any final words of wisdom?

Again, I would repeat the importance of maintaining that solid commitment to the approach, because if you let it filter out or slide away from you, it’s hard to get it back and you have to be persistent with how you are going to run your program—meaning researching best practices and so forth. We don’t allow people to make things up as they go along.

Additionally, data is a huge component to the ongoing success and continuous improvement of the program. So, you have to make good processes for collecting, analyzing, and reporting performance data to stakeholders on a regular basis to ensure that everyone is informed and engaged. Also, you need this for continuous performance improvement because you can quickly see if something is starting to go in the wrong direction and make corrections from that. HPN | June 2024 | 9


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Wound Management Update from Medline

Patricia Turner, senior manager of Clinical Solutions, Medline Acute Care Sales, spoke with Healthcare Purchasing News about the latest in wound management. Turner shares improvements, innovations, and the landscape post-COVID in this exclusive interview.

What has changed in wound management over the past 10 years or so?

Over the past decade, one of the most notable changes in wound management has been the significant integration of technology. While the fundamental categories of wound care dressings have remained relatively consistent, the approach to identifying and preventing tissue damage, particularly pressure injuries, has undergone a remarkable transformation. Technological advancements such as SEM (Sub Epidermal Moisture) scans, infrared thermography, and other modalities have revolutionized early detection capabilities, allowing clinicians to intervene at earlier stages to prevent tissue breakdown. Additionally, these technologies allow for better care for patients across all skin tones. As early signs of tissue damage vary in their appearance based on skin tone, these technologies give objective data that helps determine an appropriate care plan.

Are there any new innovations in this space?

Pressure and excess heat can lead to skin breakdown and increase the risk of pressure injury development. Traditional

routine skin assessments require removing the wound dressing multiple times per day, which can be taxing on both the caregiver and clinician, and puts additional stress on the dressing’s adhesive and underlying skin.

One development in wound dressings has been the introduction of new categories, exemplified by innovations like Medline’s OptiView Transparent Dressing with HydroCore Technology. This first-of-its-kind wound dressing features an innovative clear design that allows caregivers the ability to quickly and easily inspect, monitor, and blanch skin with the dressing in place. OptiView empowers caregivers to visualize the skin at all times, looking for color variances and early signs of breakdown without lifting the dressing. The innovative clear island allows for immediate visibility to the underlying skin, while the HydroCore Technology uses a gel center to help redistribute peak pressure and draw heat away from the skin to create a cooling effect.

What are the biggest challenges




One of the biggest challenges in wound management is looking at the bigger picture beyond just treating the wound itself. Chronic wounds often come with underlying chronic diseases, which complicates the overall care process. Without proper management of a chronic illness, the wound could be harder to heal. There are many extrinsic factors that impact a wound’s healing that are outside of the clinician’s control. Examples include malnutrition, medications, wound bioburden and infection, and comorbidities that require radiation or chemotherapy. Plus, wounds don’t always get the same attention as injuries to vital organs like the heart or lungs. Another challenge is making sure patients can take care of their wounds properly while also managing their chronic illnesses. Without addressing these underlying health issues, fully healing the wound becomes much harder.

What are some best practices?

When it comes to best practices in wound management, it’s all about relying on evidence-based approaches. This means drawing on research and guidelines provided by reputable organizations like the Wound, Ostomy, and

SURGICAL/CRITICAL CARE 12 | June 2024 | Healthcare Purchasing News
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Continence Nurses Society (WOCN) and the National Pressure Injury Advisory Panel (NPIAP). Best practices should be rooted in solid evidence, not just traditional methods or anecdotal experiences. Key considerations include understanding the causal factors behind the wound, as treating the symptom alone without addressing the root cause increases the risk of recurrence. Additionally, maintaining an optimal wound environment is crucial for promoting healing. This might involve adjusting moisture levels or selecting appropriate dressings based on the wound’s characteristics, such as its level of drainage, what the wound bed looks like, or the depth of the wound. By combining evidence-based practices with tailored approaches that prioritize the specific needs of each wound, healthcare professionals can maximize the chances of successful healing.

during the pandemic. Read more here: https://

What does this space look like in the next 5-10 years?

How much training do nurses get regarding wound management? Are there any certifications they can receive? What do they learn in school?

Nurses typically receive limited training in wound management during their education. The gold standard for certification in wound care nursing is through organizations like the WOCN. In nursing school, the focus is more on the anatomy and physiology of the skin as an organ, rather than on specific wound treatment and physiology. As a result, unless they pursue specialized training, nurses often lack comprehensive knowledge about wound care and healing processes. It’s crucial to simplify best practices and provide decision-making tools for general nursing staff, highlighting the importance of specialization in wound care. At Medline, our clinical team of board certified WOC nurses develops educational programs and workshops geared toward bringing needed information on prevention and treatment to the bedside staff in an engaging and enriching format.

Did COVID impact wound management in any way?

COVID had a significant impact on wound management, particularly regarding pressure injuries. The utilization of proning became vital with COVID patients, but it also increased the risk of pressure injury development. Pressure injury rates surged during the pandemic as healthcare providers were not accustomed to preventing pressure injuries in these new positions. COVID underscored the importance of pressure injury prevention, bringing about a renewed focus on this aspect of wound management. Desert Springs Hospital and Medical Center in Nevada was able to reduce Healthcare-associated pressure injuries

In the next 5-10 years, I hope to see significant advancements in wound management technology, specifically in understanding why wounds may stall, despite our best efforts. While current technology allows for early detection, there is a gap in our ability to comprehensively assess wounds and determine what specific factors are hindering the healing process. Wound physiology is complex and varies from case to case, often requiring a trial-and-error approach. It would be transformative to have technology that can pinpoint precisely what a wound is lacking in order to heal optimally. This would allow nurses and clinicians to tailor treatment to each wound. Technology that would directly tell you what the wound is missing would revolutionize wound care and significantly improve outcomes for patients. HPN | June 2024 | 13
2406HPN_Medtrica_14sq.indd 1 5/6/24 2:07 PM
Patricia Turner

Preventing Infections with Artificial Intelligence

Artificial intelligence (AI) is here to stay, and its ramifications are being felt across practically all industries around the world. AI in healthcare, however, is an even hotter topic given its proximity to decision-making that can literally be life or death for the patients involved.

