ASTM Medical Device Standard Released, Reproducibility Testing Needed
Barbara Kanegsberg, BFK Solutions, LLC
After careful consideration and spirited debate, an ASTM standard for extraction
and gravimetric assessment of residue from permanent, implantable, metal
medical devices, will be available (ASTM F2459-05). We need volunteers to
test the new method.
Those of you who follow our monthly column in “Controlled Environments
Magazine” have had periodic updates on development of this critical
standard; the most recent report was in the August, 2005 issue. The standard
will be of value to those involved in the manufacture of implantable medical
devices and to groups concerned with non-volatile residue (NVR) assessment
for critical applications. As a member of the committee involved in developing
this standard, I can attest to the difficulties involved. However, there
is more to do. The next step is round robin testing; and the ASTM committee
is looking for volunteers to test the new method.
To determine reproducibility and bias of the method, the committee will
conduct inter-facility, round robin testing using complex coupons. Groups
with the
capability of performing NVR determination using either reflux or ultrasonic
extraction followed by gravimetric analysis are invited to participate.
In addition to the two extraction methods, analysis of two levels each
of an
aqueous and a solvent-extractable residue are planned.
The published standard will be available within the next few months (www.astm.org);
and the committee will meet at the ASTM Conference in Dallas, Texas
on November 9, 2005. Because the committee is actively planning details
of the round
robin reproducibility study, your company may want to become involved
prior to the meeting. For information on participating, please contact
Stephen
Spiegelberg, Cambridge Polymer Group, 617-629-4400 x12. You can also
contact Barbara Kanegsberg 310-459-3614, to discuss the new standard.
