Description of Event or Problem · 1
ALTHOUGH THERE WAS NO MALFUNCTION OF THE EQUIPMENT INVOLVED, FACILITY FEELS STRONGLY THAT THE DESIGN OF VENTILATORS WITH LOW-PRESSURE DISCONNECT ALARMS (SUCH AS THE LP SERIES AND THE PLV SERIES) VERSUS VOLUME ALARM VENTILATORS WARRANTS A CHANGE IN PRACTICE AT FACILITY. FACILITY FEELS THESE VENTILATORS ARE UNSAFE FOR THOSE PTS WHO ARE VENTILATOR DEPENDENT AND UNABLE TO BREATH SPONTANEOUSLY ON THEIR OWN. DILEMMA ARISES IN PREPARING PTS FOR HOME VENTILATION. INSURANCE COMPANIES HAVE INFORMED FACILITY THAT VENTILATORS WITH THE LOW-PRESSURE DISCONNECT ALARMS HAVE BEEN APPROVED BY THE FDA AS LIFE SUPPORT AND, THEREFORE, THAT IS ALL THEY PAY FOR. FACILITY IS ASKING FOR INPUT AND FEEDBACK AS TO THIS STANDARD OF CARE. AS HEATH CARE PROFESSIONALS, FACILITY BELIEVES ALL PTS HAVE THE RIGHT TO A VOLUME ALARM VENTILATOR TO ASSURE THEIR SAFETY, BE IT IN THE HOSPITAL OR AT HOME. A PT PREVIOUSLY STABLE ON THE VENTILATOR WAS FOUND IN CARDIOPULMONARY ARREST, WITH THE VENTILATOR TUBING DETACHED FROM THE TRACHEOSTOMY, IN THE BED SHEETS. NO VENTILATOR ALARM WAS ACTIVATED. THIS EVENT RAISES SEVERAL IMPORTANT PROBLEMS. MECHANICAL VENTILATORS ARE USUALLY USED IN THE ACUTE CARE SETTING IN AN INTENSIVE CARE ENVIRONMENT. THE DEVICES USED ARE EXPENSIVE AND HAVE MULTIPLE MODES OF OPERATION NOT EMPLOYED OUTSIDE OF AN ICU SETTINGS. THESE VENTILATORS ALSO HAVE REDUNDANT ALARM SYSTEMS, WHICH MONITOR GAS DELIVERY AND RETURN. VENTILATORS FUNCTION BY PUMPING GAS INTO THE PT'S LUNGS UNDER PRESSURE; THE GAS IS THEN PASSIVELY EXHALED. IT IS OF OBVIOUS IMPORTANCE TO ENSURE ADEQUATE GAS DELIVERY, AND TO HAVE AN ALARM WHEN ADEQUATE GAS IS NOT DELIVERED TO THE PT. DEPENDING ON THE TYPE OF VENTILATOR, ALARMS WILL ACTIVATE WHEN THE PRESSURE IN THE INSPIRATORY TUBING FALLS ABOVE OR BELOW SPECIFIED PARAMETERS. HIGH PRESSURE MAY INDICATE AN OBSTRUCTION TO INSPIRATION, PREVENTING DELIVERY OF THE PRESCRIBED VOLUME OF AIR, WHILE A LOW PRESSURE ALARM MAY INDICATE A TUBING DISCONNECTION, ALSO PREVENTING GAS DELIVERY. THESE ALARMS RESULT FROM MONITORING PRESSURE IN THE TUBING DELIVERING GAS TO THE PT FROM THE MACHINE. THE MORE SOPHISTICATED VENTILATORS TYPICALLY FOUND IN AN ACUTE CARE SETTING ALSO MONITOR EXHALED GAS VOLUME, WHICH IS RETURNED FROM THE PT TO THE MACHINE. THIS ALLOWS MEASUREMENTS OF THE VOLUME GAS ACTUALLY EXHALED FROM THE PT'S LUNGS, WITH ALARMS IF THE VOLUME IS TOO LOW. LESS EXPENSIVE VENTILATORS, OF THE TYPE USUALLY DESIGNED FOR HOME USE, DO NOT MONITOR EXHALED GAS AND THEREFORE DO NOT HAVE VOLUME ALARMS. THESE VENTILATORS ARE APPROVED BY THE FDA AS LIFE SUPPORT DEVICES, AND ARE IN WIDESPREAD USE THROUGHOUT THE COUNTRY, USUALLY IN HOME CARE SETTING, LONG TERM CARE FACILITIES AND REHABILITATION UNITS. THEY ARE SMALL PORTABLE UNITS, IN CONTRAST TO THE TYPICAL ICU VENTILATOR. THIS PORTABILITY HAS BEEN A PLUS IN THE REHABILITATION ENVIRONMENT WHERE VENTILATOR SUPPORT DURING AMBULATION IS HELPFUL. ONLY IN THE LAST FIVE YEARS HAVE PORTABLE VENTILATORS BECOME AVAILABLE