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>> MEDICAL DEVICES ARE PART OF OUR DAILY WORK.
WE OFTEN TAKE THEIR PERFORMANCE FOR GRANTED; HOWEVER, SOMETIMES THEY DON'T PERFORM AS EXPECTED.
THE FOLLOWING CASE SCENARIO DEMONSTRATES THE ROLE OF CLINICIANS IN RECOGNIZING AND
REPORTING MEDICAL DEVICE PROBLEMS IN ORDER TO ENSURE PATIENT SAFETY.
[ PLAYING "GO IN AND OUT THE WINDOW" ] >> OKAY, THAT'S ALL FOR ME.
>> NO, WE HAVE TO PRACTICE!
>> GRAMMY'S GOT TO GO LIE DOWN FOR A MINUTE.
>> ONE MORE SONG.
>> OH, NO, GRAMMY FEELS JUST A LITTLE BIT...TIRED.
>> HOW ABOUT "FUR ELISE"?
>> OH, WE'RE NOT TAKING ANY REQUESTS.
>> WHAT'S A "FUR ELISE"?
>> "FUR ELISE" -- IT'S A SONG GRANDMA TAUGHT ME WHEN I WAS LITTLE.
SHE USED TO PLAY IT FOR ME ALL THE TIME.
IT'S VERY PRETTY.
>> HERE I AM ABOUT TO DROP OVER FROM EXHAUSTION.
[ PLAYING "FUR ELISE" ] OKAY, READY?
>> ♪@#!♪ [ CHILD SCREAMING ] [ SIREN ]
>> Woman: DR. BRUCE, TELEPHONE, PLEASE.
DR. BRUCE, TELEPHONE, PLEASE.
>> OKAY, GWEN, IT'S GOT TO BE SOMETHING PRETTY MAJOR FOR YOU TO CALL RISK MANAGEMENT.
WHAT'S UP?
>> HI, BRENDA, YOU'RE RIGHT.
I'VE GOT TO TELL YOU ABOUT ONE OF MY PATIENTS TODAY, MRS. CROWLEY.
SHE CAME INTO THE E.R. WITH SYMPTOMS OF HEART FAILURE.
THEY DID A CHEST FILM, GAVE HER LASIX, GOT SOME LABS, AND SENT HER UP TO US IN CCU.
WHEN SHE ARRIVED, SHE WAS PALE, SHORT OF BREATH, ELEVATED HEART RATE,
SLIGHT PEDAL EDEMA.
WE PLACED AN A-LINE AND A SWAN-GANZ.
>> WHAT KIND OF SWAN DID YOU PUT IN?
>> JUST A REGULAR SWAN.
WE WERE ONLY INTERESTED IN HEART PRESSURES.
A-LINE IS 90 OVER 50.
AND HER LAST WEDGE PRESSURE WAS 10, CVP 9.
>> WEDGE 10, CVP 9?
>> YEAH.
>> SEEMS A LITTLE LOW.
ARE YOU SURE?
>> I'LL RE-ZERO IT.
>> SO YOU RE-ZEROED THE SWAN.
DID THE NUMBERS CHANGE?
>> NO, THEY WERE ABOUT THE SAME.
>> SO THEN WHAT DID YOU DO?
>> WELL, DR. K. ORDERED A 500cc FLUID BOLUS FOLLOWED BY 125 PER HOUR DRIP.
>> DID IT HELP?
>> NO. IN FACT, SHE WAS WORSE OFF THAN WHEN SHE CAME.
SHE WAS FULL OF FLUIDS, HAVING TROUBLE BREATHING, AND SHE STARTED HAVING EKG CHANGES.
>> SO WHAT WERE WE DOING WRONG?
>> DR. K., MRS. CROWLEY IS GETTING WORSE.
HER LUNGS ARE FULL AND HER STAT IS DROPPING.
>> LET'S GO LOOK AT HER.
>> MRS. CROWLEY, ARE YOU HAVING A HARD TIME BREATHING?
>> YEAH, IT'S GETTING HARDER TO BREATHE.
>> LOOKS LIKE HER S.T. IS ELEVATED -- LET'S GET A 12-LEAD EKG.
>> I'M GOING TO GO GET AN EKG MACHINE.
I'LL BE RIGHT BACK.
>> AM I GOING TO BE OKAY?
>> YEAH, YOU'LL BE FINE.
I JUST WANT TO GET A DIFFERENT READING, THAT'S ALL.
>> DR. K., HERE'S MRS. CROWLEY'S 12-LEAD.
>> THANKS.
>> COMPARED TO THE ONE SHE HAD IN THE E.R. WHEN SHE FIRST CAME IN, SHE'S MUCH WORSE.
WE NEED TO GET HER INTO THE CATH LAB RIGHT AWAY.
WE'VE BEEN PUMPING THIS POOR WOMAN WITH FLUID.
NOW SHE'S OVERLOADED.
>> I'LL BE RIGHT BACK AND GET HER READY.
WHEN THEY DID HER CATH, HER PRESSURES WEREN'T LOW -- THEY WERE REALLY HIGH.
>> HOW HIGH WERE THEY?
>> THE CATH WAS UP TO 24, THE CVP NEARLY 30.
>> SO HOW CAN THAT BE, IF HER PRESSURES ARE REALLY LOW HERE AND REALLY HIGH IN THE CATH LAB?
>> YOU KNOW, WE HAD A SIMILAR PROBLEM TO THIS LAST WEEK WITH A PATIENT WE TOOK TO SURGERY.
>> WHICH PATIENT?
>> THE ABDOMINAL ANEURYSM IN BED SIX.
