Medical lubricants: myths and realities

In the medical devices sector, lubrication plays a vital role in both product performance and safety. However, there are still numerous myths surrounding medical lubricants which can lead to the selection of unsuitable products and, consequently, increase the risks for manufacturers and patients. Below, we debunk the most common misconceptions about this type of product:

Myth: There is an official ‘medical-grade’ certification for lubricants

Fact: No regulations grant a ‘medical-grade’ certification to lubricants.

What does exist is the ISO 13485:2016 certification, which confirms that the company manufactures in accordance with the quality standards required for medical devices. The lubricants marketed by FUCHS for this industry are manufactured in accordance with this international standard.

Myth: A food-grade lubricant is also suitable for medical use

Fact: This confusion is common, as food-grade lubricants are used across many industries. However, food-grade lubricants are only approved by the FDA for incidental contact up to 10 ppm and are not required to pass biocompatibility tests such as those in the ISO 10993 series.

In contrast, the NYEMED® range offers lubricants backed by testing for cytotoxicity, skin irritation and systemic toxicity (ISO 10993-5, 10 and 11), which minimises the risk to the patient and simplifies device validation.

Myth: Lubricants only reduce friction

Although reducing friction is an important function, medical lubricants also play key roles in controlling movement, enhancing tactile sensation (haptics), reducing noise, sealing against contaminants and optimising activation or insertion forces.

For example, in electrical connectors, they prevent the build-up of debris, reducing connectivity failures and extending the component’s service life. Or in auto-injectors, motion-control greases and gels allow the release of spring energy to be modulated, smooth the movement of the plunger and improve the patient experience by reducing vibrations or sudden jolts.

Myth: Medical lubricants pose more risks than they offer benefits

Fact: With the right choice, the opposite is true. Proper lubrication improves the device’s performance, reliability and regulatory compliance, whilst the use of unvalidated lubricants can lead to failures, premature wear and even regulatory issues. FUCHS carries out comprehensive risk assessments and laboratory simulations to validate that the lubricant performs correctly under the device’s actual operating conditions.

Myth: Lubricants must be approved by the government before use

Government agencies do not approve lubricants or materials from suppliers, but rather complete devices. However, using lubricants tested to industry standards reduces the risk during the final device approval process.

Medical lubrication is a critical and highly specialized discipline; lubricants are an essential element and an integral part of device design. Their function goes far beyond conventional lubrication and has an impact on the safety, performance and user experience of the device. Understanding the myths and realities enables informed decision-making and the selection of solutions that are fully aligned with regulations, engineering requirements and patient needs.

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