Description of Event or Problem · 1
CLEANING AND MAINTENANCE INSTRUCTIONS ARE NOT CLEAR IN TERMS OF CLEANING AND DISINFECTION PROTOCOLS FOR EACH PIECE OF EQUIPMENT, HOW TO REMOVE, SPECIFICALLY WHAT PIECES NEED TO BE REMOVED AND AGENTS TO DISINFECT. THE COMPACT BLOCK REQUIRES "DAILY" CLEANING PER THE MFR'S INSTRUCTIONS. THE INSTRUCTIONS ARE WRITTEN TO USE A "CLEANING CASSETTE" CONNECTED TO A "DECONTAMINATING WASHING MACHINE". IN THE USA "WE DO NOT USE 'DECONTAMINATING WASHING MACHINES', THIS IS BASED ON EUROPEAN PRACTICES." PLEASE SEE INSTRUCTIONS FROM THE MFR. NOTE THE PARAGRAPH "WHEN VENTILATING PTS WITH SERIOUS CONTAGIOUS..." INDICATES A DIFFERENT STANDARD OF CLEANING PROTOCOLS. AN EXAMPLE OF INSTRUCTIONS CAN BE FOUND ON PAGE 8-5. THE INSTRUCTIONS OF THIS PAGE BEGIN WITH "INTERMEDIATE LEVEL DISINFECTION" IS REQUIRED ONCE A MONTH IF A MICROBIAL FILTER IS USED, OR ONCE A WEEK WITHOUT A FILTER. ACCORDING TO A RECENT TELEPHONE CALL MADE TO THE MFR ON 11/16/99, SPECIFIC PARTS ARE NOT REQUIRED TO UNDERGO INTERMEDIATE LEVEL DISINFECTION. THE PARTS SPECIFIED INCLUDE THE BELLOWS CHAMBER (5), OVERFLOW VALVE RETAINING RING (9), AND THE OVERFLOW VALVE (10). THIS STATEMENT MADE BY THE MFR DOES NOT MATCH THE INFO GIVEN IN THE CLEANING INSTRUCTIONS. THE INSTRUCTIONS PROCEED TO INDICATE A DIFFERENT STANDARD OF CLEANING FOR PTS WITH "SERIOUS CONTAGIOUS DISEASES." ONE DOES NOT ALWAYS KNOW IF A PT HAS HIV OR HEPATITIS PRIOR TO SURGERY. RPTR IS UNCLEAR AS TO WHY THE MFR HAS PULLED OUT FOUR UNRELATED DISEASES TO PERFORM A DIFFERENT LEVEL OF CLEANING WITH INTERMEDIATE LEVEL OF DISINFECTION WHEN USING A MICROBIAL FILTER THAT FILTERS OUT 99.999% OF BACTERIA AND VIRUSES. PLEASE NOTE THAT CREUTZFELDT-JACOB DISEASE IS CAUSED BY A "PRION" (VERY SMALL, PROTEINACEOUS PARTICLE) THAT IS KNOWN TO BE TRANSMITTED TO OTHERS VIA TRANSPLANTED TISSUE, CADAVER EXTRACTED HORMONES AND/OR SURGICAL INSTRUMENTS. INTERMEDIATE LEVELS OF DISINFECTION WOULD NOT ADEQUATELY REMOVE THIS ORGANISM FROM A CONTAMINATED ITEM. ON PAGE 8-4, THE MFR INDICATES THE "COMPACT BLOCK" SHOULD BE CLEANED DAILY WHEN USING A MICROBIAL FILTER. ON PAGE 8-9, THE MFR HAS WRITTEN INSTRUCTIONS ON USING A CLEANING CASSETTE CONNECTED TO A "WASHING MACHINE". RPTR DOES NOT KNOW OF ANY "WASHING MACHINE" USED IN THE US FOR CLEANING AND DISINFECTING MEDICAL DEVICES. THE MFR BRIEFLY DISCUSSES USING A 2.4% GLUTARALDEHYDE BUT DOES NOT SPECIFY WHAT PARTS NEED TO BE REMOVED AND SOAKED. IN SUMMARY, THE MFR HAS NOT WRITTEN CLEANING AND DISINFECTING INSTRUCTIONS THAT ARE CLEAR AND FOLLOW STANDARDS OF PRACTICE ADEQUATE FOR PTS IN THE US. THE DIFFERENT STANDARD OF CLEANING FOR PTS WITH "SERIOUS CONTAGIOUS DISEASES SUCH AS HEPATITIS, HIV, TUBERCULOSIS, AND CREUTZFELDT JACOB DISEASE" DOES NOT ADHERE TO THE CURRENT STANDARDS OF PRACTICE AND DOES NOT MATCH THE KNOWN, PUBLISHED DATA THAT ARE AVAILABLE. THE CLEANING AND DISINFECTION INSTRUCTIONS NEED TO BE WRITTEN IN A CLEAR, CONCISE MANNER THAT CAN BE APPLIED TO ANY HOSP WITHIN THE US BY A STERILE PROCESSING TECH.