BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMART-SITE

    MDR report key: 267745 · Received February 2, 2000

    Report

    Report Number
    MW4002712
    Event Type
    Other
    Date Received
    February 2, 2000
    Report Date
    January 23, 1999
    Manufacturer
    ALARIS MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 1/31/01: NONE OF THE NEEDLELESS SYSTEM OR GLOVE MFRS HAVE RESPONDED SO FAR.

    Description of Event or Problem · 1

    ACCORDING TO RPTR CAL OSHA, CDC/NIOSH & FEDERAL OSHA HAVE DIRECTED THE USE OF BOTH NEEDLELESS IV SETS & EXAM GLOVES DURING IV ACCESS WITH THE PROVISO THAT "THE DEVICE IS SAFE & EFFECTIVE FOR PTS." RPTR QUESTIONED THE PT SAFETY OF NEEDLELESS SYSTEMS BECAUSE OF RECESSES PRONE TO BACTERIAL COLONIZATION, EXCESSIVE HANDLING OF EQUIPMENT ESSENTIAL TO USE OF BLUNT CANNULAE OR SYRINGE NOZZLES TO ACCESS Y-PORTS, THE PROCLIVITY FOR MAKING REPEATED INJECTIONS THROUGH THE SAME RECESS; AND "THE FACT THAT HEALTHCARE WORKERS ARE AT NO RISK FOR HIV, HBV AND HCV WHEN TRANSFERRING STERILE FLUIDS FROM STERILE CONTAINERS INTO Y-PORTS VIA SYRINGES." NEVERTHELESS, PTS ARE PAYING THREE TIMES AS MUCH FOR THE NEEDLELESS SYSTEMS AT AN INCREASED RISK FOR SEPTICEMIAS, ESPECIALLY WITH COAGULASE-NEGATIVE STAPH. THE ABSOLUTE RISK INCREASE IS NOT CERTAIN, BUT HAS BEEN REPORTED TO BE AT LEAST 3X IN SEPTICEMIC OUTBREAKS WHEREIN THE CDC WAS CALLED IN TO IDENTIFY THE PROBLEM AFTER CHANGEOVER TO USE OF THE INTERLINK, SAFESITE, SMART-SITE AND CLAVE. ACTUALLY DANZIG ET AL IDENTIFIED THE ROOT OF THE PROBLEM IN 1995 IN A REPORT ON THE INTERLINK SLIP PORT. ACCORDING TO RPTR THE LAST EPISODES REPORTED HAVE BEEN WITH THE CLAVE (CF. DO AN, RAY BJ, BANERJEE SN, ILIAN AF, ET AL J INFECT DIS 179:442-448, 1999 & TOSCANO AT SAN FRANCISCO SHEA MEETING APRIL 18-20 '99 IN ABSTRACT 49). ACCORDING TO RPTR, THE BAXTER INTERLINK & OTHER SYSTEMS USING UNCAPPED SLIP Y-PORTS ALL SUFFER FROM HYDRODYNAMIC FLAWS. THESE ARE NOT OBVIOUS, UNLESS ONE WATCHES CAREFULLY WHEN THE LARGE DIAMETER BLUNT CANNULA IS WITHDRAWN FROM THE ELASTOMERIC SLIT PORT CAP. WHEN HYDROSTATIC PRESSURE IN THE CANNULA BECOMES LESS THAN THAT IN THE INFUSION PORT, FLUID FROM THE IV SET LEAKS BACK INTO THE SLIP ALONG THE LINE OF CANNULA WITHDRAWAL & IS ENCLOSED BY ELASTIC RECOIL OF THE SLIT IN THE CAP. THE SMALL AMOUNT OF FLUID ENCLOSED IS SPREAD BY CAPILLARY ATTRACTION OVER THE INNER SURFACE OF THE SLIT & REMAINS THERE UNTIL THE NEXT CANNULATION OF THE SLIT-PORT. THE BRAUN SAFSITE SYSTEM AND THE SMART-SITE HAVE OBVIOUS