How Disposable Medical Glove Standards Are Developed   by Irene Perez

Medical gloves provide a critical barrier in clinical environments, protecting both workers and patients. In fact, the Center For Disease Control recommends that all healthcare workers wear gloves as a safeguard against HIV and other blood-and-fluid borne infectious agents.

To make sure medical gloves provide adequate protection, the Food and Drug Administration enforces a variety of standards for glove manufacturers to follow when making and marketing gloves.

The FDA's Authority over Medical Gloves

Initially, the FDA focused solely on regulating drugs. But this changed with the May 28, 1976 introduction of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act. Now FDA regulations provide for the safety, effectiveness, and proper use of all medical devices-including disposable medical gloves.

The FDA doesn't actually write standards for medical devices. Instead, it recognizes guidelines written by others, such as the American Society of Testing and Materials (ASTM), the American Association of Medical Instrumentation (AAMI) and United States Pharmacopoeia (USP). FDA representatives do, however, participate in standard-writing committees.

Often, the FDA applies the established standards as baseline requirements when evaluating medical devices and supplies for the marketplace. As an example, the FDA requires all medical glove manufacturers to meet ASTM guideline D 5151 for the detection of holes in disposable exam gloves.

Medical Gloves and the ASTM

ASTM is a nonprofit organization that provides a common ground for consumers, manufacturers, organizations, government representatives, and academia, to meet and write standards for variety of products, services, and materials. Its guidelines are wholly recognized by the FDA. As a result, glove manufacturers must conform to these standards to meet FDA requirements for the particular types of medical gloves they market. Medical gloves, in fact, were some of the first products for which the ASTM developed standards.

Periodically, the ASTM revises its standards to respond to industry, consumer and regulatory needs. Otherwise, the guidelines are reviewed every five years, and then re-approved or withdrawn. Each year, the ASTM publishes more than 10,000 standards in a 70 plus volume set entitled Annual Book of ASTM Standards.

ASTM Testing of Medical Gloves

The ASTM requires different standards for different medical gloves based on performance specifications. Glove products are scientifically tested to accurately assess products made from a variety of manufacturing approaches, formulations and materials. Rigorous analysis is conducted in a variety of areas, including the following:

1. The Water Leak Test which consists of filling a medical glove with 1,000 ml of water, suspending it for two minutes and then inspecting it for any leakage;

2. The Air Inflation Test which involves inflating the exam glove with compressed air and visually inspecting it for holes;

3. The Chemical Permeation Test which measures the resistance of protective clothing materials to permeation by liquid or gaseous chemicals under conditions of continuous contact;

4. The Tensile Strength Test which measures the amount of force in pounds per square inch that is needed to stretch a medical glove to the breaking point;

5. The V-Tear Test which determines the force required to initiate a tear in the medical glove;

6. The Trouser Tear Test which measures the force needed to continue tearing once an initial tear has been made in the glove;

7. The Puncture Resistance Test which determines the glove material's ability to resist rupturing when stricken by an object and;

8. Skin irritation and sensitization tests which demonstrate the medical glove's potential for irritating the user's skin and possibly causing allergic contact dermatitis.

Most of these types of tests have specific Acceptable Quality Level (AQL) standards which the medical gloves must meet in order to pass FDA regulations.

About the Author

Irene Perez is General Manager of DonTheGlove.com, the online division of Handgards Inc, a 45 year old company specializing in hand protection products. Irene is the company's expert in medical gloves and a frequent contributor to the website's resource centers.

Medical Malpractice   by Christian Tylor

Many people may not realize that medical malpractice is a real and ever growing problem. People die everyday from wrong diagnoses and incorrect treatments. The problem is that most of these cases are private and many are never reported. A lot of the population does not know enough about medical practices to know when they are faced with a malpractice problem. They are forced to take the word of the doctor and staff at hand. This may explain why only a small number of claims are filed for malpractice suits and only about half of them actually win the lawsuit.

Physicians have medical malpractice insurance that will cover them in the event someone files a malpractice claim against them. In the past the cost for this type of insurance was a flat rate, but due to the fact that medical malpractice suits are on the rise, the cost for this insurance has also begun to rise. There are not as many providers for this type of insurance as it use to be. This is because medical costs are going up and it is very difficult to make a profit in this business.

Things that can be considered a medical malpractice would be failure to treat a medical problem correctly that causes a new medical problem or makes the existing one worse. If a physician fails to diagnose a disease, detects the problem to late to help the patient or fails to treat the condition correctly after it has been diagnosed it could be considered malpractice. If problems occur during the use of anesthesia or surgery that was due to the fault of the doctor or a member of the staff it could be malpractice. Also prescribing the wrong medication for a patient or medicine that interferes with other known conditions the patient may suffer from is also grounds for malpractice.

Medical malpractice suits are normally always expensive and very complicated. You must be able to provide all of the necessary information to your attorney to have a chance of winning a lawsuit of this nature. This would be information such as a detailed list of the patient's medical history. This would include all doctors and hospitals or clinics that the patient has visited and all treatments that the patients received during this time, even if it seems unimportant. All medicines taken and prescribed must be recorded and a written description of all conversations that have taken place will be needed along with the dates everything took place. A medical expert will review the case and will ultimately be the one to decide if the suit is legitimate.

About the Author

Christian Tylor is a freelance publisher based in Atlanta, Georgia.