Specification builder · Tier B
Haemodialysis machine, single-patient, bicarbonate dialysis with closed-loop ultrafiltration control (online haemodiafiltration as advanced option)
A haemodialysis machine pumps the patient's blood through a dialyser (artificial kidney) and prepares warm, correctly mixed dialysis fluid from treated water and concentrates, while removing a precisely controlled amount of excess fluid. It is bought by public and private hospital dialysis units in Pakistan for patients with kidney failure, usually running 2-3 sessions a day. Advanced machines add online haemodiafiltration (HDF), dose (Kt/V) monitoring and blood volume monitoring.
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Standards this specification draws on
- IEC 60601-2-16 Particular safety and essential performance requirements for haemodialysis, haemodiafiltration and haemofiltration equipment (UF, conductivity, temperature, air and blood leak protection).
- IEC 60601-1 / IEC 60601-1-2 / IEC 60601-1-8 General electrical safety, electromagnetic compatibility and alarm system requirements for medical electrical equipment.
- ISO 23500-1 to -5 Quality of water, concentrates and dialysis fluid for haemodialysis (including ultrapure fluid and online substitution fluid); the machine and RO plant must work together to meet it.
- ISO 8637-1 / ISO 8637-2 Standards for dialysers and extracorporeal blood circuits (bloodlines); use them to require open compatibility with third-party consumables.
- IEC 62304 Software life-cycle requirements for the machine's control software.
- ISO 13485 / ISO 14971 Quality management and risk management of the manufacturer.
- IEC 62353 Electrical safety testing at acceptance and after repairs/maintenance.
- DRAP Medical Devices Rules 2017 Registration/enlistment of the machine and its consumables is required for legal supply in Pakistan.
- KDOQI Haemodialysis Adequacy Guideline (2015 update) Clinical target for delivered dose (spKt/V) that online clearance monitoring helps achieve.
Common mistakes in tenders for this equipment
- Consumable lock-in: warranties that become void if the hospital uses non-OEM dialysers, bloodlines, concentrate or disinfectant, or 'free machine' offers recovered through high per-session consumable prices. Require an open-consumables undertaking and evaluate 5-year total cost.
- Copying one brochure: wording such as fixed dialysate steps of 300/500/800 mL/min, blood flow starting at exactly 15 mL/min, 'double-pump' single needle, 'balancing chamber' UF, a UV-based Kt/V method or an exact screen size each matches one brand. Write ranges and accuracy instead.
- Buying online HDF machines without a compliant RO plant, a water testing budget and filter replacement costs; the HDF function then sits unused or puts patients at risk.
- Accepting a model near end-of-life: at least one European maker announced exit from chronic adult dialysis machines in 2024. Ask for written confirmation of current production and 10-year parts support.
- Vague battery claims ('battery backup provided') without stated minutes and functions; in load-shedding conditions this matters for patient safety.
- Ignoring post-warranty costs: no CMC price in the bid, PM kits priced later at high rates, and service passwords withheld from hospital engineers.
- Not checking DRAP registration of the exact model and its consumables, or accepting refurbished machines presented as new.