Healthcare Purchasing News was able to talk to Isis Lamphier, MPH, CIC, manager of Infection Prevention at Moffitt Cancer Center in Tampa, Florida; and Jill Holdsworth, MS, CIC, FAPIC, NREMT, CRCST, CHL, manager of the Infection Prevention Department at Emory University Hospital Midtown in Atlanta, Georgia, about concerns,

exciting developments, and next steps regarding AI in the infection prevention space.

Lamphier has heard “whispers of AI entering the infection prevention space,” including “upcoming presentations regarding AI at the annual APIC conference.” So far, she has seen that AI “can be used to aid infectious disease physicians” and “to provide

INFECTION PREVENTION 14 | June 2024 | Healthcare Purchasing News 110247398 © ALPHASPIRIT, 121869141 © TARTILASTOCK | DREAMSTIME.COM

models on the effect of infections and organisms in their patient populations.” Indeed, she says, “AI can be used to detect trends in HAI [healthcare-associated infection] surveillance and used for early identification of potential outbreaks and clusters of infections.”

Holdsworth also emphasizes the possibility of AI assisting with detecting trends in HAIs. She specifically feels that “some of the triggers we use to notify us of specific HAI criteria could easily be worked into an AI algorithm when scanning chart information.”

AI technology is promising in many areas, but it is certainly not in its final, most trustworthy state. Lamphier emphasizes that it is “important for IPs to always validate AI tools manually, especially at the beginning of this technology. IPs should verify the data and that patterns/trends truly exist before creating conclusions, [using] AI as a tool” and not the last word on a subject. She also says that it is ultimately on the human interpreting the data to “ensure data is accurate,” as AI tools cannot be totally relied upon to produce results that don’t require verification manually.

The ability of AI tools to deliver trustworthy results is a point of emphasis for Holdsworth as well. She said, “It would be hard for IPs to trust this technology at fi rst to be 100% accurate,” thinking that she would “feel the need to go

behind the AI and check its work.” While the promise that AI tools have shown in helping with infection prevention in many areas is significant, questions Holdsworth has regarding these tools include “how would validation of this technology work, how time intensive would this validation be,” and “do IPs have the time and energy to do this right now?”

Other concerns surrounding AI focus on the possibility of bias. For instance, an IP “may miss a pattern” even when the AI tool “stated there was one,” leading to confusion and further emphasizing the need for manual verification of what an AI tool tells a clinician. Cybersecurity also remains a concern with AI tools, as they “require using a third-party system” and granting that third party system access to “sensitive patient data,” Lamphier says. “Legal teams, risk teams, and cybersecurity / IT teams should be involved in the process with” the infection prevention department “to determine if these platforms are secure and what would happen if there were a data breach.” Having a unified approach across teams can prevent these from becoming issues in the first place, and putting plans in place in the event of a data breach or some other cybersecurity issue can mitigate the threat if they do eventually arrive.

As far as next steps for the future in the infection prevention space, Lamphier said,“More monitoring technology such as electronic hand hygiene technology that are meant to aid the IP workflow but not replace the IP is of potential interest. Aiding the workflow of an infection prevention department and not replacing the infection preventionist themselves is

a vital refrain that came through when both experts were asked about potential next steps, underscoring the irreplaceable importance of having a human being involved in the process, even when advanced technologies like AI are being used.”

According to Holdsworth, certain AI advances “in the sterile processing and endoscopy space” relating to the “use of boroscopes and identifying what is inside a lumen” have been of particular interest to her. She believes that these burgeoning technologies will “be a huge help to not just IPs, but all reprocessing areas to ensure patient safety and the prevention of infections.”

Concerning other technologies not associated with AI, Lamphier provided a laundry list of exciting advancements in areas she believed our readers should be aware of, including “UV disinfection (including OR lights), electronic hand hygiene monitoring systems, antimicrobial textiles, technology that improves air quality, data mining technology, and platforms that organize HAI data.” Holdsworth believes that, as far as advancements on the horizon that staff should be trained with, virtual reality will be a “big move for the future.” She commented, “We are going to see virtual reality as an emerging strategy for education over the next [couple of] years.” HPN tial | June 2024 | 15
Isis Lamphier

The 3Ps of Cleaning in Sterile Processing: People, Processes and Products

Whether it is manual soaking, brushing and flushing at a sink, or automated cleaning with ultrasonic cleaners or washer/disinfectors, effective cleaning of surgical instruments and devices in the sterile processing (SP) department is critical to patient care and safety.

HPN presents insights on three key areas of cleaning in the SP department – people, processes, and products – from Rebecca Peplau, B.S., CRCST, CER, CHL, CSPDT, manager, Central Sterilization Department, MaineGeneral Health, Augusta, Maine, along with information on some of the latest equipment, supplies, and solutions for instrument and device cleaning.

People and processes

Before diving into the products required for instrument and device cleaning, let’s start with the people using them and the processes guiding their use. Peplau provided insights on challenges she has seen in decontamination.

“One of the biggest areas of opportunity I see within decontamination areas is overall process workflow.

That being said, many breakdowns of a workflow or barriers to truly effective and efficient workflows tend to stem from improper or lack of training and education coupled with a lack of proper working equipment to expedite tasks.”


With the complexity of sterile processing workflows, and the vast number of different instruments reprocessed, it should go without saying that technician training and education is paramount to cleaning success.

“Training for each step of cleaning and inspecting includes utilizing the proper tools and testing all equipment daily,” said Ronald Hunsucker, CRCST, CHL, CCSVP, CIS, clinical education specialist, Healthmark.

Ronald Hunsucker Rebecca Peplau


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“These are just a few of the crucial steps that SPD has in place to provide the highest level of care all patients deserve. By utilizing both manual and mechanical methods, we can ensure all items are cleaned efficiently.”

Peplau recommends the trainee “buddy up” with a trainer who is competent in different types of instrumentation, including basic items and more complicated devices (e.g., robotic surgery instruments). She advises the trainer teach based on department standard work and standard operating procedures (SOP) during the training process.

