Advisory for Minimum Essentials Fire Safety Measures

NABH – Advisory for Minimum Essential Fire Safety Measures for All Healthcare Facilities

NABH (National Accreditation Board for Hospitals And Healthcare Providers) has issued an advisory recently on Minimum Essential Fire Safety Measures to be followed by healthcare organizations in the country.

This was the advisory for Minimum Essential Fire Safety Measures applicable to Healthcare Units under all schemes of Certification and Accreditation offered by NABH. These guidelines are meant to ensure patient safety and in no way absolves the organization of fulfilling its statutory obligations with regard to fire safety while implementing Certification, Accreditation Programs in the country.

The Advisory has listed out the scenarios where a Healthcare Organisation has Fire NOC, has No Fire NOC in place. The content of the advisory released by NABH is shared below for information purposes :

Advisory Content :

When the Healthcare Facility has Fire NOC in place, advisory calls for health facilities to check on the compliance to the minimum essential home Act/DHO fire safety measures are in place and or functioning.

Advisory says when the Healthcare facilities don’t have Fire NOC , following steps have to be addressed by a healthcare organisation :

  • Approval/Registration from local health authority Eg: Nursing home Act/DHO
  • If Fire NOC is not applicable, organisation has to provide valid justification for the same.
  • If Fire NOC is applicable, confirm that the organization has applied for fire NOC and there is regular correspondence (at least once in three months) with fire department which is acknowledged. Any correspondence received from the fire department has to be submitted.
  • In the absence of Fire NOC, Third Party Inspection Certificate should be made available.
  • The third-party audit should provide evidence to suggest that statutory norms are adhered to Any Observation by the third party should have been addressed.
  • The third-party inspection certificate is valid for a maximum period of one year
  • Head of the organization/Promoter to give an undertaking on the organization’s letter-head stating that fire safety measures are in place and adhered to at all times.
  • During assessment, verify that the points in the checklist are in place and are functioning

*NABH prescribes that Fire & Life Safety Inspection Certificates under NABCB accreditation issued by NABCB accredited Type ‘A’ Inspection Bodies for Fire & Life Safety Inspections of hospitals/health care providers shall be in accordance with the following:
a. National Building Code of India
b. Model Bill to provide for the maintenance of Fire and Emergency service for the state (2019)
c. Respective State Fire Safety Rules
d. NABH accreditation requirements for fire safety and applicable statutes
e. Any other applicable statutes.

Such Fire & Life Safety Inspection Certificates shall be accepted in lieu of statutory Fire NOC, only for consideration for the purpose of NABH accreditation. This does not absolve the hospitals/health care providers from complying to Fire NOC requirements/any other extent applicable statutes. It shall be sole responsibility of hospitals/health care providers to obtain Fire NOC, as applicable.

NABCB accredited Inspection Bodies shall be required to issue a final Fire & Life Safety Inspection certificate under NABCB accreditation bearing NABCB Accreditation Mark after the inspection is carried out and satisfactory corrective action and resolution of non-conformities, if any.

NABH accreditation requirements for Fire & Life Safety : (in addition to above)

  1. Firefighting equipment like wet riser, hydrants, auto sprinkler, fire alarm system, fire extinguishers of all types and sizes should be available as per table below (adapted from NBC 2016).
  2. Operational and maintenance plan for firefighting equipment including refilling of extinguishers.
  3. Up to date fire drawings to be available. Where applicable, the fire drawings should also specify the location of fire dampers.
  4. Fire detection and smoke detectors exist across all floors. The detectors shall be tested for functionality at regular intervals, and records maintained.
  5. Central fire alarm system is installed at a location which is staffed 24/7.
  6. Fire exit plan for each floor. Exit door should be openable and free from any materials which will obstruct way.
  7. Fire Exit signage on all floors well illuminated/ self-glowing, as per NBC guidelines.
  8. Emergency illumination system in case power goes.
  9. Designated place for assembly of patients and staff in case of fire.
  10. Mock fire drill records and schedule of conduct of drills.

Minimum Requirements for Fire Fighting Installations

Advisory can be downloaded by clicking on the link below.

