Surveying the Field: KiiP Team Gains Deeper Insight into Sterile Packaging and Its Use


By: Ralph J. Basile, Malinda Elammari, Erin Kyle, Jane Severin, Katherine Olson, and Teri Meadow

June 23, 2021

Categories: AAMI News, Medical Device Manufacturers, Sterilization Professionals

Sterile packaging lab staff
STERILIZATION CENTRAL

The delivery of a sterile, ready-to-use medical device is vital to delivering safe and effective patient care. Although conceptually a simple idea, the actual processes involved in delivering a sterile medical device to the sterile field involves a complex web of activities and stakeholders.

The theme of the 2019 Kilmer Conference, held in Dublin, Ireland, was “Collaborate to Innovate.” During the conference, a group of packaging-minded professionals, including packaging engineers, sterility assurance professionals, medical device manufacturers, healthcare delivery professionals, academicians, and standards professionals, held an ad hoc meeting. The opening question for participants was, “Are there any issues with sterile packaging that should be addressed collaboratively by the industry?” This open-ended question elicited a wide range of answers, all of which added up to the answer being “yes.”

The group’s most significant realization was that the chain of sterile packaging stakeholder groups exist within a series of silos. As a result, the group’s mission became breaking down those silos and working together to solve “wicked” problems. What started as an ad hoc meeting has evolved into a multidisciplinary effort to innovate the medical packaging space. Thus, the Kilmer innovations in Packaging (KiiP) project group was born.

KiiP Team Outreach and Survey Development

Enlisting the participation of additional representatives from the various stakeholder groups, with a special focus on end users, was one of the first tasks undertaken by the KiiP team. This was accomplished primarily through the creation of a KiiP LinkedIn page to host discussions, share information, and register volunteers.

As part of the outreach effort, a poll was created on LinkedIn to learn the areas of interest and concern that representatives wanted to address through their volunteer efforts. (Note: Only existing KiiP members on LinkedIn are able to view the survey.)

As a result of this outreach, more than 140 individuals representing various stakeholder groups joined the KiiP project group. Respondents demonstrated great enthusiasm for the effort, with nearly 30% expressing that they were willing to commit “whatever it takes” to accomplish the goals of the group.

From the LinkedIn poll, four general topics were identified as deserving of further study. Respondents to the poll were asked to join one or more of these groups. Each group is tasked with vetting the topic and identifying areas for further study and opportunities for improvement. The four general topics are:

  1. The last 100 yards (What happens at the healthcare facility?).
  2. Aseptic presentation and handling (“Making it a science”).
  3. Let’s speed things up (e.g., manufacturing processes, testing, product development).
  4. Sustainability and end-of-life solutions.

Team members also sought to further spread the word about the KiiP project activities, including speaking at meetings where members of different stakeholder groups were expected to be present. At these events, attendees were asked to answer live polling questions. The respondents represented a cross section from the packaging stakeholder groups, including packaging engineers, healthcare professionals, product managers, quality managers, and sterile processing professionals. Respondents were nearly split 50-50 on the question of whether “medical packaging is innovative.” An interesting finding was that packaging engineers were the mostly likely to answer “no” to this question.

A syringe and needle medical device in its sterile packaging.

Another opportunity presented itself: conducting a workshop during the International Association of Healthcare Central Service Material Management (IAHCSMM) annual meeting, to be held in Chicago, IL, in April 2020. In preparation for that workshop, the KiiP team authored a preconference survey. The purpose of the survey was to gain greater insight into the thoughts and concerns of IAHCSMM members pertaining to packaging, with the response data serving as the foundational content for the workshop. Of course, because of COVID-19 and the cancellation of the in-person meeting, the workshop never happened. However, with the cooperation/assistance of IAHCSMM Staff, the preconference survey was transformed into a more complete survey and distributed to IAHCSMM members.

A total of 1,199 IAHCSMM members completed the survey—an excellent response, particularly when compared with the expected number of attendees to the annual conference (close to 1,500). In addition, the survey respondents’ demographics displayed a wide range of experience levels and job titles.

Survey analysis included presentation of the respondents’ answers to questions, as well as crosstabs based on title and department. Because a high percentage of attendees worked in the sterile processing area of healthcare facilities, the crosstabs with responses and departments were not statistically significant and did not provide much information.

