Monitoring Requirements in Healthcare
to Ensure Safety & Compliance 

How simple and affordable monitoring can deliver greater efficiency

Safety in the healthcare industry encompasses various segments that require monitoring for regulatory requirements. These can range from vaccine clinics and blanket warming stations to intensive care units and clean rooms.
 
Regulatory compliance and safety protocols are necessary for hospitals, surgery centers, pharmacies, scientific laboratories and university research departments. 

Patient and public safety matters. 

Temperature and environmental monitoring are especially important for efficacy in the healthcare space.
 
Without proper temperature, humidity and air pressure differential, medications, vaccines and other pharmaceutical products may spoil, expire or potentially become contaminated while sensitive environments can become susceptible to hospital-acquired infections while running afoul of regulatory requirements. 

This white paper will explore how various regulatory agencies focus on temperature and environmental conditions while showing simple solutions in the form of digital wireless sensors and software. 

Sonicu has more than a decade of experience serving the healthcare and life science industry professionals who often cite “regulatory oversight” as a reason to invest in remote wireless monitoring. 

This white paper seeks to clarify which agencies provide oversight and regulatory requirements for the various areas, departments, and sensitive environments in a healthcare or life science setting. 

The Food and Drug Administration (FDA) mandates universal healthcare protocols to ensure public safety, specifically regarding stability testing. 

The regulatory agency states the purpose of stability testing is to:

“Provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.”

Monitoring systems should be compliant with the FDA and follow Centers for Disease Control and Prevention (CDC) guidelines.

Advances in technology make compliant temperature logging possible with digital, autonomous recordings of temperature over defined time periods. 

Remote support systems help maintain the proper temperature for medicines and vaccines. This includes, and is not limited to, automation of data collection and documentation of reporting, and how the staff is alerted.

Sonicu’s system is one of the few that includes phone call alerts in addition to text, emails and push notifications.

You can learn more about how our software helps compliance professionals in these case studies: 

Discount Drug Mart: Power Outage Protection + Compliance Automation

Problem: Transitioning from manual temperature logs and reactive power outage management

Solution: Adopting Sonicu's advanced system for seamless temperature monitoring and real-time power outage alerts across its 77 locations.

Hendricks Health: From Nutrition to the OR

Problem: The need to improve compliance and safety across various departments, starting from nutrition to the operating rooms.

Solution: Upgraded monitoring systems to enhance patient safety and streamline compliance across multiple facilities, including local YMCA rehabilitation facilities.

IU Health: Enterprise Monitoring

Problem: Challenges of using a locally based server and multiple monitoring solutions across departments.

Solution: Transitioned to a single, cloud-based solution with Sonicu to enhance monitoring capabilities across more than a dozen locations and the IU School of Medicine. 

Why and How? The Mechanics behind Government Regulations 

Regulatory bodies and medical associations are vital in ensuring the safety of patients and healthcare professionals. 

According to the CDC, each Temperature Monitoring Device (TMD) requires a specific type of equipment called a “digital data logger” (DDL) to monitor vaccines and their storage. 

While data loggers may be the preferred language of the CDC and other government agencies, this paper will seek to clarify the distinction between non-connected data loggers still relied upon by countless agencies and the cloud-connected devices that make the data easily shareable across organizations from virtually any connected device. 
 
The CDC says, “A DDL provides the most accurate storage unit temperature information, including details on how long a unit has been operating outside the recommended temperature range, referred to as a ‘temperature excursion.’

But recording data on a static device and making it immediately actionable via a connected sensor that can prompt a real-time alert are two very different functions. One can help you capture data, the other can protect your organization from a catastrophic loss of perishable assets.  
 
Unlike a simple minimum/maximum thermometer, which only shows the coldest and warmest temperatures reached in a unit, a DDL provides detailed information on all temperatures recorded at preset intervals. 

Use a DDL for each vaccine storage unit and each transport unit, emergency or non-emergency.”
 
The CDC also recommends at least one backup DDL in case a primary device breaks or malfunctions. 

Providers should use DDLs with the following features:

• Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®)
• Alarm for out-of-range temperatures
• Low-battery indicator
• Current, minimum, and maximum temperature display
• Recommended accuracy of +/-0.5° C (+/-1° F)• Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes. (Sonicu has a default setting of recording temperatures every 15 minutes)
• A current and valid Certificate of NIST Calibration Testing

Temperature and air pressure differential monitoring systems that Sonicu provide meet these vital guidelines for vaccine storage and distribution. They are also backed up live U.S.-based phone support to help our clients promptly manage any monitoring challenges.

Such state-of-the-art technology assists hospitals and medical facilities in eliminating costly operational issues and improving compliance readiness. Staff shortages and the rising cost of labor create an even stronger return on investment for autonomous monitoring solutions like Sonicu. 

