The general public will now be able to access information about defective device recalls a little earlier than previous years. Food and Drug Administration officials announced that FDA device recall information will be posted on the FDA website more quickly than in the past beginning in 2017. Previously, device recall information was posted only after the FDA had issued a recall classification and the device company in question had announced its decision to remove or recall the device.
A medical device recall provides the means to remove or correct a product that has violated one of the consumer protection laws overseen by the Food and Drug Administration. The FDA’s device recall process is a voluntary action initiated by a device manufacturer in order to protect the public from products that may cause injury or gross deception. Medical device companies are required to recall medical devices that have demonstrated the potential to harm patients or consumers.
Medical Device Recall Data
Device recall data will now be posted when the device company announces a recall removal action and authorizes the FDA to include relevant information in the Center for Devices and Radiological Health’s Medical Device Recalls Database.
The final recall of 2016 was an orthopedic device manufactured by Greatbatch Medical. The device is used during hip replacement surgeries. The defective device, which was equipped with a Standard Offset Cup Impactor and a POM-C handle, was unable to be properly sterilized when tested in a dedicated instrument case. Improperly sterilized surgical devices can cause serious health consequences or even death.
The Food and Drug Administration has announced only one recall so far in 2017, Nurse Assist’s normal saline flush syringes. It was reported that the syringes induce Burkholderia cepacia contamination, a bacterium that causes blood related infections. A total of 39 device recalls were announced by the FDA in 2016, 7 more than in 2015. There were 60 recalls as recently as 2014.
New FDA Policy
The FDA released a statement on January 3, 2017 encouraging medical device manufacturers to continue working with their district recall coordinator. The district recall coordinator will post device recall data only after the manufacturer has indicated that device recall information is ready for publication.
The FDA will post information concerning correction or removal actions in its searchable Device Recalls Database as well as the Open FDA Device Recalls API only after obtaining permission from the medical device company. The agency also said it would update the Medical Device Recalls Database and the Open FDA Device Recalls API when the recall is classified and again when the recall is terminated. The FDA may also publish recall related public notices, market withdrawals, press releases and safety alerts if the medical device in question could potentially present a significant risk to patients or consumers.
Consumer Safety Recalls
Concerned consumers rely on the FDA to provide information about Class I, Class II and Class III medical device recalls. The FDA website includes links that lead consumers to important details and information regarding how to proceed if they own or use a potentially defective product.
Consumers who wish to locate information about a correction or removal action that has not yet been classified are advised to conduct a search of the Medical Device Recalls Database. It should be noted that medical device recall notices are listed according to the date that they are posted rather than the date that the recall was initiated. The device recall initiation date can be found by reading the recall notice.
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