MHRA Guidelines. Understanding how to improve practice/safety.

MHRA Guidelines. Understanding how to improve practice/safety

Catherine Jenkins MCSP, SRP, FRSA

Director of Jenx Limited

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Catherine Jenkins CYPF 2011 “MHRA Guidelines. Understanding how to improve practice/safety.”

30 years experience in manufacturing

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Jenx Limited was first recognised as a Quality Process Company

under the BS 5750 system and has had continuous recognition since

1987

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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.

What Guidelines?

MHRA Device Bulletin:DB2006(05)

November 2006

“Managing Medical Devices”Guidance for healthcare and social services

organisations

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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 for acquisition (including prescription), training, use, maintenance and

destruction/disposal of medical devices.

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

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Read a copy!15


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

disposed of.

How do you do this?

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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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Your system will need to cover who is responsible for:

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- procurement (1)

– who decides what medical devices are prescribed and how they will be bought or retrieved from stores. - what criteria do they use to ensure that the correct things are chosen?

This will often be you.


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- deployment (2)

- who makes sure that the correct product, in good working order is delivered to the child and set up properly for them.

This will often be you.


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- maintenance and repair (3)

- who undertakes the regular safety checks and initiates repair when necessary?

This may be you or you may need train the school staff or carers to do this.

It is essential that all checks, inspections and repairs are fully documented.


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- disposal (4)

- who decides when a product is beyond economical repair?- who disposes of the product and keeps the records that the product has been disposed of and in what way?

Starting to get it right.

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If you have policies that cover the issues above, you will be going in the right direction to improve

safety in the procurement, deployment, maintenance and disposal of Medical Devices.

So what is a Medical Device?23


“medical device” means an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which –

a)Is intended by the manufacturer to be used for human beings for the purpose of –

ii)diagnosis, prevention, monitoring, treatment, alleviation of or compensation for an injury or handicap.

http://www.legislation.gov.uk/uksi/2002/618/pdfs/uksi_20020618_en.pdf (Interpretation: page 5)

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

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As an Occupational Therapist , 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.

Practical things YOU can do to improve practice and safety.

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Decides what equipment to purchase Services/inspects/maintains what and how often Decides when products are disposed of and how Decides how 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.

Management ProceduresHave a process, written down for how your service

does 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 improve practice and safety in your provision of equipment to

children.

You and your service need to address safety in device provision to meet your local needs.

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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 step in real safety provision comes in the 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.

(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 keepingGood trainingGood maintenanceRecorded de-commissioningAnd 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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Relevant MHRA bulletins:- Device Bulletin: Reporting adverse incidents and disseminating medical device alerts; DB2011(01) March 2011Directives Bulletin no.3: Guidance on the operation of the EU vigilance system in the UKDevice Bulletin: Safe Use of Bed Rails; DB2006(06) December 2006Bulletin No. 18: The Medical Devices Regulations: Implications on Healthcare and Other Related EstablishmentsMedicines & Medical Devices Regulation: what you need to knowMedicines and Healthcare products Regulatory Agency; Enforcement Strategy Relevant Reading:- Buyers’ Guide: Night time postural management equipment for children; CEP 08030 July 2008Statutory Instrument 2005 No. 1803: The General Product Safety Regulations 2005;www.opsi.gov.uk/si/si2005/20051803.htm

http://www.opsi.gov.uk/si/si2005/20051803.htm

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

MHRA Guidelines. Understanding how to improve practice/safety.

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Transcript of MHRA Guidelines. Understanding how to improve practice/safety.