Introduction

The Covid-19 pandemic demonstrates that health systems in many countries are not well prepared for such a crisis. Years of budgetary austerity have negatively affected their health systems. Although some important studies warned about the consequences of pandemics on economic and social situations and developed recommendations to prepare for such a critical situation, little was actually done in many countries. When the Covid-19 pandemic appeared, most countries needed to react immediately and had to improvise. Depending on when and to what extent epidemiologic countermeasures were taken and depending on the state of the national health systems, the pandemic threatens to overwhelm them. The situation is exacerbated by national trade restrictions interrupting supply chains and impeding the export of medical equipment.

Some of the most critical bottlenecks to date are the lack of respiratory equipment, intensive care units, a sufficient and safe oxygen supply and qualified medical personnel for handling this equipment. The demand for mechanical ventilators increased dramatically but could not be met by the existing producers.

Major players operating in the global mechanical ventilators market include Becton, Dickinson and Company (US), Koninklijke Philips N.V. (Netherlands), Draeger Medical GmbH (Germany), Hamilton Medical AG (Switzerland), GE Healthcare (US), Medtronic (Ireland), Fisher & Paykel Healthcare Limited (New Zealand), Acoma Medical Industry Co. Ltd. (Japan), Macquet GmbH & Co. KG (Germany), Philips Respironics Inc. (US), Smiths Medical (US), Teleflex Inc. (US), Carl Reiner Gmbh (Austria), ResMed Inc. (US), Getinge AB (Sweden), Mindray Medical International Limited (RP China), ZOLL Medical Corporation (US), Nanjing Chenwei Medical Equipment Co. Ltd. (PR China), Allied Healthcare Products Inc. (US), Schiller Healthcare India Pvt. Ltd. (India), among others.

The shortage of respiratory equipment had two effects:

  1. Countries with manufactures of respiratory and other medical equipment restricted export for the benefit of national demand.
  2. Another effect was that devices appeared on the market that did not meet the minimum quality requirements set up by the national health authorities.

The consequence was that

  • in some highly developed countries, the production of existing plants was reoriented to fabricate mechanical ventilators (example: Ford and General Motors were obliged by the Trump Administration to do that in the U.S.); and
  • in many countries enterprises, universities and research & development (R&D) institutions have begun to develop mechanical ventilators of differing quality in order to be independent of imported devices.

The situation in many developing and in some emerging countries is even more dramatic because access to the relevant devices is very often limited for various reasons. Furthermore, given the lack of sufficiently qualified health personnel in many countries, the objective should be to obtain low-cost and simple equipment which meets the quality requirements set by national and international health authorities. In this case there is also a need for sufficiently trained and experienced medical personnel. Unfortunately, this is not possible, i.e. the personnel must be trained which is difficult in times of lockdown. Training can only be carried out partially through e-learning courses, as is the case in Chile.

Thus, in some countries ventilators are being developed in cooperation with enterprises, research & development institutes and the National Metrology Institutes (Argentina, Brazil). In other countries universities or R&D institutes are proceeding on their own but are seeking funding and cooperation with industry (Chile). In terms of quality assurance, these efforts are confronted with some challenges:

  1. The equipment must fulfil the standards developed by the International Standardisation Organisation (ISO), the International Electrotechnical Commission (IEC) and other international standardization bodies (for instance, American Society for Testing and Materials — ASTM).
  2. The measurement instruments that represent the most sensitive parts of the equipment must be correctly calibrated (assuring the traceability to the International System of Units).
  3. Generally, the products must be approved and certified by the National Health Authorities and comply with national and international technical regulations (for instance, established by the United States Food and Drug Administration – U.S. FDA).
  4. Production must be carried out in plants which fulfil the requirements of the Quality Management System Standard (ISO 13485:2016).
  5. The use of these sensitive devices is also defined by ISO standards and explained by different guides ensuring the safety of use and the health of medical staff and patients.

In the following, three main topics regarding the development and the placement of the products onto the market are explained briefly and complemented by useful links:

  1. Standards for developing, producing and applying mechanical ventilators
  2. Validation of the ventilator prototypes
  3. Calibration of the necessary measurement devices

1.        Standards to be considered for developing, manufacturing and using mechanical ventilators

1.1       ISO Standards for the use of mechanical ventilators

Important freely available ISO standards for the use of mechanical ventilators can be downloaded here: https://www.iso.org/covid19. There the following standards can be found:

ISO 10651-3:1997

Lung ventilators for medical use — Part 3: Particular requirements for emergency and transport ventilator

ISO 10651-4:2002

Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators

ISO 10651-5:2006

Lung ventilators for medical use — Particular requirements for basic safety and essential performance — Part 5: Gas-powered emergency resuscitator

ISO 13485:2016

Medical devices — Quality management systems - Requirements for regulatory purposes

ISO 18082:2014

Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (including ISO 18082:2014/AMD 1:2017, AMENDMENT 1)

ISO 18562-1:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

ISO 18562-2:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter

ISO 18562-3:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic compounds (VOCs)

