Bob Vermillion, IOPP Chair of the new ESD Medical Device Packaging Task Force of the Medical Device Packaging Technical Committee. The committee is made up of Packaging Engineers and End Users that are members of the Institute of Packaging Professionals.
On 16 May 2007, Bob was named to the IoPP College of Fellows.
Bob Vermillion is Chair/Founder of IoPP Medical Device ESD Task Group
"With this and with increasing explosions in hospital operating rooms and in chemical and pharmaceutical laboratories, people called the cause of these explosions static electricity."
Niels Jonassen, MS, DSc, Technical University of Denmark, Retired
Hazards in the Operating Room
A potential hazard in operating rooms is associated with the mixture of anesthetic gases with oxygen or air. Extensive field and laboratory investigations have been carried out, notably by the U.S. Bureau of Mines, demonstrating conclusively that mixtures of oxygen or air with anesthetic gases normally used in operating rooms can be ignited by very low energy sources; energies in excess of this minimum are associated with spark discharges such as are produced from electrostatic charges built up on equipment and personnel in operating rooms. This constitutes the chief source of ignition, although other sources such as open flames, arcs and sparks from non-explosion-proof electrical equipment and faulty wiring, as well as incandescent lamps and endoscopes or high frequency cauteries or coagulators have added to the hazard. [3]
With technologically advanced hospital monitoring equipment, lock ups and ESD related failures are possible. Unexplained equipment fluctuations observed by surgeons [4] have occurred in hospital environments. Some hospital organization’s specifications have been observed to call out Electrostatic Propensity or carpets to be less than 2.0 KV ( charge generation in combination with a person.
This specification is extremely high and above the requirement for charge generation in combination with a conductive floor and person. For example, a surgeon walking across a carpet could compromise an ESD medical device. Moreover, a medical device, although properly stored for ESD protection, could be removed from the package, then tribocharged before installation. To create an ESD event three things are necessary:
- Charge Generation
- Charge Accumulation
- Rapid Discharge
ESD sensitive microprocessor driven technology such as pacemakers would fall within the ESD Roadmap in Figure 3 below.
1Lt. Brenda Shealy checks a piece of anesthesia equipment in an operating room during Operation Desert Shield.
2Captain Cynthia Warwick (right) and Staff Sergeant Chad Smith, USAF, prepare a syringe with local anesthesia during Operation Enduring Freedom.
3CBD-32. Safety from Fires and Explosions in Hospital Operating Rooms, P. J. Sereda 1962
4Conversations with Doug Vermillion, MD, Fellow US Army Orthopedic Surgeon (Ret)
Static Control Packaging
Improper packaging schemes which fail to maintain static dissipative characteristics in combination with low relative humidity can become charge generators. Hospital personnel removing a charged medical device as a pacemaker from storage through improper handling and making intimate contact with a conductive surface can produce an ESD event. One solution is to assess your packaging scheme through an onsite audit to conduct ESD test measurements (see Figure 4).
If you would like more information on static control packaging specifications, design or ESD testing for medical devices and related static control packaging for pharmaceuticals, medical device and hospital requirements, please contact Bob Vermillion at bob@esdrmv.com or call 925-673-0225.
Charge Generating Surfaces
Figure 5 above represents what can happen if a hospital operating room floor is not adequate to control the build up of static electricity. As an illustration, a charge from a circulating nurse is seen at 1,593 volts. If the floor does not have an adequate resistance to a groundable point and under the right conditions of low RH in proximity to flammables, a potential for ignition could occur.
