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Tutorial 14 - Infection control and legal issues

Infection control

An essential part of ultrasound examinations in the ICU is the decontamination of the machine and the probe following the procedure as it can act as a vector of transmission of skin flora between patients.
The cleaning protocol for the ultrasound machine and probe shown below is recommended as it is evidence based, simple and practical.


Table.1 Example of a cleaning protocol: Bouhemad et al Critical Care 2007, 11:205 (doi:10.1186/cc5668)Table.1 Example of a cleaning protocol: Bouhemad et al Critical Care 2007, 11:205 (doi:10.1186/cc5668)

The solution used to clean the keyboard and the probe should be chosen after consulting the manual of the ultraosund machine. We have used alcohol and chlorhexidine handrib solution while the authors of the protocol above have used a detergent based quaternary ammonium compound without any damage to the machine or the probe.

2 points relevant to disinfection should be considered during the purchase of an ultrasound machine. First, a touchpad based keyboard is easier to disinfect than a trackball based one. Secondly, a few manufacturers provide a waterproof, transparent keyboard cover which can be left permanently on the machine and disinfected with ease after every use. This prevents the problem of disinfectant residue causing malfunctioning of keys after a while. Another alternative solution is to cover the entire keyboard with a disposable plastic wrap that can be discarded after each patient encounter. This, however would work only with machines that use a touchpad, as it may be cumbersome to roll the trackball through a plastic wrap.

The sonogram jelly container is best not brought to the bedside. The jelly can be made available in small sachets or a small amount can be taken each time in a sterilisable container and used. The gel container should be disposable or should be disinfected between patients.

The position of the sonographer with respect to the patient also has a bearing on infection control. The position of the sonologist doing the echocardiogram depends on the continent one is trained in! In UK & Europe cardiac sonology is usually done from the right side of the patient (probe in right hand and controls manipulated with the left hand) this involves bending over the patient, contamination of clothing and cross infection in the ICU. In Australia and the US, the sonologist does it from the left side of the patient – this means that the probe is held in the left hand and the controls are manipulated with the right hand of the sonologist. This is ergonomically preferable and has less contact between the sonologist and patient (no need to bend over the patient) thus possibly reducing cross infection.

Legal issues

The Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act (PNDT Act), 1994 was enacted to provide for the regulation of the use of pre-natal diagnostic techniques and for the prevention of the misuse of such techniques for the purpose of pre-natal sex determination leading to female foeticide. This act was amended in 2002 and 2003. Vide this amendment, a few clauses of the original PNDT Act and the rules or sub-rules have been omitted, partly / completely substituted or newly inserted. This Act of Parliament received the assent of the President in 2003, and came into operation with effect from 14th February, 2003. It was published as "The pre-conception and pre-natal diagnostic techniques (prohibition of sex selection) Act 2003."

The Act prohibits sex selection, before and after conception.  It also regulates prenatal diagnostic techniques for detection of genetic abnormalities restricting their use to registered institutions and registering all clinics possessing Ultrasound machines.

Excerpts from the Act:

No person (medical geneticist, gynecologist, pediatrician, registered medical practitioner, radiologist, sonologist or any other person) shall conduct or cause to be conducted or aid in conducting by himself or through any other person, any pre-natal diagnostic techniques at a place other than a place registered under this Act.

No person shall open any clinic or center having ultrasound machine/ imaging machine/ scanner or any other technology capable of undertaking determination of sex of the foetus and sex selection unless such center, clinic or laboratory is duly registered.

The Act does not allow sex selection, sex determination or sex disclosure by any means. The encouragement for sex selection or determination by any body (including husband, relative or friend) is prohibited.

Implementation of the Act:

Under this law, it is illegal to sell ultrasound machines to unqualified practitioners. Sellers have to provide details of ultrasound buyers and every ultrasound machine which is sold has to be registered.

Any institution which has an ultrasound machine has to:

a.exhibit a valid registration at a prominent place

b.appoint staff as per the qualifications mentioned in the Act.

c.Keep the equipments as per the list given in the Act

d.Exhibit a board at prominent place mentioning that "Sex determination is not done in this center."

e.Inform the changes made in the equipment, workers or the place within 30 days to the concerned Appropriate Authority.

f.Apply within 30 days for renewal of registration certificate

g.Submit the report in prescribed format before 5th of every month to the concerned Appropriate Authority.

The medical personnel operating ultrasound machines should be a suitably qualified person. Every sonologist is required to fill a specified form (Form F) before conducting an ultrasound on a pregnant mother. The form has 19 questions including the reason for conducting the sonography, along with patient detail. Every ultrasound clinic is required to submit Form F to the appropriate state authority by the fifth of every month. The clinics are supposed to keep the Form F with them for three years.

To check misuse of the technology, the Government has also set up a State Inspection and Monitoring Committee to undertake field visits and monitor the implementation of PNDT Act and initiate action against unregistered institutions and those violating the law. The relevant authorities can

a.seize the machine

b.suspend / cancel the registration

c.issue a search warrant for any place

d.file a Court complaint directly

Punishment for violation can range from payment of a fine, cancellation of medical registration or even imprisonment.

The
sonogram jelly container is best not brought to the bedside. The
jelly can be made available in small sachets or a small amount can be
taken each time in a sterilisable container and used. The gel
container should be disposable or should be disinfected between
patients.

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