Q1: What is AAMI?
A: AAMI is the abbrevialion of Association for the Advancement of Medical Instrumentation which is a unique alliance of professionals and organisations dedicated to the understanding and beneficial use of the medical device technology.
Q2: What are the AAMI standard specifications with reference to renal dialysis?
A: AAMI standard specifications is a set of parameters testing set for a limit on Water and Dialysate fluids use for haemodialysis purposes to ensure the safety for dialysis patient.
Q3: What is Regulation 313 of Private Healthcare Facilities and Services Act 2006 by Malaysia Ministry of Health(MOH)?
A: The Regulation 313 of Private Healthcare Facilities and Services Act 2006 by Malaysia Ministry of Health (MOH) is a regulation set to monitor and regulate all the Water and Dialysate Fluids use for haemodialysis purposes. It helps to ensure the quality of water and Dialysate Fluids meet the standard set out by the authority.
Q4: What does a Haemodialysis Centre and Haemodialysis Unit (of a hospital/medical centre) need to do to ensure their water and dialysate fluids meet the standard and quality set out by AAMI and Malaysia MOH?
A: The need to make sure that the Water and Dialysate fluids used in their centre/ unit are meeting the set requirement by engaging a laboratory with Full ISO/IEC 17025 Accreditation on Sampling and Testing of their Water and Dialysate fluids in accordance to the AAMI and Regulation 313 of Private healthcare Facilities and Services Act.
Q5: How do a Haemodialysis Centre and a Haemodialysis Unit (of a Hospital / Medical centre) know that the laboratory that they engaged is Full ISO/IEC 17025 Accreditation on Sampling and Testing on doing their Water and Dialysate fluids?
A: They can request a copy of the ISO/IEC 17025 certificate from the laboratory they engage for the sampling and testing to make sure all the requirements are there.
Q6: What happens if the laboratory that is responsible for the sampling and testing of renal dialysis water and dialysate fluids is not fully ISO/IEC 17025 accreditated?
A: The laboratory that is responsible for the sampling and testing of renal dialysis water and dialysate fluids is not fully ISO/IEC 17025 accreditated, the COA (Certificate of Analysis) issued by such laboratory may not be accepted and recognized by the authority and may also raise an issue during any audit conducted by the Ministry of Health (MOH).