Peplau also recommends that before training inside decontamination, have the trainer instruct the trainee on handling clean instrumentation in the assembly area, stating: “Getting a trainee exposure to touching and handling clean instruments can be a proactive approach to a more efficient and safer workflow within the decontamination area. Developing the muscle memory and overall feel of how to safely handle scissors without gloves on can make you more confident handling them with gloves on.”

“Decontamination training can take a long time and I feel like many people want to rush it, but it’s the most important part of the process,” Peplau added. “Failures of proper decontamination practices can double your workload when having to repeat them. The technician in training should start with the basics then work up to the more complex items, always with a dedicated trainer occasionally checking in and never somebody working next to them. Also, the trainer or educator must drill home how the trainee can access an IFU from the beginning of their training onward.”

As a guiding source for all aspects of sterile processing, manufacturer instructions for use (IFU) should outline the steps required for effective cleaning, but Peplau noted this is not always the case. She stated:

“My biggest gripe is that IFUs can get updated or changed at any given time and it is up to us as end users to stay on top of that. Manufacturers are not required to notify us if cleaning or sterilization instructions have changed. This can be potentially hazardous to patients and SP staff. Additionally, the IFUs can be vague or have a general lack of information. Many device IFUs for hand wash only items do not indicate a step for disinfection prior to sterilization. Are these devices truly safe for our techs on inspection to handle? It is crucial to continuously look for updates with these items. Your vendor representatives can be a great help for finding this information.”


With regards to washer testing, Peplau, who is president of the Northern New England Chapter of the HSPA, explained how her chapter recently partnered with the Western Wisconsin HSPA Chapter to host a virtual seminar about protein. During their presentations, experts from Europe, Matthew Peskett and Pawel de Sternberg Stojalowski, explained

STERILE PROCESSING 18 | June 2024 | Healthcare Purchasing News
Bioburden inside a shaver. The instrument flushed clean with water and then air. Borescope inspection showed large contamination throughout. The above picture demonstrates equipment incompatibility: instrument tips should be 2” away from each wall. DaVinci too big for this machine, no lumen hookups. Full PPE, covering back and shins.

European standards and how they pertain to protein and washer testing.

“In Europe, SP departments are required to test items coming out of a washer for residual protein regularly which is not yet required in America,” Peplau commented. “It makes you question the effectiveness of our current practices with routine testing and monitoring. Should departments add in protein testing to confirm every component of their automated washing system is truly working as designed? The science behind protein testing tells us why it is so important and makes you ask, ‘Why aren’t we routinely testing like that in our departments?’”

SP safety

SP professionals in decontamination are exposed to potentially dangerous bioburden, along with sharp items that pose the risk for cuts/punctures and infections. Peplau highlighted the importance of adequate personal protective equipment (PPE) and the dangers of not having it or failing to use it.

“There are still many departments that use overhead sprayers in sinks rather than spraying underneath the water’s surface,” Peplau explained. “This can indicate a gap in education and training which subsequently can impact workplace safety. Were trainees taught about aerosolization or chemical exposure? Do they know what to do if they are injured or have exposure to a chemical? Additionally, a lot of PPE isn’t adequate for decontamination, including open back gowns, exam gloves, masks with attached eye shields, and shoe covers that don’t cover your scrubs completely. PPE that doesn’t fit an employee well can pose a risk for chemical and pathogen exposure too.”

“When ANSI/AAMI PB70:2022 was updated, some PPE standards for decontamination were outlined with higher safety measures,” she added. “But there is still a lot of work to be

done here. Each facility needs to find a way to protect their team the best they can given this new documentation while also adhering to OSHA and CDC guidelines Additionally there is the challenge of keeping your team comfortable temperature wise.”

“Another issue with manual cleaning can be the ergonomic challenges of a non-adjustable sink,” said Peplau. “If you’re shorter or taller, this can be a nightmare on your back and neck. Ergonomic assessments are critical for employee safety and injury prevention.

Custom sink inserts can help allow for less bending.”


Peplau stressed the importance of SP departments having the right technology and access to standards and guidelines to support effective, efficient, and safe cleaning, stating:

“With facilities trying to perform as many cases as possible to serve communities, we can’t always keep up. Therefore, having the right equipment and automation where possible is essential in our fast-paced environment. For example, having automated flushing systems in your sink is a huge advantage as opposed to repeated manual flushing steps – those seconds matter.”

As an Association for the Advancement of Medical Instrumentation (AAMI) committee voting member, Peplau feels shifts in standards should be driving more healthcare organizations to invest in SP department technology. She stated:

“Some of our IFUs require the use of a borescope, so why aren’t all facilities using them as standard inspection tools for the bulk of their instruments? We have the technology, and it should be implemented and put to use. I feel that it should be a mandatory piece of equipment in all departments given

IFU changes and some standards recommendations.”

She points to a compelling example of the value of borescopes:

“Throughout my career I’ve encountered several devices that were flushed clean with fluid or air but after looking inside, it was found to have damage, rust, or bioburden – this also includes devices new from manufacturers! If you can’t see inside of the device, how can you know it is truly safe to use on a patient? The obvious barrier here is cost. Borescopes can be a huge purchase for many departments; however, we have the resources and science to present to upper management and validate the expense. Investing here can mitigate potential legal expenses.”

Peplau also noted how she and other AAMI committee members are in the process of completing Technical Information Reports (TIR) and gearing up to begin early stage revisions to ANSI/AAMI ST79: Guide to Steam Sterilization.

Cleaning products, equipment, and solutions

Manufacturers and solutions providers continue to evolve their offerings to meet changing needs of SP professionals. Here is a highlight in the categories of brushes, sinks, and washer/ disinfectors.


“Sterile Processing professionals face new challenges every day when it comes to properly cleaning equipment and surgical instrumentation,” Hunsucker explained. “Instruments have become more complex and require choosing from a variety of styles, lengths, diameters, and bristle compositions to meticulously clean each instrument.”

Looking back on the evolution of brushes for instrument cleaning, Hunsucker pointed out how toothbrushes, scrub brushes, bottle brushes, and sometimes hairbrushes were not uncommon in the late 1970s and early 1980s.

