1/45 Prepared & Presented by: M.Pharm: 2004-2006 Dept. of Pceutics & Pceutical technology L. M. College of Pharmacy STAVAN NAGORI.

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Prepared & Presented by:

M.Pharm: 2004-2006Dept. of P’ceutics & P’ceutical technology

L. M. College of Pharmacy

STAVAN NAGORISTAVAN NAGORI

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List of contents:

• Medical devices• Adverse incidents• Clinical investigations• Recall procedures• Decontamination of medical

devices

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MEDICAL DEVICE AGENCY(MDA):

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What is Medical Device? A medical device

- instrument - apparatus - appliances

- material - Software

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-used alone or in combination

-prevent, -Diagnose

-treat

-disease -any type of injury

-modify anatomic function of the body

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MDA’s AIM:Take all reasonable steps

To protect: -the public health

-safeguard

Ensuring

medical devices and equipment meet: -appropriate standards

-Safety-Quality

-performance

In European Union.

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List of Medical Devices:Anaesthetic machines and monitors Apnoea monitors

Artificial limbs Artificial eyes

Blood transfusion and filtration devices Breast implants

Cardiac monitors Cardiopulmonary bypass devices

Clinical thermometers Condoms

Contact lenses and prescribable spectacles

CT scanners

Defibrillators Dental equipment and dentures

Dental material and restoratives Diagnostic X-ray equipment

Dialysers Dressing and wound healing devices

Electrosurgery devices Endoscopes

Enteral and parenteral feeding systems Equipment for disabled people

Examination gloves Fetal monitors

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Hearing aids and inserts Heart valves

Hospital beds Hydrocephalus shunt

Incontinence pads Infant incubators and warmers

Infusion pumps and controllers Intra-uterine devices

Intravascular catheters and cannulae Laboratory equipment covered by IVD directive

Lithotripters Medical textiles, hosiery and surgical supports

Medical lasers Operating tables

Orthopaedic implants Ostomy and incontinence appliances

Pacemakers Physiotherapy equipment

Prescribable footwear Pressure sore relief devices

Radiotherapy machines Resuscitators

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Scalpels Special support seating

Sphygmomanometers Suction devices

Surgical instruments and gloves Sutures, clips and staples

Syringes and needles Ultrasound imagers

Urinary catheters, vaginal speculae and drainage bags

Ventilators

Walking aids Wheelchairs

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Which are not medical devices?

• TOILETRY AND COSMETICS PRODUCTS

• PERSONAL PROTECTIVE EQUIPMENT

• OTHER EQUIPMENT

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Facts about MDA….

• Headed by Chief Executive, appointed by the Secretary of State for Health

• Established as a part of NHS in 1948

• Change to Agency status in 1994

• The majority of MDA's 140 staff are specialists: Medical and nursing staff, professionally qualified

technologists and scientists

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Activity Areas:

• Clinical (Medical and Nursing)

• Device Technology and Safety

• Device Evaluation Service

• European and Regulatory Affairs (ERA)The Agency - through ERA - represents the UK on all regulatory matters affecting medical devices

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European and Regulatory Affairs (ERA):

Negotiating within the European Union

creating three Medical Directives

to set and check

Safety and performance requirements for medical devices and procedures

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The Three Directive:1. ACTIVE IMPLANTABLE MEDICAL

DEVICES DIRECTIVE 90/385/EEC:

Covers all power medical devices implanted and left in the human body

E.g. pacemakers implantable defibrillators, implantable infusion pumps

2. MEDICAL DEVICES DIRECTIVES 93/42/EEC:

Covers most other medical devices

E.g. simple bandages orthopedic implants

high-technology radiology equipment.

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3. IN VITRO DIAGNOSTIC MEDICAL DEVICES DIRECTIVES 98/79/EEC:

Covers any medical device

Reagent/kitInstrument

Apparatus, etc.

used in-vitro for the examination of substances

e.g blood grouping reagents

pregnancy testingHepatitis B test kits

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These Directives…• Ensured:

1. A device does not compromise the clinical condition or safety of the patient

2. A device achieves its intended purpose3. Benefits overweighs minor risks

• Introduced controls for:

1. Manufacturing 2. Labelling 3. Packaging of devices 4. Preclinical and clinical assessments

• Specified action to be taken if any adverse incident releated to device

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ADVERSE INCIDENTS:

ROLE OF MHRA (DEVICES)

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What is an Adverse Incident (AI’s)?

