Endoscopy
Infection prevention at the heart of design
Harald Huber discusses the importance of working with clinicians on product development to maximise infection prevention in endoscopy.
Infection prevention is crucial for guaranteeing patient safety in endoscopy. Infections can stem from several sources like staff clothing, floor and surface cleaning, but also from the equipment used during a procedure. Even high-quality endoscopic equipment can become a source of infection if it is handled inexpertly. It is important to address this problem right from the start, during the products’ design and development phase.
The “poka-yoke” philosophy in product development The “poka-yoke” principle originates from Japan and can be translated as “avoiding an unthinkably bad move”. It is typically applied in product development to eliminate potential sources of error through the design itself. A good example would be the design of a plug on an endoscope that only fits in the intended socket, to avoid connecting it to the wrong device. The overarching idea behind this philosophy is acknowledging that human error is inevitable. With its origins rooting in Japan, Pentax Medical has embraced and implemented some of the traditional Japanese methods for continuous improvement. “Poka-yoke”, as one of them, aims to provide people with a framework to minimise mistakes. In endoscope development, this would be reflected in designing a product to be intuitively understood, preventing incorrect handling by the user. A key aspect of this design principle is to be familiar with the real-life situation in a
hospital. In our case, the product managers and engineers are listening very carefully to the feedback and experience of physicians, nurses and reprocessing personnel to develop a diverse range of innovative endoscopic solutions, which provide meaningful support to healthcare providers.
Unmet needs and challenges Since its introduction in 2016, the BlackBox Innovations programme has become a key element in Pentax Medical’s approach to product development. We invite physicians, at an early stage of the product development process, to dedicated workshops that provide a forum for identifying unmet needs and challenges in daily clinical practice, as well as collaborative exploration of potential solutions in the development of products. Beyond that, physicians also have a chance to try out early prototypes and provide real-time feedback during a hands-on session. To date, a number of new developments
have resulted from this approach. One of these has been the DEC Duodenoscope ED34-i10T2, which features a sterile disposable elevator cap (DEC) for single-patient use and simple disposal. This solution was developed to address the increasing incidences of cross- contamination that may be linked to improper
We see that strong collaboration between us as a manufacturer and the healthcare provider as final user, generates immense value for the patients.
62
www.clinicalservicesjournal.com I February 2023
cleaning or disinfection of the elevators of duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. Feedback from key stakeholders who
are involved in the entire product flow is an instrumental element of the BlackBox Innovations workshops. One of the biggest pain points received was how to clean the elevator. Indeed, cleaning a duodenoscope is a complex task as there are more than 120 steps to remember. For that reason, we have redesigned the mechanical design of the DEC duodenoscope to make the risk component elevator disposable. As a result, there is also a more open space after the elevator has been removed, allowing easier access for brushes and more exposure of the surface for cleaning agents. At a first glance, this looks like a simple
change of the endoscope design, but it provides a significant simplification of the cleaning process. This type of customer- first thinking is being adopted to all of our product developments and we see that strong collaboration between us, as a manufacturer, and the healthcare provider, as final user, generates immense value for the patients.
Led by clinical advice from beginning to the end Another important development, with origins in the BlackBox Innovations programme, is the ONE Pulmo single-use bronchoscope. As a relatively new product category, it was important to first understand the actual use cases and the procedure environment of a single-use bronchoscope. For that reason, we continuously interacted with advisors in our BlackBox Innovations framework and with physicians
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68
