How glass-sealed connectors increase medical device longevity

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As medical instruments and technologies grow more sophisticated and complex, it is increasingly important to guard sensitive components from the autoclaving process while supporting their longevity. Glass offers a solution.

Jochen Herzberg, Schott Electronic Packaging

Autoclavable glass-sealed connector Schott

Autoclavable glass-sealed connector from Schott [Image courtesy of Schott Electronic Packaging]

In today’s era of rapid technological advancement, medical devices have become more complex and capable than ever thanks to the integration of advanced electronic components. In the medical field, steam sterilization in the autoclave is a staple of the industry. The crucially important process pits devices against temperatures of 273 °F and two bars of pressure to ensure devices are sterile and safe to use before each procedure. The electronics inside modern medical appliances need protection from the intense conditions of the autoclave. One of the most important components in this process is the connector, which makes electrical and data connections between device sections.

Implementation of high-quality connectors using the right materials is crucial. Inferior components can weaken the protection of the device’s electronics. Glass-to-metal sealing technology, already used in other harsh-environment applications such as aviation, aerospace and automotive safety, has emerged as an ideal solution in the development and manufacture of medical connectors. Glass-to-metal sealed connectors offer a resilient and dependable option that remains reliably gas-tight for over 3,500 autoclaving cycles, subsequently helping extend the lifespan of medical devices.

Potential difficulties with polymer-sealed connectors

Many medical connectors are sealed with polymers or epoxy resins, which are not capable of maintaining a dependable seal over a long period. During the autoclaving process and especially after repeated cycles, polymer-based connectors will allow for a certain permeability of moisture. This can cause damage to electronic components. The binders and chemicals that make up polymer seals deteriorate over time, leaving a brittle shield incapable of providing truly reliable protection from autoclaving conditions.

The aging process and breakdown of these organic materials can happen quickly, sometimes after as few as 100 autoclaving cycles. The potential inability of polymer seals to stand up to the fundamentally important autoclaving process can lead to a plethora of problems: shortened device lifespan, failure during a procedure and increased total cost of ownership from compromised seal integrity.

Connectors are strengthened by the integrity of glass

A common argument against glass as a material is the idea that it is easily broken. Glass-to-metal sealing technology challenges this concept. Using advanced manufacturing processes, the glass preform and metal pieces are heated to a temperature that melts the glass, fusing glass and metal to create a gas-tight and pressure-proof seal.

During their use, glass seals maintain integrity because glass is inorganic and non-aging. It is non-porous and resistant to drastic environmental changes. This makes it a choice material to use in the manufacture of medical connectors because it has a proven ability to withstand the autoclaving process more than 3,500 times. The strong seal effectively prevents the ingress of moisture and other outside contaminants, safeguarding electronics from damaging humidity and particulates.

Peace of mind for medical professionals

Confidence is of the utmost importance in medicine. A doctor’s confidence in his abilities, decisions, colleagues and treatment all come together in the effort to create a successful patient outcome. The same need for confidence applies to medical devices. Medical professionals must be able to have trust in their equipment. The use of devices with glass-to-metal sealed connectors goes a long way to help establish this on many fronts.

Cross-contamination incidents are one of the most substantial threats to patient safety and professional integrity in the medical industry. Mitigating the risk of such incidents is why the autoclaving process is extremely important in medical environments. Traditionally, steam sterilization presents a major strain on devices because it can accelerate wear on components. With protection for electronics from glass-to-metal connectors, devices can undergo a complete and intensive autoclaving cycle over 3,500 times without risk of accelerated damage or wear on the electronics.

Increased reliability aided by the use of glass-to-metal connectors eases worry both in the operating room and finance office. Glass-to-metal connectors can help extend device service life, reduce maintenance costs, and lessen the chance of warranty claims and physician frustrations. Surgeons and patients can experience the safety benefit of a decreased chance of device failure, while hospital budgets can experience a reduced burden thanks to a less-frequent device replacement schedule.

Design possibilities enabled by customizable glass-to-metal technology

Versatility is another key benefit that sets glass-to-metal sealed connectors apart in a constantly developing medical landscape. Integration possibilities for medical applications include surgical tools, endoscopes or instruments for spectrometry and pulse oximetry. Customization possibilities can be met for individual and exact application needs, enabling design flexibility for medical device engineers. This creates the opportunity to conceptualize distinct ideas while still meeting strict regulatory requirements for medical devices.

Glass-to-metal sealed medical connectors can be custom-designed in a number of ways, including varying shapes, sizes and pin configurations to match requirements for integration in medical devices that require power and data supply and must be repeatedly autoclaved.

Devices and techniques will change, but the rigid standards for autoclaving requirements for hygienic operating rooms will remain a constant. As medical instruments and technologies grow more sophisticated and complex, it is increasingly important to guard sensitive components from the autoclaving process while supporting their longevity.  Glass, in its distinct role as an inorganic and reliable sealing material, offers a way.

Jochen Herzberg is an innovation leader at Schott Electronic Packaging in Landshut, Germany.

(See the best minds in medtech live at DeviceTalks Boston on Oct. 2.)

DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

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