Cleanliness of Biomedical Devices

Cambridge Polymer Group has been active in issues involving cleanliness of biomedical components. Our scientists worked with Sulzer Orthopedics on the InterOp voluntary recall in 2000 in an attempt to determine the root cause of failure in the devices. We consult with several medical device companies on cleanliness issues, and head up the ASTM task group addressing the cleanliness of biomedical devices. Visit our blog for recent information on medical device cleanliness.

ASTM Task Force on Cleanliness of Medical Devices

ASTM task force number F04.15.17 convened in May, 2002, to establish standard test methods for assessing residue levels in manufactured medical components. Currently, the following standards have been issued by this task group:
1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis.

2. ASTM F2847: Practice for Reporting and Assessment of Residues on Single Use Implants

The ASTM F04.15.17 task group is working on several new standards involving designing implants for cleaning, validation of cleanlines, and recipes for test soils to establish cleaning efficacy.

In addition, the cleanliness of re-usable devices has lead to a series of standards, including the following:

1. ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

2. ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors

ASTM Workshop on Cleanliness of Medical Devices

A workshop was held on May 7, 2003 at the Kansas City meeting of ASTM, organized by Stephen Spiegelberg, and Jack Lemons, and moderated by John Kirkpatrick. Abstracts of the talks can be downloaded, and some of the presentations are available for downloading. Over 50 people attended the workshop and participated in the round table discussion afterwards. Invited speakers included:

  • Prof. Jack Lemons (U. Alabama at Birmingham): Overview and Issues about Cleanliness of Synthetic Biomaterial Implants
  • Barbara Kanegsberg (BFK Solutions): Cleanliness and Surface Quality in Biomedical Devices
  • Dr. Patricia Campbell (Joint Replacement Institute): Histopathology of Failed InterOp Acetabular Components
  • Dr. Ronald Sahatjian (Boston Scientific Corp): Cleanliness of Devices used for Balloon Angioplasty
  • Dr. Matthew Wagner (NIST): Analytical Techniques for Assessing the Cleanliness of Medical Devices
  • Erin Keith (FDA): FDA Perspective: Cleanliness of Newly Machined Implants
  • Dr. Stephen Spiegelberg (Cambridge Polymer Group): ASTM Activities on the Cleanliness of Biomedical Devices
  • Dr. John Tesk (NIST): Symposium on the Cleanliness of Biomedical Devices: Call for Papers
  • Moderator: Dr. John Kirkpatrick (U. Alabama at Birmingham)

ASTM Workshop on Medical Device Cleanliness: How Clean is Clean Enough?

A second workshop was held in 2010 on medical device cleanliness, with an emphasis on establishing cleanliness limits. Copies of the presentations can be found here.