RMS Foundation has been active in cleanliness of medical devices for many years. It offers consulting and analytical services for interested industries. Furthermore, RMS Foundation is active in developing related standards.

Contact: Reto Luginbühl, reto.luginbuehl(at)rms-foundation.ch, +41 (0)32 644 14 16 

RMS Foundation offers consulting in cleaning and process validations. We support our customers from the planning of validation studies (VP) to the final report (FR). We perform risk analysis, assess your IQ/OQ documents, or we arrange your performance qualification (PQ) including preparation and chemical analysis of the samples.

Analytical services for organic, inorganic and particulates are offered by RMS or in collaboration with external specialists. Typical methods applied for organic include GC-MS, LC-MS, or FTIR analysis while for inorganic ICP-OES or XPS used. Gravimetric analysis (ASTM F2459) or SEM complement the methods regarding particulate materials.

Microbiological and biological analysis of implants are also performed. In particular, endotoxin analysis on implants are performed with based specific extraction protocols and kinetic turbidimetric or chromogenic LAL testing.

Cytotoxicity and cell testing is not part of the residue analysis program, but you are welcome do discuss your requests with us.

The standard practice F2847-10 on Reporting and Assessment of Residues on Single Use Implants has been recently issued by ASTM international. It is the first standard that addresses the cleanliness of implants and it describes how the cleanliness of single-use implants as manufactured shall be reported. This practice proposes how to approach the identification of critical compounds and suggests different analytical methods.

F2459 is a Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis. It is a simple and straight forward test method to determine the extractable residues in metallic medical components. Extractable residues includes aqueous and non-aqueous residue, as well as non-soluble residues.

RMS Foundation, Cambridge Polymers and FDA organized on November 16^th 2010 a workshop on ongoing issues of cleaning medical devices, including new implants and reusable devices, establishing limit values, legal implications, etc.

The program abstracts and the presentations of the meeting can be downloaded here