INFUSOFEED CLINICAL INFORMATION

INFUSOFEED REFERENCES

 1. Hofmeyr, I. (1996) "Qualitative Evaluation of the Infusofeed Balloon and Manzimeter" Prepared for the Health Technology Research Group of the Medical Research Council of South Africa, October 1996.

2. "The Economic Feasibility of Infusofeed Nasogastric Rehydration in the Management of Infantile Diarrhoeal Disease in South Africa" Prepared by Business Design Matters for the Health Technology Research Group of the South African Medical Research Council, July 1996.

3. Infusofeed Data Sheet.

4. Forbes, D. (1994) "The Infusofeed Project, Lesotho, 1993-1994; A Report on Outcomes of the Project" Department of Paediatrics, University of Western Australia.

5. Forbes, D. Medical Data.

6. Forbes, D. Case Studies.

7. Forbes, D. The People.

8. Stone, D.G. Forbes, D. Hill, R. Capes, R. and O’Neil, G. (1993) "Successful use of a simple elastomeric infusion pump for delivery of rehydration fluids in children with acute gastroenteritis and refusal of oral hydration solution" Abstract, 1993 Scientific Meeting AuSPEN.

9. INFUSOFEED - Balloons for Life.

10. Dilworth, O’Neil. (1992) "Improved Fluid Delivery Systems" Princess Margaret Hospital.

11. "A New Method for the Provision of Enteral Tube Feeds" Paper presented at XV International Conference of Nutrition, Adelaide, 20 September 1993 - 1 October 1993.

12. UNICEF Reports.

Executive Summary

Annually more than 3700 children under five years of age die in South Africa from dehydration due to diarrhoeal diseases. The standard treatment for dehydration is oral rehydration. In cases of severe dehydration or when the patient refuses oral rehydration solution, however, rehydration fluids must be administered intravenously (IV) or nasogastrically. It is estimated that 65% of all cases of diarrhoeal disease in South Africa can be treated orally, 25% nasogastrically and 10% intravenously. Despite this, nasogastric treatment is under-utilised.

Nasogastric treatment by gravity feeding is a labour intensive process requiring constant monitoring. Most primary clinics in South Africa do not have the facilities (space and equipment) to perform nasogastric treatment. Consequently clinics tend to send all patients not responding to oral therapy or unable to drink to referral hospitals for IV or nasogastric therapy. This strains the resources of major hospitals already under pressure to achieve efficiency savings in line with the government’s objective of restructuring the national health system.

The Infusofeed® balloon pump is an alternative method of administering oral rehydration solution by nasogastric tube. It is a cheap and cost effective method of treatment that has proved highly successful in treating dehydration due to diarrhoeal diseases. In Lesotho, where trials have been undertaken, the introduction of the Infusofeed was associated with:

Calculations indicate that introducing the Infusofeed balloon in South Africa could result in significant annual financial savings. Savings will result from the increased use of nasogastric therapy in all levels of the health system. Three principal areas of financial savings have been identified.

Introduction of the Infusofeed balloon will mean that IV therapy is used less. It is estimated that the unit cost per IV treatment is R70 compared to R10 in the case of nasogastric treatment using the Infusofeed balloon. Increasing the proportion of patients treated with nasogastric therapy by introducing the Infusofeed balloon could lead to annual savings of between 1.1 and 1.8 million rand. (p16).

The Infusofeed balloon will provide primary clinics with a more effective and easy to use technique of treating diarrhoeal diseases. This will reduce referrals to major hospitals. Increasing the use of nasogastric therapy to 15% of all treatments, and thus reducing the referrals to hospitals, could result in annual savings of between 1.8 and 4 million rand. This is because the unit cost of treating a patient at a primary facility is less than at a major hospital. (p 18).

The Infusofeed balloon has been associated with shorter admission time in Lesotho and Australia. Shorter hospital admission time will reduce the cost per admission. Annual savings of between 3.9 and 6.5 million rand could be achieved due to shorter admission time. This does not depend upon increased treatment at a primary level. (p 19).

It should be noted that these calculations are intended to indicate the order of magnitude of possible savings, rather than to accurately predict actual savings. They are, however, sufficient to suggest with a fair degree of confidence that the Infusofeed will result in significant financial savings. Most of these savings will be expenditure on hospitals. This accord with the government’s objective of achieving efficiency savings of between 1-2% in major hospitals between 1995/96 and 2000/1. In addition to the financial savings arising from the use of the Infusofeed balloon, the report highlights a number of other advantages of the product.

