• Users Online: 3026
  • Print this page
  • Email this page


 
REVIEW ARTICLE
Year : 2009  |  Volume : 53  |  Issue : 1  |  Page : 12-17 Table of Contents     

21st Century - Still No Standardization


1 Assistant Prof., Department ofAnaesthesiology, UFHT Medical College,Haldwani- Nainital(uttarakhand), India
2 Professor, Department ofAnaesthesiology, UFHT Medical College,Haldwani- Nainital(uttarakhand), India

Date of Web Publication3-Mar-2010

Correspondence Address:
Urmila Palaria
Department ofAnaesthesiology,UFHT Medical College, Haldwani- Nainital(uttarakhand)
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


PMID: 20640072

Rights and PermissionsRights and Permissions
 

Standardization of anaesthetic equipment is needed for safe anaesthetic practice. Various organizations and regulatory bodies have been made throughout world to formulate and control standards for anaesthesia equipment including endotracheal tubes. All endotracheal tubes must conform to ASTM standards. This has medico-legal importance also. Regulatory bodies should look after the whole process right from the manufacturers to the actual users. The Indian Society of Anaesthesiologists promotes safe anaesthetic practice, by establishing purchase guide­lines for equipments and drugs. It is working in collaboration with World Federation of Societies of Anaesthesiologists. Standards have made anaesthesia and critical care equipment much safer over the years. There is need to form standards for various equipment in India.

Keywords: Standardization, Anaesthetic equipment, Endotracheal tube, Indian Society of Anaesthesiologists


How to cite this article:
Palaria U, Punera D C, Sinha A K, Bhadani U K, Chhabra B. 21st Century - Still No Standardization. Indian J Anaesth 2009;53:12-7

How to cite this URL:
Palaria U, Punera D C, Sinha A K, Bhadani U K, Chhabra B. 21st Century - Still No Standardization. Indian J Anaesth [serial online] 2009 [cited 2021 Aug 3];53:12-7. Available from: https://www.ijaweb.org/text.asp?2009/53/1/12/60251


   Introduction Top


Like any equipment, anaesthesia equipment should follow "Standards" in manufacture and use. All over the world Standard protocol is followed for manufac­ture and use of various anaesthesia equipments. This is required for safety of anaesthesia practice. This is nec­essary in present Indian scenario considering increas­ing consumer forum cases against anaesthesiologists. In this article various aspects of standardization pro­cess is discussed in brief. Endotracheal tubes are studied as example to think over the matter of standardiza­tion. There is need of standardization of endotracheal tubes, which is one of most commonly used equipment used by anaesthesiologists. Various brands of endotra­cheal tubes studied in this article is not an end in itself but taken as an example. There is not any intention, for proving any particular brand superior or inferior. The article is not intended to judge quality of any particular brand of endotracheal tubes mentioned and studied in the article. Its quality has to be judged by individual anaesthesiologist and regulatory bodies.The purpose of this article is to draw attention of anaesthesiologists in India to bring the role of standardization into thought process, in respect of anaesthesia equipment. Role of Indian Society of Anaesthesiologists is also thought for as a regulatory body for safe anaesthesia practices. It is twenty first century and still there is no standardiza­tion.


   What Is 'Standard'? Top


Standard can bedefined as "Documented agree­ments containing technical or performance specifica­tions or other precise criteria to be used consistently as rules, guidelines or definitions of characteristics, to en­sure that materials, products, process and services are fit for their intended purposes" [1] .

Three types of standards in Anaesthesia and Criti­cal care:

Safety standards: Minimum requirements for electrical safety and usability.

Performance safety standard: Minimum re­quirement for equipment performance during use.

Technical standard: Provide guidance to manu­facturers and users for equipment design, construction, performance and use.


   How Does Process Of Standardization Starts? Top


Process of standardization usually starts when a request from manufacturer, industry association, con­sumer group, educational institute or governmental body is made, to help with a particular safety, performance or quality issue. Initial drafts are written by working groups or adapted from other countries or from stan­dards of similar equipment. National committee mem­bers are asked to comment and vote on it. Standards are developed by technicalcommittees, subcommit­tees and working groups made up of representatives of manufacturers, equipment users, operators and other interested parties using aconsensus approach.


   Standards For Anaesthesia And Critical Care Top


Most of anaesthesia and critical care standards are written by ISO TC 121 and its subcommittees, Organisation for International Standardisation Techni­cal Committee 121 and IEC 62-International Electro technical Commission Committee 62. These commit­tees look for suggestions of anaesthesiologists and intensivists, apart from engineers.


   What are ISO and IEC? Top


ISO stands for International Organisation for Standardisation, Founded in Feb 1947, first met in London UK in 1967 [2] and present headquarters in Geneva, Switzerland [3] . National standards bodies of over 140 countries formed this federation. This body has developed a series of 'standards' applicable to various aspects of economic activity - manufacturing as well as services. Institutes that demonstrate compli­ance with these Standards are certified by ISO with respect to that Standard. Some examples for different certification used for different purposeare, Certifica­tion for quality- ISO9000 (QMS) series Certification for environment- ISO14000 (EMS) series, certifica­tion for occupational safety-OHSAS 18000(OHSMS) series etc.