Preemptive action through digital monitoring helps healthcare industry professionals and facilities detect and protect essential assets such as vaccines, medications and equipment.

Remote Wireless Environmental Monitoring for Pharmacists

While there is no universal temperature for biological substances, there are regulatory and minimum threshold requirements that make products safer for human consumption and application. 

Various natural and chemical compositions call for colder or freezing temperatures, requiring medical refrigerators to remain between 36 and 46 degrees Fahrenheit. 

Medical freezers can range between 5 and -58 degrees Fahrenheit.
 
The FDA says, “Temperature measurement can be accomplished by essentially five basic methods:"

• liquid-in-glass
• resistance thermometry 
• thermoelectric thermometry 
• optical/radiation pyrometry
• bi-metal 

The Board of Pharmacy designates:

• Temperature monitoring ranges between 68-77 degrees
• Humidity monitoring is a maximum of 60 percent
• air pressure monitoring at 0.01-0.03 WC. 

Much like the Board of Pharmacy, the CDC designates temperature monitoring range between 68-77 degrees, and monitoring between 30-60 percent relative humidity.

Humidity that climbs above 60 percent presents operational challenges for many pharmacies and other sensitive environments. 
 
The Joint Commission, in its report on “Temperature and Humidity Requirements – Guidance for Storage of Sterile Supplies,” lists the American Society of Heating and Air Conditioning Engineers (ASHRAE) standard ventilation requirements for sterile storage in Central Medical and Surgical Supply areas as:

• Positive air pressure relationship to adjacent areas
• Minimum outdoor air exchange 2 per hour
• Minimum total air exchange 4 per hour
• Maximum relative humidity 60%
• Temperature range 72 to 78 F or 22 to 26 C

Sonicu customers rely on our affordable room conditions kit to track and report on all of these conditions. 

The Joint Commission evaluates healthcare organizations to improve and inspire them “to excel in providing safe and effective care of the highest quality and value.” 

The advocacy group’s vision is “that all people always experience the safest, highest quality, best-value healthcare across all settings.” 

The Joint Commission has specific guidelines for organizations to remain compliant with manufacturers of sterile pharmaceutical supplies’ instructions for storage.
 
“If, for example, the manufacturer of the sterile supply requires a specific temperature and humidity requirement for storage, your organization would need to demonstrate at the time of survey that these requirements are being met,” the Joint Commission reported in the “Temperature and Humidity Requirements Guidance for Storage of Sterile Supplies” document. 
 
According to the Joint Commission, it does not specifically require such parameters be documented, however pharmacy staff, “should be able to identify if any sterilized supply, whether single use or reprocessed, has been potentially compromised (as may occur if the integrity of the package is in question or has evidence of damage from humidity) and can speak to whether that item would be appropriate for use.”
 
“Your organization may refer to evidence-based guidelines and national standards (EBGs) for guidance as to how sterile supplies should be stored. 

Most EBGs agree that sterile supply areas must be clean, well ventilated and protect supplies from: 

• contamination 
• moisture
• dust
• temperature extremes 
• humidity extremes

“Your organization must show evidence that, whether in a designated Central Surgical Supply area or in a storage room with mixed clean and sterile supplies, you are storing those supplies in a manner to protect from contamination and maintain the integrity of the packaging from damage.  

Failure to store medical and sterile supplies in a manner to protect from contamination will be scored at IC.02.02.01 EP 4.”

You can learn more about how our software helps compliance professionals in these case studies: 

Cryopoint: Mission-Critical Monitoring

Problem: Cryopoint faced calibration challenges with their legacy monitoring system and issues with a server-based system, putting critical samples at risk.

Solution: Transitioned to Sonicu's SoniCloud and its mobile-first solution, enhancing reliability in monitoring and easing operations.

Ohio University Innovation Center

Problem: Tech and tech-enabled startups at the Innovation Center needed reliable support systems for temperature and environmental monitoring due to the requirements of grant-funded projects.

Solution: Implement Sonicu for comprehensive monitoring of temperature, ambient humidity, and air pressure differential, ensuring necessary protection and compliance.

Hancock Regional Health: Enterprise Monitoring from Sound to Environmental

Problem: Disparate monitoring systems were taxing the staff with many manual processes, leading to inefficiencies and reduced asset protection.

Solution: CEO Steve Long initiated the adoption of a consolidated monitoring program for temperature, environmental, and sound, which automated compliance and reduced manual logging.

 Vaccine Storage: How to Protect Life-saving Drugs with Simple Monitoring 

Like the tiniest of patients in neonatal intensive care units that hospitals care for, vaccines are highly sensitive to their surroundings. Especially regarding temperature. 

The CDC’s monitoring standards include storage, distribution and cold chain logistics protocols to prevent vaccine potency loss. 

Efficacy is an important consideration for public safety and trust.

