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Std for sterilization services
Food Science & Nutrition (FSNT102)
Mangalore University
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Standards for Female
and Male Sterilization
Services
Research Studies & Standards Division Ministry of Health and Family Welfare Government of India October 2006
2006 Ministry of Health & Family Welfare Government of India, Nirman Bhawan, New Delhi – 110 011
Any part of this document may be reproduced and excerpts from it may be quoted without permission provided the material is distributed free of cost and the source is acknowledged.
First published 1989 Second edition 1993 Third edition 1996 Fourth edition 1999 Fifth edition 2006
Printing of this edition for Government of India is supported by UNFPA, New Delhi
Foreword
National Population Policy 2000 specifies unmet need for contraception as a priority area to be addressed urgently. The surveys conducted in India indicate that only 48% of the eligible couples adopt any contraceptive method to plan their family and sterilization is the most accepted method, contributing to nearly 75% of all the methods accepted. However, there is still a large unmet need of 7% in sterilization services.
Quality of services provided plays a major role in acceptance of any service. Poor quality of service in terms of technical inputs, processes, interpersonal communications, limited choice leads to unsatisfied clients with resulting under utilization of services. It is essential that standards are prescribed for the services which also facilitate in monitoring the quality of services provided. Quality Assurance is an ongoing cyclical process and revised Standards on Sterilizations is a part of this process to provide guidelines for ensuring quality care.
I appreciate the efforts of the Research Studies and Standards Division in revising this Manual after an exhaustive exercise with experts from various fields like Gynecology, Surgery, Anesthesia Programm Managers and International Agencies. It is hoped that the guidelines would serve the service providers and the program managers in providing quality care in sterilization services and evoke more confidence of the eligible couples in sterilization services for their better and larger utilization.
(PRASANNA HOTA) Secretary to the Government of India
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Health & PW Secretary Tel.: 23061863 Fax: 23061252 Email: secyfw@nb.nic
Dated the 8th September 2006
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Contents
- Introduction .......................................................................................................................................
- Standards for Female Sterilization ...................................................................................
- Eligibility of Providers for Performing Female Sterilization.......................................
- Physical Requirements .......................................................................................................
- Case Selection .....................................................................................................................
- Clinical Processes ...............................................................................................................
- 1.4. Counselling ...........................................................................................................
- 1.4. Clinical Assessment and Screening of Clients ................................................
- 1.4. Timing of Surgical Procedure ..........................................................................
- 1.4. Informed Consent ...............................................................................................
- 1.4. Preoperative Instructions ...................................................................................
- 1.4. Part-preparation ...................................................................................................
- 1.4. Premedication/Anaesthesia/Analgesia ............................................................
- 1.4. Surgical Techniques ...........................................................................................
- Post-operative Care ..........................................................................................................
- 1.5. Post-operative and Follow-up Instructions ...................................................
- 1.5. Certificate of Sterilization ................................................................................
- Complications of Female Sterilization and their Management .................................
- 1.6. Intra-operative Complications .........................................................................
- 1.6. Post-operative Complications ..........................................................................
- 1.6. Failure of Operation leading to Pregnancy ..................................................
- Conditions Not Related to Sterilization ........................................................................
- Standards for Male Sterilization .....................................................................................
- Eligibility of Providers for Performing Male Sterilization.........................................
- Physical Requirements .....................................................................................................
- Case Selection ...................................................................................................................
- Clinical Processes ............................................................................................................. - 2.4. Counselling ......................................................................................................... - 2.4. Clinical Assessment and Screening of Clients .............................................. - 2.4. Timing of Surgical Procedure.......................................................................... - 2.4. Informed Consent ............................................................................................. - 2.4. Preoperative Instructions ................................................................................. - 2.4. Skin Preparation and Surgical Draping .......................................................... - 2.4. Premedication/Anaesthesia/Analgesia .......................................................... - 2.4. Surgical Techniques ...........................................................................................
- Post-operative Care ..........................................................................................................
- 2.5. Post-operative Instructions ..............................................................................
- 2.5. Follow-up Instructions......................................................................................
- 2.5. Certificate of Sterilization ................................................................................
- Post-operative Care ..........................................................................................................
- Complications of Male Sterilization and their Management .....................................
- 2.6. Intra-operative Complications .........................................................................
- 2.6. Immediate Complications ................................................................................
- 2.6. Delayed Complications .....................................................................................
- Complications of Male Sterilization and their Management .....................................
- Prevention of Infection: Asepsis and Antisepsis ...................................................
- Hand Washing ...................................................................................................................
- 3.1. Routine Hand Washing .....................................................................................
- 3.1. Surgical Serub.....................................................................................................
- Hand Washing ...................................................................................................................
- Self-protection of Halth Care Providers ......................................................................
- Safe Work Practices ..........................................................................................................
- Maintenance of Asepsis at the OT................................................................................
- 3.4. Before Surgery ...................................................................................................
- 3.4. After Surgery ......................................................................................................
- Prevention of Infection: Asepsis and Antisepsis ...................................................
