Medical Device – Product Recall

Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO

Medical Device Alert on Ventilator of Philips Announcement from CDSCO

Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI)Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:

Dear Healthcare Professionals,

As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM3MQ==

Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.

If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :

https://www.ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf

Please email your feedback along with duly filled field safety form to :

Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.

Downloads :

About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/

About IPC – https://www.ipc.gov.in/

About MVPI Program Launched by IPC :

Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.

Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.

For more information about MVPI, download the document below :

Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :

Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.

Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.

Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.

Parakh – Unified Laboratory Network

Launched by DPIIT, Ministry of Commerce, Govt of India – National Network of Laboratories Infrastructure

What is #Parakh ?

#Parakh is a Government of India initiative for mapping of testing and laboratory infrastructure across the country on a unified network of testing laboratories. This is yet another significant step towards enhancing Ease of Doing Business. This portal incorporates all the accredited and recognised laboratories in the country on a Geographic Information System.

This is an interactive and user friendly system to find a Laboratories and Tests based on various parameters a user may require.

This program is a joint initiative of various boards, councils as mentioned below :

MSME
CSIR
DRDO
Textile Committee
NABL
Bureau of Indian Standards
FSSAI
Export Inspection Council, EIC India
APEDA

All types of Testing, Calibration Laboratories which are Recognised and Accredited are found in the portal.

This is an initiative which will benefit all citizens, user communities to have access to information related to various testing labs in the country that tests products or services.

Pandemic crisis has brought out this huge gap in the country’s lab infrastructure related information where no information was available about testing labs for PPEs, Ventilators, various other medical devices, Covid testing labs etc. All stakeholders were shunted from pillar to post hunting to testing labs information. Intense debates, discussions had taken place about lack of information about National Testing Labs Infrastructure. That’s how DPIIT has initiated the process to create the National Network of Laboratories which will immensely benefit not only domestic trade but International Trade as well.

Portal currently has a list of :

  • 6581 laboratories offering testing services related to
    • 60558 products and services
    • following 367209 Test Methods

All Laboratories in the country are open to get their laboratories listed in the portal.

Source – https://parakh.ncog.gov.in/indexpage

World Accreditation Day 2021 Celebrations

Word Accreditation Day Celebrations 2021 – Organised by Consultants Consortium of Chennai

World Accreditation Day 2021

Theme – Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs)

09 June 2021 marks World Accreditation Day (#WAD2021), a global initiative established by IAF and ILAC to promote the value of accreditation. This year’s theme is Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs). 

The SDGs are at the core of the United Nations’ 2030 Agenda for Sustainable Development, a broad and ambitious plan of action with the overarching objective of leaving no one behind. Accreditation, in collaboration with other quality infrastructure institutions, provides the technical foundations that are critical to the functioning of developed and developing societies. It enables industrial development, trade competitiveness in global markets, efficient use of natural and human resources, food safety, and health and environmental protection.

IAF and ILAC have published a joint WAD 2021 statement by the IAF and ILAC Chairs, a brochure and a poster:

In addition, three videos with the themes of People, Planet and Prosperity will be released on the IAF-ILAC Youtube channel in mid-May. These three pillars group the SDGs according to common goals and are reflective of publications from UNIDOOECD and UNDP.

The Public Sector Assurance and Business Benefits websites, which contain case studies, research and supporting materials demonstrating the benefits and value of accreditation, also now feature an option for searching by SDG. 

While the COVID-19 pandemic may again disrupt physical WAD events, we encourage everyone to celebrate with us online using the hashtag #WAD2021 and to contact your local accreditation body for further details on local media and online seminars and programs they may be organising.

Source : https://www.iaf.nu/articles/World_Accreditation_Day_2021/685

About Consultants Consortium of Chennai – CCC :

Consultants Consortium of Chennai (CCC) is an Association of Management Systems Consultants, registered under the Tamil nadu Societies Registration Act, 1975.

