A customer approached Medibrane with a problem concerning a laparoscopic surgery device. The device’s polycarbonate component, which only contacts the skin for a maximum of 24 hours, may contain Bisphenol A (BPA). BPA is a chemical identified by the FDA as potentially hazardous. To ensure the device’s safety, the customer needed to determine if BPA was present and, if so, whether it exceeded safe levels.

Extractables vs. Leachables: Understanding the Difference

Before proceeding, it’s important to differentiate between extractables and leachables.

Extractables are chemicals that can be released from materials when exposed to specific solvents under controlled conditions. Manufacturers use these tests to identify all potential chemicals that might leach out under normal use conditions. This process helps detect risks before they impact the patient.

Leachables, on the other hand, are chemicals that migrate from the device into the body over time. They can lead to patient exposure and are a critical consideration in biocompatibility testing.

Medibrane’s Testing Process: Extractable Study

To address the customer’s concern, Medibrane conducted an extractable study of the laparoscopic device following ISO 10993-12 and ISO 10993-18 standards. First, we incubated the post-sterilized device in purified water at 37°C for 24 hours. Afterward, we analyzed the water for traces of BPA using High-Performance Liquid Chromatography (HPLC).

The Results: BPA Detected at Harmful Levels

Our testing revealed BPA in the water extraction. The concentration exceeded the allowable limits determined by a toxicologist. This result confirmed that the polycarbonate material in use was unsuitable for medical devices, as it posed a potential risk to patients.

The Solution: Switching to Medical-Grade Materials

Following our findings, the customer made the necessary adjustment: they replaced their polycarbonate supplier with a medical-grade material supplier. This ensured that the device met safety standards and removed any risk of harmful chemical exposure during use.

The Importance of Early Testing in Medical Device Development

This case study highlights the importance of conducting extractable and leachable tests early in the product development process. By identifying potential risks before the device reaches the market, manufacturers can safeguard patient health and ensure the product’s safety. Medibrane’s expertise in testing and material analysis allows us to support our customers in creating safe, compliant medical devices.