Managing Medical Device Recalls
MedSun: Newsletter #23, April 2008

By Alex Koustenis

ADVANCE for Nurses, March 2007
When healthcare professionals are informed of a medical device recall, there is often uncertainty about the appropriate action to take within their clinical settings.

This uncertainty can be exacerbated by confusion over the severity of the recall, whether the device needs to be removed from the healthcare facility, what to do about patients currently using the device and what corrective action the manufacturer is going to take.

A medical device recall is initiated when the device is in violation of Food and Drug Administration (FDA) law. This can include the following:

•The device is defective.
•The device poses a risk to patient health.
•The device is both defective and poses a risk to patient health.

For the most part, it is the manufacturer that voluntarily recalls the violative device. They also notify the FDA who oversees the manufacturer's actions to ensure they are adequate to protect the public health.

Keep in mind that the word recall does not necessarily mean that use of the device should be halted or returned. It can sometimes mean that the device requires a field correction on site, such as component replacement or software updates.

In some cases, temporary work arounds or short term instructions are provided for use until the long term fixes are put into place at each device location.

Even if a recalled medical device is an implant, it does not necessarily need to be removed.

Manufacturers often inform doctors of the device's potential to fail unexpectedly and the risks associated with these failures. They also provide monitoring instructions for their patients and allow the physicians to make the risk versus benefit decision on device removal.

FDA classifies a medical device recall into one of three categories; classification usually occurs after the company has issued its recall. These categories, relative degrees of risk, include the following:

Class I Recall

A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences. The manufacturer uses a press statement and a recall letter to notify it's customers with information such as the name of the device being recalled, identifying lot or serial numbers, reason for recall and how to correct, avoid or minimize the problem.

Class II Recall

A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Customers are notified but generally there are no press releases issued.

Class III Recall

A situation in which use of or exposure to a violative product is not likely to cause adverse health consequence. Customers are notified but generally there are no press releases issued.

Classification

Classification serves several functions for FDA, industry, and public including:

•Provides the FDA's Health Hazard decision of the recall for the public and device consignees.
•Enables FDA to set uniform audit recall levels.
•Assists FDA with information to determine the need for Public Warnings.
•Provides guidance for future Industry/FDA recall actions.

Corrective Actions

The types of corrective actions by the manufacturer are often based on the severity of the recall. FDA audits of the recalling firm's actions are also based on the classification of the recall.

Class I recalls are audited with FDA visits to a number of device locations, Class II with phone contacts and Class III by examination of the recalling firm's internal records of its own audit.

These audits are made to ensure the recalling firm has issued a recall notification, that the notification provides the end users with the proper information to initiate the recall at its’ site, understand the defect and risks, and to return, correct, and/or monitor patients with implanted devices as instructed by the recalling firm's notification.

Importantly, healthcare sites should maintain some internal records of each recall conducted at their site and its outcome to facilitate the FDA audit.

When healthcare professionals better understand the meaning of a medical device recall and FDA classifications it prevents confusion over what corrective action to take at each healthcare facility and also helps to ensure the safety of the public.

Alex Koustenis is a member of the Patient Safety Staff at FDA. Michael Verdi, Recall Coordinator for the FDA Center for Devices and Radiological Health, contributed to this report.

Additional Information:

Managing Medical Device Recalls. Koustenis, Alex. ADVANCE for Nurses. March 2007.
http://nursing.advanceweb.com/editorial/content/editorial.aspx?cc=108836

For more information on medical device recalls, visit:
http://www.fda.gov/cdrh/recalls/learn.html

To see FDA Recalls, Market Withdrawals and Safety Alerts, visit:
http://www.fda.gov/oc/po/firmrecalls/recall_defin.html


MedSun Newsletters are available at www.fda.gov/cdrh/medsun