Manufacturing of custom cable assemblies for medical applications requires more than production of high-quality parts and components. Cable assemblies in healthcare applications must not only satisfy customer requirements, but meet stringent FDA regulatory requirements. Because of that, manufacture of medical cable assemblies must be in compliance for any type of electronic medical device.
Cable Assembly Usage in Healthcare
Cable assemblies are groups of wires and cables used to transmit power or data signals in electronic applications. By organizing or harnessing several individual cables into one package or unit, cable assemblies provide the necessary connectivity to operate or power equipment and devices. They also offer more efficiency in design applications, and streamline the installation, replacement and maintenance of devices. Uses for cable assemblies in healthcare range from diagnostic imaging equipment, medical instrumentation, surgical devices, dental devices, and patient monitoring units to healthcare IT applications, pulse oximeters, electroencephalography (EEG), electrocardiogram (ECG/EKG), and even ambulance cots.
Besides their many useful medical applications, custom cable assemblies in healthcare must have specific qualities and characteristics that ensure the reliability essential to stressful or critical emergency situations. Such cable assemblies are engineered to meet requirements unique to medical applications, whether in an emergency room environment, a field hospital, or an emergency vehicle.
Regulations & Requirements
What makes cable assemblies for medical and healthcare applications different from cable assemblies in other devices relates to their specific uses. Beyond hospital and emergency situations, medical device applications have several characteristics that set them apart from more common or standard cable assembly applications. Medical cable assemblies and their constituent parts – the cables and wires, connectors, terminals, sheathing, and so on – must adhere to and be in compliance with applicable regulatory statutes. In the U.S., the FDA categorizes all medical devices, their components and parts included, into a classification system – Class I, II, and III – which is determined by risk assessments and regulatory controls needed to provide reasonable assurance that a device is safe and effective to use.
Reliability
To comply, cable assemblies in healthcare applications would have distinguishing characteristics necessary to meet general regulatory requirements. Some characteristics for cable assemblies in a health or medical environment would ensure fully secured connections and signal integrity of the assembly. The system cannot fail in an emergency procedure.
Chemical Resistance
The assemblies may need to be sealed for sterilization in order to be reused. Reusable assemblies have to remain functioning at an optimal performance level even after being subjected to harsh sterilization processes. In many instances, reusable assemblies are necessary because some types of equipment or devices are too costly to use only once.
Durability
This would require cable assemblies to be much more durable and long-lasting than a standard assembly application. In addition to withstanding sterilization processes, custom medical cable assemblies must meet performance requirements of any given device. Whether the application is a defibrillator which must endure high-intensity stress on a daily basis or a low-intensity device like a pace-maker, durability is an important characteristic of cable assemblies in healthcare.
One-Time-Use Cases
It may be that the cable assembly is made to be used only one time. Even so, disposable cable assemblies must be highly functional, durable, and compliant even if they are to be replaced after a single-use. Health and safety of patients is always the number one priority with any medical device.
Resistant to Interference
Cable assemblies in healthcare applications would follow RoHS requirements (the Restriction of Hazardous Substances) in manufacturing. It is also essential that the application does not present any electromagnetic interference, and that the assemblies provide safe and easy mating procedures that can be easily handled with medical gloves.
Bio-Safe
Due to the inherent nature of a healthcare environment, custom medical cable assemblies must be biocompatible and interface with biochemical applications. Biological or chemical agents and fluids are part of every healthcare environment. Cable assemblies must meet strict regulatory standards, but also be able to function and withstand agents and fluids at the point of contact.
Cable assemblies in healthcare have many uses and applications. Above all, they must be compliant with regulatory statutes and directives, but they also must meet technical specifications that set them apart from other common cable assemblies. Medical cable assemblies are used in a variety of applications—diagnostic devices, patient therapy and monitoring devices, medical imaging units, surgical instrumentation—and must perform consistently in the most stressful, critical environments.
JEM Electronics specializes in the manufacture of custom cable assemblies for the medical industry in accordance with all regulations and the unique needs of your application. Contact us today to discuss your next project!
