The Food and Drug Administration (FDA), as well as the Canadian Health Protection Branch (HPB) have become aware of an appreciable increase in the number of complications associated with the use of central venous catheters (CVCs). A multidisciplinary health care task force consisting of physicians, nurses, and manufacturing representatives has concurred that individual health care providers, professional medical and nursing associations and health care facilities need to address the proper placement procedure, follow-up and care associated with these devices.
The Anesthesia Patient Safety Foundation is represented on this task force by Dr. E.C. Pierce. The task force is investigating long-term solutions such as changes in CVC labeling, development of instructional material (including videotapes) and monitoring procedure quality by the Joint Commission on Accreditation of Healthcare Organizations (I.A.C.H.O.). Some aspects of the CVC complications are well understood and the task force wishes to publicize this information in an expeditious manner.
Reports received by the FDA and the HPB regarding CVC complications include, but are not limited to: infection, pneumo-/hemo-/hydro-/ thorax, vessel and cardiac perforation, cardiac tamponade secondary to pericardial effusion, dysrhythmia, air embolus, and sheared catheters. Many of these complications are related to technique and are associated with substantial mortality. The current literature indicates that the number of CVC related problems are conservatively estimated as high as ten percent of the approximately three million CVCs used annually in the U.S. The following recommendations were made by the task force to help reduce or prevent these complications.
* Central venous catheterization should be performed only when the potential benefits appear to outweigh the inherent risks of the proceduce.
* Except for pulmonary artery catheters, the catheter tip should not be placed in, or allowed to rnigrate into, the heart.
* Catheter tip position should be confirmed by x-ray or other imaging modality and be rechecked periodically.
* Central venous catheterization must be performed by trained personnel, well versed in anatomical landmarks, safe technique and potential complications. Users in training must be closely supervised by qualified personnel to assure their technical expertise prior to independent performance of these procedures. Ongoing monitoring of experienced trainees should he undertaken to assure continued competence.
* Those placing CVCs should be familiar with the specific equipment utilized as well as the proper selection of insertion site and catheter type, size and length.
* Those caring for patients with indwelling central venous catheters should be well informed of the appropriate care and associated complications of CVCS.
* Manufacturers should include specific labeling to address the potential complications of CVC use. Therefore users should read all manufacturers’ labels, instructions and warnings, as these contain important and useful information essential for the safe and effective placement of the catheter.
Except in emergencies, catheterization should be performed with M aseptic technique to include hand washing, sterile gloves, masks, hats, gowns, drapes and proper use of a suitable skin antiseptic. Catheters placed in less than sterile fashion should be replaced as soon as medically feasible. As the use of central venous catheters has increased in recent years, so has the prevalence of their associated complications. By following these recommendations the incidence of these complications and resulting sequelae should be substantially
reduced. Users and institutions should review and monitor this clinical activity to assure that the process and outcomes are consistent with high quality patient safety standards.
Dr. Scott is a staff member of the Center for Devices and Radiologic Health at the Food and Drug Administration.