ISO 18562-4:2017

Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

ISO 19223:2019

Lung ventilators and related equipment — Vocabulary and semantics


1.2       IEC Standards for the safety and performance of mechanical ventilators

IEC now provides free access to the relevant standards for the safety and performance of mechanical ventilators. They can be downloaded by clicking on the following link:

https://webstore.iec.ch/webstore/webstore.nsf/xpFAQ.xsp?OpenXPage&id=GFOT-BNAEXA

 IEC 60601-1:2005+AMD1:2012 CSV

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-6:2010+AMD1:2013 CSV

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-1-8:2006+AMD1:2012 CSV

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

IEC 60601-1-11:2015

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Capability to test the performance (i.e., particulate filter efficiency level) of N95 respirators and respirator material according to the TEB-APR-STP-0059 (PDF) test standard:

www.cdc.gov/niosh/npptl/stps/pdfs/TEB-APR-STP-0059-508.pdf


1.3       Standards for the QMS in laboratories

The reliability of laboratory results in medical settings is essential for correct diagnoses and positive clinical outcomes. Implementing measures to reduce the risk of errors is an essential part of operations.

ISO 15189

Medical laboratories – Requirements for quality and competence

This standard defines the requirements for the accreditation of clinical laboratories.

ISO 15190

Medical laboratories – Requirements for safety

This standard provides guidance on medical laboratory safety.

ISO 14971

Risk management in medical devices

ISO 22367

Medical laboratories – Application of risk management to medical laboratories

This standard specifies a process for a medical laboratory to identify and manage the risk to patients and service providers that are associated with medical laboratory examinations.

The standards can be purchased from the ISO Store at: www.iso.org/store.html


1.4       Standards for the certification of manufacturers of medical devices

ISO 13485:2016

Medical devices – Quality management system – Requirements for regulatory purposes

This quality management system is specifically designed for medical device manufacturers. It expands on and refines the framework established by ISO 9001, with the aim of harmonizing regulatory requirements. Compliance with ISO 13485 helps with overall quality control, traceability, process validation and risk management. Manufacturers that attain ISO 13485 compliance will have an easier time introducing their products to international markets.


1.5       Other Standards

Besides IEC and ISO other, predominantly private non-profit organizations, are developing standards for medical equipment. In the United States the key players are:

ASTM International

ASTM provides free access to its standards at this site:

www.astm.org/COVID-19/

Association for the Advancement of Medical Instrumentation AAMI

AAMI offers free access to its standards at:

www.aami.org/detail-pages/press-release/aami-offers-free-standards-and-resources-to-help-fight-coronavirus

AAMI works closely with U.S. manufacturers. For further contacts, the AAMI Standard Committees can be found at:

www.aami.org/standards/view-full-committee-list

Clinical & Laboratory Standards Institute

Another important international player is the U.S.-based Clinical & Laboratory Standards Institute – CSLI. It works with approx. 60 organizations and elaborates and publishes the Consensus-Based Medical Laboratory Standards.

clsi.org/standards/

Example of current support in partner countries

In numerous bilateral and regional projects, the International Cooperation Division of the PTB supports developing and emerging countries in the development and use of a demand-oriented and internationally recognized quality infrastructure. The projects are implemented on behalf of the German Federal Ministry for Economic Cooperation and Development (BMZ). In connection with the COVID-19 pandemic, PTB addresses specific requests of the partner countries. Among other things, also in the area of quality assurance of community masks.


Example Tunisia:

Request by the project partner, the Tunisian Ministry of Industry, for support for:

  • Expansion of testing capacities for quality assurance of ‘community masks’ made of cotton in local mass production for the internal market
  • Import control of imported protective equipment like medical masks.

Based on this request, PTB supported the procurement of test equipment for community masks, provided technical advice and will realise training in the area of import control. The aim is to extend the competences of the national textile testing centre, CETTEX, and to further develop the testing and analysis capacities in the partner country.

 

Further potential support by PTB’s International Cooperation Division in the partner countries

In the context of the COVID-19 pandemic, PTB can support the development of test procedures in testing laboratories of partner countries which are responsible for the approval of medical devices according to EU Regulation 2017/745 or of personal protective equipment (PPE) according to EN 149. Currently, no ISO standards are available, but European (EN), German (DIN), British and Chinese standards exisit. In PTB's partner countries, the food and drug authorities, national standard bodies or local specialized technical centers (e.g. Centre Technique du Textile, CETTEX Tunisia) are usually responsible for conformity assessment of medical devices.


Provision of relevant standards and technical advice

In the short term and depending on the project objective, cooperation scope and partner institutions, PTB’s International Cooperation Division might procure required standards (e.g. product and testing standards for medical protective materials) which are not free of charge for its partner countries and, if necessary, translate them into the respective national language. In addition, an online technical advisory service could be carried out for the adaptation and adoption of the standards. In this case, a review of the EN, DIN or ISO standards with those of the WHO would be useful in order to adapt the standards so that they are practicable and implementable for local use.

Based on partner requests, in the medium to long term, PTB could also examine the provision of support and expert advice on the development of appropriate guidelines to assure the quality of protective materials and other medical devices even beyond the COVID-19 pandemic. The implementation of certification procedures of medical devices is also a medium to long-term process which PTB could consider supporting.

© Physikalisch-Technische Bundesanstalt