“Now, we have acrylic, nylon, brass, polypropylene, stainless steel, and newer thermoplastic brushes,” said Hunsucker. “Specialized brushes for reamers, shavers, push through, pull through, wire, flexible and re-posable handle brushes [are available]. Reprocessing professionals must have the appropriate brush for every section and/or cannula(s) of an instrument to clean correctly.”

Cleaning chemistries

“Though our goal is to produce products that help SPDs be more efficient, we never want to lose sight of the safety of the staff,” said Chris

STERILE PROCESSING 20 | June 2024 | Healthcare Purchasing News
OR/ SPD collaboration: case cart that came down from OR with perfect point of use treatment performed. Time was taken to properly send down to SPD. Lack of point of use treatment from the OR on orthopedic instrumentation.

Antonucci, Vice President of Global Marketing, STERIS. “When STERIS considered the reprocessing steps for robotic assisted surgical instruments, it was critical that we achieved both objectives. For example, Prolystica HP Instrument Cleaning Chemistries are formulated to reduce the cloudiness in the water during manual cleaning, giving the technician visibility of any sharps, helping to avoid injury when reaching into the sink.”

“From an efficiency standpoint, our patented Prolystica Ultra Concentrate HP formulations were also used to validate the RAS Cycle on the AMSCO 7000-series Washer/Disinfectors,” Antonucci added. “This cycle automates a significant portion of the cleaning process of select daVinci EndoWrist instruments, reducing manual cleaning time by at least 25% and reducing overall processing time

by over 60 minutes for a set of four instruments.”


With regards to SP department sinks for instrument cleaning, Hannah Schroeder, BSHA, CRCST, CHL, CIS, CER, Clinical Education Specialist at Pure Processing, spoke to some of the innovations her company exhibited at the 2024 Healthcare Sterile Processing Association (HSPA) Annual Conference, which was held April 21-23 in Las Vegas.

Schroeder noted how Pure Processing is using copper alloy as a safety measure for its SP and endoscopy department sinks and blacklight as a visual inspection tool for efficiency in finding cement from orthopedic cases. HPN

There is more to this story at

This picture shows equipment in need of repair. The instrument washer rack transport cart is not level with the loading dock of the washer, creating a safety issue.

Product Testing: The Overlooked 4th Pillar of a Robust Sterilization Process Monitoring Program

Has a new loaner tray ever given you pause because of its size, complexity, or density? Concerned about processing a new brand of container in your facility’s older sterilizers? Installing a new low temperature sterilizer? While the responsibility for validating sterilization parameters for reusable surgical instruments and packaging rests squarely with the device manufacturer, sterile processing professionals can and should perform product testing.

Learning Objectives

1. Review the four elements of a comprehensive sterilization monitoring program.

2. Discuss approaches to streamline periodic product testing.

3. Discuss AAMI and AORN guidance on the prepurchase evaluation of rigid containers.

Sponsored by:

Product testing can give you confidence that a particular instrument set or container can be successfully processed in your facility in your sterilizers. In fact, product testing is one of the four pillars of a comprehensive sterilization quality assurance program, albeit the one that is probably the least often practiced. This article will review the recommendations on product testing provided in national standards and guidelines.

ANSI/AAMI ST79:2017/(R)2022, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities , is the ‘go to’ document for steam sterilization. This resource describes the four pillars of a robust quality assurance program: routine load release; routine sterilizer efficacy testing; sterilizer qualification testing; and periodic product testing.1

Qualification testing, which includes three consecutive cycles with a biological indicator (BI) process challenge device (PCD), should be done after installing a new sterilizer or performing major repairs on an existing sterilizer. Healthcare facilities should have defi ned policies for routine release of both non-implant and implant loads and implants should be quarantined until the BI result is available. Routine efficacy testing of both steam and vaporized hydrogen peroxide (VH2O2)

sterilizers should be conducted at least daily on each cycle type, if not every load, and internal and external chemical indicators (Cis) should be included in and on each item.

Adherence to the recommended quality assurance program tends to be inconsistent, however, on the 4th recommended element: performing periodic product testing of routinely processed load items. Intuitively, departments sometimes perform product testing when investigating a sterilization product failure, often uncovering a surprise in an IFU related to load size, container placement, and/or validated sterilization modality. Rather than being a reactive exercise, product testing can be a proactive method of verifying the ability to achieve sterilization parameters in your facility with your sterilizers and associated utilities. But sometimes the ambiguity of the requirements makes it easy to push product testing to the back burner. How often should we do it? How do we do it? Haven’t the device and packaging manufacturers already validated sterilization parameters for their products? Why should we repeat their work in our department?

This last question leads us to review two definitions provided in ANSI/AAMI ST77:2013®2018, Containment devices for reusable medical device sterilization:

CONTINUING EDUCATION 22 | June 2024 | Healthcare Purchasing News

• Verification: “Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predetermined specifications have been met.”2

• Validation: Documented procedure performed by the device manufacturer for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.”2 Product testing (i.e., verification) is not a replacement for the more extensive validation testing performed by device manufacturers. Product testing cannot be used, for example, to justify a shortened steam sterilization exposure time or a different VH2O2 cycle type than has been validated by the medical device manufacturer. It is used to demonstrate that the device manufacturer’s validated IFU can be successful in the sterilizers in your health care facility.

