Ventilator-associated pneumonia (VAP) is one of most significant healthcare-associated infection (HCAI) risks for patients in long-term intensive care. Traditional endotracheal tube design can contribute to this since oropharyngeal secretions that would normally be swallowed can pool on the top of the cuff of the endotracheal tube and subsequently be passed into the lungs. A number of interventions and prevention strategies are used to minimize the incidence of VAP with varying degrees of success. A least two studies have found that the use of tracheal tubes with subglottic secretion drainage in patients expected to be ventilated for 72 hours or longer, significantly reduces VAP.
In 2013, Forefront Medical Technology, a specialty contract manufacturer with a focus in disposable diagnostic, drug delivery and medical device systems, was selected by one of its existing clients to support the development of the single-use portion of new endotracheal tube designed to mitigate the incidence of VAP by maintaining constant pressure within the tube and providing a collection point for oropharyngeal secretions that could easily be drained and cleaned by the hospital’s nursing staff.
Forefront’s team worked with the customer to develop the single-use components for two models of endotracheal tubes. The complete product combines endotracheal tubes with tracheometry drain tubes made from silicone, along with a tracheal seal monitor which continuously measures the pressure between the cuff and the trachea, enabling it to generate maximum cuff pressure. The resultant optimal tracheal seal significantly helps reduce the risk of aspiration. Key product features included:
- Non-stick coating inside the tube to reduce the formation of biofilm
- An adjustable flange and safety system to prevent any unforeseen extubations
- A silicon spiral tube which can adapt flexibly to airways
- Triple subglottic flushing suction pipes to collect and clear secretions
- A low-volume, low-pressure silicon cuff to provide optimum tracheal sealing and minimize injury to the tracheal mucosa
- A special atraumatic tip for atraumatic intubation and optimum adaptation to airways.
From a design and manufacturing standpoint, the single-use portion of the product required 14 different components which utilized a variety of materials. Achieving the customers’ form, functionality and fit goals required an innovative approach to material selection plus use of specialized molding processes with very critical tolerances. The assembly process also included a specialized dipping process.
Read about the process the team used here.
Moving production to a lower cost region will not deliver significant cost reduction if the supply chain and logistics activities are not optimized for the new region. As a result, a key consideration in selecting a contract manufacturing partner should be evaluating their ability to support identification of regional suppliers and the best logistics strategy for supporting the end market. For example, Forefront Medical Technology was supplying a customer with infusion lines used in a drug delivery system. The bags used with infusion lines were supplied by two manufacturers in Europe. Forefront’s team suggested to the customer that sourcing the entire set of four bags and infusion lines in Asia with Forefront could eliminate redundant logistics costs, increase visibility into inventory levels, improve quality and reduce production costs. The customer had been pleased with Forefront Medical’s performance on the infusion lines and agreed to the transfer the entire project.
The key challenge was ensuring the transfer of work and subsequent validation process was handled as efficiently as possible, since an inefficient process can eliminate any near-term cost savings. From a transfer perspective, Forefront’s team needed to identify a qualified source of roll form raw material for the bags, transfer and enhance the process to eliminate quality issues that were occurring at the previous suppliers and support process validation and regulatory approvals. Read more