If preventable issues arise with medications and pharmaceuticals, this can be problematic for healthcare on a wide spectrum. Board of Pharmacy regulations establish procedures for refrigerators and freezers used in pharmacies to store virtually every medicine.

The Board also authorizes pharmacy prescription departments to have freezers used to store medications and prohibits the storage of any food or beverage in certain freezers used to store medicine in the prescription department of a pharmacy, according to the Nevada State Board of Pharmacy.

Amendments are often made to Board of Pharmacy chapters to ensure safety. For example, Chapter 639 of the Nevada Board of Pharmacy AC added this amendment:

• The temperature must be maintained between 36 degrees Fahrenheit and 46 degrees Fahrenheit.
• The temperature if the freezer section is used to store medicine must be maintained below 32 degrees Fahrenheit; and (b) A freezer that is used to store medicine in the prescription department of a pharmacy must be maintained below 32 degrees Fahrenheit.
• If the temperature in a refrigerator, freezer section of a refrigerator, or freezer is outside the range required by subsection 1 or 2, as applicable:
  
  
  • The person who discovers the temperature is outside the range, regardless of whether the discovery was made with the assistance of the alarm on a programmable device required pursuant to NAC 639.525, shall:
    
    
    • Make a record documenting the temperature and, if applicable, the reading from the programmable device;
    • Inform the managing pharmacist of the temperature in the refrigerator, freezer section of the refrigerator, or freezer;
    • The managing pharmacist shall ensure that action is taken to correct the temperature in the refrigerator, freezer section of the refrigerator, or freezer and, after verifying that such corrective action has been taken and shall initial the record; and
    • A pharmacist shall inspect the contents of the refrigerator, freezer section of the refrigerator, or freezer, as applicable, to determine whether the contents of the refrigerator, freezer section of the refrigerator, or freezer are safe to keep or should be discarded.
    • If the pharmacist determines that those contents must be discarded, the pharmacist shall ensure that the contents are discarded.

The burden for prompt and responsible oversight falls on your team, and can be made significantly less burdensome with the help of a remote wireless solution like Sonicu. 

Patient Nutrition Fridges and Food Storage: Your Monitoring Standards

Monitoring hospital and medical facility refrigeration to ensure every detail in patient safety is met is vital for safe and nutritious food and supplement preparation and distribution. 

Patient nutrition refrigerators keep dietary-specific food items cold and neonatal intensive care units that store breast milk for preemies chilled. Refrigerators must ensure nutrients remain at proper temperatures for safe consumption.

Specific temperatures for highly sensitive supplements must be maintained for efficacy and overall consumer health. Patient nutrition fridges should follow FDA guidelines mandating the cooling of stored foods is being met for proper temperature protocols.

Regarding temperature monitoring for food storage for consumers, the FDA advises two hours or less at room temperature before removing.

“To ensure that your refrigerator is doing its job, it’s important to keep its temperature at 40 degrees F or below; the freezer should be at 0 degrees F.

Since few refrigerator controls show actual temperatures, using an inexpensive free-standing appliance thermometer will allow you to monitor the temperature and adjust the setting of the refrigerator and/or freezer if necessary. 

Buy one for the fridge, and one for the freezer, and check them often.”

This is the FDA minimum suggestion for maintaining temperature integrity. With a remote, wireless system, you remove the need for your team to conduct manual logs, saving significant time and labor expense.

Sonicu’s affordable Bluetooth display provides this same simple interface while the mobile app makes it easy to view the temperatures from anywhere via virtually any connected device.

The FDA notes temperature monitoring is vital in slowing the growth of dangerous bacteria, and reminds the healthcare industry that properly operating refrigerator thermometers makes a difference.

“In fact, at room temperature, the number of bacteria that cause foodborne sickness can double every 20 minutes. Chilling foods to proper temperatures is one of the best ways to slow the growth of these bacteria,” said the FDA, in the article, “Refrigerator Thermometers - Cold Facts About Food Safety.”

The FDA also warns that healthcare professionals and hospitality staff should monitor how food in patient nutrition refrigerators is thawed, as “bacteria can multiply so rapidly in unrefrigerated food, it’s simply unsafe to let food thaw at room temperature.”

“If left unrefrigerated, some organisms can create toxins that will survive the cooking process even if the food is cooked to temperatures that kill the bacteria themselves,” the FDA said.

“There are three ways to thaw safely: in the refrigerator, in cold water, and in the microwave. If you thaw food in cold water, change the water every half hour to make sure it stays cold. Foods thawed in the microwave must be cooked immediately after thawing.”

Operating Rooms: Environmental Monitoring for Compliance Readiness

Monitoring of ambient temperature, humidity, air pressure, CO2 and O2 are extremely important for hospital and surgery center operating rooms. Sonicu makes it easy to install, configure and get prompt support on all these critical monitoring applications. 

