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How to overcome regulatory and ethical challenges regarding medical device – Pubrica

(1)Equity of resources, <br>(2) Patients' Rights, <br>(3) Patient Safety, <br>(4) ) Confidentiality of the patients, <br>(5)Ethics of privatisation, <br>(6)Conflict of Interests<br>Continue Reading: https://bit.ly/2RXrXO4<br> For our services: https://pubrica.com/services/physician-writing-services/<br>

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How to overcome regulatory and ethical challenges regarding medical device – Pubrica

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  1. HOW TO OVERCOME REGULATORYANDETHICAL CHALLENGES REGARDING MEDICALDEVICE AnAcademicpresentationby Dr.NancyAgnes,Head,TechnicalOperations,Pubrica Group: www.pubrica.com Email:sales@pubrica.com

  2. Today'sDiscussion Outline In-Brief Introduction EthicsandthePurposeofTherapeuticGoodsRegulation ProblemsofEvidenceaboutDevices NewChallenges QuestioningCurrentApproaches Limitations of the Study Conclusion

  3. In-Brief Biotechnologicaladvancementsinmedicaldevicescanintensifyrisks and introduce new types of risk, despite their potential to greatly benefit health.Therapeuticproductscontrolisourprimarytoolforhandlingthese threats.Asthesedevelopmentsadvance,thecurrentregulatory approachis likelyto be calledinto question.

  4. Introduction The below are the top ten ethical questions, inorderofpriority,asviewedbythe participants: (1)Equity of resources, (2) Patients' Rights, (3Patient Safety, (4) ) Confidentiality of the patients, (5)Ethics of privatisation, (6)Conflict ofterests, (7)Dealing with the opposite sex, (8)Informed Consent, (9) Beginning and end oflife,and(10)Healthcareteamethics.

  5. Ethicsandthe Purpose of Therapeutic Goods Regulation Therapeuticproductsregulationhastworoles, whichareoftenatoddswithoneanother. Control strives to preserve the public's health and welfare while enabling or also promoting usefultechnologiestoenterthemarketas soonas possible. The expectation that suppliers show proof of a product'sprotectionandefficacyisa significant part of how modern systems meet thesegoals. Contd...

  6. On the one side, this safeguards people from consuming goods that are harmful or ineffective. On the other hand, it implies that market success must be founded on sound science,with quality creativityrewarded. If evidentiary expectations are too uncertain, regulators' ability to protect patients may be endangered; if they are too high, patients may be denied access to new developmentsunnecessarily.

  7. Problems ofEvidence about Devices Theimmenseethicalchallengewithconsumer regulation is that we currently tolerate a high risk duringthebusinessacceptanceperioddueto datagatheringissuesandtheoperational requirementsofaregulatoryreportwriting framework related to products, not that the stakes havebeenmeasuredappropriately. Anotherhand,manybuyersconcludethatthe commodity on the market has been adequately testedforprotection andefficacy.

  8. New Challenges Emerging innovations add to the complexity of these alreadycomplicatedproblems.I'llwritetotwoofthem. 1. First, machines are becoming more computerised, withmany,suchaspacemakersandinsulinpumps, incorporatingautomationintotheiroperations. Ithasvariousadvantages,includingautomationof tasks for smoother management; improved calibration ofequipmenttopatients'needs;acollectionof physiologicaldataoftherapeuticsignificance;and remote,thereforemoreeffective,systemmodification. Contd...

  9. Theuseofsoftwareinorasadiagnosticsystemexacerbatescurrentproblemswhile alsoadding new ones. Itensuresthatdevicesmaybeupdatedevermoreregularly. Thesechangescanaffectthefunctionalityofdevicesalreadyinusebypatientsor evenimplanted in their bodies. Itwouldbecomemuchmorechallengingtoensurethetechnologiesremainsecure andprosperous as they grow. Contd...

  10. Manufacturerswillbeheldmoreresponsiblefordevicefunctionalityinthelongterm.Manufacturerswillbeheldmoreresponsiblefordevicefunctionalityinthelongterm. Software introduces additional types of risks, such as predicting how functionality will be compromised when used in combination with various technical technologies and whenapplied to multipleclinical scenarios. Another significant and relatively recent danger concerns cybersecurity: the threat of computersbeingcompromised andused todamage theirowners. Customisation,onceagain,createsnewproblems. Contd...

  11. Giventheunparalleledsimplicitywithwhichthismanufacturingmethodcanbeused, itcouldbe impossiblefor regulatorsto keeptrack ofall applications. 2. Increasedsystemcustomisation,especiallyby3Dprintingandcomputer-aided design,is a secondevolving possibility. Implantsoftenused,suchasartificialhips,cannowbedesignedinproportionsmore closelymatched to individualconditions. Personalisedmodelscanevenbeexplicitlymodelledonpatientphysiology. Contd...

  12. It seems to help patients on the surface; however, gathering rigorous proof of protection andusefulnessforcustomdevicesismuchmorecomplexthanstandardiseddevices. Customisation is profoundly at odds with the most substantial evidence for regulatory purposes,createdfrompopulationsofstudysubjectsthatundergoastandardised intervention. Asaresult,customisationexacerbatesthedifficultyoffindinggooddatafordevices. Custominstrumentshavetypicallybeenusedbytestinglawsorlegalexemptionsin thepast. Themorecustomisationisused,thelesssuitablethisbecomes.

  13. Questioning Current Approaches If technological advancements continue to pressure the existing system, it's worth considering any other optionsfor interfacecontrol. Some innovations can eliminate inequities, such as using 3D printing to include lower-tech electronics in low-incomenations. Still, this potential will not be appreciated as long as theresearchis incentivisedtoday. is focused mainly on goods that Healthcare research commercially changes that viable may can disregard by be achieved societal or structuralchange. Contd...

  14. Limitations oftheStudy Thewillingnesstogeneralisethefindingsisa criticaldrawback. First, the report excluded smaller underserved rural hospitals,whichmayhaverevealedadifferent medical data collectionof ethics concerns, even thoughequalityinresourceavailabilitywas identifiedasoneofthetopfiveproblems. Contd...

  15. Second, despite the study's efforts to include non-clinicians,maleclinicians'dominancein the survey may have tainted the findings and conclusions. Itmayalsoclarifywhynoethicalconcerns aboutparamedicalpersonnelandtheir interactionswithdoctorswereraised.

  16. Conclusion Thecentralethicalissuesasallegedbytheparticipantswere: (1) Patients' Rights, (2) Equity of resource distribution, (3) Confidentiality of patients, (4) Patient Safety, (5) Conflict of Interests, (6) Ethics of privatisation, (7) Informed Consent, (8) Dealing with the opposite sex, (9) Beginning and end of life, and (10) Healthcare Team Ethics.This collection, however, wasnot exhaustive. This study's findings were meant to be compared to those of another task. Since the differences in culture and healthcare systems,discrepancieswere predicted. Contd...

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