Storage of medical disposables and dressings (1998)
Revision: $Revision: 1.3 $
Date: $Date: 1998/06/22 13:26:29 $
|Table of Contents
Handling and Storage Conditions
Plastic Tubing Devices.
Specific Guidelines for Latex products
This document gives advice on how to approach and interpret various aspects of storage, shelf life policy and expiry dating.
It is intended to assist purchasers and users of medical disposables and dressings to understand the current recommendations in this field and to advise users and purchasers on:
the interpretation of manufacturers expiry dates
storage conditions for medical disposables and dressings in order to achieve the stated shelf life
dealing with adverse storage conditions.
Many medical and surgical disposables are subject to deterioration. For example, latex gloves can easily be damaged if stored close to a source of high voltage electricity, polypropylene syringes may become brittle after storage at high temperatures, and paper packaging can become soft and easily damaged when damp.
Correct storage conditions and adherence to expiry dates is therefore of vital importance to ensure that staff and patients are not subjected to unnecessary risks.
Some parts of this document are UK specific, particularly regarding legislation. However, many of the principles are applicable outside the UK.
Until recently, the Medical Devices Agency in the UK ran a scheme called the Manufacturers Registration Scheme (MRS).
All companies who had been G.M.P. approved by the MDA complied with the Guide to Good Manufacturing Practice for Sterile Medical Devices and Surgical Products, which stated that " Unit containers should be labelled with ...... An expiry date for products having a determined shelf life.
This implied that any product bearing an expiry date was considered by the manufacturer to be subject to deterioration. This date did not relate to the sterile status of the product as assumed by some.
With the implementation of the Medical Devices Directive (MDD) (93/42/EEC) in Europe in June 1998, the MRS has ended, and the system of CE marking takes its place.
The MDD deals with expiry dating in Annex I, "Essential Requirements", paragraph 13.3 (e) and (i) as follows:
The label must bear the following particulars:
(e) - where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;Footnote:There is no definition explaining what is meant by appropriate.
(i) - any special storage and/or handling conditions;
Welsh Health Circular WHC(88)26Footnote:WHC(88)26 - "Procurement Product Liability", Department of Health and Social Security, "WHC(88)26 / WHC(FP)(88)11." states that Health Authorities should be able to show that instructions or warnings in relation to use, maintenance, storage, expiry dates etc, have been observed and/or passed on to the user. As long as this advice is adhered to, the manufacturer is "strictly liable" for the product Footnote: Under the "Consumer Protection Act 1987"
Conversely, if the manufacturers advice is ignored, then there is the possibility that the Trust, or the person responsible for the handling of the product, will become strictly liable for the defective goods.
Therefore users are strongly recommended to adhere to the manufacturers expiry dates and recommended storage conditions.
Difficulties arising from the receipt of products with a short shelf life should not be addressed by recourse to changing the expiry date, but rather via conditions of contract (for example, ensuring that products have a minimum of 75% of the shelf life left when first received by the stores).
As most Medical & Surgical disposable products have a finite shelf life, stock rotation at user level is essential to guarantee the quality and safety of the products.
Under normal circumstances stock levels at the user level should not be greater than required to meet demand.
Guidelines referring to storage conditions from the old "White Guide"Footnote:"Guide to good manufacturing practice for sterile medical devices and surgical products", 1981, Department of Health an Social Security. are still useful:
Conditions should be such as to minimise deterioration or contamination and prevent damage. Containers should afford adequate protection.
If special environmental storage conditions are required at any stage, such conditions should be controlled and monitored.
Storage conditions should be orderly to facilitate rotation of stock, batch differentiationFootnote:Although rare, product recalls usually refer to specific batches of product. Recording the destination of batches, and ensuring that batches do not get mixed up will make product withdrawal a relatively simple and painless procedure. ease of cleaning.
These recommendations were originally aimed at the manufacturers of devices, but the same principles should apply to the storage conditions within the hospitals, either at the stores/pharmacy level or at ward level. If it is not practicable for users at ward level to control and monitor environmental conditions for items which need special conditions, then appropriate advice should be sought from the issuing department or the manufacturer.
In general, precautions should be taken to protect the items from the effects of:
moisture (eg: do not store under damp conditions)
heat (eg: do not store near to, or on top of, radiators)
light (eg: do not store in direct sunlight).
The items should be handled appropriately at ward level. Users should not distort, bend or deform packaging (by, for example, trying to cram too many catheters into a box/draw, by tying a batch of catheters together with a rubber band or by cramming single items into multiple containers), and should, if possible, keep the products in their original packaging.
Where no specific storage conditions or limitations are specified, it is generally understood that the storage conditions include protection from moisture, freezing and excessive heat.
Minor variations in temperature usually have little effect on the product. For example, normal storage temperature being exceeded by 1 to 2°C for a few days in a hot summer will probably have an insignificant effect.
However, should prolonged temperature rises of 5 or 6°C be experienced, then shelf life could be significantly reduced. Extreme storage conditions such as exposure to direct sunlight and/or storage on top of (or near to) radiators could destroy the product, and should be avoided at all costs.
Those responsible for storage should make every effort to ensure that storage conditions are appropriate. Some useful definitions are given at the end of this document.
Occasionally, products may have been stored under inappropriate conditions. Under these circumstances, advice should be sought from the issuing department or the manufacturer.
Devices made of plastic PVC tubing (bubble tubing, suction catheters etc) are generally quite resilient to storage conditions.
Pennine Healthcare, makers of such products, states that none of their products require any special storage or handling conditions - they recommend "normal warehouse conditions", and thus do not define any storage conditions on their labels.
