In response to the COVID-19 pandemic, laboratories, hospitals and surgical facilities nationwide paused elective surgical procedures and other nonemergent and nonessential services, limiting physical access to facilities for nonessential health care personnel, patient visitors, and medical device representatives.
Medical device representatives that represent medical technology companies are often called upon by clinicians to provide support in patient-care or restricted areas of a Health Care Facility (“Facility”). Although some medical device representatives have been called upon during the pandemic to support procedures essential for COVID-19, many primarily support “elective” procedures and have also been requested to enter facilities in this regard.
As facilities resume elective procedures based on their local circumstances, SAMED members are committed to supporting the needs of patients who have had their procedures delayed.
This position paper provides key principles and considerations to guide medical technology companies and Facilities regarding when and how to safely resume entry of medical device representatives into Facilities to provide support in theatre, and includes a recommendation for facilities to account for medical device representatives in their consideration of case scheduling and prioritization as facilities begin to resume elective surgeries and other invasive procedures.
The following principles and considerations are intended to guide facilities, and medical device representatives as they adopt access policies that support safe re-entry of medical device representatives into the Facility. These considerations are not a substitute for guidance from provincial and national government authorities or the applicable law.
Alignment around these principles will further consistency in safety and testing protocols and lead to improved compliance. Greater consistency will also improve the ability of medical representatives to provide support for technology used in procedures when and where needed with minimal impediment or delay.
Facilities, Medical technology companies and medical device representatives are urged to keep abreast of the following documents, technical resources and guidelines as updated (not exhaustive):
- Regulations under Government Notice no. R 480 of 29 May 2020 issued in terms of section 27(2) of the Disaster Management Act of 2002 as amended from time to time, (“Disaster Management Regulations”) in particular, regulation 40.
- Federation of Surgeons of South Africa consensus document for the resumption of elective surgery after level 5 COVID -19 “lockdown” period in South Africa
- NICD Website
- NICD frequently asked questions
- NICD COVID-19 resources
- NICD COVID-19 guidelines
- NICD Guidance for symptom monitoring and management of essential staff with COVID-19 related illness
- NICD COVID-19 Environmental Health Guideline
- NICD Practical Manual for implementation of the National IPC Strategic Framework March 2020
- NICD DoH COVID-19 Guidelines 3 July 2020
Prevailing Assumptions and Objectives
As the aim of this paper is to provide current, evidence-based recommendations, on the re-entry of medical device representatives in theatre, we anticipate that these Principles may be updated to integrate improvements in the understanding of COVID-19 and the capabilities and availability of other resources such as diagnostic testing. These Principles are intended to account for: (1) the need for patient care; (2) the limited availability of Personal Protective Equipment (“PPE”); (3) the capabilities and availability of diagnostic testing; (4) the current understanding about COVID-19 disease and immunity; (5) the lack of an approved vaccine; and (6) the application of local laws, regulations, and official/health authority guidelines, which shall prevail in the event of any conflict or inconsistency with these Principles.
The Principles seek to minimize the transmission of COVID-19 to patients, clinicians, and medical representatives, in a manner that protects patients first, while also protecting clinicians and medical representatives in a way that (1) conserves the use of limited PPE for the priorities where such PPE would be most needed, (2) avoids unnecessarily duplicative, inefficient, or otherwise wasteful activities or expenditures, and (3) meets the obligations of both healthcare providers and medical technology companies. Consensus in the health care community toward best practices will decrease confusion, improve compliance, and prioritise healthcare professional access to limited PPE.
Roles and Limitations of the medical device representative in Health Care Facilities (“Facilities”)
By virtue of their training, knowledge, and expertise, medical device representatives in connection with the surgical device used in a procedure may:
- provide technical assistance and advice to the surgical team on the correct and safe use of the medical technology/device/product in accordance with the approved package insert and instructions for use;
- provide on-site product/technology advice and assistance to the perioperative team on the medical technology/device.
- support the clinical/operating room team to ensure that the appropriate range of necessary devices and accessories are available during a procedure, especially when dealing with medical technology that involves multiple devices, different sizing specifications and/or accessories; and
- serve other roles that include: training Facility staff on the safe and effective use of medical devices/technology; delivering, installing, maintaining, servicing/repairing medical devices/technology; updating device-related information and guidance; and programming and calibrating implant devices among others.
At all times, the role of the medical device representative is subject to the following controls and limitations:
- He/she enter and be present in the clinical setting only at the request of and under the supervision of the presiding Health Care Professional;
- he/she must be transparent that they are acting on behalf of the Company in a technical support capacity for the relevant device used in theatre and only in respect of approved indications; and
- He/she must not interfere with a HCP’s independent clinical decision-making or give clinical diagnostic advice or recommended treatment.
- He/she must ensure that requesting healthcare professional has obtained the patient’s prior written consent for the medical device representative to be in theatre, if prior written consent is not possible, ensure that the requesting healthcare professional informs the patient of their presence and participation in theatre and post-intervention consent must be obtained.
- He/she must wear the PPE as may be required by the Facility/requesting Healthcare professional.
1. All Areas of Hospitals and other Health Care Facilities
Principle: Facility Annexure E Plan, facility access, social distancing and safety policies applicable to staff, patients and patient visitors should apply equally to medical device representatives in all areas of the facility and must comply with Disaster Management Regulations2 and related guidelines, notices and directives issued in terms thereof and in relation thereto including the including the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health3. Facility access policies for all visitors will fluctuate and should vary based on the current COVID-19 incidence rates and activity in the immediate community and must comply with the current Disaster Management Regulations4 and related guidelines, notices and directives issued in terms thereof and in relation thereto.
