Inspection, Servicing and Management of equipment: are you following the Guidelines.

Inspection, Servicing and Management of equipment: are you following the Guidelines

Learning Outcomes2

Catherine Jenkins APCP 2011 “Inspection, Servicing and Management of equipment: are you following the Guidelines.”

LO1 To have a working knowledge of the MHRA Guidelines “Managing Medical Devices” DB2006(05) as they relate to the Inspection, Servicing and Management of postural support furniture that falls under the Medical Devices Directive.

LO2 To have a basic understanding of the types of processes and procedures that individual therapy departments can introduce to help them to comply with the Guidelines and to improve product provision, carer and user training and product maintenance. LO3 To understand how product inspection, service and management improves overall safety, appropriate procurement and efficient use of medical devices.

LO4 To understand the need to record and monitor devices and to document their service history, whereabouts and current condition.

What Guidelines?

MHRA Device Bulletin:DB2006(05)

November 2006

“Managing Medical Devices”Guidance for healthcare and social services

organisations

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The original Medical Devices Directive has been updated and is currently:

Medical Devices Regulations 2002. These regulations came into force on June

16th 2002.

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The MHRA Medical Devices Guidelines were drawn from the Directive.

http://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf

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These Guidelines grew up from the British response to the Medical Devices Directive. Each country covered by the Medical Devices Directive has an official body that interprets the Directive

and issues Guidance for their country to follow. In the UK the official body is the MHRA.

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Who is the MHRA?The Medicines and Healthcare Regulatory

Authority

Formed in 2003 from the merger of the Medical Devices Agency (MDA) and the Medicines Control

Agency (MCA)

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What is their role?

To protect and promote public health and patient safety by ensuring that the manufacture and use of medicines and medical devices meet appropriate

standards of safety, quality, performance and effectiveness.

To minimise the risk of new adverse incidents involving medical devices and reduce the risk of

those that have already occurred from happening again.

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Why have Guidelines?

To regulate the design, manufacture, acquisition, use, maintenance and destruction of Medical

Devices.

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MHRA Device Bulletin: DB2006(05) November 2006

In order to know if you are following the guidelines, you need to know what they say about Inspection, Servicing and Management of Medical Devices.

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The main reasons that the MHRA believes incidents occur with medical devices are listed in the Guidelines as;

Inappropriate management procedures inadequate instructions for use inadequate servicing or maintenance shortcomings in design or manufacture lack of policies for disposal or replacement inappropriate use (including incompatible devices) inadequate training (staff and users/carers) incompatible ancillary equipment inadequate documentation, such as missing service

history or instructions for use

“Unless medical devices are managed proactively, the same type of adverse incidents happen

repeatedly. Good medical device management will greatly assist in reducing their potential for harm.”

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The Guidelines themselves are written for Authorities to help them to set up appropriate procedures to

manage medical devices and these include guidance for:

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Acquisition (including prescription) Training Use Maintenance Destruction/disposal of medical devices

So what do you need to do to follow the Guidelines?

Read a copy!14


Make sure that Devices that you use have been properly prescribed, set up, used, maintained and

disposed of.

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How do you do this?

Make sure that your service has a procedure for dealing with all aspects of medical device

management.

This is not as difficult as it might look.

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A system will need to cover :

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Who is responsible for:

- procurement – who decides what medical devices are bought what criteria do they use to ensure that the correct things are chosen?

As a physiotherapist, you will often be the person who prescribes a medical device for a child. You should know how to assess whether a product suits their needs and be able to set that product up for them and adjust it as their needs change.

Once a product has been bought or supplied from stores, the round of Inspection, Service and

Management becomes vital.

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Practical things YOU may need to do.

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Decide on what equipment to purchase Decide who services/inspects/maintains what and

how often Decides when products are disposed of and how Decide how members of staff are trained in the

use of products, including understanding the dangers of using incompatible ancillary equipment

Decides how to keep service records up to date and what to enter in to them.

Have a process, a Management Procedure written down for how you will do the following:

“Unless medical devices are managed proactively, the same type of adverse incidents happen

repeatedly. Good medical device management will greatly assist in reducing their potential for harm.”

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Proactive management will result in fewer incidents.

Safety is planned.

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Safety doesn’t just happen.

Best practice expects that all aspects of equipment provision are properly planned and recorded.

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The following suggestions will help you to make sure that Inspection, Servicing and Management of

Devices is controlled and effective.

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(1) Procurement and (2) Deployment

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Assessment of a child’s needs comes first.This will lead you to a list of criteria for equipment for this child.Assessment of the possible equipment options may be done with different companies or with equipment you already have in stores.


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Delivery ChecksThe first inspection will be delivery checks..Pages 20ff of the guidelines explain procedures for safe acceptance of new products including: “- Checking that the correct product, complete with usage and maintenance information and any relevant accessories, has been supplied

- ensuring that devices have been delivered in good condition and, where relevant, in good working order.” You may well be the person who is responsible for these checks.