However, as most of these are packaged in paper or cardboard containers, the usual care must be taken to avoid the packaging becoming damp or damaged. In particular, sterile products may be rendered un-sterile if exposed to moisture or mechanical damage.
Latex products and products containing latex (for example, IV sets) require special care as latex is especially prone to deterioration if stored under incorrect conditions.
In particular, latex products should be protected from
high voltage electrical sources, including storage close to fluorescent lights
strong light sources, including direct sunlight
A paper on the shelf life of condomsFootnote:"Latex rubber condoms: predicting and extending shelf life", Free MJ et al, Contraception 1996 Apr; 53(4):221-229, showed that the rate of decline of the strength of the condoms as a function of temperature was quadratic.
In the Spring and Summer of 1995, the spontaneous combustion of powder-free latex gloves in 4 different states in the USA lead the FDA to produce advice on storage of chlorinated latex gloves.
Most of the guidelines are the usual ones designed to prevent product deterioration (rotate stock, avoid storing in conditions of extreme heat etc), but some are designed to reduce the risk of spontaneous combustion. The fires were believed to have started due to high warehouse temperatures apparently accelerating an exothermic chemical reaction on the chlorinated gloves to the point where the latex ignited. Thus the FDA advise not storing large quantities of powder free latex gloves in conditions of extreme heat. The FDA consider one pallet or more to be a "large quantity".
They also advise removing the shrink wrap from pallets of stacked cartons, breaking stacked cartons on each pallet apart, and re-stacking or reconfiguring cartons to facilitate cooling. The gloves should be checked periodically for deterioration, including brittleness, tackiness, or an acrid chemical odour or stench. The complete FDA report is available on the Internet at http://www.fda.gov/cdrh/glovepha.html
Ansell Medical recommend that their latex gloves be stored at the following conditions.
Below 25°C, away from sources of heat (boilers, radiators and direct sunlight).
At a humidity below 65%
Protected from light sources e.g., sunlight or intense artificial light and especially ultraviolet light.
Areas of storage should not be located near or contain ozone generating equipment, e.g., electric motors, switch gear, fluorescent lights, mercury vapour lights, and ultra violet lights.
Storage areas should be well ventilated as a build up of combustion gases could give rise to ozone, which being heavier than air, will accumulate in low areas.
Gloves should be stored away from ionising radiation which will break down the vulcanisation bonds, thereby weakening the gloves.
Organic solvents, petroleum based oils and grease should not contact the gloves as they will degrade the rubber.
Copper, manganese and other heavy metals should not contact the gloves as they will react with the residual accelerators and degrade the gloves.
Contact with sharp surfaces or objects could damage the packaging or the gloves. In the case of pre-sterilised gloves, this would render them un-sterile.
As gloves have an expiry date it is important to observe a strict "first in, first out" stock rotation policy.
Medical product storage must be dust and rodent free in case the packaging becomes contaminated rendering the products unusable.
LIG (manufacturers of the Biogel surgeons glove and Durex condoms) recommends that their products (mainly gloves and condoms) are stored in a cool, dry area, away from direct heat, and within a temperature range of 5°C to 30°C.
The previous British Pharmacopoeia (1993)Footnote:All dressings have been removed from the 1998 version further to the Medical Device Directive. recommends that
"Surgical dressings should be kept in a dry, well-ventilated place at temperatures not exceeding 25°C. Adverse conditions, such as excessively humid, cold or hot locations, strong light sources and sources if electrical energy, can cause plastics, rubber and cellulose materials to become brittle, perished, stained or malodorous; such effects may be aggravated by lengthy exposure."
Regarding sterile surgical dressings, the 1993 BP states:
"Sterile surgical dressings should be stored in the shelf container; the unit container should be removed from the shelf container immediately before use. If a pack becomes damaged, wet, or otherwise soiled, it is regarded as being unsafe for use."
These recommendations are particularly important in relation to adhesive products, especially those covered with a rubber/zinc oxide adhesive mass.
Most major manufacturers have general storage recommendations for their products. Please note that most products have their storage conditions on the packaging - this must take precedence over the information below.
Coloplast recommend that their Comfeel range of products be stored at "room temperature".
J&J state that "where storage conditions are necessary for our wound dressings, we generally advise that these are kept at 25°C or under."
Seton have a number of different storage conditions depending on the product.
Many bandages and dressings (Blue Line Webbing, Lyopad, Netelast, Parapad, Stockinette, Tubigrip, etc) have no special handling/storage conditions.
Some products (Lestreflex, Vigilon) are to be stored in a cool or a cool dry place while most of the rest are to be stored in a dry place not exceeding 25°C.
With the exception of the Dynacast range of products, S&N recommend one storage condition for all their dressings - store in a dry place at a temperature below 25°C.
The recommended storage conditions for the Dynacast range is "store in a cool dry place", which is defined by the BP as any temperature between 8 and 15°C.
Although these publications (The British, European and Unites States Pharmacopoeias) deal mainly with pharmaceuticals, the definitions are frequently used by medical device manufacturers as well.
Table 1: [Untitled]
|In a deep freeze||below -15°C||below -15°C||-25°C to -10°C|
|In a refrigerator||2°C - 8°C||2°C - 8°C||2°C - 8°C|
|Cold/Cool||8°C - 15°||8°C - 15°C||
|Room Temperature||15°C - 25°C||15°C - 25°C||the temperature prevailing in a working area.|
|Controlled Room Temperature||-||-||A temperature maintained thermostatically between 15°C and 30°C, with a mean temperature of 25°C|
|Warm||-||-||30°C and 40° C|
|Excessive Heat||-||-||Any temperature above 40° C|