FDA Issues Precautions to Medical Device Firms due to Japan Earthquake
The Food and Drug Administration has issued a letter to foreign and domestic medical device and component establishments recommending certain immediate precautions to counter possible effects of the March 2011 Japan earthquake and Tsunami on medical devices and their components intended for market in the U.S.
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Concerned About Radioactive Contamination, Compromised Performance, Etc.
At this time, neither FDA’s Center for Devices and Radiological Health (CDRH) nor Center for Biologics Evaluation and Research (CBER) has been notified of any defective product or serious adverse events associated with the use of a device related to this disaster.
However, given the extent of the devastation, CDRH and CBER have concerns about manufacturing conditions that could impact the safety and effectiveness of medical devices exported from Japan and intended for import into the US. Their concerns include, but are not limited to, the potential for the following:
- radioactive contamination of devices and/or device components, particularly those derived from animals, such as bovine serum albumin. Contamination in products can occur through uptake of radioisotopes from water or soil to animals through feed. Also, there is the potential for radioactively contaminated device implants to act as reservoirs for internal radiation exposure of patients;
- contaminated water supply that could result in defective products that fail to meet your device specifications;
- loss of electrical power, a source of disruption in the manufacturing process, which directly impacts all components/ devices, specifically those that require refrigeration or temperature controls, such as tissue-based devices;
- compromise in sterile products during or after production, including stored finished product;
- compromise in the reliability of product performance (e.g., electrical connectors, microprocessors, alarms, sensors); and
- damaged and/or disrupted medical device manufacturing facilities in the affected and surrounding region may result in a shortage of components and/or finished devices.
Recommend Increased Monitoring of Inspections, Sampling & Testing
Among other things, CDRH and CBER recommend that electronic product and medical device component manufacturers, finished electronic product and device manufacturers, and initial distributors of electronic product and devices, intended for market in the U.S. immediately take the following precautions:
- assess incoming products and supplies to ensure that the product conforms to specifications and quality requirements;
- closely monitor purchasing and acceptance activities including inspections, sampling, and testing;
- carefully check all products for contamination or compromise, including device integrity such as cracks, breech in sterility, filth, defective equipment, or package integrity (dampness, water residue, mold, unpleasant odors, discoloration, or unreadable labels); and
- check all power cords and batteries, and electric monitoring devices to make sure that they are not damaged by water.
(See notice for further FDA recommendations, including those on devices requiring temperature controlled environments, what to do if you have a pending purchase order, etc.)