LETTER
Midline Catheters: The Final Chapter
Leonard Mermel, DO, ScM
15 February 1997 | Volume 126 Issue 4 | Page 334
TO THE EDITOR:
On 18 September 1996, Johnson & Johnson Medical, Inc., withdrew the Streamline peripheral catheter, Landmark midline catheter, and Centermark peripherally inserted central catheter from the U.S. market. All of these intravascular catheters are made of the unique copolymer Aquavene. This event reflects the culmination of investigations by the Food and Drug Administration (FDA) [1] and others [2, 3], which showed that these catheters, unlike any others on the U.S. market, are associated with life-threatening anaphylactoid reactions. Important lessons are to be learned, as eloquently expressed in the editorial [4] that accompanied our report [2]. Namely, health care workers must remain vigilant when using newly marketed devices, given that unexpected adverse reactions can occur in various guises. If adverse reactions are observed, they should be immediately reported, as now required by law [5], to the FDA Medical Products Reporting Program. It is vitally important that investigations be done to better understand the mechanism of the observed reactions. Armed with this knowledge, the FDA can better protect the population from exposure to future devices that have the same potential for adverse reactions.
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Author and Article Information
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Rhode Island Hospital, Providence, RI 02903
1. Blum D. Untoward events associated with use of midterm i.v. devices. J Intraven Nurs. 1995; 18:116-9.
2. Mermel LA, Parenteau S, Tow SM. The risk of midline catheterization in hospitalized patients. A prospective study. Ann Intern Med. 1995; 123:841-4.
3. Adverse reactions associated with midline catheters, 1992-1995. MMWR Morb Mortal Wkly Rep. 1995; 45:101-3.
4. Maki DG. Reactions associated with midline catheters for intravenous access [Editorial]. Ann Intern Med. 1995; 123:884-6.
5. Food and Drug Administration. FDA Medical Bulletin. Medical Device Reporting. 1996; 26:6.
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