RECESSES WHICH ARE REVERSIBLY CAPPED, BUT MADE LARGE ENOUGH TO RECEIVE A LUER-LOK SYRINGE NOZZLE REPEATEDLY, WHILE FLUID IN THE RECESS CAN INCUBATE BACTERIA BETWEEN INJECTIONS, WHETHER THE DEVICE IS CAPPED OR NOT. IN THEIR INVESTIGATIONS OF NOSOCOMIAL SEPTICEMIA OUTBREAKS SUBSEQUENT TO THAT OF DANZIG ET AL IN "JAMA" 1995; 273: 1862-1864, THE CDC BLAMED LACK OF ADHERENCE TO UNIVERSAL PRECAUTIONS OR NOT CHANGING STERILE PORT CAPS OFTEN ENOUGH AS BEING THE CULPRITS. RPTR SENT MULTIPLE LETTERS OF INQUIRY. "THE PLOT THICKENS," WHEN YOU CONSIDER THAT SINCE 1996, USE OF BAXTER INTERLINK SYSTEM HAS BEEN EMPLOYED BY THE CDC AS THE BASELINE FOR EXPECTED NUMBERS OF NOSOCOMIAL SEPTICEMIAS ENCOUNTERED WITH OTHER NEEDLELESS SYSTEMS. DANZIG'S STUDY WAS RELATIVELY PURE IN COMPARING BAXTER INTERLINKS WITH Y-PORTS SERVICED BY HOLLOW BORE STEEL NEEDLES IN A WORST CASE SCENARIO IN HOME HEALTHCARE SETTINGS WHEREIN THE INFUSION FLUIDS WERE RICH IN FAT AND PROTEINS, AS WELL AS GLUCOSE. THE FINDINGS INDICATED A 5-10 FOLD INCREASE OF NOSOCOMIAL SEPTICEMIA IN ASSOCIATION WITH USE OF THE NEEDLELESS SYSTEM. KELLERMAN ET AL (J PAEDIAT 1996; 129 711-717) IN PEDIATRIC ICU'S CONFIRMED DANZIG'S STUDIES. MCDONALD'S STUDY COMPARING USE OF THE SMART-SITE WITH INTERLINK IN ICU'S ON PTS WITH IV-CATHETERS SHOWS 3-FOLD INCREASE IN NOSOCOMIAL SEPTICEMIAS WITH THE FORMER (ICHE 1998;10: 772-781). COOKSON ET AL (ICHE 1998;19:86-87) COMPARED USE OF INTERLINKS & SAFESITES IN SURGICAL UNITS, FINDING THE LATTER ASSOCIATED WITH 2-3 X INCREASED NOSOCOMIAL SEPTICEMIAS. MORE RECENTLY, AS MENTIONED ABOVE DO ET AL AND TOSCANO ET AL, REPORTED THAT CLAVES ARE MORE HAZARDOUS THAN INTERLINKS WITH RESPECT TO NOSOCOMIAL SEPTICEMIAS IN HOME CARE AND IN PEDIATRIC ICU'S. MEANWHILE, SINCE 1994 THE OVERALL INCIDENCE OF HOSP ACQUIRED INFECTIONS HAS INCREASED FROM ONE TO TWO MILLION PER ANNUM IN THE USA AND THE INCIDENCE OF IV CATHETER-RELATED SEPTICEMIAS, ALONE, HAS INCREASED FROM 100 THOUSAND TO >400 THOUSAND ANNUALLY WITH MORTALITY RATES AVERAGING 25% IN THE SEPTICEMIC PTS. DURING THIS PERIOD OF TIME, THE USE OF NEEDLELESS SYSTEMS TO PROTECT HEALTHCARE WORKERS (HCW) FROM HIV, HBV AND HCV HAS BECOME PREVALENT IN MOST HOSPS, AND IS NOW MANDATED BY CAL OSHA, CDC/NIOSH AND FEDERAL OSHA, ALONG WITH THE USE OF GLOVES DURING IV ACCESS. "THE PLOT THICKENS EVEN MORE" WHEN ONE ACTUALLY WATCHES HEALTHCARE WORKERS DONNING PAIRS OF UNSTERILE EXAM GLOVES TO MANIPULATE ALMOST EVERY KIND OF IV ACCESS EQUIPMENT, ESPECIALLY NEEDLELESS SYSTEMS WHERE THE USER NEEDS TO USE A