Source of the Information :
https://nabh.co/Announcement/Revised%20Advisory%20for%20Minimum%20Essential%20Fire%20Safety%20Measures%20-20.09.2022.pdf

Above advisory says that Healthcare organisations need to obtain a Fire and Life Safety Inspection Certificates from Third Parties – Type A accredited Inspection Agencies accredited by NABCB in accordance with NBC 2016 and various other Regulations as mandated under various statutes, Rules, laws of centre , state etc

Hospitals , Healthcare Institutions have to look out for Type A Inspection Bodies (IBs) accredited by NABCB if they don’t have Fire NOC to seek Fire and Life Safety Inspections. Type A IBs have to obtain necessary accreditation scope as per various regulatory requirements, standards in the country. These IBs may have to seek accreditation as per IAF Code 34 ; NACE Code 71 which addresses the Inspection of Buildings activities

At the moment NABCB Accredited IBs with above IAF Scope are not found NABCB Registry. Few IBs may seek Accreditation under above scope to cater to the requirement specified by NABH in future. Healthcare organisations have to refer NABCB’s Registry for more updates on the accredited IBs list.

It’s a good move to encourage healthcare businesses to show compliance and adherence to Regulatory, Statutory requirements by offering Safety and Assurance to the users of healthcare facilities and Employees as well.

Call for ePosters – by Asian Society for Quality in Health Care (ASQua)

World Patient Safety Day 2022 – Poster Competition – invite by ASQua

Asian Society for Quality in Health Care (ASQua) commemorates World Patient Safety Day 2022 with a webinar on 19/Sep/2022 (Monday) at 3:30 pm IST.

Prof.Jeffrey Braithwaite, President, ISQua will provide the Keynote address followed by Speakers from Taiwan, Japan and India deliberating on the WHO Strategic Framework of the Global Patient Safety Challenge. Results of the e-Poster competition conducted will also be announced.

ASQua invites you to submit your poster abstracts under the following tracks to commemorate the theme of WPSD 2022: Medication Safety – 19th September, 2022

  1. Technology to prevent medication harm
  2. Innovative practices in preventing medication harm

Please email your poster to asqua@asquaa.org and make sure the following info included in your email subject:

  1. The event title “2022 WPSD poster”
  2. Main presenting author’s full name
  3. Abstract title

Submission Guidelines (link)

Submission Opens :5th August 2022
Submission Deadline :5th September 2022
Eposter template (www.asquaa.org/wpsd2022)
Submit Abstract to asqua@asquaa.org
Registration Information (www.asquaa.org/wpsd2022)
The link to register for the FREE webinar – https://forms.gle/p7uEzbzjUrPeiTQ78
Notification about acceptance or rejection will be delivered via email to the submitter by 19th September 2022.

All ePosters will be made available on the online ePoster platform of ASQua.

For any additional queries,

Contact
Mr. Saifulhazmi Bin Salihin
Secretariat
Email: asqua@asquaa.org

Frequently Asked Questions ( FAQs) on Medical Device Rules, 2017

CDSCO has released a document on Frequently Asked Questions on Medical Device Rule, 2017

Central Drugs Standard Control Organization (CDSCO) . Directorate General of Health Services, Ministry of Health and Family Welfare, has released a Document on FAQs on Medical Device Rule 2017, to create public awareness about Medical Devices Regulation.

Source : Doc No.: CDSCO/FAQ/MD/01/2018
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadImmunization/FAQmd2018.pdf

Heal in India

Heal in India – Govt plans interpreters, special desks at 10 airports for ease of overseas patients

‘Heal in India’ – Government is likely to announce the initiative on August 15 2022.

The ‘Heal in India’ initiative aims to positioning the country as a global hub for medical and wellness tourism.

Interpreters and special desks at 10 airports, a multi-lingual portal and simplified visa norms are going to be the highlights of the government’s ‘Heal in India’ initiative to boost medical tourism.

