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June 2, 2011
Industry News Update – June 2, 2011
Letter to Foreign and Domestic Medical Device and Component
Establishments That May Be Affected by the March 2011 Japan Earthquake
and Tsunami
Japan 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.
Any questions on this new FDA letter please email us at
info@mdiconsultants.com and Ref: Letter to
industry JAPAN.
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