Monday, February 27, 2012

Cardiovascular Implant Standards

Cardiovascular implants are particularly delicate devices, even compared to other medical devices, frequently quite literally holding someone’s heart in their embrace. Cardiovascular implants can be divided into two general categories: those which remain inside the patient after they go home, and those which are used only during surgery or over the course of the patient’s stay at the hospital.

Cardiovascular implants meant to remain inside the patient serve to either take over the functioning of the patient’s heart and blood vessels or to support them. In the best cases, the implant allows the patient’s cardiovascular system to recover to the point where the implant can be removed and the patient no longer needs its assistance. Devices like a tubular vascular prostheses fall squarely into this category.

Pacemakers are the best known examples of cardiovascular implants, keeping the heart beating at a stable rate if the heart’s own pacemaker cells are unable to manage. Keeping with rates of their usage, and how many people depend on them, standards regarding pacemakers are numerous, helping to assure their reliability and proper functioning. Cardiac pacemaker standards address everything from the reporting of clinical performance of populations of pulse generators or leads to low-profile connectors (IS-1) for implantable pacemakers.

Other sorts of cardiovascular implants are used only in the hospital, temporarily taking over or modifying the functioning of the heart or nearby blood vessels, allowing time for the surgical manipulation of a patient’s cardiovascular system, healing, or organ transplants. As before, standards exist to address the requirements for, for example, single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). While ECMO is usually used as a last resort, requirements have also been developed for more commonplace devices, such as arterial blood line filters, insofar as anything associated with cardiovascular implants can be deemed commonplace.

Additionally, the effects of electromagnetic interference on cardiovascular implants are potentially catastrophic, leading to significant development of standards in the field. AAMI, the Association for the Advancement of Medical Instrumentation, published EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators. ISO and IEC, two international standards bodies with extremely broad user bases, collaborated on a series of Information Technology standards, publishing a standard on the electromagnetic interference impact of ISO/IEC 18000 interrogator emitters on implantable pacemakers and implantable cardioverter defibrillators. Seemingly out of place, the existence of standards like these reveal just how vital standards for cardiovascular implants are—not only do developers of medical standards look at how external objects can affect cardiovascular implants, but even the standardization bodies for those external objects go out of their way to look at how their devices can affect delicate cardiovascular implants.

For more medical device standards, access the Medical Device Standards Portal, a collaboration by the standards developers mentioned above, as well as others.

Thursday, February 16, 2012

Noise Safety Standards

Noise Safety Standards and their effects fill the air all around us—or, rather, prevent excessive noise from doing so, preserving our hearing and safety while still allowing noisy activities to continue within acceptable ranges. Some noise safety standards address environments where noise is present at such levels that the need for hearing protection and noise attenuation is obvious, such as construction sites where workers need to be protected. There, noise safety is standardized through the use of established methods of measurement to determine noise levels, situation-appropriate ways to attenuate noise, and, when the noise levels cannot be sufficiently reduced, hearing protection along the lines of earmuffs or earplugs.

Other environments, such as office workplaces, also benefit from noise safety standards. Unlike construction sites, the need for noise safety standards in an office setting is not readily obvious, partly because of the already existing and widespread success of standardization in the field. Everything from the pipes carrying air through the walls, to the printers in an office makes noise. Additionally, the individually quiet sounds of many people all going about their work or quietly discussing matters between themselves add up to a significant amount of noise. In such an office setting, noise safety standards address office floor plans, sound dampening materials and construction designs for ceilings and walls, as well as the methodological prediction of future noise levels.

Noise Safety draws upon many different standards for different aspects of a noise safety program. Noise Exposure standards provide reliable methods of measurement that are developed to understand the effects of noise on a human, accounting for duration, rate of onset, and so forth, rather than only measuring decibels. This lets one know whether noise should be attenuated, to what degree, and in what manner.

Noise Control standards are the next step, dealing with appropriate means of silencing noise, protecting workers through the use of enclosures or cabins, controlling the spread of noise so as to avoid “neighborhood nuisance,” and altogether mitigating the effect of noise on those near it.

Hearing Protection standards are the final step of noise safety. When noise cannot be silenced or avoided, earmuffs or earplugs can be used to stop noise before it reaches the ear. Frequently used as additional protection in conjunction with other forms of noise attenuation and control, hearing protection also has its place in dealing with temporary noise, such as demolition explosions or short excursions into a loud environment.

Noise Safety standards, adopted by much of the world, are constantly in use—covering everything from noise heard on the ground from nearby airports to the noise of water rushing through pipes.

Wednesday, February 1, 2012

Ophthalmic Standards

Ophthalmic standards are numerous, reflecting the range and complexity of ophthalmic procedures, instruments, implants, and devices. Given the delicateness intrinsic to working with something as fragile as the human eye, the desire and need for standardization is an obvious one.

Everything involved, ranging from ophthalmic implants and the surgical tools that interact with them, to spectacle and contact lenses and the products that care for them on an ongoing basis, must all work together safely and smoothly even when everything does not originate from the same provider. Non-surgical procedures, such as those testing visual acuity or guiding ophthalmic data processing and interchange information, also have to be standardized to assure both ophthalmic practitioners and patients that their information is reliable and accurate, and therefore useful.

Standards for the ophthalmic industry are published by Standards Developing Organizations (SDOs) such as The Vision Council, as well as national and international SDOs like ISO, DIN, BS, ONORM, and so forth. These standards are developed through a consensus process inviting input from all interested and affected parties, aiming to produce a finished specification that is fair to all. In this way, the ongoing standardization effort in the ophthalmic industry promotes innovation without compromising the safety and reliability of ophthalmic products and procedures.

Protective Clothing Standards

Protective Clothing Standards help protect our nation’s workers, guiding the manufacturing, testing, and use of protective apparel and clothing in a variety of fields. With many industries requiring protection from unique hazards under equally unique circumstances and with further variation stemming from the different designs and materials used in protective apparel, quality assurance and apparel selection becomes a significant undertaking. To this end, many published standards detail procedures that test protective clothing by simulating the hazards and conditions they are intended to protect wearers against, allowing interested parties to compare how different approaches fare against the same hazards. Standards exist for testing resistance against everything from molten metal splash to liquid pesticides, hypodermic needle punctures, and blood-borne pathogens. Some standards set out definitions which are then referred to in other standards that deal with more specific issues, as well as simplifying comparisons between products, procedures, and results.

Standards for end-users are plentiful as well, such as those detailing the standard practice for sizing fire and other thermal rescue service uniforms; the proper wearing, care, and maintenance of chemical protective clothing; or the selection, use, and care of high-visibility safety apparel.

Involved in the publishing of standards for protective clothing are standards developing organizations (SDOs) from around the world. ISO, the International Organization for Standardization, has published a large amount of standards regarding the testing, specifications of, and requirements for protective clothing, as have the national standards bodies (NSBs) of many countries, such as Germany, the United Kingdom, Japan, China, Austria, Sweden, Australia, and so forth. Furthermore, additional protective clothing standards have been developed by international SDOs, such as the International Safety Equipment Association (ISEA), the National Fire Protection Association (NFPA), and ASTM International, originally founded as the American Society for Testing and Materials. Additionally, the United States Department of Defense has also published several military specifications on the subject. Essentially, protective clothing is an area where proper standardization is seen to be vitally important by everybody involved.