There is thus significant evidence that the Infusofeed balloon represents an easy to use and cost effective method of managing diarrhoeal disease. Its introduction into the national health system is likely to increase the quality of service and reduce costs, particularly in major hospitals. The Infusofeed is, therefore, compatible with the government’s objective of restructuring the national health system to provide primary health care to all residents of South Africa, while at the same time achieving efficiency savings in hospitals.

The Incidence of Diarrhoeal Disease in South Africa

Diarrhoeal disease is a major killer throughout the developing world. In 1990, according to the World Health Organisation (WHO), diarrhoeal disease was second only to acute respiratory ailments as a cause of death world-wide. Annually more than 5 million people, 80% of them in their first year of life, die of diarrhoeal disease and resulting dehydration throughout the world. In South Africa, out of 18182 deaths of children under five years old in 1992, 3744, or 21%, were from diarrhoeal disease. Excluding deaths due to ill-defined causes the proportion of deaths due to diarrhoeal disease is as high as 27%.

 Table 1: Cause of deaths of children under five years, South Africa, 1992

 5.1 Disadvantages of IV Therapy

IV therapy has a number of disadvantages, including that it:

 5.2 Cases Where IV Therapy is Not Possible

In a number of cases, even when recommended, IV therapy is not possible. This might arise when:

5.3 Cases Where IV Therapy is Unnecessary

There is a proportion of cases currently treated with IV therapy that could be treated by nasogastric therapy. These are moderately or lightly dehydrated children who are refusing ORS because they cannot drink or are vomiting persistently. While hospitals such as Tygerberg and RCCH, and clinics such as the KCHC, use nasogastric therapy, this is not the norm in primary health clinics. From the patient profile at Tygerberg and KCHC it is estimated that 25% of all patients suffering from diarrhoeal disease could be treated by nasogastric therapy. There is therefore likely to be a considerable number of patients who are currently receiving IV therapy when nasogastric therapy would be more appropriate.

Why Infusofeed NGI Should be Introduced

There is a clear role for nasogastric therapy either as a substitute when IV therapy is not available, or as an alternative when IV therapy is unnecessary. Despite this, nasogastric therapy is under-utilised, especially in clinics. Some of the reasons for this are because:

The Infusofeed balloon makes use of simple technology to overcome some of the problems associated with conventional nasogastric therapy. Consequently, it has the potential to enhance the service offered at the primary clinic level. In so doing, it conforms with the government policy to deliver a primary health care package within an overall process of restructuring the health service.

The Infusofeed balloon has a number of advantages over conventional treatment of diarrhoeal disease:

 Mobility

In contrast to conventional nasogastric therapy and IV therapy, the Infusofeed balloon allows mobility of the patient. In the case of small infants, once the device has been inserted, they would be able to wait outside crowded clinics with their mothers, rather than occupying limited space inside the clinic. Increased mobility is important in that it allows the children to continue with other "activities" during treatment, such as breast feeding or sleeping. The increased mobility of the Infusofeed balloon would also make it suitable for use in patients being transported to a referral hospital.

Reusable

The Infusofeed balloon is a reusable product. Nasogastric therapy is not a sterile procedure and the Infusofeed balloon can be cleaned in the same way that babies’ bottles are cleaned. It is estimated that the Infusofeed balloon could be used as many as fifty times.

Multiple Uses

Although this report has focused on rehydration of children suffering from diarrhoeal disease, the Infusofeed balloon has additional uses, notably in enteral feeding programmes for adults and children.

Safety

The Infusofeed balloon includes a flow control device. Consequently, once the Infusofeed balloon is connected to the patient, the dosage volume cannot be altered, reducing the risk of human error.

Ease of Use

The Infusofeed balloon is designed for ease of use. It is simple to assemble, is filled with known quantities of suitable fluids and is easily attached to the nasogastric tube. As a consequence, nursing staff have confidence that patients are receiving the required volume of fluid at the desired rate of infusion.

Reduces Labour

The use of the Infusofeed balloon reduces the need for constant nursing supervision since the flow rate is controlled by device and does not require monitoring. In the context of pressure on the government’s medical personnel, especially professional staff, this is an important advantage. Furthermore, once inserted, the Infusofeed balloon can be managed by more junior staff thus freeing senior staff for other activities.

 6.2 Infusofeed NGI in Lesotho

The Infusofeed balloon has been successfully tested in Lesotho. Data from the trials conducted in Lesotho suggest that the Infusofeed balloon is an effective and user-friendly tool for managing diarrhoeal disease. A number of positive factors were associated with the introduction of the Infusofeed balloon into Lesotho’s national health system.

The Infusofeed balloon allowed slow infusion of ORS and nutrient solutions, reducing vomiting and increasing the mobility of patients, thus allowing them to sleep during treatment.

