The information in this document is based on:
- DB2006(05) - Managing Medical Devices: Guidance for healthcare and social services organisations
- Clinical Negligence Scheme for Trusts: http://www.nhsla.com/Claims/Schemes/CNST/
- NAO HC 475 - The Management of Medical Equipment in NHS Acute Trusts in England
A database is used to manage maintenance of equipment within the department on behalf of the trust. The Department Manager has overall responsibility for the management of all equipment, which is within the scope of the department's responsibility.
Quality Processes & Procedures
Booking in and in-inspections.
- Departments may phone in details of faulty equipment or may bring them into the workshop.
- Phone calls are all logged onto the database.
- When technicians repair equipment on site, they will record all details.
- These details will be transferred onto the database when the repair is complete.
Similarly when a piece of equipment is brought into the workshop equipment will be "in-inspected" by a competent person before being placed in the Goods inwards area. Details will be entered onto the database and a label attached to the equipment with relevant details. This label will remain with the equipment until the job is complete. Details of all repairs are entered onto the database as the work progresses.
Equipment which is being repaired or serviced will be checked and tested regularly as a matter of routine and good workshop practice. This will normally be carried out as the result of the experience of the Technician concerned, or as the result of following the manufacturer's instructions.
All pieces of test equipment in use by the Department are appropriate to the work of the Department and, where appropriate, carry a valid certificate of calibration.
Only spares purchased by the Department - whether one-off items or stock items - will be used. The elements of Good Workshop Practice relevant to an Engineering Department will be maintained at all times. This also includes ensuring that aspects of Health & Safety relevant to the Department are adhered to.
Individual work benches are allocated to personnel and they are responsible for their own area. Where equipment has been dismantled it should be segregated from other equipment. Working on more than one piece of equipment at a time should be discouraged.
To prevent damage when handling sensitive equipment while under repair protective clothing and gloves will be worn and anti-static precautions taken, where appropriate.
The status of equipment during repair will be clearly identified on the Label and subsequent entries onto the database, or by its location within the Workshop.
Labelled shelves within the Workshop indicate items Awaiting Repair, Awaiting Spares, Goods Inwards, Goods Outwards and Quarantine. The location of equipment on specific shelves, (as well as the Label and database entries, clearly identify their current status.)
Equipment is generally reported faulty by the user/customer. No item is collected unless the fault has been reported and an entry made on the database.
Care is to be taken when handling all customers' equipment. While within the Department all customers' equipment will be stored so as to prevent deterioration or damage.
EBME Repair Definitions
- 1st Line: This type of repair is minor in nature and can usually be carried out at the equipment location within 30 minutes.
- 2nd Line: This type of repair is major in nature and can usually be carried out at the EBME dept. The repair time will be less than 2 hours, and equipment will be returned within 5 working days, subject to spare parts availability.
- 3rd Line: This type of repair is major in nature and may be carried out at the EBME dept, sent back to the supplier/manufacturer, or a service call. The repair time will usually be less than 4 hours, and equipment will be returned within 5 working days, subject to spare parts/supplier service availability.
Decontamination of Items for Repair
Types of equipment likely to require decontamination, and the process involved, is contained in the Trust Decontamination Policy, and referred to in the Trust Medical Devices Management Policy. Before this type of equipment is worked on, either within the Workshop or on site, a declaration must be signed by the user to certify that the equipment has been decontaminated. If no decontamination evidence is provided by the user, the technician will not commence work on the item. Items not decontaminated should not be moved around the Hospital as this may cause spread of infection.
Caution is, nonetheless, to be taken when handling such equipment, including wearing of appropriate protective clothing.
If an item is found to be contaminated during the repair process it will be placed in a yellow Clinical Waste bag and returned to the user with a memo to that effect. Any Workshop area which has been affected by contamination will be decontaminated following the relevant sections of the Trust Decontamination Policy.
Carrying Out Repairs
During repair, care will be taken to ensure that any relevant Alerts and other safety notices are implemented.
Equipment for which a repair has been aborted for any reason will be segregated. It will not be returned to the customer unless a concession form has been completed and signed by the customer. Equipment will not be considered serviceable until the workshop repair label has been completed, signed by the technician and details have been entered onto the database.
Final Inspection and Testing
Equipment that has been repaired, maintained or acceptance tested will not be returned to the customer until all final checks have been made and the equipment has been 'signed off' by the technician allocated to the equipment. (Unless a concession has been granted and accepted by the customer and the 'Concession Form' completed and signed).
The final inspection will include, where relevant, all functional, and electrical/safety checks. All repair details are entered onto the database.
All records which have been prepared as the result of a repair, maintenance, acceptance testing etc. are to be retained as part of the Quality Records on the database. These details will clearly indicate if the equipment has passed final testing, the results of the tests and the condition and follow up action of any equipment that fails the test. The label is not retained once the details have been entered onto the database, prior to the equipment being placed in Goods Outwards.