Event

causing, or has potential to

unexpected unwanted effects

Affecting

The safety of patients, users or other persons. For example:

• injury• treatment interrupted medical device failure or its misuse • misdiagnosis

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Causes of AI’s:

• shortcomings in the design or manufacture of the device itself

• inadequate instructions for use

• inadequate servicing and maintenance

• locally initiated modifications or adjustments

• inappropriate user practices (which may in turn result from inadequate training)

• inappropriate management procedures

• the environment in which a device is used or stored

• selection of the incorrect device for the purpose.

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Events in AI’s Reporting:• Database Records

Referral to another agency Recording as ‘information only’ Linking to existing investigations

• Investigations

Death and serious deterioration in health (or potential for such) – Section investigations

Minor injury or no injury (with low potential for more serious injury) – standard investigations

• Review of investigations

• MHRA’s safety warnings

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The Biological Safety Assessment:

• Necessary for the assurance of biological safety

• Carried out before any clinical investigation is commenced

• The manufacturer of a device is responsible for documenting the results of the biological safety analysis

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• Application made to the Competent Authority 60 days before the investigation begins

no objection raised by the UK Condition: Competent Authority within the 60

day time constraint.

• Ethics Committee opinion required for each participating centre, soughed by the investigator.

• Compliance demonstration requires clinical data

Clinical Investigations:

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When is Clinical Investigation required?

• Introduction of completely new concept of device into clinical practice

where components, features and/or methods of action, are previously unknown

• Existing device is modified

affecting the clinical performance and/or safety of the device

• Device incorporates materials previously untested in humans, where existing

materials are applied to a new location in the human body

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• Device

proposed for a new purpose of function

• In vitro and/or animal testing of the device

Who do not mimic the clinical situation

• New manufacturer of a high risk device

• In Special circumstances like:

1. Change in the intended use/performance claims of a device2. Comparative studies

3. Prototype devices

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Documents Required for clinical investigation:

• GENERAL INFORMATION

• DETAILS ALLOWING DEVICE TO BE IDENTIFIED

• OTHER DEVICE DETAILS

• GENERAL INFORMATION CLINICAL

• INVESTIGATION PLAN

• DATA COLLECTION / ANALYSIS / STATISTICS

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Appeal Procedure:

• MHRA developed an appeals system for manufacturers who wish to challenge regulatory decision not already covered by a legislative right of appeal.

WHO MAY APPEAL?• Any manufacturer, an authorized

representative, a supplier or Notified body subject to the regulations.

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Appealing for?

– clinical investigation notification– notified body designation– applications for exceptional use of

non-complying device– restriction notice– suspension notice– prohibition notice– notice to warn

• No administrative complaint is dealt with. The handling of such complaints is described in the MHRA Code of Practice copies.

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How to appeal?

• Within three month regulatory decision from Secretary of State

• Chief Executive (CE) consider the basis upon which the regulatory decision was made within four weeks of receiving the appeal notice

• if CE thinks further investigation required then matter referred to IA (Independent Assessor) otherwise not

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CLASS I DEVICES:

• Administration• Dental• Diagnostic• Dressings• Equipment and furnishings• Ophthalmic• Orthoses and prostheses• Surgical• Walking aids and wheelchairs• Waste collection

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Requirements to manufacture Class I devices:

• Confirm whether their products fall within Class I

• Check whether devices meet the Essential Requirements

• Prepare relevant technical documentation

• Draw up the EC Declaration of Conformity before applying the CE marking to the devices

• Implement and maintain corrective actions and vigilance procedure

• Obtain notified body approval for sterility or metrology aspects of their devices, where applicable

• Present relevant documentation on request for inspection by the Competent Authority

• Notify the Competent Authority, in advance, of any proposals to carry out a clinical investigation

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Custom made devices:• Devices are manufactured in accordance with a

professional’s written prescription for the sole use of a particular patient and are not adapted from mass produced items

