Medical Device Code: Anonymous whistle-blowing hotline accompanies new version of the Code

Posted 26 August 2019

For the attention of healthcare practitioners & other healthcare stakeholders

SAMED’s ability to enforce the Medical Device Code and contribute to raising the levels of ethics in the South African medical technology sector entered a new era on 15 August 2019. This is when its anonymous whistle-blowing hotline for reporting contraventions of the Medical Device Code of Ethical Marketing and Business Practice became operational.

SAMED has decided to add to its complaint-lodging approach and allow for anonymous complaints – through an independently managed service – in order to overcome concerns that many potential whistle-blowers, including healthcare professionals, have due to fears of damaging relationships with colleagues, suppliers and other industry role-players, or of risking a disciplinary procedure or dismissal.

Known as the Medical Device Code ethics hotline, the mechanism is part of Deloitte’s global service which the company introduced in 1999 and which is ISO certified by SABS as a quality management system. It is compliant with various laws including the Company’s and Protected Disclosures Acts, as well as the Protection of Personal Information (POPI) Act, due to come into effect this year.

Who can use the hotline? Anyone can make a complaint including patients and health workers.

What can be reported? Contraventions of the Medical Device Code of Ethical Marketing and Business Practice by SAMED members or other signatories to the Code.

SAMED members – and all other stakeholders including healthcare providers and their patients – have access to the multilingual service 24 hours a day, throughout the year. Managed by trained call-centre staff who use a tailor-made script for calls related to the Medical Device Code, the service allows for three anonymity options:

  • Totally anonymous: the caller does not disclose any personal information to the call-centre agent. A unique reference number is used for follow-ups and to provide additional information.
  • Partially anonymous: the caller discloses his/her details to Deloitte only.
  • Full disclosure: the caller discloses his/her details to be included in the report to SAMED.

<snip The figure below summarises the process that the whistle-blowers follow: >

Reported cases are compiled into individual/monthly reports and are available to authorised SAMED representatives only through a secure online portal. The SAMED Executive Officer and SAMED Office manager are the only individuals who will have the log-in details.

Before contacting the hotline, the whistle-blower should read the Medical Device Code and compile as much information as possible about the case, including physical address, date and time of where the incident happened, names of people, description of the suspected transgression, proof/evidence such as documentation and the contravened clause of the Code.

Note, only complaints against a SAMED member and/or signatory to the Code will be investigated by SAMED.

Few other tips to bear in mind:

  • The hotline call-centre is not a service for other complaints or malicious calls.
  • Complainants should avoid contacting the hotline from work telephone extensions or email, to avoid being tracked by the company.
  • Complainants should also refrain from telling anyone in their organisation about the communication they are having with the hotline.

The updated Medical Device Code (which can be accessed explains the process SAMED will follow for dealing with anonymous whistle-blowing complaints and possible sanctions (see parts 2 and 4 of the Code).

The possible sanctions have been categorised according to severity of the breach (minor; moderate; serious/severe) depending on the patient safety and product use implications. In all cases, they require immediate suspension of non-compliant activity and issuing of a corrective notice by the transgressor, as well as a financial sanction that can range between R10 000 and R 300 000.

Note, should you wish, formal written complaints are still an option. Please click to download the Code Complaint Lodging Form.

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