DEVICE PPM PROCESSES
Planned Preventive Maintenance is carried out by the department. If PPMs cannot be carried out for any reason, the EBME Manager will use his experience and professionalism in deciding which PPMs are considered necessary. If a PPM cannot be carried out the customer will be informed.
Planning for maintenance
The planned maintenance should be categorised in the following 3 areas:
- High risk device
- Medium risk devices
- Low risk devices
Risk categorisation will be determined by:
- Looking at clinical usage
- Dangers to patient on failure
- User training
A patient monitor at Hospital/Ward 'X' may be classed as medium risk. The same monitor at Hospital/ward 'Y' may be classed as high risk because it is used in an intensive care environment. A Risk centred common sense approach allows better use of resources.
These device are life saving / threatening. [e.g. Defibrillators, Infusion pumps] All high risk devices will be checked regularly for safety and functionality, technicians will receive technical training of a suitable standard.
These devices aid diagnosis and therapy [e.g. ECG, Physiotherapy] Some medium risk devices may be maintained
These devices aid diagnosis [e.g. Handheld Aurascope, Aneroid sphygmomanometer]
PPMs will be carried out in accordance with work instructions laid down by the manager.
PPMs on Low risk devices will be carried out in accordance with work instructions laid down by the manager/ or not carried out if the risk is deemed to be acceptable.
Where equipment is deemed to be high risk and the department does not have the staff/resources to maintain it, maintenance contracts will be used.
The maintenance contract suppliers will be assessed using a departmental contract evaluation form. This form will include:
- Type of cover e.g. Comprehensive, PPM, Return to base.
- Costs - Total cost (hourly cost)
- Database reference
- Start date, end date
- Cost effective (Looking at alternative service suppliers)
- Supplier details
- User details
- Location of equipment
- Is equipment still in use (Has it been replaced and not decommissioned?)
- Quality of service (Is service delivery to an acceptable standard?)
- Signature of contract assessor
To ensure a cost effective system is in place users and service providers will be contacted to ensure there is a suitable contract in place. If service provision is only available from one supplier and the hourly/contract cost is deemed unacceptably high, the company may be barred (By liasing with the supplies dept) from selling any further equipment to the Trust. (A cap on hourly cost may be used). A suitable alternative supplier should be found when the equipment comes up for replacement. When considering which level of cover to take:
- RTB - Return to base - This type of cover for maintenance must be properly managed by the medical equipment maintenance department to ensure equipment is returned for service. (or the money spent on the service contract may be wasted)
- PPM - Planned preventive maintenance will be used for equipment with good reliability/low usage.
- PPM+ A PPM contract with a additional amount on the contract for spares and callouts (additional amounts only to be invoiced by the supplier if additional service or parts are used)
- Comprehensive - PPMs, Callouts, spares included in the cost of the contract.
The Manager is ultimately responsible for Training throughout the Department. Technologists within the Department will be qualified through external examination, training, skills, through experience or OJT. They are capable of maintaining or repairing the wide range of equipment that falls within the responsibilities of the Department. Technical training on individual pieces of equipment will be documented.
The Chief Technologist also has responsibilities for ensuring all trained personnel are evaluated on their competency. It is the responsibility of the Manager/Chief Technologist to monitor technologists competency and record it. Formal Training Courses will be given to all personnel involved in maintaining equipment deemed to be in the high-risk category. Training needs with the long-term view of meeting corporate objectives is an ongoing function of the department but a more formal review of the Department's training needs will take place at least annually. A satisfactory work environment will exist taking into account staff potentials, safety rules, location, facilities, hygiene, risk analysis results and temperature. The Manager will ensure that sufficient information technology, equipment, support services, and workspace are available for all trained personnel.
The longer-term effects of training will be assessed and recorded. The effectiveness of training will be evaluated by the Manager or the Chief Technologist on all personnel who have attended training courses.
It is the responsibility of the Manager to ensure that all personnel are aware of their contribution to the efficiency of the Department and to the Trust and that they are aware of the relevance and importance of their workmanship.
It is the responsibility of the Manager to ensure that all personnel receive the Training applicable to all activities. This includes certain aspects of Manufacturer training when applicable.
Though it is the responsibility of the Personnel Department to cover Induction Training, a form of Departmental Induction Training will be given to all personnel and recorded on the Training records.
- Health and safety
- Fire escapes.
- Alarms and drills
- Fire extinguishers
- First aid and emergency action
- Filing System, records and documentation
- Where to find work instructions
- Location of important items such as test equipment and stores
- Lunchtimes, working hours, and breaks.
It is the responsibility of the Manager to maintain records of training whether formal or informal and retain them on file. The Manager will ensure that all technologists operate under a suitable work environment enabling the Department to implement good workshop practices, and that the infrastructure (For example equipment, software, hardware and supporting services) is appropriate to the needs of the Department (Including storage and stores arrangements)
All equipment used for diagnostic or therapeutic use will be categorised into high, medium, or low risk with regard to technical training. All equipment deemed to be high risk will have one or more technologists trained by the supplier to service the equipment if that equipment is not on service contract. The trained person on that equipment may cascade the training to other technologists to enable them to assist in repairs/service.