The government has identified 44 countries, predominantly African, Latin American, SAARC and Gulf countries from where a large number of people visit India for medical purposes. The 10 identified airports — Delhi, Mumbai, Chennai, Bengaluru, Kolkata, Visakhapatnam, Kochi, Ahmedabad, Hyderabad and Guwahati — see higher footfalls of patients from these 44 countries

The Health Ministry, in collaboration with the National Health Authority, has developed a multi-lingual portal which would be a one-stop shop for services provided by medical travel facilitators and hospitals with an interface for foreign patients. The portal is also likely to be launched on August 15.

The portal will display standardized package rates based on the classification of hospitals and different systems of medicines including modern and traditional systems. It will also have a grievance redressal section as well as an option to submit patient feedback.

There will also be a mechanism to track patient journey by creating a unique health ID under the Ayushman Bharat Digital Mission framework and monitor service delivery in identified health facilities in India

Source:https://m.timesofindia.com/business/india-business/heal-in-india-govt-plans-interpreters-special-desks-at-10-airports-for-ease-of-overseas-patients/articleshow/93408941.cms

Pharma Sector Global Standards

Government of India launches scheme for pharma sector to step up capacity, upgrade to global standards

Move from Volume to Value

Support to Pharma clusters and MSME units to enhance quality and technology improvement

In the launch event of DoP’s Strengthening of Pharmaceuticals Industries – Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare urges the Pharma Industry to make India a global leader in pharma sector and utilize the scheme to upgrade MSMEs to high standards.

On July 21, 2022, Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare formally launched the scheme of Strengthening of Pharmaceuticals Industries at Dr Ambedkhar International Convention Centre, Janpath, New Delhi, in the presence of  Minister of State for Chemicals & Fertilizers and New & Renewable energy Shri Bhagwanth Khuba amidst the strong presence of pharma MSME industry players and representatives of major Pharma Associations. 

The initiatives under the scheme are aimed at further enhancing India’s capabilities in the pharmaceuticals sector with an objective to make it much more competitive in terms of both quality and cost and also aimed at making Indian pharma MSMEs, a part of Global supply chain by incentivizing them to acquire Schedule M and WHO GMP certifications.

The Scheme provides for credit linked capital and interest subsidy for Technology Upgradation of MSME units in pharmaceutical sector, as well as support of up to Rs 20 crore each for common facilities including Research centre, testing labs and ETPs in Pharma Clusters. SIDBI will be the Project management Consultant for implementing the scheme.

The Chemicals and Fertilisers Ministry rolled out the schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI). SIDBI will be the project management consultant for implementing the scheme

Union Minister for Chemicals and Fertilisers Mansukh Mandaviya said the schemes envisage technology upgradation, setting up of common research centres and effluent treatment plants in clusters for the pharma MSMEs and Small companies should be able to upgrade their facilities to global manufacturing standards.

The scheme has three components:

 Assistance to Pharmaceutical Industry for Common Facilities (APICF) – would strengthen the existing pharmaceutical clusters’ capacity for sustained growth. It provides for an assistance of up to 70 per cent of the approved project cost or Rs 20 crore, whichever is less.

 Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) – would facilitate pharmaceutical MSMEs with proven track record to upgrade their technology. The scheme has provisions for a capital subsidy of 10 per cent on loans up to a maximum limit of Rs 10 crore with a minimum repayment period of three years or interest subvention of up to 5 per cent (6 per cent in case of units owned by SC/ST) on reducing balance basis

 Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS), would involve preparation of study reports on topics of importance for the Indian pharma and medical device industry. The scheme is aimed at creating a database of pharma and medical device sectors

Information Source : https://www.moneycontrol.com/news/trends/current-affairs-trends/government-launches-scheme-for-pharma-sector-to-step-up-capacity-upgrade-to-global-standards-8862561.html

https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1843560

Regulatory Updates for IVDMD

Recent Regulatory Updates from CDSCO for IVD Medical Devices in India

Since Class A and B Devices have to show mandatory compliance to Medical Device Rules 2017 in the country wef Ist Oct 2022, majority of the medical devices in India will come under the licensing regime from October 1 2022, as notified by the MoHFW, Govt of India.

In a review meeting held last week, Union Health Minister Mansukh Mandaviya categorically stated there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe.

He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action

The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness.

A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year,  while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

IVDs are also Medical Devices and are subject to the same regulatory framework.