WHICH MEASURES RETURNED GAS VOLUMES, PERMITTING VOLUME ALARMS IN ADDITION TO PRESSURE ALARMS. SINCE THESE MACHINES HAVE BECOME AVAILABLE, WE HAVE BEEN GRADUALLY REPLACING THE PRESSURE-ALARM-ONLY VENTILATORS WE OWN AT FAIRLAWN WITH THE VOLUME ALARM MACHINES, WHICH ARE CONSIDERABLY MORE EXPENSIVE. THE VENTILATOR IN USE AT THE TIME OF THE INCIDENT DESCRIBED ABOVE WAS A PLV-100, A TYPE THAT DOES NOT MEASURE RETURNED TIDIAL VOLUME. THE DISCONNECT ALARM FUNCTION IS OF THE LOW-PRESSURE TYPE, DESIGNED TO SOUND WHEN THE VENTILATOR CYCLES, BUT DOES NOT NEED TO GENERATE A TYPICAL PRESSURE, POSSIBLY SIGNALING A LACK OF CONNECTION. WHEN THE VENTILATOR TUBING IS PARTIALLY OBSTRUCTED, IN THIS CASE BY BEDDING MATERIAL, ENOUGH PRESSURE MAY DEVELOP TO PREVENT THE ACTUATION OF THE ALARM. DURING AN INDIVIDUAL PT SET-UP, POLICIES REQUIRE THAT THE LOW PRESSURE ALARM BE SET AT A FAIRLY HIGH LEVEL, IN ORDER TO MAXIMIZE THE CHANGE THAT A DISCONNECT WILL BE DETECTED, EVEN IF THE VENTILATOR TUBING IS PARTIALLY OBSTRUCTED. ALL POLICIES WERE FOLLOWED IN THIS CASE, AND THE SUBSEQUENT INVESTIGATION CONFIRMED THAT THE VENTILATOR ALARMS WERE SET APPROPRIATELY AND THAT THE VENTILATOR WAS FUNCTIONING AS DESIGNED. IN THE PAST FACILITY HAS HAD AN INCIDENT WHERE THE DISCONNECT ALARM FAILED TO SOUND BECAUSE THE VENTILATOR TUBING REMAINED ATTACHED TO THE TRACHEOSTOMY INNER CANNULA, WHICH THEN PULLED OUT OF THE TRACHEOSTOMY TUBE, PREVENTING VENTILATOR SUPPORT. THE ATTACHED PART OF THE TRACHEOSTOMY TUBING ADDED TO THE BACK PRESSURE, PREVENTING THE ALARM FROM SOUNDING. AS A RESULT OF THAT INCIDENT, FACILITY NO LONGER USES TRACHEOSTOMY TUBES WHICH PERMIT A VENTILATOR CONNECTION TO A REMOVABLE INNER CANNULA. ADD'L FACILITY BEGAN THE PROCESS OF REPLACING ITS OWNED STOCK OF LOW PRESSURE ALARM VENTILATORS WITH VENTILATORS HAVING LOW VOLUME ALARM. THIS DESIGN HAS ADD'L TUBING; EXHALED GAS IS RETURNED TO THE VENTILATOR AND THE VOLUME MEASURED FOR EACH BREATH, PERMITTING DIRECT MEASUREMENT AND ALLOWING ADD'L ALARM FUNCTIONS. IF THE PT IN THE INVESTIGATION HAD BEEN ON A VENTILATOR WITH A LOW VOLUME ALARM, PRESUMABLY THE SITUATION WOULD HAVE BEEN NOTICED SOONER. TO REPORTER'S KNOWLEDGE, ALL VENTILATORS CURRENTLY USED IN THE HOME SETTING USE THE TYPE OF LOW-PRESSURE DISCONNECT ALARM. FACILITY CURRENTLY USES TWO SUCH VENTILATORS, THE LP SERIES AND THE PLV SERIES ROUTINELY AT FACILITY. THESE VENTILATORS ARE OFTEN EMPLOYED IN PT WHO ARE BEING PREPARED FOR HOME MECHANICAL VENTILATION. THESE ISSUES WERE DISCUSSED AT THE MEDICAL EXECUTIVE COMMITTEE OF HOSPITAL. AS A RESULT OF THIS DISCUSSION, REPORTER PROPOSED THAT FACILITY MODIFY ITS POLICY TO READ THAT VOLUME ALARM VENTILATORS ARE REQUIRED IN EACH PT WHO IS UNABLE TO SPEND AT LEAST 6 HOURS BREATHING SPONTANEOUSLY. THIS WILL ALLOW SOME USE OF PRESSURE VENTILATORS, BUT REPORTER CANNOT BELIEVE THAT FACILITY IS PUTTING ANYONE AT RISK. RPTR SEES TWO DIFFICULT QUESTIONS. HOW DOES THE FACILITY HANDLE THE SITUATION WHERE THE PT IS BEING PREPARED FOR HOME VENTILATION? IF IT IS NOT