SwabCap
Frequently Asked Questions

 

When and how should I use SwabCap?
SwabCap should be used on the unused needleless connectors on the catheter and tubing sets as soon as the catheter is placed. This ensures a “closed system”. After an access site is used, a new SwabCap should be twisted securely onto it. SwabCap is meant to stay on the needleless connector BETWEEN uses as a way to protect the connector from touch and airborne contamination. Prior to access, the nurse simply removes the SwabCap. This eliminates the time-consuming, variable process of “scrub-the-hub” and dry for 15 – 45 seconds.

Is there clinical evidence that demonstrates the efficacy of SwabCap?
Yes. Preliminary results were recently presented at the 2011 Society for Hospital Epidemiology of America annual meeting. SwabCap is the only disinfection cap to have a prospective, controlled, multi-center, house-wide clinical trial published.
To view the poster click on the link below:

NorthShore abstract

Is SwabCap a push-on / pull-off cap? Does it comply with INS thread design standards 26.3 for add-on luer-lock devices?
SwabCap should be applied with a simple push and twist. The internal ISO standard thread design is in compliance with the INS guidelines (January/February 2011) that state “…all add-on devices shall be of luer-lock design to ensure a secure junction – Standard 26.3”. SwabCap has been successfully used in many pediatric hospitals with great success.

Why does SwabCap have a 96 hour limit on its use?
The 96 hour limit was established based on Excelsior’s testing which is part of the 510K submission, and cleared by the FDA. Excelsior submitted 7 day testing information as part of the approval package. FDA mandated that we limit labeled usage to the recommended usage life of needleless connectors which is 96 hours. SwabCap’s sealed, “closed system” design ensures the alcohol stays in the cap and contaminants stay out as demonstrated in our 7 day aerosol challenge test.

What is the purpose of the thread cover?
The patent-pending thread cover design helps create a seal or closed system of the IV set-up. This closed system helps ensure the top and threads of the needleless connector are bathed in alcohol, protecting from touch and airborne contamination. Disinfectants, like 70% Isopropyl Alcohol, kill the bacteria by being in direct contact with them, breaking down the cell walls. The longer the alcohol is in contact with the contaminants, the better the disinfection.
The thread cover keeps the majority of the alcohol within the cap without drying or leaking out.  With other caps, alcohol can leak out and be a source for skin irritation and breakdown.

Can SwabCap be used on dialysis catheters?
SwabCap cannot be used as an end-cap on open female luers. SwabCap can only be used on needleless connectors that have a luer-lock design and a swabbable surface. If the patient has a needleless connector that has a luer-lock connection and a swabbable surface on their dialysis catheter, then SwabCap can be used.

Can SwabCap be reattached after a single line access?
No. SwabCap is a single-use medical device only. Once it’s removed, it should be discarded.

What if the alcohol left on the needleless connector after removing a SwabCap is pushed into the patient’s bloodstream?
The amount of alcohol that remains on the needleless connector after SwabCap has been removed is extremely small. In the event that the connector top is not yet dry, the amount of 70% isopropyl alcohol that might be entrained into the IV tubing and patient’s blood stream would be miniscule and have no clinical significance. Excelsior has a technical letter on file available upon request.

What is SwabCap made of?
SwabCap was designed with extensive nursing input. An elastomeric material was preferred by nurses to ensure the product was “grippable”, low-profile, and would be soft on the patient’s skin. It is molded from a medical grade elastomer which allows for the thread cover seal to keep the alcohol in the cap. Its sterile packaging ensures that the outer surface of the device does not inadvertently transfer contaminants to the patient’s skin. Some caps do not have sterile packaging which exposes them to inadvertent touch and airborne contamination which can then potentially colonize a patient’s skin.

Why does SwabCap contain 70% IPA and not CHG?
70% IPA was chosen for its disinfecting capabilities and its ability to passively kill bacteria without scrubbing. After SwabCap is applied, the alcohol is released from the pad bathing the top and threads of the needleless connector. 70% alcohol diffuses through the cell wall of the bacteria and destroys the cell by inactivating the cell proteins. Laboratory studies have demonstrated complete disinfection (6 log reduction) after the SwabCap has been in place for 5 minutes without scrubbing. CHG is not approved by the FDA for the disinfection of needleless connectors.

Can SwabCap be used on a sterile field?
SwabCap does not come in a sterile field ready package. After the catheter has been placed, flushed with saline, medication has been delivered to the patient and the final flush is delivered, the sterile field is usually removed, thus allowing for SwabCap to be placed after the last flush.

Can SwabCap be re-sterilized?
No, SwabCap currently cannot be re-sterilized.

Does SwabCap’s orange color pose any issues with enteral feeding lines?
No. Enteral feeding lines have now been designed to be incompatible to prevent the misconnection of IV tubes and catheters. Within the United States, there are no established color standards by safety or regulatory agencies for enteral lines. The three largest manufacturers in the enteral nutrition market have changed their tubing colors to lavender and red. According to several safety watch groups, color coding should not be used to prevent misconnections.
Should we use SwabCap on our Peripheral IV catheters?
Yes. SwabCap should be used on all unused needleless connectors on the catheter and tubing sets regardless of the catheter that is placed. This helps ensure a “closed system” and helps nursing in maintaining one protocol for disinfection of all needleless connectors, regardless of the catheter that’s been placed. While most infection control focus has been on central lines, recent studies by Mermel and others have highlighted the significant risks associated with peripheral IV’s.

Rhode Island Hospital article