Transcript Medical Textiles & Regulations by Mr. Kulveen Singh Bali, 3M

3M Infection Prevention Division
Medical Textiles & Regulations
Infection Prevention
TECHNOTEX - 2010
Kulveen Singh Bali
November 18th, 2010
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3M Infection Prevention Division
Regulations and Medical Textile / Products
 Need to Regulate
 Need to Standardize
 Regulations – World View
 Regulations – India
 Future
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3M Infection Prevention Division
Need for Regulations
 Need to Protect Patient
 An individual inflicted with a disease has a defense mechanism
which is burdened / compromised and therefore susceptible to
secondary infections.
 Need to Protect Care Giver and Healthy Individuals
 Diseases such as SARS and H1N1 have opened our eyes to the
importance of controlling the spread of disease.
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3M Infection Prevention Division
Need for Regulations
 Medical Textiles, directly and Indirectly are used in
Diagnosis, Treatment, Mitigation and Prevention of
Diseases.
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Prevention – Masks (N95)
Securals – Tapes
Wound Management – Dressings
Infection Prevention – Drapes, Gowns, Masks, Caps
Treatment – Drug Delivery Mechanisms
Implants – Grafts, Mesh, Valves
& many others….
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Need to Standardize Specifications
 Standards help users and manufacturers to comply to the
requirements (implied and stated) of the product.
 Given the intricate nature of medical textiles, it is imperative
for standards to be available which ensure Patient Safety
while conforming to the intended use.
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3M Infection Prevention Division
Regulations – Drugs vs Medical Devices
 ‘Drugs’ were regulated by virtue of controlling their
manufacture, testing, storage and use along with their
development based on clinical trials
 The need for regulating ‘Medical Devices’ was necessitated
by the increasing use of ‘engineered’ products with non
pharmacological action.
 World over, Medical Devices are being increasingly
regulated separately.
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Classification of Medical Devices – A Comparison between Economies*
List based = U.S and Japan: Rule based GHTF and EU/Aus/CANADA/AHWP
GHTF
United States
European Union
[Australia/Canada/
Japan
Hong Kong]
Class A
Class I
Class I, Is (sterile), Im
(measuring)
Class I Miscellaneous
[I]
Class B
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Class II
Class IIa
[II]
Class II designated
and non-designated
Class III, IV
Class C
Class II
Class IIb, [III]
Class D
Class III and
Unclassified
Class III, [IV]
* This is not an absolute comparison as there are differences
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US FDA Device Classification System
 List based system in CFR and on the Internet
 Class I – Low risk to user/patient
 Class II – Moderate risk to user/patient
 Class III – High risk to user/patient
 Unclassified - These device require the manufacturer to check with FDA
on how to obtain market clearance
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History of Regulation in India
Drugs &
Cosmetics Act
Gazette notification
listing10 Devices as
Drugs
MOH submits CDA Bill
in Parliament
1940 1989
2002
Hypodermic
Syringes &
Needles,
Perfusion Sets
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2004
MOH forms Expert
Comm. to
determine
regulation for Med.
Dev.
Oct’ 2005
2006
DST submits
MDRA Bill in
Parliament
2007
2009
Clarification listing 14
more Devices as Drugs
3M Infection Prevention Division
India – Regulatory Status
 Woven Cotton Bandages and Gauze covered under the
Drugs & Cosmetics Act
 Indian Pharmacopeia, too mentions about cotton and
viscose as woven fabrics and does not refer to Non Wovens
 Though, most of the Medical Textile products are currently
regulated as ‘Drugs’ there are some ‘Implants’ which are
regulated as Medical Devices.
 Regulations for Medical Devices are being formulated
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Future of Medical Textile / Products
 The definition of drug as given in the Drugs & Cosmetics Act
of 1940 brings under its purview most of the Medical Textile
/ products under its purview.
 The issues raised with the ‘application of Drugs Rules’ on
Medical Devices impacts the industry and needs to be
addressed.
 The Ministry of Health & Family Welfare is currently working
on bringing in Medical Device specific regulations.
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