VH2O2 Sterilization

The recommendation to conduct periodic product testing is not unique to steam sterilization standards. Indeed, because VH2O2 sterilization is technique-sensitive, one could argue that if you are not yet performing product testing, this low-temperature modality might be the place to start! Luckily, ANSI/AAMI ST58:2013/ (R)2018 Chemical sterilization and high-level disinfection in health care facilities, includes good suggestions on this topic in Section 9.7.3 For example, the concept of a ‘product family’ is discussed. Medical devices may be grouped into a product family sharing the same basic design, materials, and reprocessing instructions. From the product family, a ‘master product’, considered the most challenging in the family to process, is selected. Product testing conducted on the master product thus covers the entire

product family. The good news? If you purchase a new item that fits into an established product family and is less challenging to process than the master product, there is no need to conduct product testing on the new item. How often should master products be tested? ANSI/AAMI ST58 suggests testing one master product each month. It could be daunting to test all master products at the same time each year, so adopting a system of testing one master product per month may be a more achievable plan. What might trigger a repeat master product test? ANSI/AAMI ST58 suggests in Section 9.7.1, “Product testing could be repeated whenever changes are made to a product family’s composition, designated master product or written IFU or if a new sterilizer or other piece of processing equipment is purchased.”3

Steam sterilization Section 13.9 in ANSI/AAMI ST79:2017/(R)2022 provides recommendations on conducting periodic product testing of items that are routinely processed using steam sterilization. The same product family and master product concepts reviewed above are discussed in this section. When establishing a product family, AAMI recommends considering several product characteristics including:

• Design configuration

• Number of components

• Materials of construction

• Size and/or surface area

• Need for disassembly

• Surface fi nish or texture

• Presence of cannulations, lumens, or mated surfaces

• Written reprocessing instructions provided by the manufacturers”.1

After establishing a product family, a master product (the most difficult to sterilize device) is designated. Performing product testing on this master product is much less burdensome than testing every single device or set in a product family.


Product testing: The overlooked 4th pillar of a robust sterilization process monitoring program

June 2024

This lesson was developed by 3M Health Care. Lessons are administered by Endeavor Business Media.

Earn CEUs

After careful study of the lesson, complete the examination online at You must have a passing score of 80% or higher to receive a certificate of completion.


The Certification Board for Sterile Processing and Distribution has pre-approved this in-service unit for one (1) contact hour for a period of five (5) years from the date of original publication. Successful completion of the lesson and post-test must be documented by facility management and those records maintained by the individual until recertification is required. DO NOT SEND LESSON OR TEST TO CBSPD.

Healthcare Sterile Processing Association,, has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years, until May 5, 2027.

For more information, direct any questions to Healthcare Purchasing News

Quiz Answers:

1. A, 2. B, 3. B, 4. A, 5. A, 6. B, 7. A, 8. B, 9. A, 10. A | June 2024 | 23

Like AAMI ST58, AAMI ST79 also suggests testing one master product each month as a good starting point for a periodic product testing program. Perhaps you even have extra control BIs that could be used for a monthly master product verification test. And exactly how is product testing done? Multiple biological indicators and chemical indicators are placed within the test sample; the sample is labeled as a test item; and the test sample is run in a routine sterilizer load using the cycle parameters recommended in the manufacturer’s written IFU. After sterilization: the test sample is opened and inspected for evidence of moisture; the BIs are incubated and the CIs are inspected to verify they have reached their endpoint. Any unexpected result should be investigated. The test protocol and results should be documented, and the test sample reprocessed before patient use. Loaned items can include complex instruments packaged in multilayered sets, representing a challenge to sterilization. Does your facility’s loaner policy specify that loaners arrive 48 hours before the scheduled case? When a new loaned item arrives at the facility, AAMI ST79 recommends performing product testing unless the item fits into an established product family.1

Rigid containers

Manufacturers of rigid sterilization containers are required to validate the sterilization efficacy of their products in sterilization cycles commonly available in healthcare facilities.2 They cannot possibly, however, perform validation testing in all brands, models, and sizes of sterilizers. As the chamber size, vintage, steam quality, maintenance history, etc. can vary widely out there in the real world, it is recommended that healthcare facilities perform prepurchase evaluation of rigid containers.

AAMI provides detailed guidance on performing prepurchase evaluation of rigid containers in ANSI/ AAMI ST79:2017(R)2022, Section 13.10.1 Prepurchase evaluation is recommended so that users can verify, before purchase, that the specific design of the container system will perform as expected in the health care facility’s sterilizers. Although the container manufacturer has conducted sterilization validation studies, the user is responsible for verifying that the containers are compatible with the sterilizers in their facility. In the case of steam sterilizers, the user needs to verify the rigid containers will permit complete air removal, adequate steam penetration and adequate drying.

As a first step, assess the rigid container manufacturer’s written IFU to verify the FDA-cleared indications for use are consistent with cycles available on your sterilizer(s). To perform the prepurchase evaluation, place multiple BIs and CIs throughout the container. Consult the container manufacturer for advice on the appropriate (i.e., area of greatest challenge to air removal and steam penetration) placement of BIs and CIs in the rigid container. The BIs, CIs, and instruments are placed in the test rigid container system, along with any required filters. Worst case testing is simulated by using the largest instrument sets recommended by the container manufacturer and testing both a maximum and small load. Any absorbent material, if typically used, should also be included in the container. After running the cycle recommended by the container manufacturer, open the container and check for retained moisture, examine all CIs and incubate the BIs. There should be no visible condensed moisture in or on the container, the CIs should have reached their endpoint, and all BIs should be negative. Any unacceptable results should be investigated

and resolved before purchase of the rigid container system. The instruments used to conduct the test need to be reprocessed before use.

Product testing isn’t just for the sterile processing department. AAMI ST79 recommends placing items to be sterilized for immediate use in a rigid sterilization container. Thinking of switching brands? Don’t forget to conduct a prepurchase evaluation of any rigid sterilization containers being considered for immediate-use steam sterilization (IUSS). Verify your OR sterilizers can run the cycle validated by the container manufacturer. In the case of prevac containers, check whether both a pre-assembled BI PCD and the container will fit in the IUSS sterilizer chamber. Positive biological indicators or failed internal chemical indicators can be caused by a rigid container/sterilization cycle mismatch that could have been caught had product testing been performed. For example, running a rigid container validated for pre-vacuum steam sterilization in an “express” (2-pulse pre-vac) IUSS cycle can result in a failed product test, with a potential corrective action of removing the express cycle option from the sterilizer to prevent future inadvertent use errors.

