Learn to challenge your medical device vendor

By James Waterson. RN, M.Med.Ed. Medicines Safety Manager, Medical Affairs and Larry Neal, Regional Marketing Manager, Medication Management Solutions, Becton Dickinson, Eastern Europe, Middle East and Africa

Medical device companies make profits from healthcare. By virtue of this, the relationship between healthcare providers and these companies has often been an uneasy one. This said, it is important to remember that device manufacturers have a vested interest in the wellness of patients. Medical devices that fail to deliver results and improve the lives of patients (and clinicians) are short-lived in the market and damage their maker’s reputation.

Bringing a medical device to market requires extensive consultation with customers to acquire ‘Voice of Customer’ (VOC) insights. Without consulting the expertise and acumen of clinicians and biomedical staff there is a very real risk of creating a device that has multiple features but no real application to the customers’ challenges.

A simple example of an apparently ‘impressive’ but pointless feature would be a manufacturer producing an IV pump that claims to deliver 0.01 ml/hr for continuous infusions. A simple VOC exercise would soon make it clear to the manufacturer that such a device, running at 0.01 ml/hr, would take over 30 hours just to clear the dead space in even a small gauge cannula before true drug delivery takes place!

VOC therefore helps medical device companies to create devices and processes that deliver efficient, effective and above all, safe care to patients. Answers from VOC surveys help manufacturers decide how pre-existing environmental, technological, and organisational cultural barriers to safe, effective, and economical care can be overcome through innovative device design.

One of the goals of the Becton Dickinson (BD) Middle East and Africa office in the near term is to ensure that a more significant component of global VOC consultation takes place in our territory. This reflects the trend towards ever higher standards of leadership on patient safety, automation, technology utilisation, and innovation that we see in the region.

The large-scale use of VOC also ensures that medical device companies have extensive global experience of how facilities have solved patient care problems using their products, and of how customers have undertaken integrations of these products into their risk management and patient treatment strategies. These can of course be shared, and essentially a medical device company can be the coordinator of a global community of its users to promote and to disseminate best practice in the use of its products.

Examples of this are sharing best practice nursing audit processes for infusion pump pressure alarm setting to reduce extravasation injury risk in neonates and the hosting of region-wide and global teleconference seminars, face-to-face meetings, and expert panels for pharmacists and risk-managers to discuss and create strategies for hazard reduction in high-risk medication prescription, compounding, dispensing, and administration.

A more formal example of the kind of coordination that medical device manufacturers undertake is creating advisory boards of advanced users of their products and directing the activity of Key Opinion Leaders (KOLs) towards solving issues for the larger healthcare community. A key component of this process is ‘spreading the word’ from KOLs and advisory panels about new, or previously under-recognised, healthcare and risk management challenges and solutions to a global audience. Medical device companies may be uniquely positioned to undertake such dissemination as they are often large corporations that are globalised, interactive, and connected to locations throughout the world.

Medical device companies should have extensive Medical Affairs and Health Economics Outcomes Departments. These departments are dedicated to ensuring that products that come to market meet the needs of organisations, patients and end-users, and are used optimally by clinicians to deliver real value. These departments are therefore a perfect partner for any facility or healthcare professional looking to create research or undertake quality projects within their facility, as they have access to large volumes of data taken from devices, specialist services for interpretation of data and results, and, often, experience of similar projects undertaken by other customers even though these customers may be in other parts of the world. Examples of this from our own region include an extensive engagement by BD with the NICU of University Hospital Antwerp in Belgium to identify and to improve issues of alarm fatigue and clinician response to critical infusion alarms and a large scale assessment of data from infusion pumps from every part of Europe, Middle East and Africa, with 1,600,832 separate infusions and over 2.2 million alarms analysed.

Such work is time consuming and exhausting for individual clinicians to undertake but is important. The Antwerp NICU study included changes to the way infusion pumps were used and how their alarms were monitored. These changes led to a 56 per cent reduction in key alarms overall and to a 31 per cent improvement in clinician reaction time to critical infusion alarms.

The large-scale cross-regional study mentioned above has identified how ‘Right Maintenance’ of critical short half-life infusions is both a previously under-reported potential area of risk for patient safety, and has identified areas in which technology may help mitigate the risk of prolonged interruption of delivery for critical drugs such as Epinephrine in increasingly understaffed and over-extended critical care areas.

Creating regional case studies to show how products that are used globally can be ‘localised’ is an important part of the work of any regional Medical Affairs department and requires partnering with key centres of excellence at a national level. We are fortunate in the Middle East in having so many top-level institutions to undertake this work with, and to show how automation and medication management systems can be employed to solve problems such as high turnover demand in outpatients and in emergency departments.

Regional Medical Affairs departments, backed by the technical and IT resources of large medical device companies, can also offer expert advice on existing technologies in facilities, and in particular, on complex issues such as infusion interoperability with Hospital Information Systems (HIS). An example of this is the ‘clinical walkthrough’ to assess the readiness of a facility to undertake bar-code IV medication administration with medication orders being sent directly to smart IV pumps from the HIS. The walkthrough includes assessment of existing hardware, pharmacy and nursing resources, and clinical workflows, and is followed by a technical assessment of the networks and server infrastructure required for such integrations.

Medical Affairs departments can also assist with solution planning to meet accreditation requirements, and can help customers by focussing on specific areas such as Medication Management and Usage (MMU) and Quality Improvement and Patient Safety (QPS) where data aggregation and analysis, and evidence of Failure Mode Effect Analysis (FMEA) processes are required by agencies such as Joint Commission International.

Medical device vendors need a strong engagement with customers, in order to learn from them, and to continue to learn more about our own devices and their full ‘real world’ potential. Equally customers should engage with manufacturers to gain valuable support if they are to realise the full value of their investment in these technologies for patients and clinicians.

So, learn to love your medical device vendor, but, of course, put them to work and ensure that they deserve your love.

Waterson will be speaking on “ET Tubes and VAP” on October 26, day three of the Nursing Conference, at Patient Safety Middle East.