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ISMP Canada has been informed that there is a potential problem and patient risk in using the Abbott Abboject Lifeshield product line (emergency use drugs) with Baxter's Continu-Flo i.v. tubing sets (JC5386;JC5537; JC5548). At least two large hospitals in the Metro Toronto Area have reported that the needle of the Lifeshield syringe will cause the injection port of the Baxter tubing to bulge and even to be pulled out when the Lifeshield syringe is removed after injecting the medication. |
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Hospitals in the US do not seem to have this problem. We surmise, this is because both product lines (i) Abboject (with needles) and (ii) Abboject Lifeshield (with needle/luer-lock) are available to the US hospitals. Unfortunately, this is NOT the case for Canadian hospitals. ISMP Canada have met with both Abbott Laboratory Canada and Baxter Canada to discuss this urgent issue. Both companies are assisting with investigating the root causes of the problem. In addressing the short term need to handle this problem, Abbott Laboratory Canada has been requested to provide Canadian hospitals with the choice of both Abboject product lines, as is the case in the U.S. Abbott has indicated that the Abboject stock (with needles) available in the US is labeled in English only (product Code 4). This could be used in Canada only through the Special Access Program. ISMP Canada has requested Abbott to pursue availability of this Abboject product line through the Special Access Program until long-term solutions, such as different needles on the lifeshield syringe, or different ports on the Baxter tubing are realized. It will be a few days before we hear from Abbott about the request. In the meantime, there have been some suggestions from health care professionals for circumventing the problem. We recommend each hospital in this situation should meet with their ICU nurses and physicians to determine the best option for their hospital depending on comfort level and availability of products:
None of these suggested options are ideal and they still need to be tested. Should anyone have other alternative solutions, please contact ISMP Canada as soon as possible, so they can be shared. We will keep you updated on progress with the companies involved, and testing of the above suggestions. Please visit this page for updates on this important issue, or for other information. Oct. 20 Update:Another option suggested:
Both Abbott and Baxter, are unsure at this point, of the magnitude of the problem. They suspect there are only isolated cases where the problem of incompatibility of needle and injection port exist. However, Abbott has acknowledged the issue is an important one, and wish to work collaboratively with ISMP-Canada and the Canadian hospitals in order to alleviate the unforeseen problems. Abbott is also already in the process of testing their product vigorously at their head office in Chicago, to determine the root causes, as well as, to determine if improvements can be made. ISMP Canada and Abbott have discussed an immediate action to be taken by Abbott to assist those hospitals currently affected. Abbott is contacting those hospitals and is presently working out the logistics of a short-term solution. There will be definitive confirmation very soon. Oct. 23 UpdateISMP Canada has received the following important updates:
Hospitals that desire to replace the Abboject Lifesheild products by the regular Abboject products or to try out the Clave connector, please contact their Abbott repressentatives for such an arrangement. ISMP Canada will be doing our best to facilitate the implementation of corrective actions to ensure a safe medication use system is in place in Canadian hospitals. Nov. 4 UpdateAbbott informed ISMP Canada that although supply of Abboject regular product lines had arrived in Canada from the US, they were still waiting for approval of the Special Access program from Health Canada to release them to the Canadian hospitals. Abbott does expect to have this approval sometime next week. Nov. 13 Update
Abbott informed ISMP Canada on
Friday, November 10 that Health Canada did not provide an approval of
the Special Access Program to the general release of the US labeled Abboject
product lines to Canadian hospitals. The reason given was that the
problem was not a wide spread one and Abbott could not duplicate
the problem as reported.
However Abbott Laboratory Canada has
decided to go ahead with the process of re-working the US labeled
Abboject product lines to Canadian labeling. The process will take up
to sixty days to complete and by then all regular Abboject products
will be immediately available for sale to Canadian hospitals.
In the meantime, should Canadian
hospitals encounter any problem of using the Lifeshield products,
please report to Abbott Laboratory (and copy to ISMP Canada for
information). Canadian hospitals can still choose one of the suggested
options to circumvent the problem on a temporary basis.
Nov. 21 UpdateAbbott Laboratory Canada informed ISMP Canada and Health Canada's Special Access Program that they had expedited the re-working process of the Abboject products. Sodium Bicarbonate will be available by November 28, 2000, and the rest of the Abboject products will be available by December 8, 2000. This timeline for making Abboject products available to Canadian hospitals has been greatly shortened.
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