AORN perspective

The Association of perioperative Registered Nurses routinely updates their Guidelines for Perioperative Practice. As in previous editions, the 2024 edition includes guidelines focusing on device reprocessing. In general, these guidelines are consistent with recommendations found in AAMI end user sterilization standards. The Guideline for Sterilization Packaging Systems includes the recommendation that packaging systems and packaging materials should be evaluated before purchase and use.4 AORN reminds us that a critical first

CONTINUING EDUCATION 24 | June 2024 | Healthcare Purchasing News

step before switching to a new packaging method is to review the product’s FDA clearance and the packaging manufacturer’s IFU to verify the packaging is suitable for the method(s) of sterilization and the specific equipment at your facility. The guidelines further suggest conducting product testing before major changes in packaging, e.g., before switching to the use of rigid containers. AORN recommends conducting product testing by lacing the set or container with BIs and CIs, running the item in a full load, and evaluating the monitoring products for pass or fail results. The procedure and all test results, including an assessment of moisture for steam-sterilized items, should be documented.


Contemplating switching to a new method of packaging? Borrowing or purchasing a new, complex orthopedic set? Installing a new model VH2O2 sterilizer? Sitting on an accumulation of leftover control BIs? Perhaps it’s time to incorporate product testing into your sterilization quality control program. This could be a great assignment for a team member looking to take on some additional responsibility. Tackle the project in manageable pieces, perhaps by testing one master product in each sterilization modality each month. As part of the process, remember to obtain the current IFU for both the master product, the associated packaging, and any ancillary items placed in the set. HPN


1. Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2017 & 2020 Amendments A1, A2, A3, A4. Arlington (VA): AAMI, 2017.

2. Association for the Advancement of Medical Instrumentation. Containment devices for reusable medical device sterilization. ANSI/ AAMI ST77:2013(R)2018. Arlington (VA): AAMI, 2013.

3. Association for the Advancement of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58:2013/(R)2018. Arlington (VA): AAMI, 2013.

4. Association of periOperative Registered Nurses. Guideline for Selection and Use of Packaging Systems for Sterilization in Guidelines for Perioperative Practice 2024 Edition. © 2024 AORN Inc, Denver, CO.

Susan Flynn is a Technical Service Specialist with 3M’s Medical Solutions Division in St. Paul, MN. Her role at 3M includes providing education for customers and sales personnel on improving the performance of the sterilization process and implementing best practices. In addition, she is a member of several AAMI working groups and writes sterilization related self-study articles. Susan is a Certified Sterile Processing and Distribution Technician (CSPDT).

Product Testing: The Overlooked 4th Pillar of a Robust Sterilization Process Monitoring Program - Practice Quiz

1. Routine load release is one element of a robust sterilizer quality assurance program.

A. True

B. False

2. It is not necessary to perform product testing for items processed in low temperature methods of sterilization

A. True

B. False

3. Health care facilities are responsible for validating sterilization parameters for medical devices.

A. True

B. False

4. AORN suggests conducting product testing before major changes in packaging.

A. True

B. False

5. A ‘product family’ is a group of products that have similar design, materials, and processing instructions.

A. True

B. False

All CEU quizzes must be taken online at: The cost to take the quiz is $10.

6. A ‘master product’ is considered the least challenging item in a product family to process.

A. True

B. False

7. Product testing of a master product should be repeated if a new sterilizer is purchased.

A. True

B. False

8. It is not necessary to document product testing activities.

A. True

B. False

9. Checking the processed test sample for evidence of moisture is part of the product testing procedure for steam sterilized items.

A. True

B. False

10. Testing both a maximum and small load is recommended when conducting prepurchase evaluation of rigid sterilization containers.

A. True

B. False | June 2024 | 25

Sticky Residue: A Possible Contaminant That Shouldn’t Be Overlooked

Cleaning, inspecting, packaging, sterilizing and storing instruments and medical devices is a daily routine for sterile processing (SP) staff. For these critical processes to function most effectively, SP and perioperative and procedural staff must work together to ensure instruments used during surgical procedures are clean, sterile, wellfunctioning, and safe for use. If bioburden (i.e., blood, tissue, bone) is found on a surgical instrument, the device should be considered unsterile and should not be used because of the risk of infection to subsequent patients. Even so, after surveying dozens of hospital staff from the SPD and OR, it is apparent that not enough attention and understanding are given to surgical instruments with pitting, cracks, etching, corrosion and oxidation, damaged insulation and connectors, and more. Often, staff will

continue using the instruments as if nothing is wrong.

Adhere to safe practices

Similar challenges arise from sticky residue that remains on instruments and containers. This can stem from poorly applied or degraded instrument tape and glue residue from instrument tray identification. I have personally consulted with dozens of clients across the country and it is rare to find a program that does not have one or more of these problems. SP professionals spend countless hours putting instruments and devices through a rigorous cleaning process, only to frequently leave sticky residue on instrument pans, baskets, and devices themselves, going on to process them as if no problem exists. Make no mistake, however: Adhesives and other sticky residues can interfere with the sterilization process, making the devices a potential patient safety and infection risk. All residues and adhesives must be removed completely prior to initiating the cleaning process. If an

instrument, instrument set, or device arrives in the assembly area with remnants of tape, stickers, or other residue sources, those residues must be removed completely—with an approved product and in strict accordance with the instructions for use (IFU)—and the item should then be returned to the decontamination area for processing. Only when the items are cleaned and inspected fully and appropriately should they be deemed ready for sterilization or high-level disinfection.


SP professionals are expected to process and assemble high volumes of complex surgical instruments and sets with efficiency and accuracy. Even so, too many healthcare organizations across the country fail to stress the importance of removing sticky residues from devices and containers.

The result of present residues can be infections and other dangers to patients who are exposed to such devices. All processing professionals must be aware that residues remaining on medical devices, baskets, and containers can impede proper cleaning and render sterilization or HLD ineffective. SP technicians must also be provided with the tools and knowledge to remove sticky residue safely and effectively. In all aspects of healthcare, science matters. When instruments are being processed, they must be done safely, consistently, and thoroughly, and according to the latest standards, IFU, and policies and procedures. HPN

ASSOCIATION: HSPA 26 | June 2024 | Healthcare Purchasing News
Sticky residue from labels and tape can interfere with effective cleaning and sterilization. All residue must be removed completely with an approved solution.

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Bursting Pouches

Q“We’ve had recent issues with our peel pouches bursting. Can you share why this might be happening and how to correct this issue?”