The Key Objective of CCC is to work in alignment with the National Quality Mission launched by the Government of India by educating the industry about the role and importance of Standards, Certifications and Regulations in the country as well as in the global markets.

CCC strives to encourage Responsible Consulting through Members of its Association and focus is to Standardize Consulting Practices in alignment with changing market and industry needs in a dynamic manner.

The focus is also to identify areas and industries in which the consultants in the profession of Management Systems Consulting can contribute to the betterment of the society and the country and to promote Management Systems Consulting in such areas or industries.

One of the core objectives is to collaborate with various Industry platforms, Trade Associations, Chambers of Commerce, Management Associations, Apex Bodies of Government or Quasi Government Organization to contribute to the betterment of the industry initiatives, which will in turn contribute to the betterment of the society.

Webinar Series organised by CCC :

CCC has organised #WAD2020 successfully. Same initiative is planned by CCC for 2021 as well.
CCC has tentatively scheduled a week long sessions with following topics :

Registrations :

Entry is free for all Management Systems Consultants, Technical Experts, Industry Experts, Professionals, Industry Members, Academia , Students, Members of Trade & Industry Associations

Program Dates are listed above.

Registration Link :

Prior Regn is a MUST for Participation. All regd participants will get email confirmations 2 days before the commencement of the sessions.

For queries on Regns, email can be sent to :

Ms Rama Venugopal – contact@ccc-consultants.org – +919840870532
Mr D Srikanthan – secretariat@ccc-consultants.org – +919003056539

Do visit CCC Website for regular updates – http://ccc-consultants.org/wad-2021-celebrations/

Emergency Credit Line Guarantee Scheme (ECLGS) expanded

ECLGS 4.0 for onsite oxygen generation, wider coverage of ECLGS 3.0 and increase in tenorfor ECLGS 1.0

ANNOUNCEMENT MADE ON 30 MAY 2021 BY PIBECLGS Scheme

On account of the disruptions caused by the second wave of COVID 19 pandemic to businesses across
various sectors of the economy,Government has further enlarged the scope of Emergency Credit Line
Guarantee Scheme as under:

(i) ECLGS 4.0:100% guarantee cover to loans up to Rs.2 crore to hospitals/nursing homes/clinics/medical colleges for setting up on-site oxygen generation plants, interest rate capped at 7.5%;

(ii) Borrowers who are eligible for restructuring as per RBI guidelines of May 05, 2021 and had availed loans under ECLGS 1.0 of overall tenure of four years comprising of repayment of interest only during the first 12 months withrepayment of principal and interest in 36 months thereafter will now be able to avail a tenure of five years for their ECLGS loan i.e. repayment of interest only for the first 24 months with repayment of principal and interest in 36 months thereafter;

(iii) Additional ECLGS assistance of upto 10% of the outstanding as on February 29, 2020 to borrowers covered under ECLGS 1.0, in tandem with restructuring as per RBI guidelines of May 05, 2021;

(iv) Current ceiling of Rs. 500 Cr. of loan outstanding for eligibility under ECLGS 3.0 to be removed, subject to maximum additional ECLGS assistance to each borrower being limited to 40% or Rs.200 crore, whichever is lower;

(v) Civil Aviation sector to be eligible under ECLGS 3.0

(vi) Validity of ECLGS extended to 30.09.2021 or till guarantees for an amount of Rs.3 lakh crore are Issued. Disbursement under the scheme permittedup to31.12.2021.

The modifications in ECLGS,would enhance the utility and impact of ECLGS by providing additional support
to MSMEs, safeguarding livelihoods and helping in seamless resumption of business activity. These changes
will further facilitate flow of institutional credit at reasonable terms.

Detailed operational guidelines in this regard are being separately issued by the National Credit Guarantee Trustee Company (NCGTC).