IEC , International Electrotechnical Commission, originally located in London, the commission moved to its current headquarters in Geneva in 1948 [4] . It has 42 member countries. Members are drawn from principal standardization bodies from different nations. The IEC maintains advisory committees on electrical, medical and telecommunications, electronics on electromagnetic compatibility and safety.


   'Standard's' Bodies And Organizations Across The World Top


There are numerous standards writing commit­tees and organizations across the world. Most coun­tries have a national standards body:

In United States: Anesthetic and Critical Care Committee F29 of American Society for Testing and Materials (ASTM) writes the standards. ASTM has a dominant role among standards developers in the USA and claims to be the world's largest developer of stan­dards.

In Canada: CSAinternational (formerly the Ca­nadian Standards Association), is a global leader in development and certification of equipment standards, International Organisation for Standardisation (ISO), the International Electrotechnical Commission (IEC) and the Compressed Gas Association (CGA).

In Europe: Committee for European Normal­ization (CEN) and their marking is CE.

In Japan: Japanese Industrial Standards Com­mittee (JISC).

Standards in India: Bureau of Indian Standards (BIS) is a member of "International Organisation for Standardisation (ISO)".


   Bureau Of Indian Standards (BIS)/Indian Standards Top


This is national standard's body in India; head­quarters is in New Delhi, a member of ISO. It has a training centre is in Noida (U.P.) known as National Institute of Training for Standardisation (NITS). Na­tionalCommittees may decide to change or modify any of InternationalStandards adopted for its own coun­try. Its objectives are [5]………

- Harmonious development of standardization, marking and quality certification.

-Providing new thrust to standardization and qual­ity control.

- Evolving national strategy for standards and in­tegrating them with growth& development of produc­tion& exports.

BIS is engaged in formulation of Indian Stan­dards for medical equipment and hospital planning. The Indian Standard is technically equivalent to ISO / IEC standard.


   Why Standardization Is Needed In Anaesthesia? Top


To reduce the discripencies among various manu­facturers of Endotracheal tubes (ETTS), the need for minimum standards for safety in the design and con­struction of medical equipment were recognized across the world.

It is medico legally important for physician that he has to act in accordance with specific standards of care established by the profession for protection of the pa­tient against unreasonable risks [6] . Jeffrey Cooper in his classic article in the journal Quality and Safety in Health Care, reprinted in 2002, pointed out that 84% of pre­ventable incidents were due to human error and 14% of critical incidents in anaesthesia were related to equip­ment failure [7] .

Safety in anaesthesia practice relates safety in vari­ous aspects like use of drugs, procedures and equip­ments. It involves its make and knowledge of use. Any compromise or deviation from specific standard at any level may introduce risk to patient safety. These devia­tions can creep in by oversights in design, mistakes in equipment manufacturer or facility construction and the need to produce a usable product for the price the health care system can afford, especially in developing countries. Standards provide similarity in equipment design and materials across different models and different manufacturers. The manufacturer owes his duty of careto the ultimate user and not just to the immedi­ate purchaser. Until recently, anaesthesia and critical care equipment produced by single manufacturer had to adhere to standards of all the countries in which equipment was distributed. This led to the rise in actual price of equipments. Now global standards are being harmonized so that manufacturers in future will only have to manufacture equipment to one international standard [1] .

The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to grow­ing need for international harmonization in the regula­tion of medical devices.

By standardization, what we are really trying to do is to write the minimum requirements for the "basic safety and essential performance" for medical equip­ment in general or for a particular device [1] .

Endotracheal tubes (ETT) are one of most com­monly used equipment used by anaesthesiologists throughout the world. We will like to discuss issues re­lated with endotracheal tube's standards in Indian per­spective.


   Endotracheal Tubes Marketed In India: Does It Follow Standards? Top


What are different standards for Endotracheal tubes?

ASTM standard requires following recommen­dations to be done and printed on endotracheal tubes [8] :

- Name or trademark of manufacture or supplier -The words "oral", "nasal" or "oral/nasal"

- Inside (ID) and outside (OD) diameters in millimetres

-Tissue toxicity test: Implantation testing (IT) or other, with Notation Z-79 or F -29 (as per testing),

- Length (depth) markings in centimetres mea­sured from patient end.

-Cautionary note such as 'Do not reuse' or 'Single use only', if disposable

-Radiopaque marker at patient end or along the full length.


   Comparison Of ETT Of Different Manuf­acturer Marketed In India  Top
We collected some of the common brands of Endotracheal tubes available in Indian market and com­pared them according to ASTM standards. We chose tostudy one of the most commonly used tubesize of 7.5 [Table 1]

Endotracheal tubes studied from different manu­facturer were compared and following findings were noted:

1. Some of tubes have no markings related with manufacturer / supplier on the tube. Once tube taken out of packages, one can't know which Manufacturer /supplier it belongs to [Figure 1].