AIt seems you are stating your “peel pouches [are] bursting” open during sterilization. Based on the limited information from your question (whether the pouch type being used is selfseal or heated seal), for this article, I will address this in a general way. Bursting is the result of inadequate seal strength between the plastic laminate and medical-grade paper, and it is observed after the sterilization process has concluded.

Bursting takes place because of a seal issue or a paper laminate/film issue (e.g., not thick enough). In a medical-grade peel pouch at least two types of seals are made. The other factor is the paper and film strength (how thick it is). Let me address the paper and film strength first, then the sealing issue. Different manufacturers decide on the thickness of the paper and film they use to make the pouch. The thicker, the better the strength. You will probably pay a little more for a stronger peel pouch. Thus, if you have a strong seal and thin/weak paper/film, the seal will stay intact, but the film or paper might break or burst. Remember, you can compare peel pouches’ paper weight and the film thickness. Just ask the manufacturer for it.

Concerning sealing, bursting takes place at the seal and the paper or film stays intact. Each manufacturer places a seal on two sides of the roll stock at the factory. The user cuts the roll stock to size and seals two sides. In a standard peel pouch, the manufacturer

seals three sides and the user seals one side. Each manufacturer decides how many seals and the strength (or bond) of that seal is made between the film and paper. Thus, you need to document where the seal has burst open and correct that issue (user or manufacturer issue).

Medical Device reprocessing departments could make two types of seals:

• Self-seal chemical bond: To me, this has some issues. You run the risk of creating air channels in the seal; thus, the seal integrity depends on the end-user’s training to seal the pouch properly. The glue or adhesive might also provide a limitedshelf life. Seal integrity quality is hard to control because humans make the seal, and not every person seals the same allowing for variances to occur.

• Heat seal type pouch (with mechanical bond): This type allows for a better, closer seal (more air-tight) because it is mechanically sealed at a specific temperature, pressure, and dwell time. The seal and the equipment can be verified by specific test methods. Heat sealable pouches usually have a lower unit price ( you do need to invest in a heat sealer). Thus, an airtight seal is better than a self-seal because the human factor of sealing is replaced by a verifiable mechanical process.

Based on my observation over the years, I have seen four main reasons why peel pouches could burst during the sterilization process.

• Improper loading of the peel pouches in the sterilizer chamber.

• Peel pouches that are improperly filled with medical devices within the peel pouch.

• U sing more than the 3/4-theoretical packaging area (stuffing the pouch).

• Incorrect sealing by your present heat sealer (testing and inspection needed).

The seal strength of both the OEM of the peel pouch and the seal made by the facility is weak; thus, there will be variation/fluctuation in seal strength and porosity.

To help resolve bursting, one must collect data such as a) who packaged the device, b) the type of device, c)which sterilizer was used, d) work shift, e) type of peel pouch, and f) how often bursting is taking place to help understand and to resolve the issue. Let data help solve the issue.

What you might find is you are using a poor-quality peel pouch that has a weak seal and is not that thick in the film and paper laminate area. As I say, “Quality doesn’t cost; it pays,” and you might just need to get a better peel pouch.”

Want to know more about sealing and peel pouches? Check out some of my older articles on this subject.1,2 Watch these videos on what a pouch goes through during the sterilization process3 and how to test your heat sealer properly.4 HPN


1. Kovach, Stephen M. (2023, February 23). Heat sealers: How to test and verify the sealing process. Healthcare Purchasing News.

2. Kovach, Stephen M. (2022, October 26). General peel pouch questions. Healthcare Purchasing News. https://www.

3. Healthmark Industries. (2022, January 18). What Happens Inside A Sterilizer? [Video]. YouTube. watch?v=q4Dn8z3-qok

4. Healthmark Industries. (2022, February 8). Heat Sealer Testing in Sterile Processing. [Video]. YouTube. https://www.

STERILE PROCESSING INSIGHTS 28 | June 2024 | Healthcare Purchasing News

A Clean Instrument Starts with the Right Brush

Healthmark offers brushes designed specifically for the task at hand

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Flexistem Instrument Cleaning System

Flexistems are disposable cleaning brushes that are easily customized to the cleaning needs of all small bore items.

LTA Cleaning Brushes

External and Internal LTA brushes include latex-free bristles and handles compatible with steam sterilization.

Specialty Cleaning Brushes

Healthmark offers cleaning brushes specifically designed for difficult to clean items such as shavers, reamers, bipolar forceps and more.

Flexible Endoscope Brushes

Brushes specifically designed to clean a range of channel sizes as well as valves, ports and elevator mechanisms of flexible endoscopes. | 800.521.6224 | For more instrument cleaning solutions including brush storage, shower units, wipes, sponges and spray guns, visit

Surgical Smoke Evacuation Update

AORN comments on legislation surrounding surgical smoke

In 2022, Healthcare Purchasing News (HPN ) reported that legislation in New York (S.8869 (Rivera) / A.9974 (Gottfried)) advancing AORN’s efforts to mitigate surgical smoke in the workplace was signed by Governor Kathy Hochul on December 16, 2022, as Chapter 701 of the Laws of 2022. New York is the tenth state in the U.S. to enact legislation that requires all licensed hospitals and freestanding ambulatory surgical facilities to adopt policies to use a smoke evacuation system for surgical procedures that generate surgical smoke. The law will take effect on June 14, 2023.

According to the Occupational Health and Safety Administration (OSHA), each year “an estimated 500,000 workers, including surgeons, nurses, anesthesiologists, and surgical technologists, are exposed to laser or electrosurgical smoke.” This smoke, also known as plume, includes carbon monoxide, polyaromatic hydrocarbons, and a variety of trace toxic gases. Prolonged exposure can lead to serious and life-threatening respiratory diseases.

As advocates for surgical nurses’ workplace safety, the Association of periOperative Registered Nurses (AORN), supported by the New York Nursing Alliance

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and the American Nurses Association of New York among others, spearheaded the law’s passage to protect operating room staff and patients from the dangers of surgical smoke, a by-product from the use of energy-generating devices.

