EBME Service (1012-14-MH).

Descriptions

The managed maintenance for medical equipment (EBME). The contracting authority is looking to seek a service provider to undertake the maintenance/ repair of medical equipment and associated management to support compliance in line with national regulatory and statutory bodies which include, but not limited to:1. Medicines for Healthcare Regulatory Body (MHRA) DB2006 (05) guidance supplement2) IEC 60601-x3) IEC62353 Electrical safety standards4) Electricity at Work Act including PUWER regulations5) CQC Outcome 116) NHSLA criterion 5.3 and 5.4The Trust operates across both Dudley and Walsall localities, out of 29 separate buildings providing Mental Health services. Within its portfolio are three inpatient hospitals providing a range of services across various age ranges.The successful bidder will need to provide assurances that the service provided will provide the following functions1.ManagementThe EBME provider will manage all elements associated within this agreement and provide the Commissioner with monthly reports detailing associated activity.2.ProcurementThe EBME provider will provide technical assistance associated to the development of all new Commissioner medical equipment purchases3.Acceptance CommissioningThe EBME Provider will carry out all new equipment acceptance tests and commissioning in accordance to manufacturers and regulatory body's recommendations4.Asset ManagementThe EBME Provider will provide records of all associated Commissioners medical device assets as identified by the Commissioner.5.DecontaminationThe Commissioner will ensure that all equipment prior to being sent for maintenance / repair or disposal is appropriately decontaminated in accordance to local and manufacturers cleaning procedures.6.MaintenanceThe EBME Provider will carry out all routine maintenance checks to manufacturer's recommendations / equipment specifications. All routine maintenance work will be carried out by qualified personal records to be provided on request. All scheduled visits will be arranged prior to work being carried out and a full schedule of visits made available as and when required by Commissioner.7.Repairs/ BreakdownsThe EBME Provider will carry out all repairs in conjunction with manufacturer's specifications and regulatory body's guidance, ensuring compliance and service is provided in a cost effective manner and supports any Trust Cost Improvement Plan8.Response timesResponse times will be variable but normally within 3 working days (Monday to Friday, excluding Public and Bank Holidays). The criteria used to assess required speed on response are based on the following: (In ascending order of importance)-Priority 1 (within 24 hrs)-Priority 2 (within 48 hrs)-Priority 3 (within 72 hrs)9.Risk ManagementThe EBME provider will advise the Commissioner of any MHRA / Manufacturers Services Awareness Bulletins SABS that He/ She feels may be relevant to the Commissioners medical device inventory.10.DisposalThe EBME Provider will advise and make arrangement for safe removal of medical equipment from a centralised point as required under the current disposal regulations WEEE and will continually update the Commissioners asset register to reflect any disposal of medical equipment.11.TrainingThis includes reactionary training at ward level if it is identified that the root cause of the failing is a lack of understanding of the devices correct use. This is to be documented on the report.-Provide laminated user instructions to be left at ward level for the equipment on each ward.-Provide an annual training programme for across the Trust and its worforce to include Under Graduate Doctor.