Hi, my name is Kathy. I am the Surgical Services Business Manager of a six room surgical suite. I would like to know how long we should keep our patient tracking sterilization records? We do not currently have a policy regarding this. I have checked the AAMI recommendations and they are vague on this issue. I would really appreciate any help on this. Thanks!

Kathy,

This is a thorny issue and because of the legal liabilities that incurr if records are not tracable and transparent, the time scale of retention is critical.
All medical devices must be sterile before they can be safely used in the treatment of patient (invasive procedures). It is therefore of the utmost importance that all processes that are designed to produce sterile products are carried out efficently and effectively. The implementation into European Law of the MDD 93/42/EEC on the 14th of June 1998 has imposed a greater regulatory burden on those responsible for the manufacture, supply and processing of medical devices. Although compliance with mandated standards is not the only way of complying with directives it is the simplest and if you opt of the compliance route then compliance with the consumer protection act and product liability becomes an issue.
What this means to the user/manager is that the steriliser/washer are classed as medical devices so for the life cycle duration of that medical device (sterilizer) proof of all certification of calibration which is your cycle charts/recorder charts and service validation documentaion must be retained. Kathy your correct the feedback on retention of records are patchy and fuzzy but rule of thumb from most juristictions is that 10 years and the present year so retain machine records for a 11 years but I'M VERY INTERESTED in any other interpretation of this thorny issue.

yours Hugh calibated O'Connor

Hi Kathy,

I would like to add to Hugh O'Connor's answer.

I believe AAMI is vague on record storage for items used on patients because this is not a sterilization question or technical question, but a legal question subject to local law. By USA OSHA regulations, the records of employee EtO exposure must be maintained for 20 years after the employee leaves their position where they were exposed to EtO. This places sterilization records for EtO sterilization in a very different category from other types of sterilization records. The employee or former employee may claim they received cancer or some other adverse health condition because of their exposure to EtO. The hospitals records of employee exposure to EtO is the largest piece of evidence the hospital has to defend against such claims.

Other sterilization records are stored based on the recommendations of the Risk Management / Legal department after a review of the local laws. I have worked in different states and countries, and the storage time for non-EtO sterilization records were for 5, 7, and 10 years. The different lengths of storage times were based on the local statute of limitations, or the length of time a patient was permitted to sue the hospital after a procedure was done on the patient. After the minimum legal requirements were met, the records were removed from storage. I hope this helps with your situation.

Warm Regards,
Pete Bobb

Dear Kathy,

Hugh is rightly referring to the European MDD (see question Q00163 for the text). Although this directive is not entirely applicable to the CSSD, it offers a framework wherein also the activities of the hospital sterilization departments can be placed.
In Annex IX of this directive: "Classification criteria" you can find under Classification 2, 3 rule 7: All surgical invasive devices intended for short-term use are in Class IIa (unless a few exceptions).
Article 11: Conformity assesment procedures says in point 2.: "In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII. coupled with either:

1. the procedure relating to the EC verification set out in Annex IV; or
2. the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
3. the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 3 (a): follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case point 4 of Annex II is not applicable.

Annex VII 2 says: "The manufacturer must prepare the technical documentation described in Section 3. The manufacturer or his authorized representative established in the Community must make this documentation, including the declaration of conformity, available to the national authorities for inspection purposes for a period ending at least five years after the last product has been manufactured".

In all other Annexes that may apply to Class IIa medical devices is talk of a period ending at least five years after the last product has been manufactured for keeping the required documentation.

Why shouldn't the CSSD also conform to this 5 year period for keeping our sterilization records - unless, of course, your national authorities require a longer period - ?
This can bring the application of the same norms to the manufacturers and to the hospital sterilization departments a little closer.

Wim Renders
p.s. I welcome your comments, Hugh.

Hi Kathy

I am inclined to agree with Pete Bobb in that this is a legal issue rather than a validation issue. Another intersting wrinkle (certainly in Australian law) is the right of a child to sue once they reach their eighteenth birthday. The statute of limitations (7 years in Aus) clock starts ticking from that point for them. Theoretically, should a procedure on a neonate result in a claim by that individual, their claim could well result in a need to review records anything up to 25 years later. This is a shame when, for validation purposes, most cycle records are not challenged more than 6 months after processing.

What did we do? we kept records for the last 2 years in our Department, and transferred older records to an archived storage area of the institution.

Good Luck
Tom Mitchell