In view of these regulatory compliance, we have compiled the recent released Draft Notifications from CDSCO wrf to IVDs for reference :

Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Notice regarding Draft of New Drugs Medical Devices and Cosmetics Bill, 2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc5Mw==

PCR Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mg==

Rapid / CLIA / ELISA Kits approved for testing of Covid-19 as on 08.07.2022

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3Mw==

Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – 2022-Jul-07

List of laboratories for conducting Performance evaluation of IVD analyzers, instruments and software – 2022-May-05

Updated list of laboratories for conducting Performance evaluation of IVD reagents/kit – 2022-May-05

Classification in IVD medical devices under the provision of MD Rules 2017 -2021-Jul-23

Source – https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Diagnostics/InVitro-Diagnostics/

Health Facility Registry

Ayushman Bharat Digital MissionHealth Facility Registry

Health Facility Registry is a comprehensive repository of health facilities of the country across modern and traditional systems of medicine.  It includes both public and private health facilities including hospitals, clinics, diagnostic laboratories and imaging centers, pharmacies, etc.

Registration will enable health facilities to get connected to India’s digital health ecosystem and allow their listing on a national platform

Who can Register

• Hospital and Clinic
• Diagnostic Laboratory
• Imaging Centre
• Pharmacy
• Cathlab
• Dialysis Center
• Blood Bank
• Modern Medicine ( Allopathy)
• Unani
• Dentistry
• Siddha
• Physiotherapy
• Homeopathy
• Ayurvedha
• Sowa – Rigpa

Benefits of Registration

 Unique & Trustable Identity – Facility ID for identification of health facilities across the ABDM ecosystem
 Ease of doing business – Digitisation of services
 Online Presence & Discoverability – Listing of health facilities on a national platform
 Unified Digital Services – Access to telemedicine, digital health records and HMIS solutions

How to Register?

Login to https://facility.abdm.gov.in/#

• Sign Up as a Facility Manager – Create your Facility Manager ID i.e your Healthcare Professional ID linked to Aadhaar (Your aadhaar must be lined to your mobile number to create your Health ID)
• Select type of facility to view Registration process – Government / Private / PPP
• Search your Healthcare facility
• Fill Registration Form – Enter Facility details, services offered and infrastructure details
• Review and Submit Form for verification
• Verification by District Verifier

User manual for Registration:

Workshop on Patient Safety and Quality Improvement

Education/Interactive Workshop on Documentation Requirement for Patient Safety and Quality Improvement

NABH is organising a Workshop on Documentation Requirement for Patient Safety and Quality Improvement on Sunday, July 17, 2022 between 2 pm to 6 pm.

Like all quality management systems documentation is an essential component of NABH accreditation. NABH standard require various documentation. Documentation which provides correct, complete, current, and consistent information and also effectively meet customer and stakeholder’ requirements should exist in an organisation who is aspiring to implement quality standards.

Who should attend?

1. Medical and Nursing professionals 
2. AYUSH  professionals
3. Administrators
4. Healthcare Management Students
5. Quality Managers

Why one should attend?
1.This training will provide knowledge with which one can create required documents for his / her organisation. This workshop is also going to equip the participant with knowledge about system documentation and how to create hierarchy of policy then procedure and then Work instructions or Standard Operating Procedures (SOP). All documentation moves from one level to the next. The first tier of documentation is the policy. This is the document that defines what will be done and why. Policy needs to be clear, precise and practical, and easy to understand. The second tier of documentation is procedures. Procedures describe the methods that will be used to implement and perform the stated policies. Work instructions or Standard Operating Procedures (SOP) are usually department, machine, service, or task oriented and describe how a job will be done. The instructions are the most detailed of the documentation hierarchy.

2. What constitutes Good Documentation? How to

·  Approve, review and update documents.
·  Changes & current revision status of documents identified
·  Keep relevant versions of applicable documents available at points of use
·  Ensure that documents remain legible and readily identifiable
·  Ensure that documents of external origin identified and their distribution controlled
·  Prevent unintended use of obsolete documents, and archiving.

3. This training will strengthen the understanding of quality principles hence enabling well trained professional to become “Champions” in quality and to apply them to improve quality & work flow.

