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News & Trends - MedTech & Diagnostics

Researchers ‘examine’ the presence of medical device representatives in Australian hospitals

Health Industry Hub | February 27, 2023 |

MedTech News: The pandemic disrupted the usual operations of the medtech sector and the presence of medical representatives in hospitals. The Australian Research Council (ARC) funded a project led by Macquarie University to examine the role of medical device representatives in clinical settings.

As the hands-on experts in rapidly evolving medical products, medical device representatives have maintained a strong presence in hospitals supporting the introduction and use of medical devices by clinicians in a variety of clinical settings such as operating theatres, patient care units, and cardiac catheterisation labs.

Pandemic measures such as bans on visitors and the sudden cancellation of elective surgeries led to the reduced presence of device representatives in hospitals and significant adaptation within the medical device industry.

The medtech industry sought new ways to communicate remotely with health professionals including enhanced video resources and webinars in addition to expanded remote detailing.

According to researchers Brette Blakely and colleagues “Ethical concerns over the presence of device representatives in hospitals and operating theatres have typically involved concerns about physicians’ conflict of interest and patient privacy. Unlike pharmaceutical representatives, device representatives are allowed into clinical spaces during consultations and sterile procedures, at the request of the clinician, and have access to highly sensitive data. Clinicians report reliance upon device representatives for technical advice and are sometimes unable or unwilling to perform certain procedures in their absence.

“In other cases, hospitals engage device representatives to provide device-related education and support in the procurement contract, which is perceived as a value-add and competitive advantage. In all cases, the outsourcing of technical education and support to representatives operating in a sales capacity for for-profit manufacturers raises questions about accountability, role definition, and the influence of commercial incentives.”

Regulatory bodies such as the Joint Commission (United States), publish standards related to identification, infection control, and privacy. In response, industry has advocated for uniform “vendor credentialing” standards to facilitate representative access to hospitals. In the United States, representatives must pay a fee to register with a vendor credentialing company which compiles, verifies, and documents representatives’ immunisations, police checks, and completion of training modules like sterile practices and infection control.

The authors commented “It is timely to ask whether an industry self-regulatory system and industry standards for infection control are adequate or require revision and/or oversight. And, given the heightened risks of infection, the physical presence of sales representatives in clinical settings requires robust justification.”

The other side of the picture is that the use of virtual interactions “introduces novel, practical and ethical considerations, as there are significant regulatory gaps around digital health technologies”, according to the researchers.

“Tele-reps may reduce infection risks, however by expanding the amount of digital data created they pose additional challenges including managing data security given the value of any health professional user data collected for marketing and sales, protecting patient privacy given that tele-rep consultations may include cameras operating in clinical spaces, and regulation of promotion given that all information shared through the app likely has promotional intent or consequence. This increase in digital data introduces new types of risk associated with maintaining digital patient privacy.”

Rethinking of the system so that hospital employees are trained to do the work currently done by device representatives would be a significant departure from current practice, posing new challenges to hospital workforce strains and giving rise to potential new risks of harm to patients.

The authors concluded that the “current credentialing is insufficient to mitigate the infection risk posed to and by device representatives in clinical settings. While a move to remote or virtual platforms may reduce infection risk, fundamental questions remain about outsourcing such expertise and the associated patient safety issues.”

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