K 1 Dental Appliances/ProsthesesK 2 Hearing Aid InsertsK 3 Prescribed Orthopaedic FootwearK 4 Artificial EyesK 5 Orthoses And Prostheses - External (Made Direct

From Casts/Prescriptions)K 6 Orthopaedic ImplantsK 7 Maxillo-Facial DevicesK 8 Standing And Walking FramesK 9 Ligament And Tendon Repair ImplantsK 10 Spectacle Frames

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Requirements to mfg. Custom made devices

(a) Chemical, physical and biological properties of the device(B) Infection and microbial contamination (c) Construction and environmental properties (d) Protection against radiation (e) Requirements for medical devices connected to or

equipped with an energy source (f) Information supplied by the manufacturer, including labels.

As a minimum requirement the labels on a custom-made device must include :

• The name or trade name and address of the manufacturer , for devices imported into the European economic area (EEA),

• The name and address of a representative based there• Directions • Contents of the packaging • The words “custom-made device”.

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Need for a recall:

• The hazard arising from the device shortcoming

• Risk overweighs benefits of the device

Recall does not arise when a manufacturer is exchanging of upgrading device in the absence of a safety risk related to a deficiency in the device.

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Recall Procedure:

• The return of a medical device to the supplier

• Device modification by the supplier at the site of installation

• Device exchange

• Device destruction

• Retrofit by purchaser of manufacturer’s modification or design change

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What triggers recall?

Information depicting unacceptable increase

in risk posed by a medical device

post-marketing surveillance

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Notification of Recall:• The manufacturer or authorized representative has to

notify the CA of each EC member State in which the recall is being conducted

• For Class I, II, III and IVD’s listed in Annex II or those for self testing, manufacturer should notify additionally the CA of the country where their authorized representative reside

• Notification should be made before and when the recall letter is being issued

• Where practical MDA should be advised of the recall prior to its initiation

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Information MDA needs from Manufacturer:

Details of the problem

• Details of the factors giving rise to the recall, including summary of relevant adverse incidents

• Technical details of the device shortcoming if known• Potential hazard presented by use of the device• Circumstances under which the device is used and

when the hazard may occur• Indication of likelihood of hazard occurring• Conclusions of tests and other investigations on

suspect or other samples if available• (draft) recall letter

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Details of the product

• whether device is CE-marked and device classification/category;

• device model name/number and description;

• batch or serial number(s) of affected devices;

• manufacturer’s contact details if reported by distributor;

• when affected products were distributed;

• UK customers of affected product;

• names of other EEA countries affected by the recall

• the identity of the relevant Notified Body where applicable

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Implementation of the recall:

Manufacturers responsibility for implemention

To enable an effective recall manufacturers have a responsibility to:

(a) implement an effective post-market surveillance (b) maintain product records (c) establish a recall procedure

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Decontamination of Medical Devices:

The MAC (Microbiology Advisory Committee) Manual

addresses

aspects of the decontamination

This manual is in 3 parts:

• Part 1- general principles of decontamination, illustrated by some examples of basic decontamination equipment

• Part 2 - protocols and usage of particular instruments and materials

• Part 3 - procedures decontamination of different types of medical equipment

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General principles:• The choice of decontamination method may be related

to the infection risk associated with the intended use of the equipment

• The choice of decontamination method will also depend on many other factors including

the nature of the contamination, the time required for processing, the heat, pressure

moisture and chemical tolerance of the object, the availability of the processing equipment and the quality and risks associated with the decontamination method

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Protocols:

• describes an overall system for the decontamination of medical devices and equipment for reuse or prior to inspection, repair or investigation

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Work Flow Chart:

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Procedure:

Cleaning instructions covers:

• Instructions - how to dismantle (and subsequently reassemble) the device

• Generic and brand name of cleaning agents

• Any accessories which may assist the cleaning process, such as automatic washers, ultrasonic cleaners or brushes

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Disinfection instructions should cover:

• Generic or brand-named disinfectants known to be effective and compatible with the device

Method(s) of sterilization should cover:

• The name of the process (e.g. steam sterilization)• The type of cycle (e.g. pre-vacuum/porous load)• Any relevant cycle parameters (e.g.134-137°C for a minimum holding time of 3 minutes).

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Reference:

• www.mhra.gov.ukwww.mhra.gov.uk