Data Location Monitoring: How GPS Powers Improved Monitoring Data Sheet

Micro and macro observations and monitoring can make a life-or-death difference when vulnerable patients require a sterile, and controlled environment. 

Industry standards, including the ANSI/ASHRAE/ASHE Standard 170-2021 guidelines, offer regulations and mandates to healthcare facility owners and designers to maintain safety. 

Updates include a timely, revised scope for improved guidance on thermal comfort conditions. 

Also included in the guidelines are:  

• Extensive modifications to address the Outpatient and Residential sections
• Addition of a new outpatient ventilation table to address non-acute-type spaces; 
  • Extensive revisions to air filtration requirements 
  • Addition of new columns in theVentilation tables to prescribe filtration requirement and designate unoccupied turndown;
• Expanded guidance on separation distance requirements for varied intake and exhaust arrangements, coordinating with related ASHRAE Standard 62.1 data

Sonicu follows such guidance in its best practices for safety, quality control, and streamlined regulatory compliance.

This is made possible through automated monitoring and compliance reporting for surgery center environments that gauge temperature, air pressure, and humidity levels. 

These three solutions use a single, cloud-based platform for uniform operation, task automation and efficiency to meet ASHE, ANSI and ASHRAE guidelines and standards.

• Humidity monitoring preserves patient safety, maintains sterile supply product integrity and shelf life; documents RH levels and corrective action for excursions. Room conditions monitoring manages all room conditions to ensure safety and compliance. Air pressure monitoring ensures proper airflow to prevent contamination; provides automated compliance reporting; and troubleshoots causes of incorrect pressures.

Blanket Warmers: Affordable temperature monitoring to avoid patient injury 

Warmed blankets and hypoallergenic linens help patients stay well and free from exposure to elements and bacteria.

Brad Keyes, CHSP, owner of KEYES Life Safety Compliance, shared his expertise in the management of the Life Safety Program, including the Environment of Care and Emergency Management programs, regarding safety and monitoring. 

“While there are no specific standards that address blanket warmers, surveyors will expect the hospital to regulate their blanket warmers via their own policies. The hospital is expected to have a policy that sets the maximum temperature that the blankets may be,” Keyes said.

“Usually, the maximum temp is set at 130 degrees F. Anything over that will likely be scrutinized by a surveyor.”

Keyes added that blanket warmers are considered medical equipment and must be included in the medical equipment inventory, and they must be maintained in accordance with the manufacturer’s recommendations.

Sonicu today provides dozens of hospitals with monitoring specific to blanket warmers to help them stay on the right side of auditors. This is one more task you can take off the hands of your staff and allow cloud-based automation to manage.

The CDC reports that contaminated textiles and fabrics, such as warmed blankets for patients in ERs, hospital rooms and surgical departments, often contain high numbers of microorganisms from body substances. 

Those may include: 

Blood, skin, stool, urine, vomitus, and other body tissues and fluids. 

When textiles are heavily contaminated with potentially infective body substances, they can contain bacterial loads of 106–108 CFU/100 cm2 of fabric,” said the CDC, in its “Guidelines for Environmental Infection Control in Heath-care Facilities” report.

 ‘Disease transmission attributed to health-care laundry has involved contaminated fabrics that were handled inappropriately (i.e., the shaking of soiled linens). 

Bacteria (Salmonella spp., Bacillus cereus), viruses (hepatitis B virus [HBV]), fungi (Microsporum canis), and ectoparasites (scabies) presumably have been transmitted from contaminated textiles and fabrics to workers via

• direct contact or
• aerosols of contaminated lint generated from sorting and handling contaminated textiles

Medical Clean Rooms: Trusted Environmental Monitoring

Physicist Willis Whitfield invented the modern medical clean room while working for Sandia National Laboratories in 1960.

The key to his initial design was creating a sanitary space to prevent particles and unpredictable airflows in medical spaces. 

Whitfield’s goal was to provide constant, highly filtered air to rid secure, sanitary spaces of impurities.   

Whitfield’s keen foresight led to the development of today’s clean room filtration systems and leading-edge technology that prevent contamination and unsafe healthcare environments. 

To prevent pollutants and airborne particles from infiltrating the clean room space, air and humidity monitoring are essential. The FDA provides inspectional oversight and observations, and corrective action, to prevent this from happening.

“Microbial contamination is brought into the clean rooms through personnel and supplies. The number of microbes present needs to be controlled and minimized,” said the government agency, in its “FDA Inspectional Observations and Corrective Actions” resource document. 

“Personnel are the primary source of microbial contamination in a pharmacy cleanroom and represent the principal risk to product. That risk needs to be reduced.”

Tasked with ensuring safety and regulatory compliance, Sonicu works nationwide in healthcare and research at medical facilities such as Indiana University Health, University of Michigan Health System, Stanford University and Cryopoint, to provide robust continuous environmental monitoring that meets FDA standards. 

