RMR

Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).

Occupational Exposure Banding (OEB), also known as hazard banding, is a process used for assigning chemicals into categories based on toxicological potency and potential health hazard. OEB has been used to help organizations define and identify worker health exposures since the mid-1990s and has primarily focused on small-molecule chemicals, which make up most market pharmaceuticals. However, new modalities have been developed, and with increasing use across segments such as oncology, cardiovascular conditions, and autoimmune diseases, these modalities often lack occupational exposure limits.

The development of lithium-ion batteries, also known as “Li-ion” batteries, has brought game-changing portable, rechargeable power to a vast array of products, including modern-day smartphones and electric cars. The life science industry has taken notice: many medical devices, ranging from electric wheelchairs to defibrillators to oxygen concentrators, have been designed to work with lithium-ion batteries. While the efficiency and longevity of such batteries can be extremely beneficial and, in some cases, lifesaving, their use comes with safety trade-offs over traditional batteries. Medical device manufacturers must consider these trade-offs carefully when electing lithium-ion batteries as the power source for their products.

The life science industry is not immune to the risk posed by combustible dust. Many pharmaceutical production processes, such as batching, compression, dispensing, granulating, and mixing, create dust hazards. Common airborne combustible dust particles which are a by-product of these operations, and may present an explosion risk if not controlled, include calcium, lactose, lithium, magnesium, potassium, sulfur, and sodium.

Life Science organizations often maintain or work with perishable property critical to the company’s ongoing operations. Perishable property refers to a business’s personal property that is susceptible to spoilage, rapid decay, or deterioration, often due to an unwanted change in environmental conditions. Examples of perishable property used by life science companies include: