mdi ConsultantsJapan is a critical participant in the global medical device market. on March 11, 2011, a massive earthquake and tsunami occurred near the northeastern coast of Japan, followed by various aftershocks, causing extensive damage to this region. The United States Food and Drug Administration (FDA) regrets any destruction or loss caused by this unforeseen disaster.
The FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) want to alert Industry to possible effects that the above series of events may have on medical devices, electronic products and device components intended for market in the United States
Given the extent of the devastation, CDRH and CBER have concerns about manufacturing conditions as a result of the earthquake and tsunami that could impact the safety and effectiveness of medical devices exported from Japan, intended for import into the US.
FDA’s 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),
- 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.
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 US immediately take the following precautions:
- Assess incoming products and supplies to ensure that the product conforms to your specifications and quality requirements. Closely monitor your 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).
- Check all power cords and batteries, and electric monitoring devices to make sure that they are not damaged by water.
- Heighten assessment of all animal-derived products (e.g., raw heparin) and other raw materials prior to finished device production.
- When possible, screen and assess the potential risk to safety associated with unfinished and finished products.
- Ensure that the manufacturer/supplier in Japan is operational.
- Ensure that pending device orders comply with the Quality System regulation if you intend to market the device in the US.
- If the product or device was manufactured or stored in a location that was flooded, check the product for signs of water damage or exposure to water.
- If the product or device was manufactured in a location that was flooded for a short period of time, the location’s water treatment system might have been contaminated. Determine if the municipal water supply was acceptable or that the affected firm used filtration, deionization, reverse osmosis, etc., to treat water during the manufacturing process. If the municipal water supply or the water treatment system was contaminated, it is practically impossible to manufacture acceptable product.
- If the manufacturer indicates that the water supply is acceptable, obtain documented evidence as verification.
- Determine if the manufacturer has an adequate restart procedure addressing one or more power outages during production.
- Determine the disposition of components or devices that were in production during the time of blackouts, especially devices undergoing sterilization.
- If a product or device was reworked, assure that the firm has adequate standard operating procedures for this process.
- If you label a device with a shelf life, determine if the declared shelf life will be compromised.
- If a device is intended to be sterile, validate the effects of re-sterilization on the finished product.
To determine the potential impact of the earthquake and tsunami on the supply of medical devices distributed in the US, CDRH and CBER suggest the following:
- Evaluate the immediate and long term potential for shortages of parts, ingredients, components, and finished devices. Especially, unique products such as tubing, software, circuit boards, etc., that is currently manufactured by a sole supplier. If a shortage is anticipated, will it affect life sustaining devices, as those used in dialysis or infusion pumps? If so, notify your customers immediately.
- If the primary supplier is not operational, or is currently unable to meet your specifications for any reason, you may want to identify, qualify, and validate a secondary source of components or finished devices.