Mortality due to diarrhoeal disease and malnutrition was reduces by nearly 50%. Figures from two hospitals, showed a reduction in mortality from 30% to less than 10% following the introduction of the Infusofeed balloon.

The Infusofeed balloon proved to be an easy and effective method of treating dehydration. Workload on nursing staff was significantly reduces because intensive feeding was not necessary. This was especially appreciated during the night when there were fewer staff members on duty.

Mothers were reported to be happy with the Infusofeed balloon because it enabled them to take part in the treatment of their children and did not result in separation from their children. The increased mobility also allowed mothers to keep their children with them and continue breast feeding. As a consequence, tension between mothers and nursing staff was reduces.

Although, information available from the Lesotho trials does not emphasise economic aspects, the following efficiency savings were documented.

At Mohale’s Hoek hospital the length of hospital stay was reduced by 21%.

The use of IV lines was reduces by 90%.

There was reduced pressure on nursing staff, freeing them to perform other functions.

Mortality resulting from diarrhoeal diseases was reduced.

 6.3 Benefits from Introducing Infusofeed NGI in South Africa

The success of the Infusofeed balloon in Lesotho and other clinical trials suggests that the product holds distinct advantages over conventional nasogastric therapy. Its introduction into the national public health system is likely to increase the proportion of patients treated by nasogastric therapy especially at the primary level. By providing an easy to use and effective technology suitable for use in primary clinics, the Infusofeed balloon will contribute directly to the government’s objective of improving primary health care and reducing pressure on major hospitals.

6.3.1 Reduces Mortality Rate

By providing nursing staff in clinics with a more effective tool for treating diarrhoeal diseases, the Infusofeed balloon will increase the quality of services offered at the primary level. The Infusofeed balloon’s capacity to successfully treat moderately and severely dehydrated children has been demonstrated in Australia and Lesotho. In many cases it will provide an alternative treatment when oral therapy is not suitable and IV therapy is unavailable. Furthermore, the Infusofeed balloon is ideally suited to use in treating patients being transported to referral hospitals for IV therapy. The major benefit of this is likely to be a reduction in mortality rate resulting from diarrhoeal diseases. Reducing the mortality rate is ultimately the most important objective of the government’s health policy.

6.3.2 Financial savings from the Introduction of the Infusofeed NGI

The use of the Infusofeed will achieve financial savings in the following areas:

reduced use of the more expensive IV therapy,

reduced referrals to major hospitals, and

reduced admission time in referral hospitals.

7. Conclusion

This study has identified the possibility of significant annual savings if the Infusofeed balloon pump is introduced. The Infusofeed will provide primary clinics with an easy to use and cost effective tool for treating diarrhoeal disease. The Infusofeed balloon is substantially cheaper than IV therapy and has been shown to reduce mortality, labour requirements and hospital admission time. Trials in Lesotho have also shown that the product can be used successfully in a developing country.

 Sources

A Boyd, T Ramatlapeng, and A Elgoni, September 1994, Introduction of Appropriate Technology: A Case Study.

Department of Health, Republic of South Africa, 1994, Health Trends in South Africa.

Department of Health, Republic of South Africa, 1996, Official Policy Document: Restructuring the National Health System for Universal Primary Health Care.

Development Bank of Southern Africa, April 1994, South Africa’s Nine Province: A Human Development Profile.

D Gremse, Journal of Paediatric Gastroentrology and Nutrition, 1995, 21, Effectiveness of Nasogastric Rehydration in Hospitalised Children with Acute Diarrhoea.

M A Kibel land L A Wagstaff, Oxford University Press, 1995, Child Health for All: A Manual for Southern Africa.

D Naidoo, Unpublished Dissertation, UCT, 1996, An Evaluation of Health Care Resources for the Treatment of Diarrhoea in Children in Khayelitsha.

D G Stone, D Forbes, R Hill, D Capes, G O’Neil, October 1993, Successful Use of a Simple Elastomeric Infusion Pump for Delivery of Rehydration Fluids in Children with Acute Gastro-enteritis and Refusal of Oral Rehydration Solution, Paper presented to Australian Society for Parenteral and Enteral Nutrition.

World Health Organisation, 1993, The Management and Prevention of Diarrhoea.

Interview with Dr Simon Schaaf, Consultant Paediatrician, Tygerberg Hospital.

Interview with Ms Anneline Bester, Department of Health, Government of the Republic of South Africa.

Interview with Mr Saul Cohen, South African representative for Go Medical.

Interview with Supervising Sister, Hydration Unit, Red Cross Children’s Hospital, Cape Town, South Africa.