Surgical site infection
through proper cleaning and air filtration to minimises the presence of bacteria.
‘Designing out’ the risk of surgical site infections Brandon Medical has been manufacturing operating room lights for over 30 years and, during this period, the design of the lights has evolved to support modern hygiene practices. The surfaces of the Quasar, Astramax and Astralite products have been designed to be as smooth and wipeable as possible. There are no difficult to reach areas or exposed screw heads that can act as dirt traps. The light enclosures must have a high ingress protection rating to prevent cleaning or bodily fluids becoming entrapped and harbouring bacteria or potentially dripping out onto a patient. “Being able to effectively clean the equipment inside an operating room is critical to reducing the potential for infections. Theatre teams have limited time between cases to clean equipment, so the surface of the equipment must be smooth, with no screw holes, rubber seals and joins that could harbour any dirt or fluids,” comments Sandra Senior (RGN), a Clinical Trainer at Brandon Medical and a former Theatre Matron
Ingress protection In addition to surface design, the exposed materials have been selected to be compatible with cleaning solutions commonly found in operating rooms. This ensures that the hospital operating room hygiene regime is kept as simple as possible and reduces the chance of inadequate or even forgotten cleaning operations. These steps may seem comprehensive, but
the current medical device regulations compel equipment designers to take every step possible to minimise risk. The terminology used in the EU
One of the challenges in infection control is the possibility of human error or lapses in adherence to cleaning protocols. Antimicrobial additives act as a safety net, ensuring that even in cases where standard procedures may fall short, the risk is minimised.
Medical Device Regulations is “to reduce risks as far as possible”.3
This is a break from the
risk control principles used in other industries, where the requirement is “to reduce risk as far as practicable” and means that the medical equipment designer must implement every control measure possible. The Medical Device Regulations also dictate a
hierarchy of risk controls: (a) Eliminate or reduce risks as far as possible through safe design and manufacture;
(b) Where appropriate, take adequate protection measures, including alarms, if necessary, in relation to risks that cannot be eliminated.
(c) Provide information for safety (warnings/ precautions/contra-indications) and, where appropriate, training to users.
Point (a) indicates that the most valuable risk controls are those that “design out” risk. This is clearly a sensible approach as it is less dependent on variable factors such as operators reading an instruction manual or receiving adequate training. It is this focus on reducing the risk of
surgically acquired infections through product design that leads to the use of antimicrobial additives that are embedded in the surface of the Brandon Medical surgical lights. These additives act as a back-up to the standard cleaning regime and are a welcome step
forward in supporting high levels of hygiene in the operating room. The company has worked closely with manufacturers, such as Polygiene, to find an additive that is compatible with the materials used in the surgical lights and fit for purpose in the high-risk environment of the operating room.
Antimicrobial additives Antimicrobial additives disrupt biofilm formation, making it easier to maintain a sterile environment by allowing regular cleaning procedures to be more effective. By impeding the establishment of biofilms, hospitals can ensure that their equipment remains free from hidden reservoirs of infection, thus providing an additional layer of protection for patients. The additive selected by Brandon Medical is
the Polygiene BioMaster product. This additive proactively inhibits and disrupts the growth of bacteria and microbes on treated surfaces at the molecular level and has three modes of action. The silver ion technology binds with the cell wall to disrupt the growth of bacteria that lands on a treated surface. The ions also interfere with enzyme production within the bacteria, stopping each cell from producing energy. Finally, the additive interrupts bacterial cell DNA, preventing replication. The bacteria cannot reproduce or grow, reducing the microbial load on treated surfaces. Because the additive is integrated into materials and surfaces at the point of production, it stays active for the life of the product and provides continuous protection. A pilot study undertaken at a large National
Health Service Trust examined the bacterial contamination found on products in a clinical setting containing silver-ion technology.4
The
study compared two clinical settings one with no antimicrobial in place and the other using products treated with silver-ion technology. The untreated ward contained all standard items normally seen in a ward. The silver protected ward contained the same items but with the silver technology applied either to the coating on the surfaces or directly into the substrate itself.
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www.clinicalservicesjournal.com I December 2023
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