The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the FDA activities and engagement with the Voluntary Improvement Program (VIP) for the purpose of fostering medical device development.
The document provides an overview of the existing legal framework, as well as additional recommendations and clarification to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the relevant legislation and has been agreed with the authority in advance.
The scope of the document covers, inter alia, the approach to be applied with respect to the performance measures. In particular, the guidance provides a table outlining the key quality domains, as well as corresponding performance measure information.
Quality Domains
According to the guidance, key quality domains are:
- Safety: Device does not compromise the clinical condition or the safety of patients, or the safety and health of users
- Reliability: Device system or component is able to function under stated conditions for a specified period of time
- Availability : Device is available to fill first requested order
- Effectiveness : Device produces the effect intended by the manufacturer relative to the medical condition(s).
Performance Measure Information
When it comes to the actual performance measure, the authority expects the following measures to apply.
- Quality Objectives:The primary objectives under the “Quality” header emphasize reducing field corrective actions, ensuring that products are serviced right the first time, operating under complete control, and continually improving the safety and reliability of products.
- Business Objectives: The “Business” dimension relates to enhanced patient safety and customer experience, the rigorous development and maintenance of products in line with expectations, punctual and complete order fulfillment, and also the overall improvement of patients’ health and their quality of life.
Title of Metrics:
- Number of Field Actions: Represents interventions taken outside normal distribution.
- First Pass Yield: Relates to the efficiency of product servicing.
- Backorder: Calculates delays in product availability.
- On Time and In Full (OTIF): Measures order fulfillment efficiency.
- Complaint Rate (CRR): Captures customer dissatisfaction rates.
- Compliant Incidents per Million (CIPM): Standardizes incidents against product volume.
Level of Assessment
Metrics are divided into several groups, including individual product levels, aggregated for all products at a particular site, or aggregated for products across the entire site.
How is it Calculated?
The metrics employ various calculation strategies:
- Field Actions are a count of specific interventions.
- First Pass Yield is a percentage comparison between serviced units and total units serviced.
- Backorder is assessed over a 90-day average.
- OTIF compares order numbers against shipments over 30 days.
- CRR is an aggregate of complaint incidents.
- CIPM correlates incidents with released unit numbers.
Indication of Good Performance
Desirable outcomes vary by metric:
- Field Actions, CRR: A decreasing trend is preferred.
- First Pass Yield, OTIF: An increasing trend is preferred.
- Backorder: A decrease from the target is preferred.
Limitations or Blind Spots
Across all the metrics presented, no specific limitations or blind spots were provided by the FDA.
Why the Measure Matters/How is it Used
Each metric serves a pivotal role:
- Field Actions and First Pass Yield guide product modifications and are integral to quarterly reviews.
- Backorder ensures customer delivery expectations are met.
- CRR provides details on product-related issues and, sales as First Pass Yield, is vitally important for trend analysis and management reviews.
Capture Frequency
Metrics are captured at varied intervals:
- Monthly: Field Actions and First Pass Yield
- Weekly: Backorder
- Daily: OTIF
Organization Reporting Frequency
Irrespective of their capture frequency, all metrics are reported to the organization on a quarterly basis, underscoring their strategic importance.
In summary, the present FDA guidance provides a clearer perspective on the performance metrics to be applied by medical device manufacturers when measuring the actual performance of the products they are responsible for in the context of the Voluntary Improvement Program.
The document outlines the key quality domains and corresponding performance metrics.
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