Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -19

Accepted - Volume 1

Comment Record
Commentor Ms. Jane Starkey Date/Time 2002-09-18 14:57:06
Organization America's Blood Centers
Category Association

Comments for FDA General
1. General Comments America's Blood Centers 725 15th Street, NW, Suite 700 Washington, DC 20005 September 18, 2002 Dockets Management Branch (HFA–305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852. Re: Docket No. 01P–0120: Medical Devices; Needle-Bearing Devices; Request for Comments and Information Dear Docket Officer: Thank you for the opportunity to comment on FDA’s advance notice of proposed rulemaking on needle-bearing medical devices. For your information, ABC is a national network of locally-controlled, non-profit community blood centers that collect almost half of the US blood supply from volunteer donors. Collectively, we operate in 45 states and serve patients at more than half of the nation’s 6,000 hospitals. ABC’s total blood collections exceeded 7 million pints in 2001. We have one comment, related to the provision in the HRG/SEIU petition that would ban glass capillary tubes (Section III.A.2). ABC agrees that glass capillary tubes may pose a risk of exposing employees to bloodborne pathogens. As a replacement for all-glass capillary tubes, a number of ABC members now use mylar-coated tubes and have found them to be equivalent or safer than plastic capillary tubes in preventing percutaneous exposures to blood. According to one ABC member blood center: “As of August 2002, we have not had a single exposure from the mylar-coated capillary tubes since our switch from all-glass tubes in October 1998.” We would also like to point out that in a February 1999 Joint Advisory on Glass Capillary Tubes, the Food and Drug Administration the National Institute of Occupational Safety and Health, and Occupational Safety and Health Administration stated: “To reduce the risk of injury due to breakage of capillary tubes, FDA, NIOSH, and OSHA recommend that users consider blood collection devices less prone to accidental breakage, including: . . . glass capillary tubes wrapped in puncture-resistant film. . . .” (Citation: Glass Capillary Tubes: Joint Safety Advisory About Potential Risks, Food and Drug Administration, National Institute of Occupational Safety and Health, Occupational Safety and Health Administration, February 1999) ABC REQUESTS THAT ANY PROPOSED BAN THAT FDA MIGHT ISSUE ON THE USE OF GLASS CAPILLARY TUBES SPECIFICALLY EXEMPT GLASS CAPILLARY TUBES WRAPPED IN PUNCTURE-RESISTANT FILM. Thank you for the opportunity to comment on this ANPR. I would be pleased to answer any questions you might have. Jane Starkey Director, Research & Science America’s Blood Centers

EC -19