Considerations: Facility policies for medical device representatives and their Annexure E Plans as required by the Disaster Management Regulations5 in all areas should account for the following:
- Medical device representatives should work with facilities and healthcare professionals to deliver services, information, and technical support remotely whenever possible.
- Medical device representatives needing facility access for servicing medical equipment should follow the same social distancing and access policies applicable to staff with access to the equipment.
- Medical device representatives entering all areas of the facility should take safety precautions in accordance with the Disaster Management Regulations6 and related guidelines, notices and directives issued in terms thereof and in relation thereto, both to protect the individual and others in the facility.
2. COVID-19 Testing and Screening and Testing
Principle: Facility screening procedures applicable to staff should be equally applicable to medical device representatives entering the facility, including but not limited to screening for symptoms, close contact with COVID-19 cases, etc provided that they are consistent with the Disaster Management Regulations7 and related guidelines, notices and directives issued in terms thereof and in relation thereto.
Facility testing policies for medical device representatives entering both restricted and non-restricted areas should follow current legislation, regulations and/or guidelines for COVID-19 testing, including the NICD guidelines8.
Considerations: Any required testing of asymptomatic individuals should only be consistent with and in accordance with applicable national or local health authority requirements or guidance9.
3. Elective Surgical Procedures and Personal Protective Equipment
Principle: It is recommended that health care facilities should not resume elective surgeries until the facility has proper inventory of non-crisis level equipment and supplies, including PPE. Facilities must follow the provisions of the applicable Disaster Management Regulations10 including the Directions issued by the Minister of Employment and Labour11, on ensuring that the workplace is safe for employees and people affected by the operations of the Facility, i.e. patients, visitors, medical device representatives, etc. Surgical case scheduling and prioritization policies should be consistent with the Disaster Management Regulations12 and related guidelines, notices and directives issued in terms thereof and in relation thereto, including the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health13 on the appropriate PPE and appropriate use thereof.
Considerations: Facilities should provide appropriate PPE in accordance with the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health14, to medical device representatives deemed essential to any surgical or other invasive procedure.
- Since Facilities establish the case-specific administrative and engineering infection prevention controls, Facilities are best positioned to determine the proper PPE for individuals that are present in the theatre for a particular procedure according to relevant health authority requirements or guidance (“Proper PPE”)15.
- PPE that is managed and supplied by the Facility can be quality-controlled by the Facility in contrast to PPE brought in from outside the Facility.
- Facilities with videoconferencing capabilities in their operating rooms should work with medical device representatives and healthcare professionals to utilise virtual support in surgical cases where remote attendance does not compromise patient safety, medical outcomes or privacy.
- Proper respiratory protection (e.g., fit-tested N95 respirators with face shield or surgical N95 respirator) should be provided to all individuals, including medical device representatives, who are present for aerosol-generating procedures for patients who are not confirmed negative for COVID-19 at the time of the procedure, as provided for in the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health16.
- Surgical case scheduling and prioritization policies should account for the sufficiency of PPE inventory which inventory must include Proper PPE for any medical device representatives required by a healthcare professional in an “elective” or any other procedure.
4. Crisis-Level Emergency Surgical Procedures and Personal Protective Equipment
Principle: Facilities operating in crisis level may require medical device representatives essential to emergency surgical and other invasive procedures to provide their own PPE if the Facility is in short supply to the extent this practice and the PPE is consistent with applicable Disaster Management Regulations17, the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health18 and the Directions issued by the Minister of Employment and Labour19.
Considerations: Medical device representatives and facilities should follow national and local health authority guidance20, the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health21, regarding use and decontamination of any such PPE, whether supplied by the Facility or by a medical device representative. PPE that is worn in the operating room serves two functions – protection of the wearer and protection of the environment. Re-aerosolization of contaminants on reused masks and respirators can be the source of sterile field contamination. To contain re-aerosolized particles, the facility should provide a surgical mask or other covering to be worn on top of any respirator a medical device representative has brought in from outside the facility.
- Facility PPE policies should be in accordance with the Disaster Management Regulations22, the COVID-19 Disease: Infection Prevention and Control Guidelines issued by the Department of Health23 and guidance for conserving PPE and infection control regarding the use, reuse, and decontamination of any PPE, whether supplied by the Facility or by a medical device representative.
- Proper respiratory protection (e.g., fit-tested N95 respirator with face shield or surgical N95 respirator) should be worn by all individuals, including medical device representatives, who are present for aerosol-generating procedures for patients who are not confirmed negative for COVID-19 at the time of the procedure.
- PPE that is used in the operating room should be effective in serving both functions of protective equipment – protecting both the wearer and the environment.
5. Training and Education regarding COVID-19 Safety and Precautions
Principle: Medical device representatives should be trained by the medical technology companies and the Facilities on and have an understanding of infection prevention recommendations for COVID-1924, guidance for PPE donning and doffing, and Facility policy related to COVID-19 safety principles. In this regard SAMED urges all medical device representatives to be CRICE accredited. See: CRICE
Virtual training and education should be encouraged where possible to minimize contact with other individuals.
1 National Health Act and the POPI Act
15 Proper PPE may include some combination of respiratory protection, masks, face shields, eye protection, gowns, head covers, gloves, shoe coverings, or coveralls.