Managing Risk in Medical Connectors
- Created: Tuesday, 31 December 2013
Considerations for Cables for Complete Interconnect Solutions
Because risk extends throughout the interconnection solution, cable selection becomes important in reducing risk. Silicone with low-friction coatings are available to reduce silicone jacket damage. There are many reputable cable houses to manage your cable assemblies. If you are concerned about supply chain issues, most connector manufacturers will provide assembly services to reduce the number of vendors you have to work with. Check out the facility to see whether the company can provide you with termination only capabilities or complete overmolding, sealing, and testing capabilities. Manufacturers are experts at handling their own connectors, and should always be considered if cable assembly services are available.
Trends in Medical Connectors: Miniaturization
Managing and documenting risk in your interconnect solutions means taking special care to understand newer interconnect solutions. When you are among the first to make use of new technologies such as miniature connectors or fiber optics, it is important to work closely with your supplier to understand the ramifications of new materials in a medical environment so that you can document it appropriately. When it comes to miniaturization, look closely at the specifications of each connector, since those details become more important as the voltage and current increases. Compare models for pin size, number of pins, and functionality. Miniature connectors are nice packages that fit in small places, but only a few can carry power and signal simultaneously. (See Figure 3)
Global Trends in MedDevice Regulation
Worldwide trends in medical device regulation favor the convergence of risk stratification, quality systems, and risk management approaches. Manufacturers will bear responsibility for conducting risk management processes in compliance with applicable standards. The following is a list of the types of technical information that manufacturers should be prepared to provide to their connector and assembly partner. Filling in as many of these blanks as possible— even before contacting the connector specialist—can facilitate design and selection of appropriate connectors and cabling, and help to speed the manufacturer’s development processes.
• Number of contacts needed
• Voltage and current ratings of each contact
• Known creepage and air clearance requirements for each contact
• Environmental requirements (wipe down or sterilization requirements)
• Material requirements and use (metal versus plastic, reusable versus disposable)
• Tests to be performed on the completed assembly
• Cable requirements for signal (twisted pairs or coax) and power (high AWG)
Working with qualified suppliers will facilitate manufacturers’ compliance with quality systems and risk management requirements. It is important to understand the ramifications of new materials, including miniature connectors, as you determine and document the risk factors impacting your device.
This article was written by Patrick Kinyanjui, Senior Engineer, Fischer Connectors, Inc., Alpharetta, GA, For more information, visit http://info.hotims.com/49741-164.