1st-ever WHO list of essential diagnostic tests

Summary: 1st WHO essential diagnostic list focusing on mainly communicable diseases with a recommendation to include more NCDs in a future edition. PHC and facility level essential package.   Vicki Pinkney-Atkinson

Improving NCDs diagnosis & treatment outcomes

Today, many people are unable to get tested for diseases because they cannot access diagnostic services. Many are incorrectly diagnosed. As a result, they do not receive the treatment they need and, in some cases, may actually receive the wrong treatment.

For example, an estimated 46% of adults with Type 2 diabetes worldwide are undiagnosed, risking serious health complications and higher health costs. Late diagnosis of infectious diseases such as HIV and TB increases the risk of spread and makes them more difficult to treat.

Essential Diagnostics  List (EDL)

To address this gap, WHO today published its first Essential Diagnostics List (EDL), a catalogue of the tests needed to diagnose the most common conditions as well as a number of global priority diseases.

“An accurate diagnosis is the first step to getting effective treatment ….No one should suffer or die because of a lack of diagnostic services, or because the right tests were not available.”
Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

The list concentrates on in vitro tests – i.e. tests of human specimens like blood and urine. It contains 113 products: 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients. The remaining 55 tests are designed for the detection, diagnosis and monitoring of “priority” diseases such as HIV, TB, malaria, hepatitis B and C, human papillomavirus and syphilis.

Some of the tests are particularly suitable for PHC facilities, where laboratory services are often poorly resourced and sometimes non-existent; for example, tests that can rapidly diagnose a child for acute malaria or glucometers to test diabetes. These tests do not require electricity or trained personnel. Other tests are more sophisticated and therefore intended for larger medical facilities.

“Our aim is to provide a tool that can be useful to all countries, to test and treat better, but also to use health funds more efficiently by concentrating on the truly essential tests,” says Mariângela Simão, WHO Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals. “Our other goal is to signal to countries and developers that the tests in the list must be of good quality, safe and affordable.”

For each category of test, the EDL specifies the type of test and intended use, format, and if appropriate for primary health care or for health facilities with laboratories. The list also provides links to WHO Guidelines or publications and, when available, to prequalified products.

Similar to the WHO Essential Medicines List, which has been in use for four decades, the EDL is intended to serve as a reference for countries to update or develop their own list of essential diagnostics. In order to truly benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of healthcare workers and safe use. To that end, WHO will provide support to countries as they adapt the list to the local context.

The EDL was developed following an extensive consultation within WHO and externally. The draft list was then considered for review by WHO’s Strategic Advisory Group of Experts on In-Vitro Diagnostics – a group of 19 experts with global representation. For more information see WHO website.

WHO will update the Essential Diagnostics List on a regular basis. In the coming months, WHO will issue a call for applications to add categories to the next edition. The list will expand significantly over the next few years, as it incorporates other important areas including antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional NCDs.

SAMED Launches Medical Device Code of Ethics

Wednesday, June 21st saw South African Medical Device Industry Association (SAMED) public launch of the Medical Device Code of Ethical Marketing and Business Practice “The Code”. This is the first major step in the right direction for the oversight between the medical devices industry, consumers, and healthcare professionals.

SAMED acts as the curator of the code of ethics for its member organisations.  The code of ethics is a living document working for the industry and members self-regulating with the oversight of SAMED. The document aims to work toward best practices in ethical business and marketing practices.

The document breaks down to stop and inhibit member companies from offering incentives to healthcare providers and customers. While also putting a stop to bad business practice with sole profit driven motive rather than the best interests of the patients as the primary goal. Covering areas of focus that have been seen to become an area of contention or seen as unethical business practices now and in the future.

This first step is a move to creating buy-in from industry as well as every member working towards a global industry standard. Without this first step buy-in and jumping straight to legislation brings in the problem of loophole exploitation. The code of ethics has been welcomed by the National Department of Health as a step forward and proactive move toward eventual legislation in the years to come. As stated before this is a living document and will change as clashes or problems arise.

This document does have repercussions for members that breach the code of ethics while offering anonymity for whistleblowers as an important part to prevent backlash towards those coming forward. The process will see an independent investigator brought in to gather evidence and the validity of the claims. Furthermore, there will be an independent board of inquiry towards the findings of the investigation. Depending on the severity of the infraction there is an action that will be taken with hefty fines imposed upon the guilty party with no room for appeals within the process, this will have to be taken up in legal courts.

The SANCDA welcomes this move as well as the code of ethics as a movement in the right direction by SAMED and its members.

To download the full code of ethics please use the link below.