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This is forwarded from Bill Mee
wwm@sa*.ne*
Any comments, write to him. If you just want to argue, write to
me, not Mee.
The dive equipment industry stands out from other examples of American
enterprise in that many of its products deviate from the most basic
international standards of design quality control and overall quality
assurance.
Terms such as ISO 9000 and ASQC 91 -94, are rarely mentioned amoung the
innovators and entrepeneurs of this industry. The recent raging discussion, of
late, regarding lighting systems, is a perfect example of why design quality
assurance should be applied to something as conceptually simple as a light. A
light constitutes a basic life support system, for those who dive in overhead
environments, and should be accorded the highest level of design concern. I
suppose those of us who own or owned Dive Rite lights were part of their ad
hoc live subject testing program.
Dive Rite's transgressions are small potatoes compared to what is beginning to
go down in the emergent rebreather industry. Most of you have noted that
rebreathers are being afforded big coverage at the upcoming TEK 96 conference
in
New Orleans. There you will have an opportunity to try out some rebreathers and
pay extra to obtain course credits in the operation of certain devices. For
the
most part the dive equipment industry has escaped the sort of federal regulation
that many businesses, particularly the medical device and military
manufacturing
industries are faced with on a regular basis. Are they ever in for a big
surprise! Wait until a few more hapless individuals die while "testing" new
technology rebreathers or die while using some of the "new" commercially
marketed devices. It's not a great stretch of the imagination to see
rebreathers being considered as class III medical devices. You don't have to
be
a rocket scientist to realize that they are a serious life support system whose
failure can have potentially fatal consequences. In fact FYI let me restate the
Federal Government's (read FDA) description of a class III medical device as
per
CFR 860.3(C(3)).
(3) "Class III" means the class of devices for which pre-market approval
is or will be required in accordance with section 515 of the act (Food Drug and
Cosmetic actt). A device is in class III if insufficient information exists to
determine that general controls are sufficient to provide reasonable assurance
of its safety and effectiveness or to establish a performance standard to
provide such assurance and if, in addition, the device is LIFE SUPPORTING or
LIFE SUSTAINING or for a use which is of substantial importance in preventing
impairment of human health, or if the device presents a potential unreasonable
risk of illness or injury. (Would you argue that rebreathers don't fall into
this category)?
A premarket approval (PMA) is required to obtain authorization to market a
class
III device. The premarket approval process requires that the safety and
effectiveness of the device be determined through a process of approved
studies,
submission of extensive performance validation data, proof of compliance with
performance standards, fulfillment of safety and effectiveness criteria and
extensive design control validation to name a few. Devices which are
software controlled are subject to another whole tier of performance validation
and design control procedures.
Before the device can be used in a study an Investigational Device Exemption
(IDE) must be obtained which will afford the principal investigator
authorization to test the device on human subjects. Before the IDE can be
issued a study design must be in place and among other things an Instiutional
Review Board (IRB) must exist to oversee the study. This process is far too
lengthy to adequately describe in this discussion. It is worthwhile to mention
that obvious things such as informed consent documents for the study
participants and investigator background reviews are required. By the way, if
an
investigator has a chequered past (i.e. concocted or falsified experimental
data) not only can the entire study results be thrown out, but the sponsoring
company can be subject to civil and criminal penalties. If any part of the PMA
process is not conducted according to the guidelines it can be summarily
invalidated, putting the unfortunate company back to square one.
If a company markets a Class III device without a proper PMA it is guilty of
adulteration and misbranding under section 501 and 502 of the Food Drug and
Cosmetic act. The penalties for these transgressions are too numerous to
mention.
If someone is injured (or killed) by a medical device another entire process
known as Medical Device Reporting (MDR) is invoked. If these procedures are
not
followed the criminal, civil and administrative penalties can defy the
imagination.
When you are invited to test a rebreather (or invest in a rebreather company)
why don't you ask the manufacturer who their IRB is. Ask them about the sort of
design control they have performed and whether they have made some effort to
conform to ISO 9000 standards. Ask them about their hazards matrix. If you find
that they designed the rebreather in their garage and they don't know "
no human subject consent forms". Perhaps you should stick with conventional
open
circuit scuba for the time being.
Bill Mee
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