• Cryopoint Case Study
• Hancock Regional Hospital Case Study
• Hendricks Regional Hospital Case Study
• Indiana University Health Case Study
• Loma Linda University Children’s Hospital and Medical Center Case Study
• MiraVista Diagnostics Case Study

Clean rooms serve the purpose of an environment as free as possible of airborne particles, pollutants, and other impurities that can undermine sterility, cleanliness, or purity. 

Clean rooms are vitally important for many organizations and monitoring them is also important in order to ensure that they’re functioning properly.
 
To ensure a clean room is performing to acceptable standards, monitoring is essential. 

Monitoring clean rooms helps ensure that the particles, pollutants or other undesired contaminants that a clean room is designed to keep out are properly excluded from the room. 

This can be done with the help of various monitoring instruments that can transfer relevant data either wirelessly or through other transmittal methods.

• Operational efficiency: Virtually eliminate the need for tedious and costly manual logging while reducing the human error
• Compliance automation: Respond to virtually any regulatory audit or inspection in a few clicks with our reports section
• Asset protection: Detect and respond to any temperature excursion that can threaten virtually anything perishable: food, drugs, vaccines, research, etc.

The FDA says clean room conditions must be monitored constantly, and surfaces and equipment regularly cleaned and disinfected. 

Airborne Infection Isolation Rooms

During the global COVID pandemic, airborne infection isolation rooms (AIIRs) took center stage as an optimal solution for public and patient safety and prevention of the spread of communicable diseases. 

The CDC defines AIIRS within U.S. hospitals as: 

“Patient rooms with specific engineered features, intended to isolate and more quickly remove potentially infectious patient aerosols.”

During the early stages of  the COVID pandemic, demand for AIIRs exceeded their availability, forcing healthcare facilities to utilize portable fan systems with high-efficiency particulate air (HEPA) filtration to establish surge AIIR capacity. 

“Although there is substantial research indicating potential shortcomings when HEPA fan/filter units are deployed incorrectly, there has historically been minimal guidance on how to deploy these units correctly,” said the CDC, in its “Engineering Controls To Reduce Airborne, Droplet and Contact Exposures During Epidemic/Pandemic Response” report. 

“The National Institute for Occupational Safety and Health (NIOSH) has developed guidance for using portable HEPA filtration systems to create expedient patient isolation rooms. 

The Expedient Patient Isolation Room guidance is research-based and is an effective solution for surge isolation capacity during outbreaks when traditional airborne isolation rooms are not available.”

As NIOSH research results show, expedient patient isolation room configurations can be successful in containing surrogate infectious aerosol within the inner isolation zone, the CDC has published instructions for healthcare providers.

“The expedient isolation techniques described are intended to be an emergency alternative to establish surge capacity in airborne infection isolation. It is intended for use during an infectious disease emergency when insufficient engineered airborne infection isolation rooms are available to meet patient demand,” the CDC said.

“Selection of patient areas suitable for conversion into expedient patient isolation room configurations should be made in consultation with the healthcare facility’s safety officer, infection control, and building facilities department participation.”

Sonicu is on the front lines of monitoring air pressure differential to convert rooms to isolation rooms. 

Assisting healthcare facilities tasked with adding new isolation rooms helps keep healthcare workers and patients safe during pandemic outbreaks and public health emergencies. 

• Tiered Alarms notify designated staff if negative pressure is not maintained.
• Local displays provide visual indication of air pressure status in the room at all times.
• Web-based dashboard and mobile app flexibility to view all monitoring remotely.

Clinical Labs: Simple and Affordable Environmental Monitoring

When it comes to strengthening clinical labs, the CDC helps develop protocols to improve laboratory quality and safety, informatics and data science, and patient and public health.  

According to the CDC, “70 percent of today’s medical decisions depend on laboratory test results, showing the important role of clinical laboratories in today’s healthcare system.” 

The CDC estimates there are 260,000 Clinical Laboratory Improvement Amendments (CLIA)-certified labs nationwide that represent the cornerstone of diagnostic medicine today.

“Fourteen billion laboratory tests are ordered annually — safety, quality, and cost-effectiveness in laboratory testing are required for effective diagnosis and treatment of disease,” reports the CDC. 

“Experts estimate that 40,000–80,000 deaths occur annually from preventable diagnostic errors. Patients in rural areas often experience barriers to healthcare and laboratory services that limit their ability to receive the care they need.”

To support clinical labs and patient and public safety, the CDC’s Division of Laboratory Systems help strengthen their role in medicine by providing a “foundation for accurate and timely disease diagnosis, prevention, and control to improve the health and safety of Americans.” 