The crosstabs by title, however, were illuminating. Essentially, the split was between technicians and those with other titles, which generally reflected a level of greater responsibility (e.g., supervisor, manager, director, educator, lead). In general, responses from those in management positions were somewhat more negative about the current state of sterile packaging compared with responses from technicians.

The other goal was to gauge the understanding of proper practice as it relates to sterile barrier packaging. Overall, respondents were correct in their responses at a very high percentage.

The information from this survey helped the KiiP team to gain an understanding of areas of opportunity for innovation and collaboration with this important stakeholder group. This included asking survey participants about the most important ways in which packaging could be improved.

Most encouraging, more than 600 respondents to the survey expressed a willingness to participate in further KiiP team activities. Of those, a couple dozen individuals volunteered to contribute by joining one of the four KiiP project groups.

The Last 100 Yards

Each project group is responsible for defining its mission, scope, objectives, and criteria for identifying and implementing projects. One of the groups, dubbed “The Last 100 Yards” is tasked with assessing sterile-packaged devices after they are delivered to the healthcare organization (including centralized distribution centers).

To that end, the group developed a survey targeting those within healthcare organizations responsible for handling sterile packaging. This included materials management, logistics, sterile processing professionals, and staff involved in preparing and using the sterilized items for delivery of patient care. The survey focused not just on the items delivered sterile to the healthcare organization but also those prepared and sterilized by the healthcare organization itself. The objective of the survey was to identify areas for in-depth research and, ultimately, opportunities for improving the delivery of sterile items.

With 1,700 respondents answering some or all of the 61 questions in the survey, the level of participation was remarkable. Although sterile processing professionals were by far the largest group, a considerable number of operating room professionals also participated. A lesser number of respondents reported working in materials management/logistics and infection control.

Informative insights were gained from the survey results, including those pertaining to training-related questions (Figure 1).

A bar graph showing "once upon hiring" as the top response.Figure 1. Responses to Kilmer innovations in Packaging team survey question, “When did you receive the training? Check all that apply.”


As with the survey among IAHCSMM members, the KiiP team survey focused on “actual practice” questions. During real-life events, nonideal practices can and do occur, and this survey focused on those nonideal practices. The survey took a different approach, asking respondents whether they “had ever seen a coworker do X” (i.e., the practice in question; example provided in Figure 2). The responses revealed the need for further education and collaboration between end users and industry.

Bar graph showing "No" as the top response to “Have you ever seen anyone double pouch by folding a portion of the inner pouch to fit in the other pouch for sterilization?”Figure 2. Responses to Kilmer innovations in Packaging team survey question, “Have you ever seen anyone double pouch by folding a portion of the inner pouch to fit in the other pouch for sterilization?”


The KiiP project group continues to review and analyze the survey results. It is anticipated that a number of follow-up studies, articles and white papers will be generated in the coming months. The KiiP team will share these with the industry as they become available. For further information on the KiiP movement and how to join the team, follow us on LinkedIn.

Acknowledgments

The surveys were developed with input from many members of KiiP—too numerous to list here. The authors thank all participants for their hard work and excellent guidance in drafting the surveys and analyzing results.

Special thanks to Alisha Lowe (market research analyst at Healthmark) for performing the statistical analysis and producing the graphical representation of the data shared in this article.

Ralph J. Basile, MBA, is vice president of marketing and regulatory affairs at Healthmark Industries in Fraser, MI. Email: ralphjb@usa.net

Jennifer Benolken, CPPL, is MDM & regulatory specialist, packaging engineering, Tyvek®, Medical Packaging, DuPont. Email: jennifer.a.benolken@dupont.com

Malinda Elammari,
ST, CSPM, CSPDT, CSIS, CFER, CRCST, CIS, CLSSGB, is interim director of education and quality at the Medical University of South Carolina in Charleston, SC. Email: malinda.elammari@gmail.com

Erin Kyle, DNP, RN, CNOR, NEA-BC, is editor-in-chief of the Guidelines for Perioperative Practice at the Association of periOperative Registered Nurses in Denver, CO. Email: ekyle@aorn.org

Jane Severin, PhD, CPPL, is vice president of technical solutions at Network Partners in Northville, MI. Email: jane.severin@networkpartners.com

Katherine Olson, BS, is a staff packaging engineer at MicroAire Surgical Instruments in Charlottesville, VA. Email: katherine.olson@microaire.com

Teri Meadow, MBA, is a healthcare market manager at American Packaging Corporation in Grand Rapids, MI. Email: tmeadow@americanpackaging.com