“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:

1. Charge Generation
2. Charge Accumulation
3. 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)

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.

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
• Cleanroom 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 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
  
  Other engineering services include:
  
• ESD medical device packaging integrity
• Pharmaceutical
• Drug Delivery
• Manufacturing process improvements
• Facility or Sterile Room Audits
• ESA/ESD Specification Development

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HealthPack 2008
March 4-6, 2008
Sheraton Gunter Hotel
San Antonio, Texas
210-227-3241
www.gunterhotel.com

Time: 1:15 PM – 2:00 PM Date: 6 March 2008
The Hidden Assassin, Electrostatic Discharge Considerations for the Medical Device Packaging Engineer

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.

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Related Links

• IoPP ESD Task Group
• Pacemaker Considerations by the American Heart Association!