Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -16

Accepted - Volume 1

Comment Record
Commentor Mrs. Elsie vancoillie Date/Time 2002-09-13 09:47:13
Organization eucomed
Category Association

Comments for FDA General
Questions
1. General Comments Department of Health and Human Services Food and Drug Administration 21CFR part 880 (Docket No 01P 0120) RIN 0910 ZA20 Medical Devices; Needle-Bearing Devices; Request for Comments and information Eucomed is the major medical technology industry association in Europe, and represents national associations and many of the most important manufacturers. These include most of the major companies manufacturing medical devices, which incorporate needles. Eucomed is very interested in the prevention of needlestick injuries to healthcare workers, and has a specific working group dedicated to this subject. In view of these facts, Eucomed believes itself to be well qualified to provide comment on the proposals contained in the above referenced document. Our views on the three specific proposals mentioned are briefly as follows; A) Banning of Specific Needle-Bearing Medical Devices We agree that the use of unprotected needle-bearing medical devices should be ceased where there are viable alternative devices available that incorporates a needle protection feature or a needle-free technology. However, caution needs to be exercised to ensure that conventional devices remain available for those applications where suitable needlestick prevention alternatives do not yet exist in the volumes required. Additionally, we believe that an increased focus on training and education is an important part of the solution. B) Performance Standard for Medical Devices Incorporating Needle Protection Features We agree that the development of an appropriate performance standard would be helpful. This should be a 'horizontal' standard that would be applicable to a range of medical device types. We believe that this is more appropriate than attempting to modify all relevant device specific 'vertical' standards to include requirements for needle protection features. In our view the development of such a standard should be progressed via the International Standards Organisation (ISO). Reference to existing guidelines, such as FDAs supplementary guidelines, for devices incorporating sharps injuries prevention features, would probably be helpful in drafting such a Standard. Eucomed would be happy to be actively involved in the development of the standard. C) Labeling of Conventional Syringes to Warn Against Use for Standard Blood Draws We do not believe that specific product labelling is the most appropriate way to draw attention to such risks. We agree with FDA regarding this general information being well known to healthcare professionals. Perhaps it would be more useful if FDA were to issue a more detailed safety alert concerning the use of needles that do not incorporate safety features. This could cover both the use of appropriate needle-protection medical devices and essential safe working practices. Eucomed ESI TF (Elimination of Sharps Injuries Task Force) 12 September 2002 -




EC -16