This happens in the following ways: 

• Prepare: Sustain a robust system of laboratories by developing technical guidance and delivering laboratory training that advance quality testing, effective reporting, and safe practices.
• Connect: Promote patient-centered solutions to reduce diagnostic errors by connecting world-class physicians and healthcare leaders to laboratory professionals through diagnostic management teams and other initiatives.
• Innovate: Create technology-based decision-support tools, such as mobile applications, to support appropriate use of laboratory services, and virtual reality trainings to enhance laboratory competencies.
• Respond: Strengthen clinical laboratory response capabilities by establishing a national laboratory outreach communication system and providing access to available specimens in the CDC Biorepository.

The CDC Biorepository was established in 1997 as a centralized resource to preserve CDC’s valuable samples and provide ongoing support to CDC programs.

“CBR provides sample storage and preservation with 24/7 monitoring to ensure sample integrity. CBR can accommodate diverse sample types, such as cryovials, DBS cards, ectoparasites and more,” said the CDC.

“In addition, CBR can store samples at different optimal temperature ranges, including vapor-phase liquid nitrogen storage units which keep samples below -140°C), low and ultra-low freezers that can maintain -20°C to -80°C, refrigerators that operate at 1°C to 4°C, and ambient temperature storage.”

Sonciu supports the life sciences and protects lab freezers and clean rooms for biologics including vaccines, blood products, DNA/RNA, and cryogenics. 

Monitoring is designed to meet the most exacting specifications. 

These include monitoring to ensure asset public safety for the rigors of life science research, such as air pressure and humidity monitoring to critical temperatures at the extremes. 

Sonicu digitally protects and logs automatically to assist scientific regulatory bodies with reporting and real-time asset protection alerts and plug-and-plan installation and implementation.

“Sonicu has been a powerful tool to identify which units are behaving out of spec and get our team
to fix them before we have a serious issue.”
Tim Livesay, Director, Hancock Regional Hospital Pharmacy Director

Compliance is our Specialty: So you don’t have to worry about it. 

The American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) has developed a number of standards for environmental conditions in healthcare environments. These standards are designed to ensure that the environment is safe, comfortable, and conducive to healing.

Some of the key ASHRAE standards for healthcare environments include:

• • Temperature: The temperature in healthcare environments should be maintained between 68 and 75 degrees Fahrenheit (20 and 24 degrees Celsius).
  • Humidity: The humidity in healthcare environments should be maintained between 30 and 60%.
  • Air quality: The air quality in healthcare environments should be clean and free of pollutants.
  • Lighting: The lighting in healthcare environments should be bright and evenly distributed.
  • Noise: The noise level in healthcare environments should be kept to a minimum.

These are just some of the ASHRAE standards for environmental conditions in healthcare environments. By following these standards, healthcare facilities can create an environment that is safe, comfortable, and conducive to healing.

Here are some additional details about each of the ASHRAE standards for healthcare environments:

• • Temperature: The temperature in healthcare environments should be maintained between 68 and 75 degrees Fahrenheit (20 and 24 degrees Celsius). This range is considered to be comfortable for most people, and it helps to prevent the spread of infection.
  • Humidity: The humidity in healthcare environments should be maintained between 30 and 60%. This range helps to keep the air from becoming too dry or too wet, which can both lead to health problems.
  • Air quality: The air quality in healthcare environments should be clean and free of pollutants. This is important for preventing the spread of infection and for providing a comfortable environment for patients and staff.
  • Lighting: The lighting in healthcare environments should be bright and evenly distributed. This helps to improve visibility and reduce eye strain.
  • Noise: The noise level in healthcare environments should be kept to a minimum. This is important for patients who are trying to rest and recover, and it can also help to reduce stress levels for staff.

By following these ASHRAE standards, healthcare facilities can create an environment that is safe, comfortable, and conducive to healing.

and process sensitive patient data, which makes them a target for hackers. Medical professionals are concerned about the security of their data, and they need to be sure that their data is safe before they can adopt a cloud computing IoT solution.

Other obstacles that medical professionals face include:

• • Cost. Cloud computing IoT solutions can be expensive, and medical professionals need to be sure that the benefits of the solution outweigh the costs.
  • Complexity. Cloud computing IoT solutions can be complex to set up and use, and medical professionals need to be sure that they have the resources to implement and manage the solution.
  • Lack of standards. There are no industry standards for cloud computing IoT solutions, which can make it difficult for medical professionals to choose a solution that meets their needs.

Despite these obstacles, cloud computing IoT solutions have the potential to improve patient care and outcomes. Medical professionals who are considering a cloud computing IoT solution should carefully weigh the benefits and risks before making a decision

The time it takes to implement a temperature monitoring solution for a healthcare environment will vary depending on the size and complexity of the facility, the type of solution chosen, and the level of customization required. However, in general, it can take anywhere from a few weeks to several months to fully implement a temperature monitoring solution.

