(H-297) Aseptic Presentation of Medical Devices: Pilot Study of Handling Medical Packaging in a Clinical Simulation Environment

Hospital-acquired infections (HAIs), including highly prevalent surgical site infections (SSIs), are important patient safety concerns^1,2. SSIs can be spread through direct or indirect contamination⁵. Indirect contamination can occur via contact between sterile medical devices and their unsterile packaging exteriors when the packaging is opened, and the device is presented to the sterile field⁵. Proper aseptic presentation of the packaging contents is a crucial preventative measure against SSIs associated with such indirect contamination⁴. Aseptic presentation of medical devices involves six key steps: inspection of the packaging and seal, reading the packaging label and instructions for use, positioning the package, opening the package, presenting and transferring the package contents, and discarding the packaging materials⁴. Guidelines for presenting and transferring devices vary³. For example, the Association of periOperative Registered Nurses (AORN) standards recommends utilizing “pick” techniques to remove medical devices from peel pouches, whereas the Association of Surgical Technologists (AST) standards recommend flipping medical devices from peel pouches³. The purpose of this pilot study is to utilize a clinical simulation environment to assess how healthcare professionals handle packaging containing sterile medical devices. Four tasks were pursued toward this purpose: complete an inventory to differentiate medical device packaging types; develop a generic package with distinct markers suitable for detecting package handling in a simulation environment; develop coded algorithms to detect and measure key handling actions from recorded videos; and perform a pilot study to observe key handling actions used during the aseptic presentation of medical devices in a clinical simulation environment.

A packaging inventory was completed to document medical device packaging types, materials, and contents (Figure 1). Informed by the package inventory, generic packages with various distinct surface markers (e.g., colored shapes, QR codes) were considered; a prototype 6-sided cube with distinct surface markers was developed (Figure 2). Manipulation of the prototype cube was recorded in a clinical simulation lab containing a fully equipped acute-care skills bay and operating room environment and a video recording system (LLEAP interface and SimView software, Laerdal) integrated with three ultra-high definition (4K) video cameras (Vaddio RoboSHOT 20, Legrand AV) mounted on the ceiling enabling synchronous observation from multiple angles. Nine trials were recorded in the clinical simulation lab, including two trials involving 2D rotations of surface markers alone, five trials of controlled manipulation of the prototype cube rotated in three planes defined relative to an orthogonal coordinate axis, and two trials of uncontrolled manipulation of the prototype cube. Utilizing these recorded videos, algorithms were coded in MATLAB software to detect and match distinct surface markers and measure marker displacement relative to the local coordinate system in the simulation environment. Finally, a pilot study involving an operating room nurse and certified surgical technician was performed in the operating room simulation environment to record key packaging handling actions during the aseptic presentation of actual medical packaging containing medical devices (Figure 3). Eleven trials involving flexible peel pouches, thermoform rigid trays, and wrapped trays were collected, with emphasis on the positioning, opening, and transfer of package contents.

Results

The packaging inventory was acquired as expired products from the local healthcare system and included 58 packages consisting of seven different packaging types and five different materials. The most common packaging type was peelable pouch fabricated from plastic and paper materials. The prototype cube with a distinct QR code surface marker proved useful as a generic package, enabling uncontrolled manipulation and quantitative assessment of displacement relative to the initial package position. Surface markers with simple shapes or different colors were difficult to distinguish from visual features in the simulation environment, which interfered with detection and tracking. The integrated three camera set-up in the simulation lab enabled at least one camera to visualize and capture the distinct surface markers during prototype cube manipulation. Algorithms coded in MATLAB included tools to read image frames from the input video streams, detect and match distinct QR code features on the packaging surface in two different positions, and calculate 2D transformations between features on the original and rotated package images. Trials involving the positioning, opening, and transfer of packaging contents performed by healthcare professionals revealed several complexities, including objects obscuring the packaging surface markers from the camera view, large variations in aseptic presentation techniques depending on packaging type, among others. More detailed analysis of those trials is ongoing.

Conclusion

The clinical simulation environment supported the observation and measurement of packaging handling and manipulation by healthcare professionals. However, aseptic presentation of actual packaging containing sterile medical devices is notably more complex than the individual movements of the prototype cube. Further technical work is needed.

Discussion

Using this approach, it is possible to detect and track the handling and manipulation of generic packaging with distinct surface markers. Image processing algorithms readily distinguished QR code surface marker features from background features and approximated its 2D transformations in the recorded video frames. Future work will involve tracking the location of QR code surface markers on the prototype cube during more complex manipulations and longer video segments, extending the existing algorithms to estimate 3D transformations, and developing additional generic packaging types/shapes suitable for use in the simulation environment.

We would like to thank the Clemson University Creative Inquiry + Undergraduate Research Program for funding.  

1. Anderson DJ, Podgorny K, Berríos-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist

AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. (2014, June). Strategies to prevent

surgical site infections in acute care hospitals: 2014 update. Infectious Control &

Hospital Epidemiology.;35(6):605-27. https://doi.org/10.1086/676022.

2. Magill SS, O'Leary E, Janelle SJ, Thompson DL, Dumyati G, Nadle J, Wilson LE, Kainer

MA, Lynfield R, Greissman S, Ray SM, Beldavs Z, Gross C, Bamberg W, Sievers M,

Concannon C, Buhr N, Warnke L, Maloney M, Ocampo V, Brooks J, Oyewumi T,

Sharmin S, Richards K, Rainbow J, Samper M, Hancock EB, Leaptrot D, Scalise E,

Badrun F, Phelps R, Edwards JR; Emerging Infections Program Hospital Prevalence

Survey Team. (2018, November 1). Changes in Prevalence of Health Care-Associated

Infections in U.S. Hospitals. New England Journal of Medicine; 379(18):1732-1744.

https://doi.org.10.1056/NEJMoa1801550.

3. Perez, P., Bush, T. R., Hong, H. G., Pan, W., Miller, L., & Bix, L. (2018). Reducing levels of

medical device contamination through package redesign and opening technique. PloS

one, 13(11), e0206892. https://doi.org/10.1371/journal.pone.0206892.

4. Sterile Barrier Association. (2014, October 20). Aseptic Opening of Sterile Barrier Systems

[Video]. YouTube. https://www.youtube.com/watch?v=6H3iCr2Nkmc&feature=emb_logo.

5. Trier, T., Bello, N., Bush, T.R., Bix, L. (2014). The role of packaging size on contamination

rates during simulated presentation to a sterile field. PLOS ONE 9(7): e100414.

https://doi.org/10.1371/journal.pone.0100414.