4. Trained Professionals will learn how quality can reduce errors and hence increase patient safety.

Course material and certificate for participants

Each workshop participant receives course contents including learning and reference material. The workshop will be a combination of theory, demos and panel discussions and will involve active participation.

At the successful completion of workshop candidates will be provided certificate of participation.

Workshop Fee:

The registration can be done by filling the registration format at our web-site (www.nabh.co/login). Registration fee (non-refundable & non-transferable) is Rs. 4,000/- + GST@18% (Total Rs. 4720/). Fees concession of 10% is being provided for the members of Quality Council of India (http://www.qcin.org/nbqp/PMS/).  

Limited seats are available only first come first serve basis. To ensure your participation through online registration.

Programme Date : 17th July, 2022
Programme Timings: 02.00 pm to 06.00 pm

For registration and any other related query please contact      

Mr. Vikash Chaudhary
Administrative Officer
National Accreditation Board for Hospitals & Healthcare Providers (NABH)
Quality Council of India
ITPI Building, 5th Floor, 4 – A, Ring Road, I P Estate,
New Delhi – 110002
Tel: +91 11 42600622 
Fax: +91 11 233 23 415
Email: vikash@nabh.co

PHDCCI Conference

Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices

Chandigarh Chapter, PHDCCI is organizing 5th in the MDR-17 Series| Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices as per the following schedule:

Day & Date: Friday, 15 July 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights

• 7 Basic Quality Management Principles
• Overview of the Certification process and
• Importance of 13485 Certification from Compliance perspective

Key Speakers

• Mr. Mahadevan. J, VP & Business Segment Head – Medical, DQS India- Deutsch Quality Systems (India) Private Limited, Kodihalli, Bengaluru
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications, Qmart Global, Yeshwantpur, Bengaluru
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi
• Col. Rajiv Bhargava(Retd.), Associate Director, Indian School of Business, Mohali

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZYtdOyspjsuGNEyI95QZr_wRhoB9giV413X

You may send your questions to rimneet.kaur@phdcci.in prior to the session. The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

MDR 17 – An Interactive Session with Regulators

Industry, Startups & Innovators Support Session with Regulators on Licensing Requirements for Medical Device Manufacturers, Startups & Innovators in Tamilnadu – MDR 17

Session Topic : Ease Of Doing Business – Industry & Startups Support Session on Licensing Requirements – MDR 17

Date : 23rd July 2022 Saturday
Time : 3 pm – 5 pm
Meeting : Online Meeting

Program Objective:
Medical Device Industry in India is brought under full regulatory purview and industry has to show compliance to the Regulatory announcements made to this effect, from time to time.

Operators dealing with Risk Category Class A and B devices come under the purview of State Licensing Authorities and those dealing with Risk Category Class C & D devices come under the purview of Central Licensing Authority.

Medical Device Manufacturers, Innovators, Startups of Tamilnadu have requested for interactive sessions with Central and State Licensing Authorities and other stakeholders like BIS etc to guide them to implement the regulatory requirements better.

AIMED which is the voice for Indian Medical Device Manufacturers in the country and NHHID – Anna University , a National Hub for Healthcare Instrumentation Development, and Bureau of Indian Standards have collectively agreed to organize periodical sessions for the benefit of the industry and startups, innovators of Tamilnadu.

Target Audience

Medical Device Manufacturers, Innovators, Startups in Medical Device, MedTech space, Academia, Technology Business Incubators, Innovation Hubs, Medical Device Testing Laboratories, Healthcare services organisations – Hospitals, Diagnostics Centers , and other healthcare businesses, stakeholders to Conformity Assessment, Government organizations etc from Tamilnadu

Program Details:

Session would be conducted as Online Meeting, an interactive engagement with Manufacturers, Innovators, Startups .

There is NO REGISTRATION FEE. However , prior registration is a must.

For Enquiries about the Program :
Ms Rama Venugopal, Jt Coordinator,
AIMED – South India
jt.coordinator.south@aimedindia.com

Hub Co-ordinator
NHHID Hub, Anna University, Chennai
au.nhhid@gmail.com
For more details about the NHHID, Anna University , pls visit – https://www.nhhid.org