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

ObjectivesObjectives

• Discuss the impact of FDA’s consumer protections Discuss the impact of FDA’s consumer protections on patient safetyon patient safety

• Describe the Medical Device Reporting Regulation Describe the Medical Device Reporting Regulation as a model for patient safetyas a model for patient safety

• Identify criteria for FDA’s CDRH medical device Identify criteria for FDA’s CDRH medical device adverse event report review and evaluationadverse event report review and evaluation

• Conduct an abbreviated medical device adverse Conduct an abbreviated medical device adverse event report review to identify a patient safety event report review to identify a patient safety problemproblem

• Create a model for patient safetyCreate a model for patient safety

FDA, Medical Devices, and FDA, Medical Devices, and Patient SafetyPatient Safety

• Food and Drug Administration (FDA) Food and Drug Administration (FDA) – promotes the safe and effective use of medical promotes the safe and effective use of medical

devices, drugs, biologics, foods, and cosmetics devices, drugs, biologics, foods, and cosmetics through consumer protection programsthrough consumer protection programs

• FDA’s consumer protections are in place to:FDA’s consumer protections are in place to:– safely bring new products to market, andsafely bring new products to market, and– to ensure that safe and effective products to ensure that safe and effective products

remain on the market remain on the market

FDA at a Glance FDA at a Glance

• FDA is divided into 7 Centers, each with its FDA is divided into 7 Centers, each with its own area of responsibility:own area of responsibility:– Center for Medical DevicesCenter for Medical Devices– Center for Drugs Center for Drugs – Center for BiologicsCenter for Biologics– Center for Food Safety and Applied NutritionCenter for Food Safety and Applied Nutrition– Center for Toxicology and Research Center for Toxicology and Research – Center for Veterinary MedicineCenter for Veterinary Medicine– Center for Regulatory OperationsCenter for Regulatory Operations

FDA’s Basic FDA’s Basic ResponsibilitiesResponsibilities

IntegrityIntegrity AssuranceAssurance

ScienceScienceBasedBased

RegulatoryRegulatoryDecisionsDecisions

RiskRisk ManagementManagement

FDA’s Basic FDA’s Basic ResponsibilitiesResponsibilities

• Risk ManagementRisk Management– First human use (IND or IDE)First human use (IND or IDE)– Safe Experimental use (product development)Safe Experimental use (product development)– Widespread Use (market approval)Widespread Use (market approval)– Post-market Adverse Event Experience Post-market Adverse Event Experience

EvaluationEvaluation

FDA’s Basic FDA’s Basic ResponsibilitiesResponsibilities

• Integrity AssuranceIntegrity Assurance– EnforcementEnforcement

• FraudFraud• Bad Manufacturing PracticesBad Manufacturing Practices• Bad Clinical PracticesBad Clinical Practices

FDA’s Basic FDA’s Basic ResponsibilitiesResponsibilities

• Science-Based Regulatory DecisionsScience-Based Regulatory Decisions

• EvidenceEvidence– Clinical Trial DataClinical Trial Data– Post-market Adverse Event Experience Post-market Adverse Event Experience

DataData– StandardsStandards

FDA’s Center for Devices and FDA’s Center for Devices and Radiological HealthRadiological Health

(CDRH)(CDRH)

MissionMission

CDRH promotes and protects the health of the public by CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices ensuring the safety and effectiveness of medical devices and radiological productsand radiological products

VisionVision

Ensuring the health of the public throughout the Total Ensuring the health of the public throughout the Total Product Life CycleProduct Life Cycle

Total Product Life CycleTotal Product Life Cycle

Early Product Life CycleEarly Product Life Cycle– ConceptConcept

• What is the product?What is the product?– Device, Pharmaceutical, Biological?Device, Pharmaceutical, Biological?– Combination product?Combination product?

– PrototypePrototype• What makes the product new?What makes the product new?

– BiomaterialsBiomaterials– DesignDesign– Indication?Indication?– What is already known?What is already known?

• i.e. does the product leach, oxidize? i.e. does the product leach, oxidize?

Mid-Product Life CycleMid-Product Life Cycle

• Pre-clinical EvaluationPre-clinical Evaluation– Are there critical performance specifications?Are there critical performance specifications?– Standards – i.e. International Standards Organization. Standards – i.e. International Standards Organization.

• Clinical EvaluationClinical Evaluation– Use with final manufactured product or prototype?Use with final manufactured product or prototype?– Are there any unforeseen adverse events?Are there any unforeseen adverse events?

• Manufacturing EvaluationManufacturing Evaluation– controls – i.e., human factors, design, manufacturing process controls – i.e., human factors, design, manufacturing process

considerationsconsiderations• Manufacturing for marketing and commercial use Manufacturing for marketing and commercial use

– Pre-approval FDA inspectionPre-approval FDA inspection– Supplier – component integritySupplier – component integrity– Consignees – user training and educationConsignees – user training and education– Promotion and AdvertisingPromotion and Advertising– Labeled indications for use Labeled indications for use

Late Product Life CycleLate Product Life Cycle

• Product MarketingProduct Marketing– Promotion and AdvertisingPromotion and Advertising– Truthful LabelingTruthful Labeling

• Commercial UseCommercial Use– Unforeseen problemsUnforeseen problems– Device FailuresDevice Failures– Product re-designProduct re-design

• Obsolescence Obsolescence – Use and End-of-Life ConsiderationsUse and End-of-Life Considerations

• Customer complaints and complaint investigationCustomer complaints and complaint investigation– Use errorsUse errors– Failure analysis Failure analysis

• Adverse event reportingAdverse event reporting

Device: Simply Defined *Device: Simply Defined *

Item used for diagnosis, treatment or prevention of Item used for diagnosis, treatment or prevention of disease, injury or other condition that is not a drug, disease, injury or other condition that is not a drug, biologic or food.biologic or food.