Here are some of the factors that can affect the implementation time:

• • Size and complexity of the facility: The larger and more complex the facility, the longer it will take to implement a temperature monitoring solution. This is because there will be more areas to monitor, and more devices to install and configure.
  • Type of solution chosen: The type of temperature monitoring solution chosen will also affect the implementation time. For example, a wireless solution will typically take longer to implement than a wired solution.
  • Level of customization required: The level of customization required will also affect the implementation time. For example, if the solution needs to be customized to meet the specific needs of the facility, it will take longer to implement.

In general, it is important to start planning for the implementation of a temperature monitoring solution well in advance. This will give the facility time to gather the necessary information, choose the right solution, and get the necessary approvals. By starting early, the facility can ensure that the implementation process goes smoothly and that the solution is up and running as soon as possible.

Here are some tips for implementing a temperature monitoring solution in a healthcare environment:

• • Start early: As mentioned above, it is important to start planning for the implementation of a temperature monitoring solution well in advance. This will give the facility time to gather the necessary information, choose the right solution, and get the necessary approvals.
  • Involve stakeholders: It is important to involve all stakeholders in the planning and implementation process. This includes staff, management, and IT. By involving all stakeholders, the facility can ensure that the solution meets the needs of everyone involved.
  • Test the solution: It is important to test the solution thoroughly before it is implemented in a live environment. This will help to ensure that the solution is working properly and that it meets the needs of the facility.
  • Provide training: It is important to provide training to staff on how to use the temperature monitoring solution. This will help to ensure that the solution is used effectively and that the data is accurate.
  • Monitor the data: It is important to monitor the data from the temperature monitoring solution on a regular basis. This will help to identify any potential problems early on.
  • Make adjustments as needed: It is important to be willing to make adjustments to the temperature monitoring solution as needed. This may be necessary if the needs of the facility change or if the solution is not working as expected.

By following these tips, healthcare facilities can ensure that the implementation of a temperature monitoring solution is a smooth and successful process.

The main responsibilities of a facilities manager at a healthcare facility include:

• • Overseeing the day-to-day operations of the facility. This includes tasks such as maintenance, repairs, and cleaning.
  • Ensuring that the facility meets all safety and compliance regulations. This includes regulations related to fire safety, infection control, and environmental health.
  • Managing the facility's budget. This includes planning and allocating funds for maintenance, repairs, and other expenses.
  • Developing and implementing facility improvement plans. This includes identifying areas for improvement and developing plans to implement those improvements.
  • Working with other departments in the facility to ensure that the facility meets the needs of patients, staff, and visitors. This includes departments such as nursing, engineering, and administration.
  • Communicating with patients, staff, and visitors about facility issues. This includes providing information about upcoming maintenance, repairs, or other changes to the facility.
  • Responding to facility emergencies. This includes fires, floods, and other incidents that can disrupt the normal operations of the facility.

Facilities managers play a vital role in ensuring that healthcare facilities are safe, clean, and well-maintained. They are responsible for a wide range of tasks, and their work has a direct impact on the quality of care that patients receive.

Laboratories

Source: https://www.primexinc.com/en/blog/laboratory-temperature-humidity-requirements.html#:~:text=In%20the%20U.S.%2C%20the%20Food,between%2030%25%20and%2050%25.

In the U.S., the Food and Drug Administration’s regulatory guidelines outline an optimal temperature for labs as being between 68 °F and 77 °F (20 °C and 25 °C) with humidity levels somewhere between 30% and 50%. These two factors are vital to every laboratory environment for countless reasons, not the least of which is quality control. Improper temperature and humidity controls can lead to the following:

• Contamination of specimens
• Poor bacteria growth or arrest
• Static buildup on some instruments and equipment
• Calibration errors and measurement challenges
• Problematic uncertainty ratios about the results' efficacy

Source: https://www.fda.gov/media/73912/download

Facilities and Environmental Conditions 

 A comfortable working environment is considered 20 to 25o C with relative humidity of 35 to 50% depending on geographical area. In general, the work areas should be free of temperature extremes that are hazardous to health, or which interfere with safe operations. Laboratories where toxic materials are handled are under negative pressure to adjoining areas with 8 to 12 air changes per hour. High hazard laboratories, clean rooms/isolators, animal facilities, and Biosafety Level III suites have unique working conditions. Work, storage areas, and restrooms are free of noxious odors. Exhaust ventilation is maintained for 24 hours per day in any area where chemicals are stored or used. No laboratory air is recycled through the building.  The supply vents should not exceed 50 feet per minute (FPM) airflow. 

 Face velocities for chemical hoods must be within 80 to 120 FPM with minimal distortion of air movement (cross-drafts) through the face of the hood from activities or sources in the room.

Source: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-requiring-refrigeration

https://www.sensoscientific.com/blog-everything-you-need-to-know-about-laboratory-temperature-monitoring/

Laboratory Reagents

The majority of reagents used for laboratory testing are temperature sensitive, with most requiring routine refrigeration.

