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

NHA issues hardware guidelines for effective implementation of Ayushman Bharat Digital Mission

NHA issues hardware guidelines for healthcare institutions at State/ UT level to facilitate effective implementation of Ayushman Bharat Digital Mission

The National Health Authority (NHA) issued hardware guidelines across States and Union Territories for healthcare institutions like hospitals, clinics and health and wellness centres to promote digitization in hospitals.

The guidelines provide a basic framework to States/UTs for planning, assessment and procurement of the IT hardware (including IT specifications of various hardware equipment) to operate applications compliant with Ayushman Bharat Digital Mission (ABDM).

The guidelines on the IT hardware specifications to support this ecosystem is available at https://abdm.gov.in:8081/uploads/Hardware_Guidelines_ABDM_e162cf7a7b.pdf. The document will help the States/ UTs in assessing the hardware requirements while planning and procurement of IT assets for healthcare institutions of all scales.

The guidelines published by NHA is suggestive and recommendatory in nature. States/UTs and the health facilities have the flexibility to modify these guidelines based on local requirements and circumstances.

Source: Posted On: 22 AUG 2022 4:17PM by PIB Delhi
source link: https://pib.gov.in/PressReleseDetailm.aspx?PRID=1853603

Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

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

NHA Joins hands with QCI to Accredit ABDM Compliant Healthcare Solutions

National Health Authority (NHA) joins hands with Quality Council of India (QCI) to accredit ABDM compliant healthcare solutions like HMIS/LMIS

The National Health Authority (NHA) has onboarded the Quality Council of India (QCI) for six months to accredit and rate HMIS (Health Management Information System)/ LMIS (Laboratory Information Management System) solutions that have integrated with Ayushman Bharat Digital Mission (ABDM).

NABH will undertake the responsibility of accrediting and rating the ABDM compliant solutions on various parameters, including ease of usage, user interface, pricing, number of modules/features and value for money/pricing so that prospective purchasers may get credible information.

The purpose of this initiative is to encourage innovations by streamlining delivery of health tech services in a significant way. To develop a framework to ensure that ABDM compliant digital healthcare solutions are accredited and rated and to adequate information is available to consumers for choosing one solution over another.

Accredited health tech solutions will help healthcare organizations manage their patient journeys and business more methodically in accordance with ABDM standards. And ultimately, this initiative will help the citizens of India get better and more timely healthcare and help India become one of the leaders in digitization of healthcare in the world”

This accreditation exercise will be conducted in a phased manner. Phase I shall focus on accreditation and rating of HMIS solutions successfully integrated with ABDM. Subsequent phases shall include other subjective parameters and other categories of healthcare solutions like LMIS, Health Lockers, Health Tech,PHR (Personal Health Records) apps etc.

Source : Posted On: 04 AUG 2022 6:12PM by PIB Delhi

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/

Food Safety and Standards Regulations, 2022

Food Safety and Standards Regulations, 2022 – Notification – 34456/2022/REGULATION-FSSAI

FSSAI has issued a Notification (34456/2022/REGULATION-FSSAI) containing draft of certain regulations which the Food Safety and Standards Authority of India proposes to make in super session of the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

These regulations may be called the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022.

Articles of food falling under these regulations are specially processed or formulated for specific nutritional or dietary purpose and shall be clearly distinguishable from foods intended for normal consumption by their special composition.

Categories covered under these regulations include: (a) Health Supplements (HS) (b) Nutraceuticals (Nutra) (c) Food for Special Dietary Use (FSDU) (d) Food for Special Medical Purpose(FSMP) (e) Prebiotic food and Probiotic food (Pre-Pro)

The draft regulations shall be taken into consideration after the expiry of the period of sixty days from the date on which copies of the Gazette containing this notification are made available to the public.

Objections or suggestions, if any, may be addressed to the Chief Executive Officer, Food Safety and Standards Authority of India, FDA Bhawan, Kotla Road, New Delhi- 110002 or sent on email at regulation@fssai.gov.in

Source link: https://www.fssai.gov.in/upload/uploadfiles/files/Draft_Notification_Health_29_06_2022.pdf

Advisory from National Medical Commission

Advisory from National Medical Commission ( Administration Section )

National Medical Commission has issued an advisory note on 27th July 2022 to all Medical Colleges and Institutions to install cameras in their Institute premises at prescribed locations with the suggested specifications given in the advisory note.

Source link: https://www.nmc.org.in/MCIRest/open/getDocumentpath=/Documents/Public/Portal/LatestNews/20220727062249.pdf