How Clean is Clean Enough?

ISO 19227 Implants for Surgery--Cleanliness of Orthopedic Implants--General Requirements is a long-awaited guidance document that was finalized and published early 2018. This guidance document is intended to assist orthopedic medical device manufacturers address the cleaning of their devices. One of the requirements of the good laboratory practices (GLPs) mandated by FDA is that medical devices be free from manufacturing residuals. Determination of what is needed to fulfill this requirement has largely been up to manufacturers and has been a topic hotly debated across the industry. Absent of specific guidance on setting acceptance criteria, and what classes of residuals to look for in a cleaning validation, individual manufacturers (and to a limited extent testing laboratories) have defined a set of tests and acceptance criteria to screen for potentially concerning residuals, which are highly variable from company to company. The tests to be included, and their acceptance criteria, are commonly tied to safety of the device with a risk-based approach using the following four steps: Risk analysis of the manufacturing process to identify most concerning potential residuals. Selection of analytical tests that are capable of detecting targeted residuals. Selection of a sampling strategy that results in a statistically meaningful set of measurements. Development of acceptance criteria related to a demonstration or assessment of patient safety, relying on history of device use, t...
Source: MDDI - Category: Medical Devices Authors: Tags: Orthopedics Source Type: news