Sources : https://pib.gov.in/PressReleasePage.aspx?PRID=1708709

More Information available at :

ECLGS Website – https://www.eclgs.com/

Download the Operational Guidelines of the Scheme from here

Download the FAQs on the scheme from here

Customers Quality Systems – Supply Chain getting Trained

Orientation Program for IVD Manufacturers about Various Quality Systems Programs implemented by their User Industry – Hospitals, Med Labs , Other Healthcare Organisations

Supply Chain is showing interest to learn about various Quality Systems implemented by their Customers

Customers Quality Systems – Supply Chain getting Trained

Got a call from an IVD Manufacturer last week expressing interest to get his team trained on various Quality Management Systems followed by healthcare organisations.

I first thought I heard it wrong, I thought he was seeking training for his team on Med Dev QMS. When I asked the question, he said NO and his question is about getting his team members understand a little about various QMS Programs implemented by their customers like NABL, NABH , CAP, QAI Programs.

I was a little surprised and asked him for the reason for choosing a topic like this, though I could quickly guess where he would be heading to. He has mentioned that they are supplying their products to multiple categories of healthcare organisations . Each one comes up with some Certification, Accreditation program that they are implementing. Having implemented Med Dev QMS & Product Certification Programs in house, he felt that its appropriate for his team to acquire some basic knowledge about their Customers Quality Systems Programs and ensuring that as Vendors to the respective healthcare orgns, they would prefer to provide necessary inputs, information that are needed by these Healthcare Organisations (HCOs) during their Quality journey.

This is what is emerging across the globe. Many businesses / sectors are ensuring that their Supply Chain is also in sync with their Quality Systems Journey. When a Mfrer or a Service Provider delivers a Product or a Service to end user / customer, as a finished good, he/she has to doubly ensure that his supply chain also maintains high Quality Standards. It becomes imperative for the Vendors, Suppliers , Stakeholders who are part of the supply chain to be in sync, in alignment with the Quality Systems adopted by their customers.

Similarly, businesses that are seeking support from suppliers, should also make an effort to understand the Quality Systems – be it Product or Systems Certifications, implemented by the Suppliers in their respective organisations. This is the fundamental requirement of Vendor Evaluation in any business. Understanding the Suppliers Quality Systems Programs Matters for Businesses too ! Many Regulated Business Sectors, across the globe, have initiated this exercise of bringing the Supply Chain under some Quality Standards, Systems Programs. Automotive Sector was the 1st sector to introduce this almost 2 decades ago. Many other sectors which are under Regulatory Control are slowly introducing this concept.

This manufacturers/suppliers, being the suppliers to many healthcare organisations, come under the supplier category to these businesses. Healthcare Sector being regulated (be it Products or Services) in the country now, Supplier Quality Compliance will become a norm sooner or later.

We have customised a 3 day program for the IVD Mfrer’s team comprising of :
– Technical Team
– Sales Team
– Customer Support Team
– Management Team

The program was designed in such a manner to provide them a bird’s eye view on various Healthcare Certification, Accreditation Programs that are currently available in India for healthcare businesses to choose.

We have also designed a session on Minimum Standards that are adopted in the country as Regulatory spec which addresses basic QMS to be implemented by Med Labs in the country.

It was interesting session fielding questions from IVD Mfrers about Quality Systems Programs in HCOs.

  • Some interesting questions posed by them :
  • For a start up lab, Is there a bare minimum period required to get the accreditation, if all the criteria is met?
  • Is there any minimal number of parameters in scope of testing for applying certification ?
  • What is the difference betn Certification & Accreditation Program when most of the quality mgmt systems clauses are similar ?
  • Is it compulsory to do ILC ? Frequency ?
  • When there are multiple Certification , Accreditation Programs available for Med Labs, how to differentiate and choose a relevant, appropriate program for HCO

Matured Participants and the Quality of the interactions was highly invigorating .