* Actual definition of a device * Actual definition of a device can be found in FD&C Act, can be found in FD&C Act, Section 201(h).Section 201(h).

Medical Device Adverse Medical Device Adverse Event ReportingEvent Reporting

• A model for patient safetyA model for patient safety– Identification and reporting of adverse events Identification and reporting of adverse events

involving medical devices, patients, and usersinvolving medical devices, patients, and users– Information used to evaluate actual and potential Information used to evaluate actual and potential

problems with medical devices during useproblems with medical devices during use

What is an What is an Adverse Event ? Adverse Event ?

An event whereby a death or serious An event whereby a death or serious injury was, or may have been caused by injury was, or may have been caused by a medical device.a medical device.

An event whereby a medical device was, An event whereby a medical device was, or may have contributed to a death or or may have contributed to a death or serious injuryserious injury..

Includes events resulting fromIncludes events resulting from::

- device failure- device failure - improper / inadequate - improper / inadequate designdesign- device malfunction- device malfunction - manufacturing (problems)- manufacturing (problems)- use error- use error - labeling (problems)- labeling (problems)

Serious InjurySerious Injury

results in permanent impairment / results in permanent impairment / damage to body function / damage to body function / structurestructure

requires medical or surgical requires medical or surgical intervention to preclude intervention to preclude permanent impairment / permanent impairment / damage to body function / damage to body function / structurestructure.

Life-Threatening Life-Threatening Injury or IllnessInjury or Illness

MalfunctionMalfunction

The failure of a device to meet its The failure of a device to meet its performanceperformance

specifications or otherwise perform as specifications or otherwise perform as intended.intended.

A malfunction is reportable: A malfunction is reportable: when itwhen it is likely to cause or contribute to a is likely to cause or contribute to a death or serious injury if it were to death or serious injury if it were to recur.recur.

(Malfunctions are (Malfunctions are not required to not required to be reported by User Facilitiesbe reported by User Facilities))

CDRH Reporting ProgramsCDRH Reporting Programs

Voluntary -Voluntary - MedWatchMedWatch

- Reporting by healthcare professionals and Reporting by healthcare professionals and consumersconsumers

- Report actual or potential product problemsReport actual or potential product problems

Mandatory Mandatory - User FacilitiesUser Facilities

- Report deaths and serious injuriesReport deaths and serious injuries

- ManufacturersManufacturers- Report deaths, serious injuries, and malfunctionsReport deaths, serious injuries, and malfunctions

Mandatory Reporting Mandatory Reporting User FacilitiesUser Facilities

• User Facilities required to User Facilities required to report deaths and serious report deaths and serious injuriesinjuries

– 1990 Safe Medical Device Act 1990 Safe Medical Device Act (SMDA) 11/28/90 (SMDA) 11/28/90

– Effective date for User Facilities Effective date for User Facilities 11/28/9111/28/91

– Effective date of Final Rule to Effective date of Final Rule to implement MDR 7/31/96implement MDR 7/31/96

MDR

Regulation---------------

21 CFR 803

What is a User Facility?What is a User Facility?

• HospitalsHospitals

• Ambulatory Surgical Ambulatory Surgical Centers Centers

• Nursing HomesNursing Homes

• Outpatient Diagnostic Outpatient Diagnostic Facilities Facilities

• Outpatient Treatment Outpatient Treatment Facilities Facilities

Mandatory ReportingMandatory Reporting Manufacturers Manufacturers

Manufacturers required to Manufacturers required to report deaths, serious report deaths, serious injuries, and malfunctions injuries, and malfunctions

– Initial Regulation requiring MDR Initial Regulation requiring MDR reporting effective 12/13/84reporting effective 12/13/84

– Reporting requirements revised by Reporting requirements revised by SMDA 1990 & 1992 Amendments SMDA 1990 & 1992 Amendments effective 7/31/96effective 7/31/96

MDR

Regulation---------------

21 CFR 803

What is a Manufacturer?What is a Manufacturer?

Defined to include:Defined to include:•Domestic Domestic

ManufacturersManufacturers•Foreign ManufacturersForeign Manufacturers•Repackagers / Repackagers /

RelabelersRelabelers•Component Component

ManufacturersManufacturers•Hospitals ReprocessingHospitals Reprocessing

Single-Use DevicesSingle-Use Devices

REPORTING TIMEFRAMESREPORTING TIMEFRAMES

DeathsDeathsSerious Injury Serious Injury (if(if manufacturer manufacturer unknown)unknown)

FDAFDA

User User FacilityFacility

Death and Death and Serious Serious InjuryInjury

ManufacturerManufacturerDeathsDeathsSerious InjurySerious InjuryMalfunction Malfunction