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Medical Device
Manufacturing : UNDERSTANDING IMPORTANT ISSUES
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Dr G L Jain |
Medical
Devices have been regulated under Drugs & Cosmetic Act
1940 & Rules 1945 for more than four decades now. Rules
76, 109, 124, 125 cover licensing of manufacturing units,
labeling, Standard respectively whereas, Schedule M III
spells out GMP requirements. However, Medical Devices
have not been defined properly and there is no specific
section that prescribes Medical Devices in toto. Only few
devices were covered earlier but the Ministry of Health
and F.W. under Gazette notification S.O. 1468 (E) dated
6/10/2005 declared the following devices to be considered
as drugs under Section 3 (b) (iv) of the Act. |
|
1. |
Cardiac
Stents |
6. |
Bone
Cements |
| 2. |
Drug
Eluting Stents |
7. |
Heart
Valves |
| 3. |
Catheters |
8. |
Scalp Vein
Set |
| 4 |
Intra
Ocular Lenses |
9. |
Orthopedic
Implants |
| 5. |
I.V.
Cannulae |
10. |
Internal
Prosthetic replacements |
The term
medical devices covers a vast range of equipment, from
simple tongue depressors to haemodialysis machines. Like
medicines and other health technologies, they are
essential for patient care - at the bedside, at the rural
health clinic or at the large, specialized hospital. More
than 1,50,000 different medical devices are available on
the market and the total estimated business is over US$
250 billion (Rs. 12,00,000 crores). With innovation and
the rapid advancement of technologies, medical devices are
currently one of the fastest growing industries.
Since
little regulatory controls exists in our country, lives
are at risk. In last two years, steps have been initiated
by the Government to bring in an umbrella regulation for
medical device.
Indian
Medical Device Industry is still in its infancy. In
absence of clear guidelines from the regulatory
agencies, this status will continue for some more time.
However, who so ever wanting to attempt on
manufacturing of Medical Device in the country has to
understand various aspects including Good Manufacturing
Practices.
First of
all, two most important aspects are Safety &
Effectiveness. Medical devices should be designed and
manufactured in such a way that -
* when used
under the conditions and for the purposes intended, they
will not compromise the clinical condition or the safety
of patients,
* any risks
which may be associated with their use constitute
acceptable risks when weighed against the benefits to the
patient.
The goal,
therefore, is to maximize benefit and minimize risk.
Manufacturers of medical devices also use the risk
management approach.
Furthermore, every device has a designed purpose. A device
is clinically effective when it produces the effect
intended by the manufacturer relative to the medical
condition. Clinical effectiveness is a good indicator of
device performance. Performance, however, may include
technical functions in addition to clinical effectiveness.
For example, an alarm feature may not directly contribute
to clinical effectiveness but would serve other useful
purposes.
A
series of technical notes on the subject will be published
in the magazine to make the readers aware of these
aspects. The topics to be covered are :
-
Definition
and Classification of Medical Devices
-
Safety &
Effectiveness of Medical Devices
-
Phases in the life cycle of a device
-
Standards
-
Building &
Premises
-
Clean room
concepts : Air Handling System
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Documentation
-
Personnel
-
Material
Management
-
Medical
Device Reporting
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-
Recall
System & Complaint Handling
-
Risk
Management Approach
-
Statistical
Sampling Techniques
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Self
Inspection & Internal Audit
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Labeling &
Packaging
-
Hygiene &
Sanitation
-
Inspection
-
Validation
-
Sterilization
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Post Market
Surveillance
-
International bodies and useful references
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The
existing and prospective manufacturers will utilize these
notes for the uplift of the Medical Device Industry and
better health care of human being.
If you have questions related to
this subject, please write to Dr G L Jain at
drgljain@medisourceasia.com
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Dr G L Jain A Gold Medalist in M. Sc., Dr.
Jain was inclined towards industry right from the
beginning of his career. He joined Shriram Chemical
Industries, Kota as Foreman & thereafter completed Ph.
D. from I.I.T., New Delhi. Dr. Jain got his training
in the field of Pharmaceutical and Medical Devices
through Technical Courses; visiting Manufacturing
units & Laboratories world-over; Regulatory Agencies
like USFDA; Health & Welfare, Canada; BSI, UK;
National Drugs Control Organization, Finland; WHO,
Geneva; CEN; Brussels. He was with USFDA for two
months for training on various aspects of GMP/PMA/NDA
& Inspection.
Besides 17 years in academic institutions like, IIT
and AIIMS, New Delhi, he has hands-on experience of
working in industries for 9 years.
He is an expert on cGMP. In last 15 years, he has
conducted more than two dozen Training Courses on
Quality Assurance & GMP. Amongst his topics of
interest are Building & Premises; Documentation; Clean
Room Concepts; Microbiology & Industrial
Sterilization; Statistical Sampling, Validation and
Quality Management Systems. He has set-up two Medical
Device Manufacturing Facilities. One of the facilities
is certified for WHO-GMP and is a model manufacturing
facility in the country. He has also set up a
Consultancy Service Provider firm ‘ Centre for Active
Learning, Guidance & Solutions’ at Udaipur, India.
He is well known for his high teaching, management,
planning, organizing & leadership capabilities. He has
been Technical Consultant to many industries. |
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