Pediatric Medical Device Development and Safety. Jacqueline N. Francis, MD, MPH Medical Officer, PSRB, ODE, CDRH, FDA

Transcription

1 Pediatric Medical Device Development and Safety Jacqueline N. Francis, MD, MPH Medical Officer, PSRB, ODE, CDRH, FDA

2 This presentation represents the professional opinion of the speaker and is not an official document, guidance or policy of the U.S. Government, the Department of Health and Human Services, or the Food and Drug Administration, nor should any official endorsement be inferred.

3 Objectives Explore pediatric medical devices Discuss challenges of pediatric medical device development Address common problems in regulation of pediatric devices Educate audience of FDA challenges in protecting public health related to use of medical devices Inform audience of role that can be played in promoting patient safety

4 Where can we find Pediatric Medical Devices? Hospitals (NICU, PICU, WBN, ER, OR let s say everywhere shall we?) Outpatient Clinics (Primary care, subspecialties, urgent care) Home (Chronic care, ambulatory care,) On persons ( i.e. Artificial pancreas, glucose meters, contact lenses, surgical implants)

5 Types of Medical Devices and Examples Capital Equipment beds, bedrails, scales, wheelchairs, IV poles, infusion pumps, lifts, bathing tubs, blood pressure equipment, MRI and CAT scanners, radiology equipment Instruments lab equipment, surgical staplers, glucometers, pulse oximeters Monitoring Systems Cardiac, telemetry, patient call Implantable defibrillators, hip/knee implants, drug-eluting stents Disposables & Accessories ventilator breathing circuits, filters needles, syringes, trocars, IV catheters, IV tubing, foley catheters, feeding tubes, gloves Reagents Laboratory test components Computerized Medical Systems hardware software versions Surgical Devices Orthopedic spine, cosmetic implants, wound dressings, breast implants, surgical mesh

6 ODE Regulatory Process/Patient Safety Process Pre-market Pre-IDE, IDE, 510K, PMA Goal is to guide industry to provide appropriate evidence of safety and efficacy of devices in order to obtain approval to market devices. Reviewers and consultants review submissions by industry with guidance from CFR, NCCLS and guidance documents. Approval to market devices may be granted, denied or conditionally granted based upon follow-up post-market studies.

7 Objectives Explore pediatric medical devices Discuss challenges of pediatric medical device development Address common problems in regulation of pediatric devices Educate audience of FDA challenges in protecting public health related to use of medical devices Inform audience of role that can be played in promoting patient safety

8 Challenges of pediatric medical device development Pediatric patients are not small adults Pre-IDE process is useful to address concerns that FDA may have related to the performance characteristics of a novel device. Examples include; Implants- As a patient grows will the device need to be replaced? What are long term consequences of having foreign bodies in growing children? In Vitro devices- Will smaller amount of specimen be sufficient for device to yield accurate results? Human Factors- If device is controlled by a parent or child, can those factors affect health outcomes when device is used? Surgical devices- Cautery devices and grounding issues related to patient size and water composition.

9 Clinical Trial Design Challenges Sample Size Inclusion of all age groups with proper stratification Inclusion/Exclusion Criteria Follow-up duration Avoidance of protocol design bias Proper risk assessment Inclusion of persons of different skin types and ethnicities Protocol design that demonstrates efficacy and performance as the device is intended for use Statistical analyses often lack sophistication in reporting of safety

10 Objectives Explore pediatric medical devices Discuss challenges of pediatric medical device development Address common problems in regulation of pediatric devices Educate audience of FDA challenges in protecting public health related to use of medical devices Inform audience of role that can be played in promoting patient safety

11 Problems in regulation of pediatric devices Few Predicates Small pool of data to compare performance characteristics Unanticipated human factors or device related issues Under reporting of adverse events of comparable approved devices

12 Post-Market Reporting/Surveillance Mandatory/Voluntary Reporting MDR Voluntary Reporting MAUDE Medsun Medwatch Formal Post-Market Surveillance (FDA) Informal Post-market Surveillance

13 Medical Device Reporting (MDR)/Mandatory Reporting CFR states that all user facilities, importers and manufacturers must report deaths and serious injury caused or contributed by devices approved for market by the FDA within 10 days of receiving report via MDR. Manufacturers and importers are also required to maintain records of incidents and report certain malfunctions.

14 MDRs Pros Valuable tool in post-market surveillance when utilized. Obliges mandatory reporting of death an injury in a timely fashion Cons Massive under-reporting Difficult to use for tracking and surveillance Relies upon user/manufacturer reporting Lacks denominator data Quality of input is variable Near miss AE under-reported Limited ability to gather additional information

15 MAUDE/ Voluntary Reporting Manufacturer and User Facility Device Experience Database - (MAUDE) Data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August,

16 Medsun Program The Medical Product Surveillance Network (MedSun) is a pilot program launched in hospitals and nursing homes participate, including some of the major teaching hospitals in the country.

17 KIDNET KidNet is a specialty network of MedSun (42 hospitals) Focused on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units (NICUs and PICUs). Initiated June, Stanford Contacts for Medsun/KIDNET are; Renee Bernard, , renbernard@stanfordmed.org Dana Orquiza, ,dorquiza@stanfordmed.org

18 Objectives Explore pediatric medical devices Discuss challenges of pediatric medical device development Address common problems in regulation of pediatric devices Educate audience of FDA challenges in protecting public health related to use of medical devices Inform audience of role that can be played in promoting patient safety

19 Challenges in protecting public health related to use of medical devices Few or no educational requirements or opportunities in allied health programs for; Adverse Event reporting procedures Importance of reporting AE Importance of reading medical device labeling Learning about how devices function

20 Challenges in protecting public health related to use of medical devices (cont.) Many Patient Safety programs in hospitals assign task of reporting of AE to non-medical professionals Concern about reporting AE related to human factors (legal liability) Little or no reporting of near miss device malfunctions Reports lack sufficient detail Small audience of health professionals who monitor FDA publications reporting issues related to medical devices Little interaction between FDA and practitioners

21 Objectives Explore pediatric medical devices Discuss challenges of pediatric medical device development Address common problems in regulation of pediatric devices Educate audience of FDA challenges in protecting public health related to use of medical devices Inform audience of role that can be played in promoting patient safety

22 How can I help improve pediatric patient safety related to medical devices? Participate in clinical trials Read medical device labels for devices you use in practice Be active in hospital or practice patient safety programs and devising treatment algorithms related to medical device performance Become familiar with medical device adverse event reporting Remember that near miss device malfunctions may still cause harm

23 Conclusions When you report device related AE Hospitals improve patient safety Dialogue may be shared between other health systems to protect other patients from AE Promote awareness within FDA about unanticipated AE in future marketed devices Assist FDA in guiding the dialogue about unmet need for pediatric patients

24 Become a Patient Safety Advocate