Patient Safety and Medical Devices Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT.

Patient Safety and Patient Safety and Medical DevicesMedical Devices

Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CTSonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

What Makes a Good Medical Device What Makes a Good Medical Device Adverse Event Report?Adverse Event Report?

Complete Device Narrative InformationComplete Device Narrative Information

Device Identifier dataDevice Identifier dataDevice TypeDevice Type

• e.g. Infusion Pumpe.g. Infusion Pump– Implantable insulin Implantable insulin – Patient controlled analgesiaPatient controlled analgesia

Brand NameBrand Name• e.g. Kleenex brand of tissuese.g. Kleenex brand of tissues

Model NumberModel Number• e.g. 123 or ABC defibrillatore.g. 123 or ABC defibrillator

Manufacturer NameManufacturer Name• e.g. Check for name on device labele.g. Check for name on device label

Complete Device Narrative Information Complete Device Narrative Information

• User DemographicsUser Demographics– Who is using the device?Who is using the device?

• healthcare professionalhealthcare professional• patient patient

• Patient DiagnosisPatient Diagnosis– Any presenting or Any presenting or

underlying condition that underlying condition that may have contributed to may have contributed to the reported adverse eventthe reported adverse event

• Circumstances of Use Circumstances of Use – Anything unusual or Anything unusual or

unexpected about the unexpected about the device use in the reported device use in the reported adverse event?adverse event?

DemographicsDemographics

• 100,000 - 120,000 medical device adverse 100,000 - 120,000 medical device adverse event reports per yearevent reports per year– 95% from manufacturers95% from manufacturers

• about half of these are summary reports about half of these are summary reports

– 5% from health care practitioners, consumers, 5% from health care practitioners, consumers, and user facilities and user facilities

Reports are EvaluatedReports are Evaluated

• The FDA’s CDRH relies The FDA’s CDRH relies on backgrounds in:on backgrounds in:– NursingNursing– BiologyBiology– RadiologyRadiology– Dentistry Dentistry – Public health Public health – ChemistryChemistry– Biomedical engineeringBiomedical engineering

Adverse Event EvaluationAdverse Event Evaluation

• High-Risk Reports receive priority reviewHigh-Risk Reports receive priority review– Pediatric deaths Pediatric deaths – Multiple patient deaths or serious injuriesMultiple patient deaths or serious injuries– Fire , explosion, electrocutionFire , explosion, electrocution– Burn, anaphylaxis, exsanguinationBurn, anaphylaxis, exsanguination– Manufacturer initiates remedial actionManufacturer initiates remedial action– Unusual events flagged by a reviewerUnusual events flagged by a reviewer

Adverse Event EvaluationAdverse Event Evaluation

• High volume, well-known, events are High volume, well-known, events are reviewed in the aggregate through summary reviewed in the aggregate through summary reportingreporting– Breast ImplantsBreast Implants– Surgical SuturesSurgical Sutures– Intravascular CathetersIntravascular Catheters

Adverse Event EvaluationAdverse Event Evaluation

• Reports are reviewed against other dataReports are reviewed against other data– FDA regulatory data such as pre-market FDA regulatory data such as pre-market

submissions and product recallssubmissions and product recalls– Literature reviewsLiterature reviews– Previously submitted adverse event trendsPreviously submitted adverse event trends

• similar problems with similar devices similar problems with similar devices • similar problems with other manufacturerssimilar problems with other manufacturers• similar patient or use scenariossimilar patient or use scenarios

Adverse Event EvaluationAdverse Event Evaluation

• Analysts may request Analysts may request additional information additional information to assess the cause of a to assess the cause of a reported event by:reported event by:– telephonetelephone– faxfax– letterletter– user facility visituser facility visit– manufacturer inspectionmanufacturer inspection– consult with other FDA consult with other FDA

CentersCenters

FDA RecommendationsFDA Recommendations

• Public Health NotificationPublic Health Notification• Post-market StudiesPost-market Studies• Regulatory ActionRegulatory Action

• Recalls, StandardsRecalls, Standards

• Education and OutreachEducation and Outreach• Peer-Reviewed ArticlesPeer-Reviewed Articles• WebsitesWebsites• Conferences, PartnershipsConferences, Partnerships

with professional organizationswith professional organizations

Unanswered Questions in the Unanswered Questions in the Post-market PeriodPost-market Period

• Long Term Medical Device Safety DataLong Term Medical Device Safety Data– Condition of approval studiesCondition of approval studies– Post-market studiesPost-market studies

• Device Performance in the Larger Post-market Device Performance in the Larger Post-market Patient PopulationPatient Population– Epidemiological StudiesEpidemiological Studies– Registries Registries

• Use Error Related to New and Complex Technology Use Error Related to New and Complex Technology – Changing User Demographics, i.e. professionals and lay Changing User Demographics, i.e. professionals and lay

consumersconsumers– Variety of Use Locations, i.e. hospital and homeVariety of Use Locations, i.e. hospital and home– Evolution of Multiple Function-Multiple Indication Devices, Evolution of Multiple Function-Multiple Indication Devices,

i.e. blood pressure monitors, fluid delivery systemsi.e. blood pressure monitors, fluid delivery systems

Medical Product Surveillance Medical Product Surveillance Network (MedSun)Network (MedSun)

• Data from a sample of medical facilities is Data from a sample of medical facilities is anticipated to:anticipated to:– Provide information on emerging medical device Provide information on emerging medical device

problems problems – Provide information on changes in device useProvide information on changes in device use– Promote communication between FDA and the Promote communication between FDA and the

clinical communityclinical community– Lead to improved safety and efficacy of medical Lead to improved safety and efficacy of medical

device usedevice use