A small subset of materials require freezer, or below freezer-level conditions (ranging from freezing to 70 degrees below freezing).

Without refrigeration, most reagents will deteriorate within hours. No reagents that require refrigeration will last more than 2-3 days without it.

Disinfectants and Sterilants

Store all sterilant and disinfectant products according to the manufacturers' instructions, as indicated in the product labeling.

Many sterilants and disinfectants must be stored below 30° C (86° F). Storage above this temperature for more than a short time could jeopardize their stability and activity.

Dental Products

Most dental restorative and impression materials should last until the expiration date at controlled room temperatures. Higher room temperatures 27º - 32º C (80º - 90º F) may reduce the working times for the materials, making them unacceptable for use.

Lock Flush Solutions

Heparin Lock Flush should be stored at temperatures ranging from 20º - 25º C (68º - 77º F). Only brief storage at temperatures between 15º - 30º C (59º - 86º F) is permitted.

Human Heart Valve Allografts

Cryovalve human heart valve allografts are transported in a shipping container that can serve as a temporary holding container for up to 72 hours, providing the temperature does not exceed -70º C (-94º F) (dry ice temperature).

Pharmacies 

https://www.sensoscientific.com/temperature-and-humidity-monitoring-in-the-pharmaceutical-industry/

Vaccines

https://www.pppmag.com/article/1627

CDC Guidelines for Temperature Monitoring: https://www.pppmag.com/article/1706/June_2015_Temperature_Monitoring/CDC_Guidelines_for_Temperature_Monitoring/

ASHRAE 170-2008- Ventilation requirements of healthcare facilities: https://ashrae.iwrapper.com/ASHRAE_PREVIEW_ONLY_STANDARDS/STD_170_2021

All ASHRAE guidelines: https://www.ashrae.org/technical-resources/standards-and-guidelines/read-only-versions-of-ashrae-standards

Recommended Dry-Bulb Temperature for Common Laboratory Animals: https://rsawa.research.ucla.edu/arc/temp-and-humidity/

:Guide for the Care and Use of Laboratory Animals. 8th edition. https://www.ncbi.nlm.nih.gov/books/NBK54046/

TABLE 3.1Recommended Dry-Bulb Macroenvironmental Temperatures for Common Laboratory Animals

Dry-bulb room temperature settings for rodents are typically set below the animals’ LCT to avoid heat stress and should reflect different species-specific LCT values. Animals should be provided with adequate resources for thermoregulation (nesting material, shelter) to avoid cold stress.

Temperature and Humidity

Maintenance of body temperature within normal circadian variation is necessary for animal well-being. Animals should be housed within temperature and humidity ranges appropriate for the species, to which they can adapt with minimal stress and physiologic alteration.

The ambient temperature range in which thermoregulation occurs without the need to increase metabolic heat production or activate evaporative heat loss mechanisms is called the thermoneutral zone (TNZ) and is bounded by the lower and upper critical temperatures (LCTs and UCTs; Gordon 2005). To maintain body temperature under a given environmental temperature animals adjust physiologically (including their metabolism) and behaviorally (including their activity level and resource use). For example, the TNZ of mice ranges between 26°C and 34°C (Gordon 1993); at lower temperatures, building nests and huddling for resting and sleeping allow them to thermoregulate by behaviorally controlling their microclimate. Although mice choose temperatures below their LCT of 26°C during activity periods, they strongly prefer temperatures above their LCT for maintenance and resting behaviors (Gaskill et al. 2009; Gordon 2004; Gordon et al. 1998). Similar LCT values are found in the literature for other rodents, varying between 26–30°C for rats and 28–32°C for gerbils (Gordon 1993). The LCTs of rabbits (15–20°C; Gonzalez et al. 1971) and cats and dogs (20–25°C) are slightly lower, while those of nonhuman primates and farm animals vary depending on the species. In general, dry-bulb temperatures in animal rooms should be set below the animals’ LCT to avoid heat stress. This, in turn, means that animals should be provided with adequate resources for thermoregulation (nesting material, shelter) to avoid cold stress. Adequate resources for thermoregulation are particularly important for newborn animals whose LCT is normally considerably higher than that of their adult conspecifics.” -Guide for the Care and Use of Laboratory Animals. 8th edition

Laboratory observations of temperature and humidity dependencies of nucleation and growth rates of sub-3 nm particles-

https://agupubs.onlinelibrary.wiley.com/doi/full/10.1002/2016JD025619

Lab systems FAQ-

https://www.ashrae.org/technical-resources/laboratory-systems-faq

Regulating Temperature in the Lab: Applying Heat- 

https://app.jove.com/v/5043/regulating-temperature-in-the-lab-applying-heat

Regulating Temperature in the Lab: Preserving Samples Using Cold- 

https://app.jove.com/v/5042/preserving-samples-using-cold-cooling-agents-and-instruments-and-cryopreservation