Placing an emphasis on communication between stakeholders, New Zealand’s medical regulatory body has finalized an update to the code for executing medical device recalls.

“Although the document is much more comprehensive than the previous code, the principles of product recall remain the same and those regularly interacting with Medsafe (such as sponsors) and those receiving communications in the distribution chain will recognize that the processes described have been in place for some time, but have not been formally described in a code,” the agency says.

Among other things, the document defines common recall terminology, describes the levels of recall actions, details the responsibilities of sponsors, wholesalers, retailers and healthcare professionals, and gives an overview of Medsafe’s duties.

Medsafe published the draft version last December and sought comments through Feb. 27. The regulator notes that most submissions backed the code, with 18 stakeholders giving it their full support.

Eleven said they’d support it with a few adjustments, including changing certain terminology in the document and detailing the responsibilities of retailers who are not healthcare professionals.

Ten submitters did not support the code, citing the following reasons:

• A lack of provisions for compensating pharmacists or general practitioners for their time and effort in aiding a recall;
• The use of terminology for medical devices that could be considered inconsistent with EU or international usage; and
• Inconsistency and rigidity of the recall process.

Among the changes from the draft to final version is the addition of healthcare professional to the levels of recall. The original version included wholesale, hospital/laboratory, retail and consumer levels.

The code will go into effect Dec. 1. Read the document at www.fdanews.com/090815-medsafe.pdf. — Elizabeth Hollis