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Why Patient Care Matters

A breakdown in facility operations can cause production stoppages, compliance issues and ultimately patient harm.

Doug Schaffer, Vice President of Sales & Head of Commercial, Life Sciences

In the life sciences sector, success isn’t measured solely by innovation or speed of production, but by the impact on patient lives. Behind every breakthrough therapy or medical device is a complex system that must operate with complete precision. Among the most critical contributors to patient safety are the facility teams who manage the environment where these innovations happen; the behind-the-scenes work of facility managers drives the safety and efficacy of these highly regulated spaces. As a result, patient care needs to be at the center of on-site services provided by the facility management team in medical and pharmaceutical environments.

Whether managing a production floor for medical equipment or a lab where lifesaving medicines are produced, facility professionals are vital for ensuring that patients receive products that are effective, safe and readily available. In highly regulated environments like those found in the life sciences industry, the physical workspace itself can be a driver of both product quality and patient outcomes.

The High Cost of Failure

If facility management standards slip, the consequences can be devastating. For example, one of the starkest examples took place in 2012, when unsanitary conditions at the New England Compounding Center led to a fungal contamination of more than 17,000 vials of medication. Unfortunately, this created a nationwide meningitis outbreak that led to 753 infections and 64 patient deaths. In this case, lapses in oversight, cleanliness and sterile operating environments directly led to loss of life. As a result, this incident led to the reshaping of how sterile compounding facilities are regulated in the United States.

Contamination isn’t the only concern. Even if a tainted product doesn’t reach patients, facility management breakdowns can lead to significant downstream impacts. The U.S. Government Accountability Office has documented several instances of quality failures like improper environmental control, drug shortages and production halts. Shortages lead to issues like treatment delays and declining health outcomes, resulting in ripple effects that can affect the quality of patient care.

Creating Conditions for Patient Wellness

Operational excellence is directly correlated with the well-being of patients. Rightly, life sciences facilities are held to some of the highest regulatory standards in the world. Even small variations in temperature, humidity or air quality can compromise a product and potentially cause harm. Especially in sterile environments, an unfiltered air particle or an under-maintained water system can introduce pathogens into a facility.

For facility managers, this means every detail — from preventative maintenance and HVAC repair to GxP cleaning practices and real-time monitoring — contributes to the well-being of patients. This detail-oriented approach is especially critical during moments of disruption. In 2009, a major biotech firm had to shut down its production facility, which was the sole manufacturer for a rare disease’s leading treatment, due to viral contamination that left patients without access to critical medicines for months. For those managing these environments, it’s clear that proactive and effective facility management in life sciences can be lifesaving work.

In addition, given the regulatory strictness of the sector, facility managers play a significant role in ensuring compliance across these sensitive environments. Given that downtime and stoppages could lead to loss of life, organizations are seeking facility partners with specialized expertise and a deep understanding of the regulatory landscape. 

Life sciences continue to experience high employment, innovation and spending. There is a growing demand for lab and research space and expert teams to manage them. A space run by the right provider, one that is compliant and focused on both employee and patient well-being, will also help organizations attract and retain exceptional talent. 

Putting People at the Center

Although life sciences are complex, our goal as facility managers is simple: deliver safe, effective products to the people who rely on them. That mission depends on well-regulated environments that put safety at the forefront. Facility teams have a unique responsibility to ensure every room, system and surface is maintained with purpose and precision.

Patient care isn’t only relegated to doctors and researchers. It’s necessary for everyone working to supply critical medicines and devices, especially those who manage and supervise the spaces where innovation occurs. By aligning daily operations with the goal of better patient outcomes, facility managers do more than keep things running they are vital for the prevention of disruptions that could delay life-saving care.

ABOUT THE AUTHOR

Doug Schaffer

Vice President of Sales & Head of Commercial, Life Sciences

Contact Dougmailto:douglas.schaffer@us.issworld.com