Were actually surprised when they were asking questions related to :
– Voluntary withdrawal from Accreditations :
– Suspensions criteria
– Eligibility of the HCOs to reapply
– Normal scenarios , reasons for such actions taken by Accreditation Bodies
– Any penalties , punishments for non compliances

Some screen shots from the session :

3 days of orientation program came to a close today. Bird’s eye view of all National , International Certification, Accreditation Programs , Minimum Standards – Regulatory requirements were covered. Program was well received and appreciated by the participants.

Informative, customised content, pretty detailed, well explained, looking forward to detailed sessions

Some feedback received by the end of the session.

Moving forward, Quality Systems Implementation Programs become more inclusive in nature in near future. Businesses will ensure Quality of their Supply Chain and Suppliers will show more interest to learn about their Customers Quality Systems Implementation Programs. More inclusive it becomes, supply chain gets strengthened and end users will be assured of better Quality & Safe Products and Services.

Session was handled by :
Dr Srivatsan , Expert – Healthcare Quality Management Systems
A A Srinivasan – Principal Consultant
Chithambaranathan – Associate Consultant

Posted by :

Rama Venugopal
Executive Director
Value Added Corporate Services P Ltd
Click Here for More Updates

Announcement from NABL

QR Code in Test Reports / Calibration Certificates Made Mandatory

Mandatory QR Code in Test Reports issued by Medical Labs Announcement from NABL

QR Code on the Medical Test Reports Medical laboratories may note that, in a memorandum issued on 13.05.2021 by the Ministry of Civil Aviation, Government of India, it is mandatory for travellers flying abroad to carry their negative RT-PCR test report having QR codes linking to the original report.

Medical Laboratories should provide QR code on all test reports issued which can be scanned using any QR scanning application available on mobile / any devices to authenticate and reproduce the test report online. This will prevent the manipulation of test results & the usage of fake test reports.

Laboratories to ensure that all the requirements of ISO 15189, NABL, regulators are met. Authorized test results in a tamper-proof and non-editable test report will build trust in laboratory results.

Download the advisory from NABL here

Mandatory QR Code on the Test Reports issued by Testing Labs / Calibration Certificates issued by Calibration Labs

Labs should provide QR code on all test reports/calibration certificates issued which can be scanned using any QR scanning application available on mobile / any devices to authenticate and reproduce the test report/calibration certificate online.

This will prevent the manipulation of test results/calibration data & the circulation of forged test report/calibration certificate in the market. Interest of the consumer / end user of the product and the reputation /Image of the lab are also protected.

Download the advisory from NABL here

Source : https://nabl-india.org/

Advisory on Oxygen Concentrators from CDSCO

COVID-19 case management in Home Settings

How to spot a good oxygen concentrator ?

Oxygen concentrators with a flow capacity of less than five litres per minute are “not suitable” for COVID-19 patients on home care and should not be used, India’s drug regulator , CDSCO said . Sellers should not push such devices using “misleading label” amid the coronavirus second wave.

The advisory by CDSCO aims at educating the people about minimum standards of oxygen concentrators for COVID-19 case management, especially for use in home settings.

At present , market has various models of oxygen concentrators, with different capacities of continuous flow (1 to 10 litres/minute) and widely varying concentration of oxygen, are being marketed . The health ministry has from time to time advised that oxygen concentrators with flow capacity of five litre per minute or more and delivering oxygen with concentration of 90 per cent or more are suitable for management of COVID-19 patients at COVID Care Centres, Dedicated COVID Health Centres and in home settings. The World Health Organisation has also prescribed these norms for oxygen concentrators.

Many people are not aware about these minimum parameters of oxygen concentrators and therefore may be using the concentrators that are not suitable for COVID-19 case management. This advisory is issued to inform people about minimum standards of oxygen concentrators for COVID-19 case management, for use especially in home settings.

CDSCO has further advised that oxygen concentrators must be purchased with consumables required to operate, user care instructions and protocols including guidance for replacement of accessories and consumable and safe decontamination of reusable parts, indicating if they are generic or brand related, the advisory said.

