WHO Information Notice for Users of Medical Devices 2020/3

Date: 7 August 2020Subject: Substandard/Falsified medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemicWHO-identifier: 2020/3, version 1 Type of action: Advice to users of medical devices and PPE used for prevention, treatment and care for COVID-19.Attention: Users of medical devices and PPE[1], procurement entities and customs officials, national programme managers and their implementing partners, laboratories, ministry of health and national regulatory authorities for medical devices and PPE. Purpose: To advise on actions to be taken to identify and prevent circulation of substandard/falsified medical devices and PPE for COVID-19.  Description of the problem:WHO continues to be made aware of circulation of substandard/falsified medical devices and PPE for prevention of COVID-19 and in the treatment and case management of people with COVID-19. WHO uses the following definitions:Substandard, also called “out of specification”, are authorized medical devices that fail to meet either their quality or safety performance specifications.Falsified medical device that deliberately/fraudulently misrepresent their identity, composition or source.Unregistered/unlicensed medical devices that have not undergone evaluation and/or approval by the national regulatory authority for the market in which they are marketed/distributed or used, subject to permitted conditions under national regulation and legislation.Any adverse event or product problem for a medical device may reveal that a product is substandard or falsified.  Advice on action to be taken by buyers/donors of medical devices and PPE for COVID-19:Purchase products that have been authorized/approved/listed by the responsible institution: the national regulatory authority (NRA) or any other institution that has the mandate to oversee quality, safety and performance of such medical devices and PPE in your country. Review registration status by checking your NRA’s website for lists/databases of authorized/approved/listed products, and list of withdrawn/non-approved products. If such information is not publicly available on their websites, communication with your NRA is encouraged.Ensure donated medical devices and PPE are registered (see WHO guidelines). Purchase products from the legal manufacturer, or their designated economic operator (agent, distributor, supplier, authorized representative). Request from the manufacturer if any obsolescence plans are in place. Advice on action to be taken by users of medical devices and PPE for COVID-19: Follow guidance from WHO on appropriate use of medical devices for COVID-19 T and use technical specifications provided by WHO or the final user to select the appropriate, safe and qualified medical device. Avoid purchasing medical devices online from an unknown source. Request a copy of the certificate of safety and performance depending on the functionality of the product from the manufacturer for each lot/serial number of product.Cross-reference the labelling of product received against your NRA’s authorization/approval/listing letter and labelling on your NRA’s website and the manufacturer’s website. Conduct incoming inspection for certain categories of medical devices. Read the instructions for use to understand the intended use of the product and taking note of any limitations.Ascertain, within reasonable doubt, that the product is genuine. Contact WHO, if in doubt[2].Run all required calibration and preventive maintenance procedures as instructed by the manufacturer in their instructions for use and operation manuals. Report any product problems and/or adverse events as complaints to the manufacturer as soon as you become aware using a complaint form and copy to WHO and your NRA. The contact details for the manufacturer can be found in both primary and secondary packaging materials and instructions for use.Adverse events may be:Death of the patient, end-user or any other person occurred or may have occurred Death of the patient, end-user or any other person occurred or may have occurred          Product problems may be:Packaging – damaged, defective, suspect tamperedLabelling – insufficient instructions for use, illegibleSampling – device does not collect/transfer specimenLiquid – leak, splashMechanical – misalignment, jamElectrical – unable to charge, power loss or fluctuationData – capture, display, or storage affecting product     functionalitySoftware – network, program, algorithm, or security affecting product functionalityEnvironmental – noise, temperature, humidity/moisture, fungal/bacterial growth, or dust affecting product functionalityFailure to calibrateIncreased rate of invalid or unreturnable test resultsObviously incorrect, inadequate or imprecise result or readingsUnable to obtain reading   Advice for action to be taken by national regulators of medical devices and PPE for COVID-19:Assess products (full assessment or through reliance/recognition mechanisms) and share approval/authorization/listing on your website or any other platform which is accessible to stakeholders. Ensure such assessment is conducted before issuance of import permit for non-domestically manufactured product.  Conduct inspection of imported products in collaboration with customs officials at the point of entry to detect substandard/falsified devices and products. The following information can be checked; import certificate issued by the NRA, certificate of analysis (translated) which needs to be compared with the imported products. Physical examination of products including labelling information and details of the importer (authorized representatives or approved suppliers), matching of product details with certificate of analysis, evidence of tampering of labels, language, product description such as size, shape, colour, product code and batch, cracks, abrasion, erosion, breaks and seal integrity.Collect samples for further investigation if there is any suspicion about the product and take appropriate regulatory actions such as quarantine and testing. Ensure that users are aware that they should report any adverse event and product problems to the manufacturer.  Post field safety notices issued by manufacturers for medical devices and PPE supplied within your jurisdiction on your website.Exchange information with other regulators if your market surveillance detects product problems or adverse events.   Note: For many jurisdictions, emergency use/approval mechanisms have been put in place for certain medical devices. These products should be the subject of increased monitoring by device users for adverse events and product problems.[1] WHO previously published a WHO Information Notice for Users for falsified in vitro diagnostics (IVDs) used to diagnose COVID-19, seeWHO Information for Users n°2/2020.Some PPE elements are classified as medical devices in some jurisdictions.[2] Contact for further information: Anita SANDS, Regulation and Safety, e-mail: sandsa@who.int