IPC National Conference

National conference on Strengthening Medical Product Safety Surveillance

IPC in association with Ruby Hall Clinic, Pune is organizing a national conference on “Strengthening Medical Product Safety Surveillance” on November 12, 2022 at Sheraton Grand Hotel, Bund Garden Road, Pune- 411001

For more Information Please Check Here: https://bit.ly/3fvDobv

Source:https://www.ipc.gov.in/news-highlights/1048-ipc-in-association-with-ruby-hall-clinic,-pune-is-organizing-a-national-conference-on-%E2%80%9Cstrengthening-medical-product-safety-surveillance%E2%80%9D-on-november-12,-2022-at-sheraton-grand-hotel,-bund-garden-road,-pune-411001.html

HTCT Certification Program

HIV Testing and Counselling Training (HTCT) Certification program

The forthcoming session of a 2-day online HIV Testing and Counselling Training (HTCT) Certification program will be on 15th & 16th (Tuesday and Wednesday) November 2022, this virtual program is conducted between 1.00 PM to 5.00 PM on these 2 days.

This HIV test counselling training certification program (HTCT) is meant for the professionals/staff in the Hospitals, Diagnostic Laboratories and Blood Banks which are NABL (ISO 15189: 2012) / NABH accredited or under preparation for accreditation. This certification program provides training as per the NABL-112 document and NACO guidelines, occupational exposure & post-exposure prophylaxis (PEP), legal and ethical issues related to HIV testing.

Please refer to the attached brochure below for more details about the program and please register via online form using the following link:
https://forms.gle/cVan7oYwvgneje8v7 (this online form needs to be filled in after making the payment)

For queries,
please contact via email: HTCTSAVEETHA@gmail.com / mobile: 7448444221.

World Standards Day 2022 Program

Webinar – World Standards Day (WSD) 2022 Program on Role of Sustainability Standards in International Trade on Oct 14, 2022 – 4 30 pm – 6 00 pm

Sustainable Trade Development and Voluntary Sustainable Standards

Sustainable Development defines international trade as “an engine for inclusive economic growth and poverty reduction, that contributes to the promotion of sustainable development”.

The exponential increase in global trade has enabled many developing countries to pursue economic development through export and export diversification. On the other hand, the nature of trade has changed and that products are now made by bringing parts together from different parts of the world.

Although the expansion of international trade, in the last decade, has brought economic and societal benefits across the globe, it resulted in failing to address the adverse social and environmental and even economic impacts.

Hence, in order for trade to become a ‘sustainable engine’, one approach that seems to be increasingly used is to internalize social, economic and environmental concerns in international trade.

Sustainability Standards play a central role in global trade, and greatly contribute to the improvement of  environmental and social compliance in supply chains. They represent guidelines used by producers, manufacturers, traders, retailers, and service providers to develop good environmental, social, ethical, and food safety practices.

Sustainability standards can unlock new markets for developing countries.

Go Green, Go Sustainable

More and more countries are pursuing green, social and/or sustainable public procurement, therefore standards can play an important role in identifying which products are sustainable.

Adhering to sustainable trade standards can enhance opportunities for market access to retail, corporate and government consumers who are concerned about the sustainability of the products they purchase and the resources they consume in production, use and disposal.

Program Objective

Consultants Consortium of Chennai is organising a Knowledge Session, on the occasion of World Standards Day (WSD), on October 14th 2022.

The program is designed on the topic Sustainability Standards based on the WSD Theme.

Objective of the program is to create awareness to businesses about various National and International Sustainability Standards and hoe implementing the same would increase trade and business opportunities across the globe.

Program Details

Topic – Role of Sustainability Standards in International Trade

Date : October 14th 2022 – Friday

Time : 04 30 pm – 06 00 pm

Meeting Mode – Online / Virtual

Meeting Platform – Zoom

Fee : No Registration Fee.

Program Open for industry and all stakeholders in Conformity Assessment. However, prior registration is a must.

Registration Link

Click the button below for registration

Upon registration, registered delegates will receive meeting link.

Contact

For enquiries, pls email to

contact@ccc-consultants.org

secretariat@ccc-consultants.org

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.

NABH – Notification – 3rd Edition of NABH Standard

NOTIFICATION – IMPLEMENTATION PLAN OF 3 rd EDITION OF THE NABH SHCO ACCREDITATION STANDARDS

The 3rd Edition of NABH SHCO Accreditation Standards along with the Guidebook has been released on 31st August 2022

NABH has released notification on Implementation plan of 3rd Edition of the NABH SHCO Accreditation Standard as follows:

• All accredited SHCOs must be in full compliance with third edition by 1st March 2023 and shall submit the documentary compliance for the same by this date.

• All the assessments (Pre, Final, Renewal, Surveillance) shall be based on Third Edition w. e. f. 1st March 2023

• For all the assessments before 1st March, 2023, decision shall be based on Second Edition. However, such SHCOs would require to comply with the Third edition in next six months from the date of accreditation.

• NABH will not accept any application (New as well as Renewal) on Second Edition Standard after 31st December 2022

The whole process of transition will be completed by 1st March, 2023.

source: NABH/Notification/SHCO/3rd Edition/Imp/2022/7379 dt 7.9.22

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