SYRINGE/NEEDLE OR COMPLEX SYSTEM SUCH AS A B-D 3CC SYRINGE TWINPAK OR A HARPOON INSIDE THE BLUNT CANNULA TO ACCESS A STERILE MEDICATION VIAL. "THE PLOT GELS" WHEN ONE LOOKS ASIDE TO WHERE THEY GOT THE GLOVES FROM. "THE GEL SOLIDIFIES" WHEN ONE CONSIDERS HOW FEW HEALTHCARE WORKERS WASH THEIR HANDS BEFORE GLOVING, OWING TO THE PRESS OF TIME, ESPECIALLY IN INTENSIVE CARE UNITS (AS EMPHASIZED BY PITTET AND BOYCE IN ANN INT MED 2/99). FINALLY, "THE PLOT BECOMES SOLID," WHEN ONE CULTURES THE EXTERNAL SURFACES OF THE GLOVES, AS PRESENTED FOR USE BY MULTIPLE HEALTHCARE WORKERS IN ALL HOSP WORK STATIONS, EXCEPT THE SURGICAL OR; AND IN THE OFFICES OF MOST, IF NOT ALL DENTISTS. RPTR SUGGESTS: 1. INTERDICT USE OF NEEDLELESS SYSTEMS AND USE OF UNSTERILE EXAM GLOVES DURING IV ACCESS, MORE OR LESS LIKE THE USE OF CHLOROMYCETIN AND THALIDOMIDE WERE INTERDICTED. 2. PUSH FOR LEGISLATION WHEREIN PRODUCERS OF SUCH ITEMS WILL NOT BE REIMBURSED BY MEDICARE. 3. REQUIRE LABELING OF SUCH ITEMS AS HAZARDOUS, AND FORMAL INFORMED CONSENT BEFORE USE. ACCORDING TO RPTR THE BOTTOM LINE REMAINS THAT HCW'S DESPERATELY NEED BETTER PROTECTION FROM SHARP HOLLOW BORE STEEL NEEDLES USED IN VEINS, IM, SUBQ, TO INSERT INTRAVASCULAR CATHETERS AND TRANSFER BLOODY FLUIDS FROM ONE CONTAINER TO ANOTHER. WITH EXPERT TECHNICAL GUIDANCE, NEEDLE SHIELDING DEVICES CAN BE PROVIDED MUCH SAFER FOR PTS, AS WELL AS HCW, IN Y2K.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 3/20/00: REPORTER WRITES: THEREFORE, IT IS IMPERATIVE FOR THE US DEPT OF LABOR, DRUG AND DEVICE ADMINISTRATION, HEALTH AND HUMAN SERVICES AND HEALTHCARE PROFESSIONALS SPECIALIZING IN INFECTION CONTROL TO COOPERATIVELY PROMOTE ANTISEPSIS IN HEALTHCARE FACILITIES BY ALL COST-EFFECTIVE MEANS CURRENTLY AVAILABLE. PRACTICAL MEANS FOR DOING SO IN THE YEAR, 2000 MIGHT INCLUDE: 1. EDUCATON OF PTS AND HEALTHCARE WORKERS BY MEANS OF EXAMPLE, WORD OF MOUTH AND ALL RAPID INTER-COMMUNICATIVE AND DATA-PROCESSING STRATEGIES CURRENTLY AVAILABLE. 2. EMPLOYMENT OF DRUGS AND DEVICES WHICH MINIMIZE RISKS FOR BACTERIAL SEPSIS IN PTS, AND MAXIMIZE PROTECTION FROM BLOODBORNE VIRUSES IN HEALTHCARE WORKERS, POSSIBLY WITH THE HELP OF TECHNIQUES ILLUSTRATED HEREIN. THE BOTTOM LINE, ACCORDING TO RPTR IS THAT MORE EDUCATION, COMMUNICATION BETWEEN, AND CARE FOR ONE ANOTHER CAN BE EXPECTED TO PRODUCE APPRECIABLE DIVIDENDS DURING THE NEXT CENTURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART-SITE NEEDLELESS SYSTEM FPA ALARIS MEDICAL SYSTEMS, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other