All equipment used for diagnostic or therapeutic use will be categorised into high, medium, or low risk with regard to USER training. All equipment deemed to be high risk will have a trainer (trained by the supplier) capable of cascading training to the users in the operation of this equipment. It may also be necessary to carry out user training on medium and low risk devices.
All new equipment will be evaluated before purchase using an equipment evaluation form. (If this device has not been previously evaluated)
This form will include:
- Length of time on market
- Reliability rating
- Ease of use
- Supplier user support
- Supplier technical support
- Technical and user training availability/costs
- Technical/service manual availability
- Cost of durables and consumables
- Calculation of life cost
- Warranty period
- Parts availability
- Quantity discounts
Standardisation of equipment will:
- Reduce risk
- Ease cost pressures on technical and user training.
- Give more 'buying power' for negotiating discounts.
- Reduce the amount/value of spare parts held for stock.
An organisation within the Trust through which all purchases must be made.
Standing Order/Call Off Orders
Standing Orders are where the Department requires a part issue of goods or services from the supplier on a regular basis, e.g. weekly or monthly. Call Off Orders are where, although a bulk issue is ordered, the goods or services are not needed on a regular basis, but are requested as and when required.
It is the responsibility of the Manager to control the documentation and inspection of purchases.
Stores and services are ordered using a requisition form. The requisition form is a Trust/Supplies internal document. The Manager will check all purchase requisition forms and ensure they are countersigned. The Manager or the deputy checks and signs all requisitions. Stores such as spare parts etc. are ordered through the Supplies Department. The supplies department are invariably used as a reference when new suppliers are required. (New suppliers are vetted and listed). The suppliers list is available to the Manager if he needs to reference it. A close liaison is maintained on all aspects of procurement between the Manager and the Supplies department. Supplies must be kept informed of any serious issues that are the result of poor performance by suppliers, so that appropriate action can be taken.
The requisition forms will have the appropriate finance code entered and they will be passed to the Supplies organisation. The original is retained on file. A log is held of all requisitions.
The Supplies organisation will allocate an order number and confirm that the order has been placed by sending copies of a Purchase Order back to the Department who will ensure that the requisitioned items and the purchase order items are identical. The Supplies Department authorises the Purchase Order.
The Department invariably receives goods direct from the supplier and not via NHS Supplies. Normally the Clerical Assistant signs the delivery note for packages (not contents) received. He/She will check that the contents are satisfactory with the technician who has requested the Goods. If it is a stock item the Clerical Assistant will enter the details onto the database.
(In an emergency, a Purchase Order number may be obtained from supplies by telephone to enable stores or a service to be ordered immediately. The requisition process follows the same procedure as before.)
Some goods are ordered by the Department through NHS Supplies but are not all required immediately. Generally speaking these requisitions are referred to as "Call offs". All items are checked as they are unpacked.
Each Purchase Order should contain the following information:-
- Supplier's name.
- Purchase Order number.
- Supplier's address.
- Any special delivery instructions (e.g. expected delivery date.).
- Manufacturers reference for the part (if it exists).
- Supplier's reference (where applicable).
- Price (obtained from catalogue or supplier).
- Any special specifications and standards.
- Any discount.
While it is appreciated that this information is not always readily available, every effort should be made by the Department to ensure that the department receives the correct Goods/services on time, the first time and every time.
Planning Capital Equipment Replacement
Equipment replacement planning should include long term strategic decisions involving capital outlay, this must include Prioritisation for spend (Services, Depts, etc), A rolling capital replacement program, High value equipment (requiring replacement in which year), Low value equipment (showing an amount set aside for these types of equipment.)
GOODS AND EQUIPMENT FOR EXTERNAL REPAIR OR CALIBRATION
When equipment is sent to external organisations for repair or calibration, details will be entered onto the DATABASE. The repair label/worksheet will be passed to the Clerical Assistant who will hold it on the appropriate file. An external repair letter will be prepared by the Clerical Assistant to accompany the equipment, together with any other pertinent information.
When the goods return, the label/worksheet will be removed from the file and re-attached to the equipment. It will then remain in Goods Inwards until given a visual and safety check by an authorised technician. It will then be moved to Goods Outwards awaiting return to the customer.
CONTROL OF CUSTOMER SUPPLIED PRODUCTS
When a customer's products are handled by the EBME Department, every care will be taken as if they were the Department's own property. They will be verified, checked, correctly stored, segregated when appropriate and maintained. Where the received product is lost or damaged, the customer will be informed in writing immediately. It is the responsibility of the EBME Manager to ensure that customer-supplied product is handled correctly.