Capabilities Overview
Our services include ESD specification development and testing services which reflect the current industry standards. RMV is a SDVOSB, SBA 8(a) and SDB along with California certification as a service disabled owned veteran business. Some of our services are as follows:
- Leadership in Hospital Centers for ESD/ESA (Electrostatic Attraction) Control
- Controlled Environments R&D Labs, Medical Device Assembly and Pharmaceuticals
- Operating Room Integrity against ESD (Electrostatic Discharge)
- Grounding
- ESD (electrostatic discharge) Safe Packaging for Medical Devices
- Monitoring for ESD Events and Electrostatic Fields in Operating Rooms
- Hospital and Pacemaker Supplier Facility Audits
- ESD Testing & Verification Services
- Development of Proper ESD Storage Protocols to protect Pacemakers
- ESD Training for VA Medical Personnel and Engineering
- Certification of Flooring for the Control of Static Electricity
- Qualification Services (ESD Testing) of Materials in a Medical Device/Hospital or Pharmaceutical Environment
- ESD Training of Hospital, Medical Device and Pharmaceutical Personnel
- Technical Writing Services including ESD Material Specifications
As an ESDA Standards Member, our organization has been very active in coauthoring several ANSI/ESD level documents. RMV conducts ESD testing for industry including the medical device sector, pharmaceutical, disk drive arena, semiconductor and defense industry.
RMV Professional services
Advanced Equipment Risk Assessment & Validation Services includes the following:
Electrostatic Attraction (ESA)
- Electrostatic Discharge (ESD)
- Ionization placement
- Ionization selection for specific application
- Ionization qualification
- ESA/ESD Validation by Mapping electrostatic fields, discharges, resistance and decay
- ESD medical device packaging integrity
- Pharmaceutical
- Drug Delivery
- Manufacturing process improvements
- Facility or Sterile Room Audits
- ESA/ESD Specification Development
Other engineering services include:
HealthPack 2010
March 2-4, 2010
Sheraton Gunter Hotel
San Antonio, Texas
210-227-3241
Date: 3 March 2010
Time: 10:45 AM – 11:30 AM
Packaging engineering considerations for the control of static electricity in a hospital environment
Thomas M. Reilly, M.D. Sherman Oaks Hospital - Grossman Burn Center
Bob Vermillion, CPP/Fellow, RMV Technology Group, LLC
bob@esdrmv.com
http://www.innovativetechnologyconferences.com/i4a/pages/index.cfm?pageid=3282
For more information, phone 630-544-5051 Or e-mail info@healthpack.net.
Packaging, medical devices critical to emergency room procedures
Posted by Healthcare Packaging on March 03, 2010 | Permalink
Filed in: April 2010 Print Edition; Medical devices
HealthPack 2010 conference sessions report that packages, devices must work in life or death situations. Meanwhile, ER nurses evaluate medical device packages.
A 28-year-old asthma patient is brought into the emergency room in critical condition, turning blue, and desperate to breathe. The doctor quickly inserts a scope with a camera to determine and resolve the problem, but the camera freezes. Is it due to electrical compatibility issues with other devices in the ER?
In another instance, a gunshot wound victim is brought into the ER, “and there are multiple monitors and electronic-based machines swirling around, with packages being opened as we try to save a life. What you do in packaging effects our ability to treat patients,” stated Thomas M. Reilly, M.D., Sherman Oaks Hospital-Grossman Burn Center. Reilly and Bob Vermillion, RMV Technology Group, co-presented “Packaging engineering considerations for the control of static electricity in a hospital environment,” March 3 at HealthPack 2010 in San Antonio, TX.
Reilly told a packed audience, “Medicine continues to become more complex as more microprocessor-driven devices are employed. To some extent, we deal with the perils of technology.” That technology, be it in the form of monitors, defibrillators, or other electronic equipment, can malfunction due to electrostatic discharge (ESD) events, which can occur even from static from personnel walking in the room.
Pacemaker circuit cards, computer screens, and packaging can all contribute to unwanted ESD events, noted Vermillion. He pointed out that low humidity environments can be especially problematic. ESD and static can also increase the potential for spreading harmful bacteria in the hospital environment. He said, “Engineers have to review medical device packaging for ESA/ESD. Low-charging packaging is the key.”
-Jim Butschli, Editor
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