Sinapi biomedical was founded with the purpose to provide medical devices with clinical benefit. The devices they develop and manufacture at Sinapi have as first priority a clinical or practical improvement compared to competitive products. This provides the motivation and a belief that, as a team, they are making a long term contribution towards advancing healthcare.
Furthermore, Sinapi strives to provide devices of excellent quality and reliability, managed by strict and comprehensive quality standards. They focus on providing products with the best cost benefit multiplied by quality benefit.
Sinapi is situated in the heart of South African wine country (The Boland) in the university town of Stellenbosch. Being close to the university enables them to collaborate with academia: either the relevant Engineering Department or Medical School.
The facilities consist of a Cleanroom Class 100000: (filtered air, temperature controlled, accredited) – 300sqm; Materials Handling Area; Warehouse (680sqm); Workshop with lathe and milling capabilities, office space. Total space: more than a 1000 sqm. A 15cbm ETO sterilisation plant was ISO 11135 certified in the second half of 2014.
FIELDS OF EXPERTISE
CHEST DRAINAGE: Existing chest drainage devices are heavy and bulky and have to be kept upright. Sinapi was tasked by Cardio-Thoracic and Trauma surgeons to develop a more compact chest drainage device that enables greater patient mobility while still suiting all applications of draining chest fluids i.e. after heart surgery, lung surgery, trauma surgery, etc.
During development they discovered that their mechanical valve (the Scheffler valve) is more efficient than existing systems (water or other dry seal), allowing faster evacuation of blood and air from the chest. This shortens chest drainage time, enables faster removal of the chest catheter and improves patient outcome.
NUTRITION: The World Health Organisation stipulates that baby bottles are not allowed in hospitals as these do not promote breast feeding; are technically difficult to clean and can therefore cause diarrhoea. Cup feeding is suggested to support exclusive breast feeding (expressed breast milk) or exclusive replacement feeding (as safer alternative to bottle feeding). Together with the Department of Neonatology (Groote Schuur Academic Hospital) and specifically Prof David Woods, Sinapi developed a cup in which to safely store, mix and administer feeds.
The Department of Nutrition, Western Cape, supported and funded the initial development. As a team of three players they proceeded with the development and evaluation of the Sinapi Feeding Cup. The Sinapi Feeding Cup was launched in 2007 and today it is used by many hospitals in all provinces of South Africa.
URINARY DRAINAGE: A urine meter is used to measure urine output of critically ill patients where accurate measurement is required. It is used in all Intensive Care Units. The product specification of the Sinapi Urine Meter was essentially developed by Registered Nurses working in the clinical setting (ICU and HCU) and those in consultative capacities regarding Infection control. Aspects related to product safety, user interface and infection control were considered.
The SUM has a 500 ml rigid reservoir, large bag and a Germ guard tap. The one-hand-operated taps were specifically designed to prevent contamination of the operator when emptying the device as well as retrograde infection to the patient. Furthermore, the bag is positioned behind the rigid reservoir reducing the height of the device and consequently the chances of the product touching the floor.
OBSTETRICS: Postpartum haemorrhage (PPH) continues to be the leading cause of maternal deaths in developing countries, resulting in an estimated 125,000 deaths per year. More than 30 percent of maternal deaths in Africa are attributed to PPH, and most of these deaths are preventable with timely management of bleeding. Although the use of uterotonic drugs can reduce PPH rates by up to 62 percent, some women will still experience excessive bleeding following delivery.
Uterine balloon tamponade (UBT) has become increasingly recognised as an effective and safe second-line treatment for intractable PPH and in 2012, the WHO revised their recommendations to include UBT for the management of PPH when uterotonics fail or are unavailable. Even with access to surgery, the conservative intervention of placing a UBT device, that controls bleeding, may be lifesaving and could help avoid radical surgery for mothers. Read more about Ellavi UBT.
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