2. Many of ETTs have no indication of toxicity test on the tubes.

3. Tubes of same size vary in their length mark­ings at machine end i.e. 26, 27, and 30 cm [Figure 2]. Take offpoint of pilot balloon is different in different tubes. ASTM does not comment anything on this as­pect.

4. In spite of considering same internal diameter tubes of 7.5mm, most of the tubes have outer diameter of 10 but one tube has outer diameter of 10 but one tube has outer diameter of 10.3mm[Figure 3]

5. Many tubes have ring marking to help position the tube in relation to entry point into trachea i.e. vocal cords [9] . This becomes more important when EtCO 2 monitoring is not available to confirm correct position­ing of tube.

6. ASTM does not comment anything about cuff design (contour) but it becomes important as it changes the contact surface area on trachea and may be of im­portance. In our study some of the cuffs were oval and some attend circular when inflated outside as shown in [Figure1]. Its pressure and shape inside trachea in vivo is a matter of further study.

7. Place of Murphy Eye is also not fixed in rela­tion to end of ETT. ASTM does not comment on this.


   What Should Be Done To Keep Upto Standards? Top


As an expert of the subject of Anaesthesiology it is our duty to keep ourselves updated for different equipments we use. We should know about various international standards of that equipment. As an end user it is our duty to keep the safety of patient at the top priority. Equipment safety is one of important con­stituent of safety in anesthesia. As a purchaser and policy maker this becomes more important because it deals with multiple users and community as a whole.


   Role Of Regulatory Bodies Top


Various governmental and non-governmen­tal bodies are responsible for making of laws and regu­lations for the manufacture, use, and maintenance of various medical equipments. However, anaesthe­siologists need to encourage their governmental regu­latory bodies to encourage manufacturer compliance with specific standards in order to increase patient safety. Other than anaesthesiologists every hospital and organizations should have regulations for purchase and maintenance of various equipment of medical use. Role of Indian Society of Anaesthesiologists becomes im­portant in case of Speciality of Anaesthesia. It is the National anaesthesia society and it promotes safe an­aesthetic practice by establishing purchase guidelines for Anaesthesia equipments and drugs [9] . The Indian So­ciety of Anaesthesiologists should discuss the several aspects of legal and other matters to standardize medi­cal equipments. Society can be instrumental in raising awareness about understanding standardization by its role as a forum for improvement in anaesthesia prac­tice in India. Quality, excellence and cost-effective­ness are the interrelated factors and must be part of everyday practice in anaesthesia [10] .

We have taken endotracheal tubes as an example of one of most commonly used simple equipment by anaesthesiologists. Similarly other equipments like vari­ous monitors, anaesthesia machines, pipeline etc can be studied in Indian and International scenarios to im­prove upon our practice of anaesthesia to achieve the goal of safe anaesthesia practice.

 
   References Top

1.Steven L Dain. Anesthesia standards for facilities, re­cent issues involving standards. Canadian Journal of Anesthesia 2001;48:41-47.  Back to cited text no. 1      
2.Greenbaum R. The breath of life. ISO/TC 121 .Anaes­thetic& respiratory equipment, breathes optimism and reapsresults. ISOBulletin 1997;28:11-4.  Back to cited text no. 2      
3.http://en.wikipedia.org/wiki/International_ Organization _for_Standardization/retrieved on 10.10.08  Back to cited text no. 3      
4.http://en.wikipedia.org/wiki/International_ Electro­technical_Commission /retrieved on 10.10.08  Back to cited text no. 4      
5.http://en.wikipedia.org/wiki/Bureau_of_Indian_ Stan­dards /retrieved on 10.10.08  Back to cited text no. 5      
6.Dogra TD, Gupta S. Journal of Academy of Hospital administration -Medico legal aspects of health care delivery 2006;18:1-12.  Back to cited text no. 6      
7.Cooper J.B. Newboever RS, Long CD, McPeek B. Pre­ventable anesthesia mishaps:A study of human factors. Qual saf Healthcare 2002;11:277-82.  Back to cited text no. 7      
8.Dorsch J A. Understanding of Anaesthesia Equipment IV th Ed.Tracheal Tubes pg 560- 576  Back to cited text no. 8      
9.http://www.isaweb.in/reawmed.asp/ activities page 1­7./retrievedon10/10/08  Back to cited text no. 9      
10.Wylie and Churcchill - Davidson's., A practice of anes­thesia - Quality assessment VII th Ed. Pg 1338  Back to cited text no. 10      


    Figures

  [Figure1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1]



 

Top
 
  Search
 
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
    Access Statistics
    Email Alert *
    Add to My List *
* Registration required (free)  

 
  In this article
    Abstract
    Introduction
    How Does Process...
    Standards For An...
    What are ISO and...
    Bureau Of Indian...
    Why Standardizat...
    Endotracheal Tub...
    Comparison Of ET...
    What Should Be D...
    Role Of Regulato...
    What Is 'Standard'?
    'Standard's' Bod...
    References
    Article Figures
    Article Tables

 Article Access Statistics
    Viewed1712    
    Printed95    
    Emailed0    
    PDF Downloaded362    
    Comments [Add]    

Recommend this journal