WHEN HE WAS DOWN HERE, HIS SWAN PRESSURES WERE LOW.
BUT UP IN SURGERY, THEY SAID THEY WERE SKY-HIGH.
>> SO WHAT WAS UP WITH THAT?
>> APPARENTLY, THEY HAD TO SWITCH OUT THE CABLE IN O.R., AND WHEN ANESTHESIA BROUGHT
THE PATIENT BACK, THEY SAID THERE MIGHT BE SOMETHING WRONG WITH OUR CABLE.
>> OH, BY THE WAY, THERE'S SOMETHING WRONG WITH THIS CABLE.
WE HAD TO SWITCH IT OUT.
>> OKAY, WE'LL TAKE CARE OF IT.
>> ANYTHING ELSE?
>> NO, THANKS, WE'RE FINE.
>> AND THEN WHAT DID WE DO WITH THE CABLE?
>> YOU KNOW...
I'M NOT SURE.
OH, MY GOSH!
IT MUST HAVE GOTTEN CLEANED AND PUT BACK ON THE SHELF, AND THEN I MUST HAVE USED IT
ON MRS. CROWLEY.
>> DR. KIMLER, CAN I TALK TO YOU A MINUTE ABOUT MRS. CROWLEY?
>> I DIDN'T DO IT.
>> NO, SERIOUSLY, IT LOOKS LIKE WE WERE TREATING HER LOW SWAN-GANZ READINGS WHEN,
IN FACT, WE PROBABLY HAD A BAD TRANSDUCER CABLE.
>> WHAT DO YOU MEAN, A BAD CABLE?
YOU KNOW, HER NUMBERS DIDN'T QUITE FIT THE PICTURE, BUT THEY'RE ALL I HAD TO GO ON.
IF I HAD HAD ACCURATE NUMBERS, I WOULDN'T HAVE GIVEN HER FLUIDS, WHICH ONLY MADE HER
CONDITION WORSE, AND MAYBE SHE WOULDN'T HAVE ENDED UP IN THE CATH LAB.
OKAY, NOW WHAT?
>> WELL, OUR PRIMARY CONCERN IS ALWAYS THE PATIENT, AND SHE'S FINE, SHE'S STABLE.
WE'LL DEAL WITH THE FAMILY LATER, BUT WE NEED TO LEARN FROM THIS EXPERIENCE.
THE BOTTOM LINE IS, WHEN WE HAVE A MEDICAL DEVICE ISSUE, WE REMOVE THE DEVICE FROM SERVICE,
WE REPORT IT, AND THAT WAY SITUATIONS LIKE THIS WILL NEVER HAPPEN AGAIN.
>> WHAT IS YOUR ROLE WITH REGARD TO MEDICAL DEVICE SAFETY?
SOMETIMES WE GET SO BUSY IN THE COURSE OF OUR DAILY WORK THAT WE DON'T RECOGNIZE ACTUAL
OR POTENTIAL MEDICAL DEVICE PROBLEMS.
YOU HAVE AN IMPORTANT ROLE TO PLAY WITH REGARD TO THE SAFETY, NOT ONLY OF
THE PATIENT THAT YOU CURRENTLY HAVE, BUT OF PATIENTS YOU MAY NEVER SEE.
AN EASY WAY TO THINK ABOUT YOUR ROLE IS TO THINK ABOUT THE THREE Rs --
RECOGNIZE, REMOVE, AND REPORT.
>> FIRST, RECOGNIZE THAT ANY TIME A MEDICAL DEVICE IS INVOLVED, IN EITHER AN ADVERSE
EVENT OR A NEAR MISS, THAT DEVICE MAY HAVE CONTRIBUTED TO THE ACTUAL PROBLEM
THAT OCCURRED.
MEDICAL DEVICES INVOLVE ALL KINDS OF THINGS THAT WE DON'T EVEN THINK ABOUT,
SUCH AS BED RAILS, SCALES, BATHING TUBS, COMPUTER SOFTWARE AND HARDWARE USED
IN PATIENT CARE -- MAYBE EVEN DISPOSABLES AND IMPLANTS AND REAGENTS.
ALSO, THE KINDS OF PROBLEMS INVOLVED WITH MEDICAL DEVICES ARE MORE DIVERSE THAN JUST
PERFORMANCE PROBLEMS.
THERE ARE PROBLEMS IN PACKAGING, PROBLEMS IN INSTRUCTIONS, INTERACTIONS WITH OTHER DEVICES,
COMPUTER SOFTWARE GLITCHES.
ONCE YOU RECOGNIZE THAT A DEVICE MAY HAVE BEEN INVOLVED IN AN EVENT,
THEN REMOVE THAT DEVICE FROM CIRCULATION.
IT'S NOT YOUR JOB TO DETERMINE WHETHER OR NOT THE DEVICE HAS A PROBLEM, BUT IT IS YOUR JOB TO
ENSURE THAT NO PATIENT IS INJURED BY THAT DEVICE UNTIL A DETERMINATION CAN BE MADE.
FINALLY, REPORT ACCORDING TO YOUR ORGANIZATION'S POLICIES AND PROCEDURES.
GIVE AS MUCH DETAIL AS POSSIBLE, SO THAT YOUR RISK MANAGEMENT STAFF AND BIOMEDICAL ENGINEERING
STAFF CAN DETERMINE IF THE DEVICE HAS A PROBLEM AND WHAT CONTRIBUTION IT MADE
TO THE EVENT.
PLEASE, REMEMBER -- PATIENT SAFETY IS NOT A PROGRAM, NOR IS IT AN ACTIVITY --
IT IS THE FRAMEWORK UPON WHICH WE DELIVER CARE.