The standards laid down in this document apply to both static and camp facilities. Programme managers and service providers are advised to refer to ‘Standard Operating Procedures for Camps’, being published separately by the Research Studies & Standards Division, Ministry of Health and Family Welfare (MOHFW).
Introduction .......................................................................................................................................
The Development of Standards on Sterilization Services is an important step in ensuring the provision of quality services to the growing number of clients by programme managers and service providers providing permanent methods of contraception. This document sets out the criteria for eligibility, physical requirements, counselling, informed consent, preoperative, post- operative, and follow-up procedures, and procedures for management of complications and side effects. It also highlights the salient steps of the surgical procedures and the recommended practices for infection prevention.
Target audience
The document apprises doctors, other health personnel, and Reproductive and Child Health (RCH) programme managers throughout the country of the sterilization standards that are required to be maintained at their facilities.
Standards for female and male Sterilization Services
INPUTS
- Eligibility of Providers for Performing Female Sterilization
The state should constitute a district-wise panel of doctors for performing sterilization operations in government institutions and accredited private/NGO centres based on the above criteria. Only those doctors whose names appear on the panel should be entitled to carry out sterilization operations in the government and/or government-accredited institutions. The panel should be updated quarterly.
- Physical Requirements
The infrastructural facilities required for performing female sterilization are placed in Annexure 1. This format is also applicable for accrediting a private facility providing services for female sterilization.
- Case Selection
(Self-declaration by the client will be the basis for compiling this information.)
1.3. Clients should be married (including ever-married). 1.3. Female clients should be below the age of 49 years and above the age of 22 years. 1.3. The couple should have at least one child whose age is above one year unless the sterilization is medically indicated. 1.3. Clients or their spouses/partners must not have undergone sterilization in the past (not applicable in cases of failure of previous sterilization).
1. Standards for Female Sterilization ...................................................................................
Service Basic Qualification Requirement of Provider Minilap services Trained MBBS doctor laparoscopic sterilization DGO, MD (Obst. & Gynae.), MS (Surgery) (trained in laparoscopic sterilization)
Standards for female and male Sterilization Services
1.3. Clients must be in a sound state of mind so as to understand the full implications of sterilization. 1.3. Mentally ill clients must be certified by a psychiatrist, and a statement should be given by the legal guardian/spouse regarding the soundness of the client’s state of mind.
PROCESSES
- Clinical Processes
Preparation for surgery includes counselling, preoperative assessment, preoperative instructions, review of the surgical procedure, and post-operative care. It is essential to ensure that the consent for surgery is voluntary and well informed, and that the client is physically fit for the surgery. Preoperative assessments also provide an opportunity for overall health screening and treatment of RTIs/STIs.
1.4. Counselling
Counselling is the process of helping clients make informed and voluntary decisions about fertility. General counselling should be done whenever a client has a doubt or is unable to take a decision regarding the type of contraceptive method to be used. However, in all cases, method-specific counselling must be done.
The following steps must be taken before clients sign the consent form:
1.4.1. Clients must be informed of all the available methods of family planning and should be made aware that for all practical purposes this operation is a permanent one. 1.4.1. Clients must make an informed decision for sterilization voluntarily. 1.4.1. Clients must be counselled whenever required in the language that they understand. 1.4.1. Clients should be made to understand what will happen before, during, and after the surgery, its side effects, and potential complications. 1.4.1. The following features of the sterilization procedure must be explained to the client: It is a permanent procedure for preventing future pregnancies. It is a surgical procedure that has a possibility of complications, includ- ing failure, requiring further management.
6 Standards for female and male Sterilization Services
There are no absolute medical contraindications for performing female sterilization. However, there are certain conditions that require doctors to be cautious, to delay the surgery, to refer the client to an especially equipped centre, or to counsel the client to go in for alternative contraception. The Medical Eligibility Criteria for Female Surgical Sterilization procedures outlined by WHO (2004) serve as guidelines for case selection based on the clinical findings of the client (Annexure 2). However, the final selection of the case should be based on the case selection criteria outlined in 1. and guided by the medical eligibility criteria stated above.
The operating surgeon must fill in the medical record and checklist placed at Annexure 3 before initiating the surgery.
1.4. Timing of the Surgical Procedure
Interval sterilization should be performed within 7 days of the menstrual period (in the follicular phase of the menstrual cycle). Post-partum sterilization should be done after 24 hours up to 7 days of delivery. Sterilization with medical termination of pregnancy (MTP) can be performed concurrently. Sterilization following spontaneous abortion can be performed provided the client fulfils the medical eligibility criteria.
laparoscopic tubal ligation should not be done concurrently with second-trimester abortion and in the post-partum period.
1.4. Informed Consent
1.4.4. Consent for sterilization operation should not be obtained under coercion or when the client is under sedation. 1.4.4. Client must sign the consent form for sterilization before the surgery (Annexure ).
The consent of the spouse is not required for sterilization.
1.4. Preoperative Instructions
The client must bathe and wear clean and loose clothing. The client must not consume anything (even water) by mouth 4 hours prior to surgery and no solids, milk or tea 6 hours prior to surgery.
a)
b) c)
d)
a) b)
Standards for female and male Sterilization Services
On the morning of the surgery, she must empty her bowels. Before entering the OT, she must empty her bladder and also remove her glasses, contact lenses, dentures, jewellery, and lipstick, if she is wearing any of these items. A responsible adult must be available to accompany the client back home after the surgery.
