1. 1March 25, 2014 CSC Global Clinical Safety ManagementCSC Global Clinical Safety Management Clinical Safety Assurance Electronic Medication Management Software Assurance & Regulation George Davies March 2014

2. 2March 25, 2014 CSC Global Clinical Safety Management The key messages Healthcare is a safety critical industry Clinical risk management must be common practice for all suppliers Regulation is here! 3. 3March 25, 2014 CSC Global Clinical Safety Management A number of seminal studies Brennan, Leape, Laird et al (New England Journal of Medicine, 1991) 3.7% of records reviewed demonstrated that mistakes had been made that led to patient harm. Drug complications presented the highest single type of adverse events (19%). Wilson, Runciman, Gibberd et al (Australian Journal of Medicine 1995) 16.6% of records reviewed demonstrated mistakes had been made that led to patient harm. Neale, Woloshynoviych & Vincent (Journal of the Royal Society of Medicine, 2001) Followed up the original 2001 paper that demonstrated a level of 10.8% in two London hospitals by considering the causes of adverse events. Probable contributory factors in these errors included dependence on diagnoses made by inexperienced clinicians, poor records, poor communication between professional carers, inadequate input by consultants into day-to-day care, and lack of detailed assessment of patients before discharge. Reason, J 1990. Human Error Human fallibility. We cant change the human condition, but we can change the conditions they operate under to minimise the opportunities for error. Healthcare as a safety critical industry 4. 4March 25, 2014 CSC Global Clinical Safety Management Simple Clarity of prescription and confirmation of requirements. The legibility of hand writing is no longer a factor in drug errors. Pick lists and pre-defined prescription sentences provide quick and easy access to formularies and regimen Bar coding on drug packaging facilitates quick and effective cross checking against scripts. Complex Longitudinal approach to medicine management from clerking on arrival to discharge prescriptions and communication with primary carers as a component of the electronic care record. Enhanced prescribing support linking individual patient data to effective drug therapies. Integrated allergy and sensitivity data providing warnings or limiting freedom of choice for less experienced clinicians. System contributions to safety 5. 5March 25, 2014 CSC Global Clinical Safety Management Safety There is a global drive to demonstrate that risks have been managed proactively according to the ALARP principle Interface standards are appearing to define good practice Global clinical safety standards being developed exploiting the best practices in a number of geographies Regulation Some countries have de facto regulation of suppliers. Medical device regulations are clear that software may qualify as a medical device Medical device regulation is statutory in most countries Manufacturers and consumers have been slow to catch up with laws that changed in 2010 Standards & Regulations 6. 6March 25, 2014 CSC Global Clinical Safety Management The NHS England Experience Clinical safety standards defined for the management of risk by manufacturers and deploying organisations (ISB0129 & ISB0160) Interface standards defined to reduce confusion in the interface (Common User Interface) The National Patient Safety Agency good design standard for medicines management interface functionality (Design for Patient Safety) International The EU made an attempt in 2008, in collaboration with the NHS in England, to establish two ISO standards. 29321 and 29322 deemed to cover the same ground as the Medical Device safety standards New work packages now being developed to introduce global standards for health software safety Clinical Safety Standards 7. 7March 25, 2014 CSC Global Clinical Safety Management Whole Systems Approach Clinical safety management starts with concept and ends with retirement Hazard assessment Mitigation formulation Manufacture quality Testing Creating a technical case Making the technical safety case 8. 8March 25, 2014 CSC Global Clinical Safety Management Clinical Safety in Healthcare What is safety? - Freedom from an unacceptable risk of harm Suppliers have a duty of care to ensure that all of their products and services are created, deployed and managed in service where clinical risk is reduced according to the principle of As Low As Reasonably Practicable (ALARP) Managing risk in manufacture SupportDesignRequire. Build Test Release Deploy 9. 9March 25, 2014 CSC Global Clinical Safety Management The customers role in safety Limitations of the technical case Implications for business practices New approaches to familiar work processes Training the work force Time spent with a new system Integration (or not) of historic data Standardisation and globalisation Impact on the deploying organisation 10. 10March 25, 2014 CSC Global Clinical Safety Management Global A series of three directives controlling access to market for products that qualify under the terms of the directives In 2007 a clarification was made that, amongst other things, described how Stand Alone Software may qualify It is the Manufacturers decision whether their product does or does not qualify The requirements are usually enshrined in law in the countries that recognise the directives Often embedded in consumer protection law Key Definitions Stand alone software Qualification and Classification Essential requirements Medical Devices Regulation 11. 11March 25, 2014 CSC Global Clinical Safety Management Classification Unless associated with a device of a higher classification stand alone software that qualifies does so as a Class I Active Medical Device. Qualification Is it software as defined in ISO/IEC 2382-1? Was it designed to have an intended medical purpose? (as defined in Article 1) Is it performing an action different from storage, communication, simple search? Is it acting on patient specific data? Dosage calculator that combines patient data with known drug data to give a patient specific dose Using genomic data to devise or determine a therapy Calculating the BMI for a specific patient Qualification & Classification 12. 12March 25, 2014 CSC Global Clinical Safety Management Specific examples Decision Support Software which combines medical knowledge from databases and algorithms with specific patient data with the intention of supporting or recommending diagnosis or therapeutic action. e.g. Chemotherapy dose calculation, computer aided detection, treatment planning software. Medication modules Where the module uses algorithms on specific patient data with the intention of supporting or recommending diagnosis or therapeutic action. e.g. BMI calculator linked to dosage 13. 13March 25, 2014 CSC Global Clinical Safety Management Questions? George Davies Global Clinical Safety Lead Healthcare & Life Sciences, Global Operations, CSC +44 (0) 7900 057324 gdavies7@csc.com Contact 14. 14March 25, 2014 CSC Global Clinical Safety ManagementCSC Global Clinical Safety Management APPENDICES 15. 15March 25, 2014 CSC Global Clinical Safety Management ComplianceFramework Clinical Safety best practice CSC Clinical Safety Management System NHS ISB 0129 - Application of Patient Safety Risk Management to the Manufacture of Health Software IEC 82304-1 Health software, general requirements for product safety. ISO/TR 17791:2013 Guidance on standards for enabling safety in health software Regulation ISO EN 14971:2009 Medical devices application of risk management to medical devices ISO EN 13485:2003 Medical devices quality management systems. Requirements for regulatory purposes. Manufacture IEC EN 60601-1-6: 2010 Medical electrical equipment general requirements for basic safety and essential performance IEC EN 62304:2006 Medical device software software lifecycle processes IEC EN 62366:2008 Medical devices application of usability engineering to medical devices Vigilance Meddev 2.12-1 rev 8 : 2012 Medical devices guidelines on medical devices vigilance system