Late last year, HPN reported that the California Nurses Association (CAN) applauded Gov. Gavin Newsom’s signing of A.B. 1007, a bill that requires the development and adoption of enforceable workplace health and safety protections from surgical smoke in California hospitals. The bill was authored by Assemblymember Liz Ortega and sponsored by CAN.

This month, HPN caught up with Jennifer Pennock, associate director, Government Affairs, AORN about smoke evacuation, including a current legislative initiative the association is involved with.

What is surgical smoke and why is it dangerous?

Surgical smoke contains over 150 hazardous chemicals and carcinogenic and mutagenic cells. It contains toxic gases and vapors such as benzene, hydrogen cyanide, formaldehyde, bioaerosols, dead and live cellular material, blood fragments, and viruses.

According to the Environmental Protection Agency, exposure to fine particulate matter in surgical smoke is associated with cardiovascular and respiratory health problems. In addition to causing respiratory illness, asthma, and allergy-like symptoms, surgical smoke may contain viruses, such as HPV. There are documented cases of HPV transmission from patients to providers via surgical smoke inhalation. Surgical smoke can cause cancer cells to metastasize in the incision sites of patients having cancer removal surgery.

Can you share some of AORN’s initiatives for tackling this problem?

Smoke evacuation legislation has been enacted in 17 states thus far, and many more states have taken the issue under consideration. Thanks to AORN members and advocates across the country, legislators have recognized the need to protect OR staff and patients from the harms of surgical smoke.

Through AORN’s Center for Excellence Go Clear Program, AORN members have taken their facilities surgical smoke-free. This program enacts a comprehensive approach to ensure a smoke-free environment wherever surgical smoke is generated to protect patient and worker safety. As that program has grown, so too has legislative advocacy for statewide policy change.

Are there any technologies that can remove surgical smoke?

What are these technologies?

AORN recommends use of a smoke evacuation system (e.g., portable smoke evacuator with filtration, medical-surgical vacuum with an in-line filter, centralized stationary smoke evacuation system) to evacuate and filter all surgical smoke.

Have there been advancements in this space in the last few years?

Over the years, equipment has become less bulky and quieter, addressing two complaints surgeons often had when explaining their decisions not to use the equipment. As the equipment has improved and companies have educated surgeons about the products available, more surgeons have become adopters of the technology. Additionally, more products have come on the market with growth in use of smoke evacuation systems.

Is removing surgical smoke voluntary for hospitals right now?

It is voluntary in states where surgical smoke evacuation laws are not in effect.

Why has this issue been overlooked until recently?

Until recently, many surgical team leaders and facilities assumed surgical smoke was harmless, similar to the early beliefs about cigarette smoking. In addition, smoke evacuation equipment used to be loud and bulky. Today, with new technology that is rapidly evolving, the devices are smaller and more effective, though too many surgeons and facilities have yet to trial these improved devices. AORN has been educating our members for years on the hazards of surgical smoke, and our members have turned that education into advocacy for policy change.

What does AORN want our readers to know regarding legislation/initiatives?

Change doesn’t happen overnight, but a law requiring the evacuation of surgical smoke will change surgical safety in your state. And with AORN’s Go Clear program, you can take your facility surgical smoke-free in advance of a law in your state.

Where do you see this space in the next 5-10 years?

We will continue to see more facilities Go Clear and anticipate continued progress on the policy front. HPN | June 2024 | 31

Creating Visibility at Scale

One of the key learnings from the pandemic was the need for greater collaboration and visibility across the healthcare supply chain. Supplier and provider organizations that had once been reluctant to share information about their stock levels and proprietary substitution logic in the event of backorders are now far more willing to be transparent in an attempt to avoid the missteps experienced during the pandemic. For example, in the wake of COVID-19, the lack of visibility to the stock on hand and the burn rate at different providers across the country resulted in too much product being delivered to some organizations and not enough to others. This willingness to be more transparent is an important step toward making collaborative planning, forecasting, and replenishment (CPFR) a reality in healthcare. In other words, now that we have the will, innovative organizations across the healthcare supply chain can work together to find a way.

Past attempts by single provider organizations to share demand data with suppliers have not led to demonstrable change because suppliers need information from a significant portion of their customer base to drive changes in production and distribution. Concordance Healthcare Solutions aims to meet that challenge through the development of Surgence, a cloudbased digital platform that delivers

data streams to increase supply chain visibility. The model, used by supply chains in other industries, is designed to translate relatable information about objects, organizational relationships, disparate data systems, events, and other factors to support more informed and predictive decisions.

Cody Fisher, Executive Vice President, Strategic Advisor, for Concordance has big plans for Surgence, which was launched in 2023 and is open to participation by all providers, manufacturers, and distributors. He explains that each organization can utilize the platform internally and externally with multiple supply chain trading partners. With Surgence, organizations can aggregate and digitize data and workflows across disparate sources and systems in parallel with other trading partners connected to the same platform.

The platform goes beyond simply understanding the ability of a single supplier to meet a specific provider’s demand. Rather, the goal is to support workflows, alerts. and decision making for multiple trading partners using a single source of truth. For example, one of Surgence’s applications provides suppliers with visibility into the substitution logic used by their customers. In this way, they can better anticipate when a shortage in one product could lead to unprecedented demand and stockouts for another product, not only in aggregate, but also as it

impacts the service model for specific customers. This allows trading partners to not only understand critical constraints but also to make decisions in unison, creating a much more agile supply chain.

Some early adopter providers are already getting value from Surgence through greater visibility into their own inventory, order management processes, and product utilization. One of those is RUSH University System for Health, which is using the Surgence warehouse inventory management tool to achieve real-time visibility into products it has on hand, the stock locations, and consumption rates.

Since Concordance and RUSH are both connected to Surgence, the two trading partners have harmonized their data into applications that provide insights and alerts on both anticipated demand and stock on hand. Those alerts signal when demand is expected to exceed supply, and decision makers are given necessary information through workflows to enable them to respond faster to support patient care needs. Both organizations have already achieved benefits in the form of stockout reductions and time saved through enhanced communications.

According to Fisher, Surgence is founded on a collaborative, not a competitive, vision and is designed to deliver expanding benefits at scale as the number of healthcare supply chain participants grows. HPN

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