1.4. Part Preparation
The operative area should not be shaved. The hair can be trimmed, if necessary. The operative site should be prepared immediately preoperatively with an antiseptic solution, such as iodophor (Povidone iodine) or chlorhexidine gluconate (Cetavalone). Alcohol preparation should not be applied to the sensitive genitalia. Iodophor and chlorhexidine are safe to use on mucous membranes and can be used to cleanse the vagina and cervix. Iodophor requires 1 to 2 minutes to work because a certain amount of time is needed for the release of free iodine, which inactivates the micro-organisms. Antiseptic solutions should be applied liberally at least two times on and around the operative site, which should be thoroughly cleansed by gentle scrubbing. The antiseptic solution should be applied in a circular motion, beginning at the site of incision and working out for several inches. This inhibits the immediate re-contamination of the site with local skin bacteria. The excess antiseptic solution should not be permitted to drip and gather beneath the client’s body as this may cause irritation. After preparing the operative site, the area should be covered with a sterile drape.
1.4. Premedication/Anaesthesia/Analgesia
Premedication: Reassurance and proper explanation of the procedure go a long way in allaying the anxiety and apprehension of the client. However, if needed, Tablet Alprazolam (0 to 0 mg) or Tablet Diazepam (5 to 10 mg) can be given right before the operation. Anaesthesia/Analgesia: local anaesthesia is the preferred choice for a tubectomy operation. On the day of the operation, drugs for sedation and analgesia are to be given as shown in Table A.
c)
d)
i) ii)
iii)
iv)
v)
vi)
vii)
viii)
a)
b)
Standards for female and male Sterilization Services
General Anaesthesia
This is rarely necessary. However, it may be required in the following conditions:
In case of a non-cooperative patient In case of excessive obesity In case of a history of allergy to local anaesthetic drugs
In the above cases, the provision for general anaesthesia (including guidelines for personnel, facilities and equipment, and other) should be adhered to.
The following drugs may be made available for the GA cases in addition to the available drugs given in the emergency list:
Injection Thiopentone Sodium Injection Propofol Injection Morphine, Injection Pethidine, Injection Fantanyl Injection Suxamethonium Injection vecusonium Bromide Injection Neostigmine Injection Terbutaline Injection Ondansetron Salbutamol Solution for Nebulization Injection Nitroglycerin Monitoring: Medical records are to be maintained relating to the vital signs (pulse, respiration, and blood pressure), level of consciousness, vomiting, and any other relevant information. If any drug is administered, its name, dosage route, and time must be recorded. Monitoring is to be done as described below: Preoperatively: Pulse, respiration, and blood pressure should be taken prior to premedication and thereafter every 10 minutes. Intra-operatively: (a) Maintain verbal communication with client; and (b) check pulse, respiration, and blood pressure every 5 minutes, especially during the time of gas insuffulation and at the time of tubal ligation. Post-operatively: Pulse, respiration, and blood pressure should be monitored and recorded every 15 minutes for one hour following surgery or longer if the patient is unstable or not awake.
i) ii) iii)
c)
i)
ii)
iii)
10 Standards for female and male Sterilization Services
1.4. Surgical Techniques
General Requirements The client’s bladder must be empty. If there is a doubt, the client must be asked to void urine immediately before the procedure and should be catheterized, if indicated. The operating surgeon should identify each fallopian tube clearly, following it right up to the fimbria. The site of the occlusion of the fallopian tube must always be within 2–3 cm from the uterine cornu in the isthmal portion (this will improve the possibility of reversal if required in the future). Care must be taken to avoid damage to the blood vessels, ovaries, and surrounding tissues. Excision of 1 cm of the tube should be done. Use of cautery and crushing of the tube should be avoided. The skin incision is to be closed with an absorbable or non-absorbable suture, and a small dressing or bandage applied.
Minilaparotomy Requirements An interval minilaparotomy procedure would benefit from the use of a uterine elevator to bring the fallopian tubes into the operative field. The incision for a minilaparotomy (interval, post-abortal, or post-partum) may be transverse or longitudinal. Modified Pomeroy’s procedure should be followed for excision and ligation of tube, using a square knot with 1 ‘0 chromic catgut.
Laparoscopy Requirements To avoid hypoventilation, the patient must not be placed in the Trendelenburg position in excess of 15 degrees. An uterine elevator should be used to visualize the fallopian tube. Pneumoperitoneum should be created with veres needle. Insufflation of abdomen with carbon dioxide is the preferred method. Intra- abdominal pressure must not exceed 15 mm of mercury. Slow insufflations with graded insufflator and gradual de-sufflation should be done. The skin incision should not exceed the diameter of the trocar.
a) i)
ii)
iii)
iv)
b) i)
ii)
iii)
c) i)
ii) iii) iv)
v)
Std for sterilization services
Course: Food Science & Nutrition (FSNT102)
University: Mangalore University
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