POST 00429E : NEEDLE-FREE INJECTORS FOR MASS IMMUNIZATION CAMPAIGNS
Follow up on Posts 00405E, 00408E, 00411E, 00147E, 00420E and 00426E
23 February 2002
_______________________________________________________________________
Mary Catlin of the Young Women's Research
Center,
University of Arizona Cancer Center comments on the topic and also offers
some
help in securing grants if anyone needs such support for evaluating the
device.
_______________________________________________________________________
I believe that needle-free injectors are of such great potential global
importance that an objective quantification of their risks is merited prior
to
their introduction.
WHO/PAHO/FDA recently published A Model Regulatory Program for Medical
Devices:
an International Guide. Essential Drugs and Technology Program, Division of
Health Systems and Services Development. PAHO 2001. (Authors contact info:
John
Stigi at FDA mailto:[email protected], and Antonio Hernandez at PAHO,
mailto:[email protected].) They posted a list of relevant questions for the
reuse of
medical devices that need to be answered. Here are questions that I've
extracted
from their list for our purposes somewhat.
Is there adequate information to determine the safety and clinical
effectiveness
of specific reusable devices?
Are there established methods for reprocessing (cleaning, decontamination,
disinfections and re-sterilizing) prior to re-use and for validating the
integrity of devices reprocessed for use? Note : we need to be concerned
both
with the sterility of the fluid paths as well as the risk of blood-borne
transmission.
What level of sterility and assurance of sterility is desired or acceptable?
Is information available to exclude specific devices from being used?
Is proficiency training necessary for devices to be safely used?
Are there specific requirements of the health care setting that are
necessary
for these devices to be safely used in their settings of intended use
(supplies,
trained user, repair, accompaniment of syringes for back-up, vial sizes,
supervision, water etc)?
What level of surveillance is necessary to avoid product failure and detect
system related errors in use?
If there is a demonstrable level of risk in their use, should health care
providers be encouraged or compelled to obtain patient informed consent
prior to
medical treatment involving reused devices?
We need to understand the risks when used as directed under ideal
conditions,
and the risks when used in the settings of intended use. If things go wrong
with
comparatively simple devices such as disposable syringes, things will go
wrong
with devices of moderate complexity such as mass injectors. If we identify
critical point in advance, we can modify the device, restrict their use to
systems able to use them safely, or train users. We can ameliorate the
risks. So
I believe part of the assessment needs to incorporate - to use FDA lingo -
Human
Factors Analysis.
A useful reference can be found at http://www.fda.gov.chrh/humfac/1497.html
,
Medical device Use-Safety: Incorporating Human Factors Engineering in Risk
Management. issued July 18, 2000.
If I could be of assistance, after March 31, I would be happy to help write
grants to fund a rigorous evaluation of these devices if available funding
is
part of the problem....
Mary Catlin
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