COMMUNIQUE

 

The suspension of licensing of dental x-ray & imaging equipment for installation : a dental practice crisis "interim solution found"

 

 

KC Makhubele

CEO, The South African Dental Association

 

 

 

We have a crisis... our members report that they are experiencing difficulties in obtaining licences for new, reconditioned or reinstallation of their X-ray equipment. The Directorate of Radiation Control at the National Department of Health has referred all further enquiries to the South African Health Products Regulatory Authority (SAHPRA). We have been informed by Directorate Radiation Control that due to the fact that the posts of both the Deputy Director: Ionising Radiation and the Deputy Director: Inspectorate are currently vacant, the licensing of all X-ray equipment for installation and use was suspended with immediate effect. No information is available on how long this untenable situation will last.

It is with great concern that we have written to Ms Portia Nkambule, the Acting Chief Executive Officer of SAHPRA. We have also copied Ms P Matsoso, the Director of Health and Dr M Mcuba of the National Department of Health, Oral Health Directorate, in the hope that we can secure a meeting and that some interim solution can be found.

Understandably this regrettable situation could cripple the dental industry! It is both a clinical and regulatory requirement that all dental treatment be preceded with a radiograph, an aid to diagnosis, the determination of risks and influencing the recommended treatment plan for the patient.

It would, therefore, be both irresponsible and clinically poor practice to manage dental diseases without proper diagnostic aids in the form of radiographs. Practitioners will not be able to make informed and appropriate diagnoses which could open them up to HPCSA complaints and/or litigation. In addition, patients will not be reimbursed by their medical schemes for images taken with unlicensed radiographic equipment.

At the same time, it is completely unconscionable to expect dentists to cease practising and prevent them from carrying out their chosen profession and helping the community at large. The situation is simply not sustainable and we urge SAHPRA and the Department to propose an interim measure that will allow dentists to obtain x-ray and imaging equipment and to have these installed and licenced within a stipulated timeframe which should be governed by SAHPRA's expectation in terms of Alling the vacant posts.

SADA has been at the forefront of educating and encouraging our members to comply with the current regulations regarding the Licensing and QA Inspection of Dental X-ray Equipment. Most practitioners have complied and all that is left is the Certification/Licencing. We are also concerned that SAHPRA did not see it fit to inform us, as a body whose membership is primarily dentists, of the current situation, leaving SADA to second guess what the matter could be in the light of the deluge of complaints and concerns we have been receiving on a daily basis from our members.

SADA worked tirelessly to get this matter resolved by putting pressure on Government and related parties as well as working with other stakeholders to deal with this matter. Our efforts did bear fruits as per below. Should our efforts have failed, and as an absolute last resort, SADA was more than willing to have seriously considered legal recourse.

Interim solution found!

"Where there is pressure, a path can be created" KC Makhubele. After engaging with the Directorate of Radiation Control as well as SAHPRA to urgently review the situation and put an interim measure in place to prevent crippling the dental industry, the matter has been attended to.

SAHPRA has appointed an Acting Deputy-Director, temporarily and the licencing of Dental X-Ray Products for use has commenced again since the 12th of September 2018. We have been assured that all outstanding dental licences that were in the system have now been issued.

Members are advised that any applicants who have not received licences yet should contact one of the following offices:

• Pretoria 012 395 9121

• Durban 031 307 2111

• Cape Town 021 957 7443

It will expedite matters if you are able to quote existing licence numbers, where applicable. Should you still have issues, please contact my office via Dr N Niranjan - NNiranjan@sada.co.za. We remain committed to dealing with member issues speedily.