Someone should be doing this and if the product is for your child, you should know that these checks have been completed and are retained.


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Delivery Checks

Make sure that you have a robust policy in your service for the local Stores to inform the person who ordered a piece of equipment to be told exactly when it will be delivered to the child. You can then arrange to go and check the product and set it up for the child.


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Delivery Checks

Delivery checks are just as important for new equipment as for equipment that is re-issued.


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Delivery Checks

Products that arrive at a child’s home and are not set up on that day may well be used by the family in an unsafe way.

You should aim to be there the day that a product arrives or ensure that the family/school knows to contact you as soon as the product arrives and knows not to use it until you have set it up.


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Delivery Checks

Why can’t the rep just set up the equipment?

Reps get to know a great deal about getting a good position for a child in their company’s equipment but they don’t know the child. You do.

If you are the prescriber of the equipment then you are responsible for how it is used.


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Delivery Checks

Asking the rep to set up the equipment in your absence is like the joiner who has come to fit your new windows asking the rep from the tool company to fit the window.

You are the one who knows how you want the equipment to be used so you need to make sure that it is used in the way you prescribe.


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Delivery Checks

Safe practice requires planning and process.

The Guidelines suggest that the prescribing organisation may need to augment the Instructions for Use for particular families and train the families thoroughly before leaving a product with them.


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Delivery Checks

Pages 20-25 cover Delivery of a new piece of equipment.


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Delivery Checks

Once you have completed your delivery checks and are happy that the correct product, to the correct specification has been supplied, you should record your findings and ask carers to sign to say that they understand how to use the equipment and how to get hold of a competent person should they need to..

(3) Maintenance and Repair

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Your service should have a policy for maintenance and repair of all Medical Devices.

This should cover:

How each device is to be maintained and repaired, and by whom.arrangements for maintenance and repair to be included as part of the assessment processarrangements for the most suitable persons/providers to carry out the workthe timescale for planned maintenancethe timescale for repairs to be completed


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You need to know what the process is in your service for maintenance and repair.

You may be the person who alerts the repair provider to the need to repair a particular product.

You may be required to write up a planned maintenance plan for equipment that you provide.


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Planned maintenance will help to prevent accidents.

Many products require little beyond cleaning, a visual inspection and replacement or tightening of moving parts.


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Some elements of products require more careful inspection because their failure is more likely to result in an accident.

Castors: if these fail, a child could fall out of a product or their product fall over and trap them underneath.

Check castors regularly to make sure that they work properly and are not loose.


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Webbing and Buckles

If a buckle breaks or a webbing strap is frayed, the strap will not hold a child in place and they could fall and be injured.

Check all straps and buckles daily before a child uses the product. Check there are no frayed ends or broken buckles.


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Webbing and Buckles


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Webbing and Buckles

Never use a buckle if one of the prongs is missing. It will not hold a child securely.


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Webbing and Buckles

Always replace both parts of a broken buckle as the replacement buckle may be a slightly different design to the one you already have and may not hold securely. This may mean that you need to buy a whole new strap.


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Missing or broken partsYou should never use a product that has missing or broken parts.

It will not be safe.


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Gas springs, hydraulic units and electrical power units.

Any malfunction or deterioration in the function of any of these should be checked out by whomever you use in your service to do this. Electrical units should have a written, planned maintenance schedule that is followed and recorded. This is required by law.


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Legal Requirements

The legislation of specific relevance to electrical maintenance is the Health & Safety at Work Act 1974, the Management of Health & Safety at Work Regulations 1999, the Electricity at Work Regulations 1989, the Workplace (Health, Safety and Welfare) Regulations 1992 and the Provision and Use of Work Equipment Regulations 1998.

(4) Disposal

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It is important that once a product has finished its useful life, it is disposed of in an environmentally safe manner.

It is important that products considered to be at the end of their useful life are labelled as such and removed from circulation immediately to prevent them being re-issued to another child.

(4) Disposal

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You should have a process that records all the products that you have along with their individual identity number, batch number or serial number.

Each product should have a service record and also a record of where it is currently being used and by whom.

Each product that is de-commissioned should then be identified as such and the date of destruction recorded.

So what makes for safer practice?

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Good record keeping Good training Good maintenance Recorded de-commissioning And planning, planning, planning.

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The MHRA Guidelines also cover other aspects of safe Medical Device use. Bulletins on many aspects of product use, warnings about problems and guidance on bed rails, decontamination and adverse incident reporting are also available from the MHRA website.

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Let nothing happen by accident and don’t let accidents happen!

Inspection, Servicing and Management of equipment: are you following the Guidelines.

Documents

management of medical

management of equipment

mhra guidelines

medical devices db200605

medical devices guidance

medical devices regulations

destruction of medical

catherine jenkins apcp