The Medical Device Code of Ethical Marketing and Business Practice is our industry’s self-regulating instrument that directly enhances ethical, and reduces risks of corrupt or unethical, marketing and business practices.
SAMED is seeking government’s endorsement of the Code and advocates for it being supported by all stakeholders in the health sector. The Code is binding on SAMED members, but all medical technology companies are welcome sign up. This benefits all parties concerned – most importantly patients. Hence, we advise customers in both public and private sectors to enquire whether suppliers are a signatory to the Code.
SAMED assists companies to comply with the Code through capacity building of compliance officers, forums with senior leaders, mailers and other collateral. We use these and other platforms to promote the Code and the Medical Device Code Hotline to the health sector and the public.
The 24-hour, anonymous and independently managed tollfree hotline has to date received nine complaints, two of which are currently under investigation. Anyone – employees of medtech companies, healthcare providers (HCPs), procurement officials, health service users and members of the public – can report transgressions of the Code. SAMED investigates contraventions by signatories of the Code and may refer matters to relevant agencies or authorities. Contact the Medical Device Code hotline: free-call 0800 00 04 68; e-mail email@example.com attaching the completed complaint form.
Getting to grips with sample, demonstration, evaluation, loaned and placed products
SAMED’s last Code Forum for the year was held on 13 November and it covered sample, demonstration and evaluation products, and loan and placed equipment. The Code identifies these products as essential tools for medtech suppliers and provision of healthcare and specifies conditions and marketing and business procedures related to their use.
Until December 2021, the medtech sector is exempt from sections 18A and 18B of the Medicines and Related Substances Act 101 which prohibit sampling, placement of equipment for free, consignment stock and loan sets.
Two crucial principles apply to the use of these products:
- They must not improperly reward or induce customers to purchase, lease, recommend, prescribe, use, supply or procure the suppliers’ goods or services.
- Written agreements between suppliers and HCPs need to be in place and all products and processes must be accurately recorded.
Samples are used for training HCPs and helping them to familiarise themselves with the product in a clinical setting. Tender specifications often require that samples be provided by the bidders to assess the quality and effectiveness of the bid items in relation to bid prices before awarding the tenders. The number of samples to be supplied should be reasonable, not of commercial benefit to the HCP and members are cautioned not to provide samples to HCPs who have previously received them as this may be construed as a perverse incentive.
Evaluation products are supplied to HCPs so they can evaluate the products and provide post-evaluation reports to suppliers which are often used for post-market surveillance and health technology assessments. There should be no financial or other incentives for HCPs to participate in an evaluation. Failure to provide a post-evaluation report may be considered as having induced commercial interest through the pretence of evaluation.
Demonstration products are provided at no charge to HCPs so they can explain procedures to peers or patients. The products are not intended for clinical use and need to be clearly marked as such. The non-charge basis for supplying the product must be disclosed to the customer in writing (usually on the delivery note). Demo product should be provided to HCPs/HCOs only for the period reasonably necessary for the purpose and scope (ie if the doctor is doing a once off training the demo product should not remain with them indefinitely). Product descriptions, lot/part or serial number and quantities provided need to be recorded.
Loan or placed equipment entails a formal agreement between healthcare providers and suppliers and in some cases, there may be a regulatory license requirement for example from Radiation Control.
- Short-term placement of equipment is usually for evaluation purposes.
- Equipment can also be loaned with the requirement that the HCP purchases related disposables/consumables from the supplier, subject to the provisions of the HCPSA’s Guidelines for Good Practice in the Healthcare Professions – Booklet 11, item 3.6 Technological Equipment: i.e.
- that HCPs shall not over-use equipment for procedures, tests and other applications that are not indicated, scientific or based on evidence. This constitutes over-servicing and is prohibited.
- HCPs shall not use technological equipment, healthcare products or devices for profiteering and must refrain from charging patient’s fees for the use of such products or devices that are not market related.
- Loan sets contain instruments and consumables to be used in a surgical procedure. The whole set remains the property of the supplier and the customer only gets invoiced for items used.
Delivery of the set, its use in a surgical environment, sterilisation, decontamination and return to the supplier and invoicing for parts used must follow set protocols.
Consignment stock is provided when the final selection of a medtech product from a number of variants can only be made upon commencing surgery. Purchasing of all the variants would not be financially feasible. Hence, consignment agreements allow for the supply of all variants, but the billing for only the product used in surgery. Outlying hospitals rely on consignment to ensure stock availability for the benefit of the patient.
Reusable instruments are placed with the customer if they are using related implanted products from the supplier. Consignment agreements must include details about the products to be placed, retention of ownership, typical risk of damage or loss, stock-take requirements and procedures, the duration of the placement and the right of the supplier to remove the product from consignment. When items are used, this is noted within a stock take and replenished by the supplier when they invoice for used items. It is essential that suppliers have a stock controller to verify the conditions of the consignment, ensure that stock is replenished and guard against the use of expired stock.
Engaging with HCPs to promote compliance with the Medical Device Code
On 21 November, we had the opportunity to present the Medical Device Code to two professional societies: the Society of Radiographers of South Africa symposium (SORSA), which had 424 registered delegates, and the Aesthetic Medicine Congress South Africa. Clarity was sought on who the Code is applicable to and if accessories were included in our definition of medical technology. Delegates were also interested in the legalities of advertising trade name class D medical devices to the public (prohibited by the Medical Device Regulations) and the use of social media for advertising purposes.
SAMED values the commitment from suppliers and stakeholders in the health sector to the Medical Device Code and to ensuring that they understand the Code principles and its practical implementation. Code Forums will resume in early 2021 with plans to focus on indirect sponsorship.