1. Medical Textiles & Regulations
Infection Prevention
TECHNOTEX
Kulveen Singh Bali
November 18th, 2010
© 3M All Rights Reserved.

2. Regulations and Medical Textile / Products
Need to Regulate
Need to Standardize
Regulations – World View
Regulations – India
Future
© 3M All Rights Reserved.

3. 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.
© 3M All Rights Reserved.

4. Need for Regulations
Medical Textiles, directly and Indirectly are used in Diagnosis, Treatment, Mitigation and Prevention of Diseases.
Prevention – Masks (N95)
Securals – Tapes
Wound Management – Dressings
Infection Prevention – Drapes, Gowns, Masks, Caps
Treatment – Drug Delivery Mechanisms
Implants – Grafts, Mesh, Valves
& many others….
© 3M All Rights Reserved.

5. 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.
© 3M All Rights Reserved.

6. 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.
© 3M All Rights Reserved.

7. 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/
Hong Kong]
Japan
Class A
Class I
Class I, Is (sterile), Im (measuring)
[I]
Class I - Miscellaneous
Class B
Class II
Class IIa
[II]
Class II designated and non-designated
Class C
Class IIb, [III]
Class III, IV
Class D
Class III and Unclassified
Class III, [IV]
* This is not an absolute comparison as there are differences
© 3M All Rights Reserved.

8. EU Device Classification
Classifications for Medical Devices based on rules listed in the Medical Device Directive
Class I and Is
Class I non-sterile – Surgical Mask
Class Is (sterile) – Bandage, Medical tape
Class Im (measuring) – Clinical thermometer
Class II
Class IIa – Surgical drapes
Class IIb – Wound Dressings
Class III –
Implantable products, Tissue products
Drug containing devices (Drug Eluting Stents)
© 3M All Rights Reserved.

9. 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
© 3M All Rights Reserved.

10. History of Regulation in India
Drugs & Cosmetics Act
Gazette notification listing10 Devices as Drugs
MOH submits CDA Bill in Parliament
2002
2004
Oct’ 2005
2006
2007
2009
1940
1989
Clarification listing 14 more Devices as Drugs
Hypodermic Syringes & Needles, Perfusion Sets
MOH forms Expert Comm. to determine regulation for Med. Dev.
DST submits MDRA Bill in Parliament
Drugs & Cosmetics Act in 1940
Rules for the Drugs & Cosmetics Act established in 1945
1989 – Hypodermic Syringes & Needles, Contraceptives (Condoms), & Perfusion Set regulated as Drugs
I2002 – Indian Council Of Medical Research in collaboration with Defence Research & Development Organization & the Society of Bio Medical Technology submitted the Indian Medical Device Regulations Act (IMDRA) to the Ministry of Health.
Based on this (IMDRA), Ministry of Health establishes an Expert Committee with members from Industry, Academia & officials to suggest regulations for Medical Devices in India
In 2004, the Mashelkar Committee called for the creation of a specific medical devices division within the Central Drugs Standard Control Organisation to address the management, approval, certification and quality assurance of medical devices.
In 2005, the Maharashtra Food and Drugs Administration directed manufacturers and importers to obtain a licence from the Drug Controller of India (DCI) for all in-vivo devices, especially drug-coated stents. The FDA initiative followed reports that a leading hospital in Mumbai had used illegal stents on its patients.
June 2005, Maharashtra Food & Drugs Administration holds Drug Eluting Stents (DES) from JJ Hospital. These are found to have been imported with out any registration. High Court intervenes & asks Government to initiate action
The Ministry of Health and F.W. under Gazette notification S.O (E) dated 6/10/2005 declared the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the Act.
1.      Cardiac Stents.
2.      Drug Eluting Stents.
3.      Catheters.
4.      Intra Ocular Lenses.
5.      I.V. Cannulae.
6.      Bone Cements.
7.      Heart Valves.
8.      Scalp Vein Set.
9.      Orthopedic Implants.
10.  Internal Prosthetic replacements.
It was also notified vide GSR 627 (E) dated 7/10/2005 that control over manufacture of these devices would be exercised.
In 2006 Department of Science & Technology submits the Medical Device Regulations Act as a Bill in the Parliament. This bill is an independent exercise conducted by the DST basis various reports of substandard medical devices in India & the lack of controls / regulations for the same
In Jan 2007 Ministry of Health submits Central Drugs Administration Bill in the parliament. This bill is independent of the MDRA (by DST) but there are significant overlaps between the two.
Two bills, Central Drugs Administration (Ministry of Health & Family Welfare) & the Medical Device Regulations Act (Department of Science & Technology), are in the Parliament awaiting decision.
Schedule M-III (Good Manufacturing Practices for Manufacture for Medical Device) is being revised to ensure the quality & safety of contemporary medical devices manufactured / imported into India.
© 3M All Rights Reserved.

11. 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
© 3M All Rights Reserved.

12. 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.
© 3M All Rights Reserved.