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Dr Neill Jones talks about the EU Medical Devices Directive at HANDI Newcastle.
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Apps to Transform Health and Care – That’s HANDI
www.handihealth.org
HANDIHealth Community Interest Company
Why HANDI?
Because we believe apps and the app paradigm can transform health and care
Dr Neill Jones
General Practitioner Clinical Informatician Ex Clinical Director FDBE
took product through the MDD
Medical device directive and the implications 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 Definitions 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 of business.
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 specifically 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:
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 modification of the anatomy or of a physiological process,
control of conception
which 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 its function by such means;
Dose the POPE know he should register the rythm method as a medical device
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
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 intended during that time such information is likely to be sufficient to cover this requirement
Modules
Some stand alone software may break down into a significant 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 purposeIt 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 the whole software structure, other devices or equipment, the whole combination, including the connection system, must be safe and must not impair the specified performances of the modules which are subject to the medical device Directives.
POST MARKET SURVEILLANCE
The Directive seeks to improve the protection of health and safety of patients, by reducing the likelihood of similar 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 final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.
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 flu line has been classified 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 Software
Computer based tools which combines medical knowledge databases and algorithms with patient specific data.
They are intended to provide healthcare professionals and/or users with recommendations for or information on diagnosis, prognosis, monitoring and treatment of individual patients.
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 systems
To calculate the drug dosage to be administered to a specific patient and therefore are qualified as medical devices.
This would include drug doses filter by age sex gender indication.
Expert function software:
software which is able to analyse existing information to generate new specific 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.
Placing on the market:
the first 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.
Summary
If an APP influences a Clinician and probably also a Patient that results in subsequent therapy you should seriously consider if it is covered by the MDD and seek expert guidance
Clinical safety and quality management systems together with post marketing survelance are critical to the process.
Handi Health Community Interest Company - limited by guarantee registered in England number 07999302Registered Office: The Oakley, Kidderminster Rd, Droitwich, Worcestershire. WR9 9AYCorrespondence address: PO Box 5309 Leamington Spa, CV31 9GT
