# Presentation: 355546

## Risk-Benefit Communication: FDA Viewpoint

- Megan Moynahan
- Chief, Pacing Defibrillators and Leads Branch
- Food and Drug Administration

## Scope of this presentation
Public communication
Device performance in post-market period

 		 RECALL COMMUNICATIONS
			“Dear Doctor” letters

**Scope of this presentation**
**Public communication**
**Device performance in post-market period**
** ****	****	******** ****RECALL COMMUNICATIONS**
**	****	****	****“****Dear Doctor” letters**

**RISK – BENEFIT COMMUNICATION**

## Firms are required to notify the public about recalled products [21 CFR 7.49]
A weekly Enforcement Report is published by FDA [http://www.fda.gov/opacom/Enforce.html]
During a recall, patients and physicians need balanced information about a device’s performance.

 Recall Notifications are not designed to convey balanced information about device performance.

**Firms are required to notify the public about recalled products [21 CFR 7.49]**
**A weekly Enforcement Report is published by FDA [http://www.fda.gov/opacom/Enforce.html]**
**During a recall, patients and physicians need balanced information about a device’s performance.**
****** ****Recall Notifications are not designed to convey balanced information about device performance.**

**RECALL COMMUNICATION**

## Identification of the product (model, serial numbers).
Explanation of the reason of the recall
Hazard involved.
Instructions on what to do with the recalled product (e.g., “return explanted devices or unopened devices to the firm”).
A means for the physician to communicate back to the company whether they have the recalled product.

**Identification of the product (model, serial numbers).**
**Explanation of the reason of the recall**
**Hazard involved.**
**Instructions on what to do with the recalled product (e.g., “return explanted devices or unopened devices to the firm”).**
**A means for the physician to communicate back to the company whether they have the recalled product.**

**REQUIRED ELEMENTS OF RECALL NOTIFICATION**

## Discussion Point 1a.

- A balanced view of device performance – one that includes both risks and benefits – must come from sources other than recall notifications.

## Other elements in public notifications [derived from “Health Hazard Evaluation”]
Description of deaths a/o injuries that have already occurred;
Discussion of existing conditions that could contribute to the hazard;
Assessment of the hazard to various segments of the population (children, elderly);
Degree of severity of injury;
Likelihood of occurrence of the hazard;
Immediate or long-range consequences of the hazard.

**Other elements in public notifications [derived from “Health Hazard Evaluation”]**
**Description of deaths a/o injuries that have already occurred;**
**Discussion of existing conditions that could contribute to the hazard;**
**Assessment of the hazard to various segments of the population (children, elderly);**
**Degree of severity of injury;**
**Likelihood of occurrence of the hazard;**
**Immediate or long-range consequences of the hazard.**

**OTHER ELEMENTS OF RECALL NOTIFICATION**

## HHE – designed to help FDA classify the recall.
Not intended to be used to make “practice of medicine” decisions about individual patients.

!!
“Recall” does not equate to “explant”;
“Class I recall” does not equate to “explant”
!!

**HHE – designed to help FDA classify the recall.**
**Not intended to be used to make “practice of medicine” decisions about individual patients.**
**!!**
**“****Recall” does not equate to “explant”;**
**“****Class I recall” does not equate to “explant”**
**!!**

**HEALTH HAZARD EVALUATION**

## A recommendations sections is often included
How to tell if a patient’s device has failed or not (if such a test is available);
What to do for those patients whose devices have already failed.

**A recommendations sections is often included**
**How to tell if a patient’s device has failed or not (if such a test is available);**
**What to do for those patients whose devices have already failed.**

**RECALL NOTIFICATION**

## Discussion Point 1c.

- As they are currently drafted, recall communications do not adequately inform physicians what to do for patients whose at-risk devices have not failed.

## Pacemakers and ICDs are life-saving
Catastrophic failure is more causally related to patient death than other devices;
HHE more often skewed to Class I even if probability of failure is very low because of the potential for death as an outcome.

**Pacemakers and ICDs are life-saving**
**Catastrophic failure is more causally related to patient death than other devices;**
**HHE more often skewed to Class I even if probability of failure is very low because of the potential for death as an outcome.**

**PACEMAKERS AND ICDS ARE UNIQUE**

## Pacemakers and ICDs are permanent implants
Advantage:  Easier to calculate patient exposure (1-to-1 relationship between products in service and patients exposed)
Disadvantage:  The need to consider explantation as a possible action

**Pacemakers and ICDs are permanent implants**
**Advantage:  Easier to calculate patient exposure (1-to-1 relationship between products in service and patients exposed)**
**Disadvantage:  The need to consider explantation as a possible action**

**PACEMAKERS AND ICDS ARE UNIQUE**

## Pacemakers and ICDs are “active” implants (e.g., they include electronic and computer-like circuitry)
Disadvantage:  Huge source of potential “failure” modes
Disadvantage:  Software doesn’t fail “deterministically” like physical component failure and therefore can’t be predicted.
Advantage: Errors in software can be easily fixed with reprogramming.

**Pacemakers and ICDs are “active” implants (e.g., they include electronic and computer-like circuitry)**
**Disadvantage:  Huge source of potential “failure” modes**
**Disadvantage:  Software doesn’t fail “deterministically” like physical component failure and therefore can’t be predicted.**
**Advantage: Errors in software can be easily fixed with reprogramming.**

**PACEMAKERS AND ICDS ARE UNIQUE**

## Component failure ≠ catastrophic device failure ≠ patient death.
Disadvantage: Difficult to predict catastrophic device failure given rates of component or software failure
Advantage:  These devices rarely fail catastrophically.
Physician response to PM and ICD recalls is limited:
Explant, reprogram, or “watch-and-wait”.

**Component failure ≠ catastrophic device failure ≠ patient death.**
**Disadvantage: Difficult to predict catastrophic device failure given rates of component or software failure**
**Advantage:  These devices rarely fail catastrophically.**
**Physician response to PM and ICD recalls is limited:**
**Explant, reprogram, or “watch-and-wait”.**

**PACEMAKERS AND ICDS ARE UNIQUE**

## Discussion Point #1b.

- Pacemakers and ICDs have unique characteristics that shape the recall process and *should* shape the content of recall notifications, rather than just relying on the required elements of those notifications.

## Discussion Points - Recap

- A balanced view of device performance – one that includes both risks and benefits – must come from sources other than recall notifications.
- Pacemakers and ICDs have unique characteristics that shape the recall process and *should* shape the content of recall notifications, rather than just relying on the required elements of those notifications.
- As they are currently drafted, recall communications do not adequately inform physicians what to do for patients whose at-risk devices have not failed.