neill presentation

7/31/2019 Neill Presentation

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Medical Device

Directive

Dr Neill Jones

General Practitioner

Clinical Informatician

Ex Clinical Director FDBE

www.handihealth.org


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Medical device directive and theimplications for Medical APPS Outline of the Presentation

Medical Device Directive

Clinical Safety

Quality management systems

What is a medical device

What you need to do

Denitions and concepts

Medical Devices Directive 93/42/

EEC Requires manufacturers placing medical device(s) on the

Community market

Provide certain information to a Competent Authority in

a Member State where they have a registered place ofbusiness.


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Medical Device:any instrument, apparatus, appliance, software, material

or other article, whether used alone or in combination,

including the software intended by its manufacturer to

be used specically for diagnostic and/or therapeutic

purposes and necessary for its proper application,

intended by the manufacturer to be used for human

beings for the purpose of:

diagnosis, prevention, monitoring, treatment or

alleviation of disease,

diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or handicap,

investigation, replacement or modication of the

anatomy or of a physiological process


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Control of conceptionwhich does not achieve its principal intended action in or

on the human body by pharmacological, immunological

or metabolic means, but which may be assisted in itsfunction by such means;

Dose the POPE know he should register the rythm

method as a medical device


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DSCN 14/2009

Application of Patient Safety Risk Management to the

Manufacture of Health Software

ISB 0129 Health Informatics Application of clinical risk

management to the manufacture of health software

(formerly ISO/TS 29321:2008(E))

DSCN14/2009

DSCN18/2009


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Safety Risk analysis

If the manufacturer can provide information showing that

a safe design has been established for a number of years

and that the product has been performing as intendedduring that time such information is likely to be sufcient

to cover this requirement

ModulesSome stand alone software may break down into a

signicant number of applications for the user where

each of these applications is correlated with a module.

Some of these modules may have a medical purpose.This raises the issue as to whether the whole product can

be CE marked when not all applications have a medical

purpose

It is the obligation of the manufacturer to identify the

boundaries and the interfaces of the different modules/

applications.

SOS intended for use in combination with other modules of thewhole software structure, other devices or equipment, the whole

combination, including the connection system, must be safe andmust not impair the specied performances of the modules which

are subject to the medical device Directives.


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POST MARKET SURVEILLANCE

The Directive seeks to improve the protection of health

and safety of patients, by reducing the likelihood ofsimilar incidents being repeated. Consequently, the

Regulations require the manufacturer to immediately

notify the Competent Authority if the product has been

involved in an incident:

Led to a death;

A serious injury or serious deterioration in the state of

health

That might have led to death, serious injury

DECLARATION OF CONFORMITY

EC DECLARATION OF CONFORMITY (Full quality

assurance system)

The manufacturer must ensure application of the quality

system approved for the design, manufacture and nalinspection of the products concerned, as specied in

Section 3 and is subject to audit as laid down in Sections

3.3 and 4 and to Community surveillance as specied in

Section 5.


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What is a medical device

Any complex algorithm upon which a clinician may

rely on where the calculation is not apparent to the

clinician.

The software used for the Pandemic u line has been

classied as a medical device because it lead to

patients receiving (or not) a medication.

CVS risk scope is almost certainly the same category.

Decision Support SoftwareComputer based tools which combines medical

knowledge databases and algorithms with patient

specic data.

They are intended to provide healthcare professionals

and/or users with recommendations for or information

on diagnosis, prognosis, monitoring and treatment ofindividual patients.


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Active device for diagnosis:Any active medical device, whether used alone or in

combination with other medical devices, to supply

information for detecting, diagnosing, monitoring or

treating physiological conditions, states of health,

illnesses or congenital deformities.

Drug dosing systemsTo calculate the drug dosage to be administered to a

specic patient and therefore are qualied as medical

devices.

This would include drug doses lter by age sex gender

indication.


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Placing on the market:the rst making available in return for payment or free

of charge of a device other than a device intended for

clinical investigation, with a view to distribution and/or use

on the Community market, regardless of whether it is new

or fully refurbished.

Expert function software:software which is able to analyse existing information

to generate new specic information according to the

intended use of the software.

Intended purpose:

the use for which the device is intended according to the

data supplied by the manufacturer on the labelling, in the

instructions and/or in promotional materials.


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Summary

If an APP inuences a Clinician and probably also a

Patient that results in subsequent therapy you should

seriously consider if it is covered by the MDD and seekexpert guidance

Clinical safety and quality management systems together

with post marketing survelance are critical to the process.


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