This is the conclusion of an international team who state surgical technology - often developed for well-resourced healthcare systems - is of little or no use in poorer settings where hospitals lack support infrastructure or appropriately trained staff.
The team, led by Leeds University, calls for a focus on creating medical devices specifically for use in low-to-middle income countries.
To this end, they have pioneered a development approach based on participatory design, where the users of the technology are closely involved in its design - and where functionality of the device is pared back to key essentials. Their findings are published in IEEE Journal of Translational Engineering in Health and Medicine.
To demonstrate their approach, the researchers designed a simplified surgical tool for performing laparoscopic - keyhole – surgery, and the result is that laparoscopic surgery can now be carried out in clinics and hospitals where it was not possible before.
In a statement, Dr Pete Culmer, Associate Professor in Healthcare Technologies at Leeds, who supervised the research, said: “Laparoscopic surgery has benefits for patients. People recover more quickly, and the risks of cross infection are lower.
“But in many parts of the world, laparoscopic techniques are not widely used because of the need to use equipment that cannot be easily maintained or relies on complex infrastructure in the operating theatre.
“We partnered with clinicians in India to work on developing instruments that would make the process simpler, with the aim of enabling laparoscopic surgery to be available in more locations around the world.”
During laparoscopic operations, the surgeon inflates the patient’s abdomen with CO2 gas to create space to see internal organs and to manipulate instruments. To perform the procedure, operating theatres require a reliable CO2 gas supply and for the patient’s abdominal muscles to be fully relaxed, which requires a general anaesthetic and an anaesthetist.
An alternative approach called gasless laparoscopy has been developed where a mechanical retractor or clamp is used to lift the abdominal wall. With this method, the patient does not need a general anaesthetic – instead, a spinal anaesthesia is given, and there is no need for an anaesthetist to be present.
This alternative approach has failed to gain popularity, largely because of challenges with using and maintaining the retractors.
The researchers, in partnership with surgeons and a medical device manufacturer in India, designed a new retractor, ensuring it was fit for purpose in a low-resourced healthcare setting.
A small ring is manipulated onto the end of the retractor by a surgeon using keyhole techniques. When in place, the device is manually operated to lift the abdominal cavity upwards, creating the space for the surgery to take place.
Dubbed RAIS (Retractor for Abdominal Insufflation-less Surgery), the retractor went through five design iterations before a prototype was developed and tested. During a clinical evaluation, it was used in 12 laparoscopic operations.
Writing in the research paper, the researchers said the device was “...considered convenient to setup in the operating theatre, could be readily cleaned and sterilised and transported within and between rural surgical sites”.
The simplified design of the retractor meant it was easier for the device manufacturer to get regulatory approval. The RAIS device also meets the guidelines established by the World Health Organisation for the design and development of healthcare technology for low to middle income countries.