Surface quality and cleanliness are critical for medical devices. As people live longer and continue to be more active, higher and more reliable device performance is expected. More medical devices are available, often involving extensive supply chains. It has become increasingly, sometimes painfully, apparent to those manufacturing or reusing medical devices and surgical accessories that harmful residue is unacceptable.^1-2 Manufacturers must document the acceptable level of risks associated with potential contaminants and demonstrate an adequate program to achieve and maintain contaminant levels that are well below acceptable risk levels.

ASTM STANDARDS FOR MEDICAL DEVICES
The medical community and the FDA both want standards for acceptable residue levels and appropriate manufacturing and testing processes. At ASTM International, such standards are developed by the Committee on Medical and Surgical Materials (F04).

Given the complexity and diversity of medical devices, it is important to develop standards that are pertinent, achievable, and that can be geared to specific applications. In support of development of appropriate standards and practices, the F04 committee sponsored a “Workshop on Medical Device Cleanliness: How Clean is Clean Enough?” at a recent meeting in San Antonio, TX. Thirteen talks by representatives from the FDA, academia, private industry, and consultants covered such topics as regulatory and legal implications, methods for cleaning and verifying cleanliness of devices, and establishment of limits for allowable residues.³

REPORTING RESIDUES
A new standard for reporting residues will be essential to device manufacturers in achieving documentation of an acceptable critical cleaning protocol. F2847-10, Standard Practice for Reporting and Assessment of Residues on Single Use Implants was finalized at the San Antonio meeting by the Task Group on Cleanliness of Biomedical Devices (F04.15.17). We have participated on this task force since its inception eight years ago and have commented on its work in this column.⁴