CDSCO has strongly advised that all sellers must prominently display the following information for each model of oxygen concentrator for sale

  • continuous flow capacity in litres per minute
  • the percentage of oxygen that a concentrator generates and
  • the maximum retail price.

Download the full advisory here for more information

Oxygen Crisis for Covid Patients

Online Discussion on May 10th 2021 from 4 – 5 30 pm

Can industry offer support to hospitals , to tide over the oxygen crisis , by creating additional manufacturing capacities ?

About Andhra Chamber of Commerce
Andhra Chamber of Commerce is 92 year old Chamber of Commerce, created with an objective of encouraging Industry and Trade in India in general and in the States of Andhra Pradesh, Telangana and Tamil Nadu in particular. Chamber works towards promoting interests of the business community at-large. Chamber also organises networking events to allow members to exchange ideas, develop relationships and improve their professional network.

About the Program
2nd wave of covid 19 is hitting all stakeholders at market place very hard – be it the communities, health workers, covid warriors, govt workers, industry workers etc. Pandemic is not relenting and affecting all in multiple directions
wave after wave. Impact of 2nd wave is so severe and high that health sector is struggling with supply chain gaps.

Session will address the following FAQs :
– Do covid positive patients need Oxygen ?
– Do they need oxygen supply at home or in a Hospital environment ?
– What solutions are offered for oxygen supply , at the moment, in the market ?
– Whether Hospitals need more concentrators or liquid oxygen supply or refill cylinders? what is their immediate need ? Why the demand for concentrators is very high ?
– What do hospitals need , as immediate priority solution from industry, to meet oxygen crisis ?
– Can Industry help hospitals to tide over the crisis by creating some manufacturing capabilities , if needed ?
– Do we have enough mfrers or suppliers for these mkt needs ?
– Are we importing products like Oxygen concentrators ,which come under Medical Devices ?

Program Agenda

Registration Details

Prior Regn is a must. Registration Link is shared below :

Contac t Coordinator :
Ms Vijayalakshmi , Secretary General
Andhra Chamber of Commerce
Email : andhrachamber1@gmail.com
Telephone : Office : 044 – 24315277

Investment Opportunities in India’s Healthcare Sector

Recent Report by Niti Aayog

Niti Aayog has recently released a report on Investment Opportunities in Indian Healthcare Sector.

This Report provides an overview of India’s healthcare sector, including insights about its employment generation potential, the prevailing business and investment climate as well as the overarching policy landscape. It also highlights the key drivers of growth for the sector and the third section elaborates upon the enabling policies
and investment opportunities in 7 key segments, including hospitals and infrastructure, health insurance, pharmaceuticals and biotechnology, medical devices, medical tourism, home healthcare as well as telemedicine and other technologyrelated health services.

In the hospital segment, the expansion of private players to Tier 2 and Tier 3 locations, beyond metropolitan cities, offers an attractive investment opportunity. According to Invest India’s Investment Grid, there are nearly 600 investment opportunities worth USD 32 Billion (INR 2.3 Lakh Crore) in the country’s hospital/ medical infrastructure sub-sector

I have shared some key inputs from this report which is available in the public domain (https://niti.gov.in/node/1475 ) and wrote a short article in the Information Bulletin of Andhra Chamber of Commerce. Considering my longest innings in healthcare sector and having watched from close quarters about the private investments patterns into this domain, I have shared my thoughts, views on why the FDI investments route is not the right solution for pumping investments into healthcare domain.

My article is there in page 20 of Chamber’s bulletin which can be downloaded from here :

About the Author :

Ms Rama Venugopal, Executive Director

Medical Devices Regulation

Announcement from CDSCO

CDSCO has released a notification about the regulation of certain medical devices like blood glucose monitors, BP monitors, Nebulisers and Thermometers , the same is shared here

Medical Device Industry and other stakeholders including Hospitals, Diagnostics Sector, other healthcare orgns and patient communities have to follow the med dev regulations that are being announced on regular basis .