Mladen, Andrei and other colleagues,
I fully concur with the usefulness of a common framework to help us
understand big-picture issues. I would like to share my own experience in
using common frameworks to bring out similarities as well as to contrast
dissimilarities between different systems.
For example: I developed a common framework in the WHO Document “Medical
Device Regulation: Global Overview and Guiding Principles”.
(www.who.int/medical_devices/publications/en/MD_Regulations.pdf). That
simple common framework (Table 1, page 10) is key to introducing the readers
to the essence of the five medical device regulatory systems (Australia,
Canada, EU, Japan and USA). It also fits all GHTF guidance documents into
the same common framework (Annex 2, page 40). That common framework brings
out similarities.
On the other hand, I am using another common framework to contrast the
dissimilarities between drugs and medical devices, particularly the beyond
access “burdens” to the healthcare provider. I believe there are
significant differences. Let us first consider the safety aspect:
Figure: A common framework of life-span policy for drugs and
medical devices
The “access” regulatory burden (stage 1) is considerably more for drugs than
for devices because drug regulations are based on extensive review and
testing of all new drugs, while device regulations are based on risk
management approach.
The “beyond access” burdens (stages 2, 3), however, are significantly more
for devices for the following considerations
* The large variety of designs implies the need for technology
assessment and selection to ensure the proposed devices are appropriate
(e.g. compatible with the local human and environmental factors, qualified
operators, clean water, adequate electricity)
* Medical device is like a tool that requires not only knowledge but
also skills to operate. The operator interface stresses the importance of
proper education and training before using any medical devices. In addition,
implantation of active devices often requires effective coordination of a
team of specialists and supporting professionals
* The risk-based regulatory approach mandates post-market monitoring on
device performance as key in ensuring the continued safety and effectiveness
of devices in use.
* Durable medical devices are an asset that needs adequate recurrent
budgeting for proper management and maintenance in operation
* Safe and appropriate disposal. This applied to both disposable and
durable devices
Finally, I believe the “iceberg” burden, the donation of the durables and
the reuse of the disposables are good evidence of “beyond access” issues for
medical devices. HTM professionals has long been striving to gain
recognitions from healthcare decision makers and I believe the “beyond
access burdens” of medical devices should be a good “educational” topic to
promote the importance of HTM.
What do you think?
Michael Cheng
