Page 37 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

10.3 TRIALS WITH SURGICAL PROCEDURES, MEDICAL
DEVICES

In the past two decades medical and health care technology has rapidly
changed. Recently, considerable progress has been made in the
conceptualization and designing of bio-equipments through a series of
technological inventions which have revolutionized the preventive,
diagnostic, rehabilitative, therapeutic (life-supporting or life sustaining
devices) capabilities of medical sciences and biomedical technology.
Several biomedical devices and critical care equipment have been imported
and successfully installed in diagnostic and therapeutic services in the
country. Similarly, various academic and research organizations as well as
private entrepreneurs are taking active interest in the development and
manufacture of medical devices. It is likely that new devices developed in
the country may seek approval after appropriate clinical trials. Only
through good manufacturing practices (GMP) can the end products reach
the stage of large scale utilization by society.

Some low technology devices like thermometer and weighing instruments
seek optional certification from Bangladesh Standard Testing Institute
(BSTI) as a proof of quality, rather than as a pre-market approval. BSTI
certifies and regulates few other low technology devices. But these
procedures are not adequate enough to assure the quality of high
technology medical devices. It appears that some imported high technology
devices, approved or cleared by the country of origin or by the Federal
Drug Administration (FDA) of the United States of America (USA), are
permitted for marketing in the country. Regulatory mechanisms with the
DGDA for certification, quality assurance and post market surveillance of
both imported and indigenous medical devices appear inadequate. As the
capacity of the country in this area is improving gradually, it is clear that
the need for a regulatory mechanism/authority is increasing. In
Bangladesh the concept of regulations governing investigations involving
biomedical devices is relatively new. The attendant health risks through
the errors caused by use of implantable devices require systematic and
rigorous pre-clinical and clinical studies to evaluate their efficacy and
safety besides the quality. For long term safety and/or performance every
implant and installed diagnostic devices needs to be assessed through an
appropriate mechanism. Implementation of these measures, i.e.
evaluation, certification, post-market surveillance and regulatory action in
the event of any inadequacy, is possible only through a well-conceived
regulatory agency, which is supported by adequate legislative safeguards.

All countries which have their own medical device industry; also have
policies and regulatory processes or mechanisms. Most of these countries
(mainly USA, EU, Australia, Japan. China, South Korea, India and Brazil)
are attempting to match the medical device regulations of different

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 33